prior authorization review panel mco policy …...cpb 0858 organ prolapse: selected procedures...

Prior Authorization Review PanelMCO Policy Submission

A separate copy of this form must accompany each policy submitted for review.Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 04/01/2019

Policy Number: 0858 Effective Date: Revision Date: 03/28/2018

Policy Name: Organ Prolapse: Selected Procedures

Type of Submission – Check all that apply: New Policy Revised Policy

Annual Review – No Revisions* *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0858 Organ Prolapse: Selected Procedures

Clinical content was last revised on 03/28/2018. No additional non-clinical updates were made by Corporate since the last PARP submission.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

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03/26/2019

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Organ Prolapse: SelectedProcedures

Policy History

Last Re

view

04/04/2018

Effective: 08/09/201

Next

Review: 09/26/2019

Review

Histor

y

Definitions

Additional Information

Number: 0858

Policy Pleasesee amendment forPennsylvaniaMedicaidattheendofthis CPB.

Aetna considers the following procedures medically necessary:

▪ Dynamic magnetic resonance imaging (MRI) in persons with complex organ

prolapse to supplement the physical examination

▪ Laparoscopic suture rectopexy in persons with rectal prolapse

▪ Lefort colpocleisis medically necessary for severe utero-vaginal prolapse in

elderly persons and chronically ill persons who no longer desire coital

function

▪ Sacrocolpopexy for the treatment of vaginal apical prolapse repair

Aetna considers the following procedures experimental and investigational because

their effectiveness has not been established:

▪ Biologic graft for the treatment of vaginal apical prolapse

▪ Genetic testing for pelvic organ prolapse

▪ Vaginal tactile imaging for diagnosis and evaluation of vaginal and pelvic

floor conditions (e.g., atrophy, incontinence, pain and prolapse).

See also CPB 0223 - Urinary Incontinence (../200_299/0223.html) (Pessary for the

treatment of pelvic organ (uterine) prolapse).


https://www.aetna.com/

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http://www.aetna.com/cpb/medical/data/800_899/0858.html 03/26/2019

Clinical

Policy B

ulletin

Notes

Background

Pelvic organ prolapses (POP) is a relatively common condition in women that can

have a significant impact on quality of life. Pelvic organ prolapse typically

demonstrates multiple abnormalities and may involve the urethra (urethrocele),

bladder (cystocele), vaginal vault, rectum (rectocele), and small bowel (enterocele).

Symtpoms may include pain, pressure, urinary and fecal incontinence, constipation,

urinary retention, and defecatory dysfunction. Total vaginal collapse occurs when

the upper portion of the vagina loses its normal shape and sags or bulges down into

the vaginal canal or outside of the vagina. It is usually caused by weakness of the

pelvic and vaginal tissues and muscles and may occur alone or along with prolapse

of other pelvic organs. The bladder (cystocele), urethra (urethrocele), rectum

(rectocele), or small bowel (enterocele).

Magnetic resonance imaging (MRI) uses a strong magnetic field, radio waves, and

computers to produce 2- or 3-dimensional images of the inside of a patient's body.

It is non-invasive and there is no ionizing radiation exposure to the patient.

Dynamic MRI differs from standard MRI in that a large number of images are formed

successively and rapidly, by continually updating or reacquiring image data. Based

on the clinical evidence, dynamic MRI is an acceptable alternative modality in

patients with complex organ prolapse to supplement the physical examination.

Rectal prolapse, or procidentia, is the abnormal protrusion of the rectal mucosa

down to or through the anal opening. The main symptom is a protrusion of a reddish

mass from the anal opening, especially following a bowel movement. The rectal

mucosa is visible and may bleed slightly.

In a laparoscopic suture rectopexy the rectum is fixed to the presacral fascia with

suture as opposed to mesh or an Ivalon sponge. Based on the long-term clinical

outcomes, laparoscopic suture rectopexy can be considered a treatment option for

patients with rectal prolapse.

Vaginal prolapse or pelvic organ prolapse, occurs when the structures of the pelvis

protrude into or outside of the vaginal canal. The pelvic organs are the bladder,

rectum, or uterus. The term prolapse means slipping from the normal position.

Pelvic organ prolapse is caused most commonly by pregnancy, labor and childbirth.

It also can be related to diseases that cause increased pressure in the abdomen,

such as obesity, respiratory problems with a long-lasting (chronic) cough,


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constipation, and pelvic organ cancers. Pelvic organ prolapse can occur after

hysterectomy for another gynecological health problem, such as endometriosis,

dysfunctional uterine bleeding, or uterine fibroids.

In the LeFort colpocleisis, anterior and posterior rectangular flaps of vaginal mucosa

are removed, and the denuded areas are reapproximated with horizontal layers of

interrupted absorbable sutures, leaving 2 small tunnels laterally for drainage. Based

on the clinical evidence, Lefort colpocleisis should be used only when there is a very

good reason not to perform one of the usual operations for prolapse. It is indicated

for severe utero-vaginal prolapse in elderly patients and chronically ill patients who

no longer desire coital function.

Levin et al (2012) noted that genetic studies require a clearly defined phenotype to

reach valid conclusions. These researchers characterized the phenotype of

advanced prolapse by comparing women with stage III to IV prolapse with controls

without prolapse. Based on the pelvic organ prolapse quantification examination,

women with stage 0 to stage I prolapse (controls) and those with stage III to stage IV

prolapse (cases) were prospectively recruited as part of a genetic epidemiologic

study. Data regarding socio-demographics; medical, obstetric, and surgical history;

family history; and body mass index (BMI) were obtained by a questionnaire

administered by a trained coordinator and abstracted from electronic medical

records. There were 275 case patients with advanced prolapse and 206 controls

with stage 0 to stage I prolapse. Based on the recruitment strategy, the women

were younger than the controls (64.7 ± 10.1 versus 68.6 ± 10.4 years; p < 0.001);

cases were also more likely to have had 1 or more vaginal deliveries (96.0 % versus

82.0 %; p < 0.001). There were no differences in race, BMI, and constipation.

Regarding family history, cases were more likely to report that either their mother

and/or sister(s) had prolapse (44.8 % versus 16.9 %, p < 0.001). In a logistic

regression model, vaginal parity (odds ratio [OR], 4.05; 9 5% confidence interval

[CI]: 1.67 to 9.85) and family history of prolapse (OR, 3.74; 95 % CI: 2.16 to 6.46)

remained significantly associated with advanced prolapse. The authors concluded

that vaginal parity and a family history of prolapse are more common in women with

advanced prolapse compared to those without prolapse. These characteristics are

important in phenotyping advanced prolapse, suggesting that these data should be

collected in future genetic epidemiologic studies.


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Wu et al (2012) evaluated the association of laminin gamma-1 (LAMC1) and

advance pelvic organ prolapse. These researchers conducted a candidate gene

association of patients (n = 239) with stages III to IV prolapse and controls (n = 197)

with stages 0 to I prolapse. They used a “linkage disequilibrium (LD)-tagged”

approach to identify single-nucleotide polymorphisms (SNPs) in LAMC1 and focused

on non-Hispanic white women to minimize population stratification. Additive and

dominant multi-variable logistic regression models were used to test for association

between individual SNPs and advanced prolapse. A total of 14 SNPs representing

99 % coverage of LAMC1 were genotyped. There was no association between SNP

rs10911193 and advanced prolapse (p = 0.34). However, there was a trend toward

significance for SNPs rs1413390 (p = 0.11), rs20563 (p = 0.11), and rs20558 (p =

0.12). The authors concluded that although they found that the previously reported

LAMC1 SNP rs10911193 was not associated with non-familial prolapse, these

results supported further investigation of this candidate gene in the pathophysiology

of prolapse.

Ward et al (2014) stated that given current evidence supporting a genetic

predisposition for pelvic organ prolapse, they conducted a systematic review of

published literature on the genetic epidemiology of pelvic organ prolapse. Inclusion

criteria were linkage studies, candidate gene association and genome-wide

association studies in adult women published in English and indexed in PubMed

through December 2012, with no limit on date of publication. Methodology adhered

to the PRISMA guidelines. Data were systematically extracted by 2 reviewers and

graded by the Venice criteria for studies of genetic associations. A meta-analysis

was performed on all SNPs evaluated by 2 or more studies with similar

methodology. The meta-analysis suggested that collagen type 3 alpha 1 (COL3A1)

rs1800255 genotype AA is associated with pelvic organ prolapse (OR, 4.79; 95 %

CI: 1.91 to 11.98; p = 0.001) compared with the reference genotype GG in

populations of Asian and Dutch women. There was little evidence of heterogeneity

for rs1800255 (p value for heterogeneity = 0.94; proportion of variance because of

heterogeneity, I(2) = 0.00 %). There was insufficient evidence to determine whether

other SNPs evaluated by 2 or more papers were associated with pelvic organ

prolapse. An association with pelvic organ prolapse was seen in individual studies

for estrogen receptor alpha (ER-α) rs2228480 GA, COL3A1 exon 31, chromosome

9q21 (heterogeneity logarithm of the odds score 3.41) as well as 6 SNPs identified

by a genome-wide association study. The authors concluded that overall, individual


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studies were of small sample size and often of poor quality. They stated that future

studies would benefit from more rigorous study design as outlined in the Venice

recommendations.

Genetic Testing for Pelvic Organ Prolapse:

Cartwright et al (2015) noted that family studies and twin studies demonstrated that

lower urinary tract symptoms (LUTS) and pelvic organ prolapse are heritable. In this

review, these investigators aimed to identify genetic polymorphisms tested for an

association with LUTS or prolapse, and to assess the strength, consistency, and risk

of bias among reported associations. PubMed and HuGE Navigator were searched

up to May 1, 2014, using a combination of genetic and phenotype key words,

including "nocturia", "incontinence", "overactive bladder", "prolapse", and

"enuresis". Major genetics, urology, and gynecology conference abstracts were

searched from 2005 through 2013. These researchers screened 889 abstracts and

retrieved 78 full texts. In all, 27 published and 7 unpublished studies provided data

on polymorphisms in or near 32 different genes. Fixed and random effects meta-

analyses were conducted using co-dominant models of inheritance. They assessed

the credibility of pooled associations using the interim Venice criteria. In pooled

analysis, the rs4994 polymorphism of the ADRB3 gene was associated with

overactive bladder (OR, 2.5; 95 % CI: 1.7 to 3.6; n = 419). The rs1800012

polymorphism of the COL1A1 gene was associated with prolapse (OR, 1.3; 95 % CI:

1.0 to 1.7; n = 838) and stress urinary incontinence (OR, 2.1; 95 % CI: 1.4 to 3.2; n =

190). Other meta-analyses, including those for polymorphisms of COL3A1, LAMC1,

MMP1, MMP3, and MMP9 did not show significant effects. Many studies were at

high-risk of bias from genotyping error or population stratification. The authors

concluded that these meta-analyses provided moderate epidemiological credibility

for associations of variation in ADRB3 with overactive bladder, and variation of

COL1A1 with prolapse. Moreover, they stated that clinical testing for any of these

polymorphisms cannot be recommended based on current evidence.

Khadzhieva and colleagues (2017) stated that POP is a highly disabling condition

common for a vast number of women worldwide. These investigators performed a

systematic review of expression studies on both specific gene and whole-

genome/proteome levels and an in-silico analysis of publicly available datasets

related to POP development. The most extensively investigated genes in individual

studies were related to extra-cellular matrix (ECM) organization. A total of 3 pre-

menopausal and 2 post-menopausal sets from 2 Gene Expression Omnibus (GEO)

studies (GSE53868 and GSE12852) were analyzed; Gene Ontology (GO) terms


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related to tissue repair (locomotion, biological adhesion, immune processes and

other) were enriched in all 5 datasets. Co-expression was higher in cases than in

controls in 3 pre-menopausal sets. The shared between 2 or more datasets up-

regulated genes were enriched with those related to inflammatory bowel disease

(IBD) in the NHGRI GWAS Catalog. ECM-related genes were not over-represented

among differently expressed genes. The authors concluded that up-regulation of

genes related to tissue renewal probably reflected compensatory mechanisms

aimed at repair of damaged tissue; and inefficiency of this process may have

different origins including age-related deregulation of gene expression.

The authors stated that this study had some drawbacks with the main limitation

being in a small number of datasets and a small number of samples in these

datasets. These data appeared to be insufficient for construction of co-expression

networks. The results of the enrichment analysis for the overlapping up-regulated

genes with GWAS association signals should be discussed as preliminary. They

stated that these results raised a question rather than provided an answer on a

possible shared genetic component for IBD and POP. The authors noted that this

analysis provided some in-depth data important for understanding POP

pathogenesis. In terms of genetic overlap between IBD and POP, the work has

translational impact. Moreover, they noted that the study findings are biologically

plausible; however, they require verification in independent studies.

Bilateral Abdominal Sacrocolpopexy with Polyvinylidene Fluoride Mesh:

Rajshekhar and colleagues (2016) evaluated the safety and effectiveness of a

modified technique of bilateral abdominal sacrocolpopexy in which both utero-sacral

ligaments are replaced with polyvinylidene fluoride mesh to provide support to the

cervix (cervico-sacropexy [CESA]) or vaginal vault (vagino-sacropexy [VASA]). In a

retrospective, observational study, a total of 50 women with post-hysterectomy vault

prolapse or recurrent apical prolapse following previous vaginal repair underwent

bilateral sacrocolpopexy between July 1, 2013, and December 31, 2014. Before

surgery and 3 months afterwards, prolapse was assessed using the Pelvic Organ

Prolapse Quantification scale and functional outcomes were recorded using the

International Consultation on Incontinence Questionnaire for vaginal symptoms and

urinary incontinence. At 3 months, 47 (94 %) patients reported no bulge symptoms

and the mean point C was -7.6. Complications comprised bladder injury in 1 (2 %)

and minor wound problems in 3 (6 %) patients. No mesh erosion was reported. The


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authors concluded that bilateral abdominal sacrocolpopexy appeared to be a safe

and effective option for apical prolapse. However, they stated that longer-term

follow-up is needed to detect prolapse recurrence and mesh-related complications.

Biologic Graft:

On behalf of the Society of Gynecologic Surgeons Systematic Review Group,

Shimpf and associates (2016) updated clinical practice guidelines on graft and mesh

use in transvaginal pelvic organ prolapse repair based on systematic review. Eligible

studies, published through April 2015, were retrieved through ClinicalTrials.gov,

Medline, and Cochrane databases and bibliography searches. These investigators

included studies of transvaginal prolapse repair that compared graft or mesh use

with either native tissue repair or use of a different graft or mesh with anatomic and

symptomatic outcomes with a minimum of 12 months of follow-up. Study data were

extracted by 1 reviewer and confirmed by a 2nd reviewer. Studies were classified by

vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic,

synthetic absorbable, synthetic non-absorbable), and outcome (anatomic,

symptomatic, sexual function, mesh complications, and return to the operating

room). They found 66 comparative studies reported in 70 articles, including 38

randomized trials; quality of the literature has improved over time, but some

outcomes still show heterogeneity and limited power. In the anterior vaginal

compartment, synthetic non-absorbable mesh consistently showed improved

anatomic and bulge symptom outcomes compared with native tissue repairs based

on meta-analyses. Other subjective outcomes, including urinary incontinence or

dyspareunia, generally did not differ. Biologic graft or synthetic absorbable mesh

use did not provide an advantage in any compartment. Synthetic mesh use in the

posterior or apical compartments did not improve success. Mesh erosion rates

ranged from 1.4 to 19 % at the anterior vaginal wall, but 3 to 36 % when mesh was

placed in multiple compartments. Operative mesh revision rates ranged from 3 to 8

%. The authors concluded that synthetic mesh augmentation of anterior wall

prolapse repair improved anatomic outcomes and bulge symptoms compared with

native tissue repair. On the other hand, biologic grafts did not improve prolapse

repair outcomes in any compartment; mesh erosion occurred in up to 36 % of

patients, but re-operation rates were low.

Sacrocolpopexy:


http://ClinicalTrials.gov

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Alas and Anger (2015) stated that pelvic organ prolapse is a prevalent condition,

with up to 12 % of women requiring surgery in their lifetime. These investigators

reviewed the therapeutic options for apical prolapse, specifically. Both conservative

and surgical management options are acceptable and should be based on patient

preferences. Pessaries are the most commonly used conservative management

options. Guided pelvic floor muscle training is more beneficial than self-taught Kegel

exercises, though may not be effective for high stage or apical prolapse. Surgical

options include abdominal and vaginal approaches, the latter of which can be

performed open, laparoscopically, and robotically. A systematic review has

demonstrated that sacrocolpopexy has better long-term success for treatment of

apical prolapse than vaginal techniques, but vaginal surgery can be considered an

acceptable alternative. Recent data has demonstrated equal effectiveness between

uterosacral ligament suspension and sacrospinous ligament suspension at 1 year.

To-date, 2 randomized controlled trials (RCTs) have demonstrated equal

effectiveness between robotic and laparoscopic sacrocolpopexy. Though abdominal

approaches may have increased long-term durability, when counseling their

patients, surgeons should consider longer operating times and increased pain and

cost with these procedures compared to vaginal surgery.

The authors concluded the following:

▪ Pelvic floor physical therapy (PFPT) with a physical therapist is the best

approach to conservative management of apical prolapse

▪ Pessaries should be managed with regular follow-up care to minimize

complications

▪ Minimally invasive sacrocolpopexy appears as effective as the gold standard

abdominal sacrocolpopexy (ASC)

▪ Robotic assisted sacrocolpopexy (RASC) and laparoscopic assisted

sacrocolpopexy (LASC) are equally effective and should be utilized by pelvic

floor surgeons based on their skill level and expertise in laparoscopy

▪ Uterosacral ligament suspension (USLS) and sacrospinous ligament

suspension (SSLS) are considered equally effective procedures and can be

combined with a vaginal hysterectomy

▪ Obliterative procedures are effective but are considered definitive surgery

▪ The use of transvaginal mesh has been shown in some studies to be

superior to native tissue repairs with regard to anatomic outcomes, but

complication rates are higher. Transvaginal mesh should be reserved for

surgeons with adequate training so that complications are minimized


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Costantini and colleagues (2016) noted that sacrocolpopexy is considered a

reference operation for pelvic organ prolapse repair but its indications and technical

aspects are not standardized. A faculty of urogynecology surgeons critically

evaluated the peer-reviewed literature published until September 2015 aiming to

produce evidence-based recommendations. PubMed, Medline, and the Cochrane

Library were searched for RCTs published in English language. The modified

Oxford data grading system was used to access quality of evidence and grade

recommendations. The Delphi process was implemented when no data was

available. A total of 13 RCTs were identified, that provided levels I to III of evidence

on various aspects of sacrocolpopexy. Sacrocolpopexy is the preferred procedure

for vaginal apical prolapse (Grade A), monofilament polypropylene mesh is the graft

of choice and the laparoscopic approach is the preferred technique (Grade B).

Grade B recommendation supports the performance of concomitant procedures at

the time of sacrocolpopexy. Grade C recommendation suggests either permanent or

delayed sutures for securing the mesh to the vagina, permanent tackers or sutures

for securing the mesh to the sacral promontory and closing the peritoneum over the

mesh. A Delphi process Grade C recommendation supports proceeding with

sacrocolpopexy after uncomplicated, intra-operative bladder or small bowel injuries.

The authors concluded that there is insufficient or conflicting data on hysterectomy

(subtotal or total) or uterus preservation during sacrocolpopexy (Grade D). They

stated that sacrocolpopexy remains an excellent option for vaginal apical prolapse

repair. The issue of uterine preservation or excision during the procedure requires

further clarification. Variations exist in the performance of most technical aspects of

the procedure.

Also, an UpToDate review on “Pelvic organ prolapse in women: Surgical repair of

apical prolapse (uterine or vaginal vault prolapse)” (Kenton, 2016) states that “No

high quality evidence is available to guide surgeons regarding uterine preservation

at the time of vaginal apical suspension procedures … Apical prolapse repair via

open abdominal sacral colpopexy is more effective at restoring vaginal topography

than traditional vaginal repairs, although subjective outcomes are similar after the

two types of procedures. We suggest abdominal sacral colpopexy rather than

transvaginal repair for most women undergoing apical prolapse repair.

Laparoscopic sacrocolpopexy is as effective as open sacrocolpopexy but results in

decreased blood loss and shorter hospital stays. For women with apical prolapse

undergoing abdominal sacral colpopexy, we recommend synthetic mesh over

biografts. Synthetic mesh use in sacral colpopexy reduces the risk of recurrent

apical prolapse … For women undergoing repair of apical prolapse, a concomitant


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continence procedure is often performed to treat or prevent stress urinary

incontinence. Mid-urethral slings are the preferred concomitant procedure if a

vaginal route is used for prolapse repair; some surgeons also place a mid-urethral

sling at the time of abdominal sacral colpopexy”.

Furthermore, and UpToDate review on “Pelvic organ prolapse in women: Choosing

a primary surgical procedure” (Jelovsek, 2016) states that “The common wisdom

has been that retaining the uterus increases the risk of recurrent prolapse, although

there are no data to support this. The role of hysterectomy at the time of surgery for

POP is currently debatable and there are no data supporting hysterectomy at the

time of surgery for POP. There are 3 under-powered studies that describe uterine

preservation at the time of surgery for POP and uterine preservation did not affect

the risk of POP recurrence”.

Surgical Treatment of Primary Pelvic Organ Prolapse:

On behalf of 5 French academic societies (Association Française d'Urologie,

Collège National des Gynécologues et Obstétriciens Français, Société

Interdisciplinaire d'Urodynamique et de Pelvi-Périnéologie, Société Nationale

Française de Colo-proctologie, and Société de Chirurgie Gynécologique et

Pelvienne), Le Normand and colleagues (2016) developed guidelines for surgery for

primary POP. The guidelines listed the following:

▪ It is useful to evaluate symptoms, their impact, women's expectations, and to

describe the prolapse prior to surgery (grade C).

▪ In the absence of any spontaneous or occult urinary sign, there is no reason

to perform urodynamics (grade C).

▪ When a sacrocolpopexy is indicated, laparoscopy is recommended (grade B).

▪ A bowel preparation before vaginal (grade B) or abdominal surgery (grade C)

is not recommended.

▪ There is no argument to systematically use a rectovaginal mesh to prevent

rectocele (grade C).

▪ The use of a vesico-vaginal mesh by vaginal route should be discussed taking

into account an uncertain long-term risk-benefit ratio (grade B).

▪ Levator myorrhaphy is not recommended as a 1st-line rectocele treatment

(grade C).

▪ There is no indication for a vaginal mesh as a 1st-line rectocele treatment

(grade C).


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▪ There is no reason to systematically perform a hysterectomy during prolapse

repair (grade C).

▪ It is possible to not treat stress incontinence at the time of prolapse repair, if

the woman is advised of the possibility of a 2-step surgical treatment (grade

C).

Trans-Labial Ultrasound for the Assessment of Levator AniDefects and Levator Ani Biometry in Pelvic Organ Prolapse:

In a systematic review, Notten and colleagues (2017) evaluated the diagnostic

accuracy and clinical implications of trans-labial 3-dimensional (3D) ultrasound for

the assessment of levator ani defects and biometry in women with POP. These

investigators performed a systematic literature search through computerized

databases including Medline (via PubMed), Embase (via OvidSP), and the Cochrane

Library using both medical subject headings and text terms from January 1, 2003, to

December 25, 2015. They included articles that reported on POP status and

diagnostic accuracy measurements with trans-labial 3D ultrasound or trans- perineal

ultrasound for the detection of levator ani defects or for measuring pelvic floor

biometry, that is, levator ani hiatus, or reported on the clinical relevance of using

trans-labial 3D ultrasound for levator ani defects or measuring pelvic floor biometry in

women with POP. A total of 31 articles were selected in accordance with parts of the

Preferred Reporting Items for Systematic Reviews and Meta- Analyses guidelines

that can be applied to studies of diagnostic accuracy; 22 articles (71 %) were co-

authored by 1 expert in this field. Detecting levator ani defects with trans-labial 3D

ultrasound compared with MRI showed a moderate-to-good agreement, whereas

measuring hiatal biometry on trans-labial 3D ultrasound compared with MRI showed

a moderate-to-very good agreement. The inter- observer agreement for diagnosing

levator ani defects and measuring the levator hiatal area showed a moderate-to-very

good agreement. Furthermore, levator ani defects increase the risk of cystocele and

uterine prolapse, and levator ani defects were associated with recurrent POP.

Finally, a larger hiatus was associated with POP and recurrent POP. The authors

concluded that trans-labial 3D ultrasound is reproducible for diagnosing levator ani

defects and ballooning hiatus. Both levator ani defects and a larger hiatal area were,

in a selected population of patients with pelvic floor dysfunction, associated with POP

and recurrent POP. However, these researchers stated that more research is

needed regarding external validation since most of the data in this review were co-

authored by 1 expert in this field.


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Furthermore, an UpToDate review on “Pelvic organ prolapse in women: Diagnostic

evaluation” (Fashokun and Rogers, 2017) does not mention ultrasonography as a

diagnostic tool.

Use of Mesh Repair for Prolapse of Anterior Compartment of the Vagina:

In a Cochrane review, Maher and colleagues (2017) determined the safety and

effectiveness of surgery for anterior compartment prolapse. These investigators

searched the Cochrane Incontinence Group Specialised Register, including the

Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In

Process (August 23, 2016), hand-searched journals and conference proceedings

(February 15, 2016) and searched trial registers (August 1, 2016); RCTs that

examined surgical operations for anterior compartment prolapse were selected for

analysis Two review authors independently selected trials, assessed risk of bias

and extracted data. Primary outcomes were awareness of prolapse, repeat surgery

and recurrent prolapse on examination. These researchers included 33 trials (3,332

women). The quality of evidence ranged from very low-to-moderate. Limitations

were risk of bias and imprecision. They summarized results for the main

comparisons. Native tissue versus biological graft -- Awareness of prolapse:

Evidence suggested few or no differences between groups (risk ratio (RR) 0.98, 95

% CI: 0.52 to 1.82; 5 RCTs; 552 women; I2 = 39 %; low-quality evidence), indicating

that if 12 % of women were aware of prolapse after biological graft, 7 % to 23 %

would be aware after native tissue repair. Repeat surgery for prolapse: Results

showed no probable differences between groups (RR 1.02, 95 % CI: 0.53 to 1.97; 7

RCTs; 650 women; I2 = 0 %; moderate-quality evidence), indicating that if 4 % of

women required repeat surgery after biological graft, 2 % to 9 % would do so after

native tissue repair. Recurrent anterior compartment prolapse: Native tissue repair

probably increased the risk of recurrence (RR 1.32, 95 % CI: 1.06 to 1.65; 8 RCTs;

701 women; I2 = 26 %; moderate-quality evidence), indicating that if 26 % of women

had recurrent prolapse after biological graft, 27 % to 42 % would have recurrence

after native tissue repair. Stress urinary incontinence (SUI): Results showed no

probable differences between groups (RR 1.44, 95 % CI: 0.79 to 2.64; 2 RCTs; 218

women; I2 = 0 %; moderate-quality evidence). Dyspareunia: Evidence suggested

few or no differences between groups (RR 0.87, 95 % CI: 0.39 to 1.93; 2 RCTs; 151

women; I2 = 0 %; low-quality evidence). Native tissue versus polypropylene mesh

Awareness of prolapse: This was probably more likely after native tissue repair (RR

1.77, 95 % CI: 1.37 to 2.28; 9 RCTs; 1,133 women; I2 = 0 %; moderate-quality

evidence), suggesting that if 13 % of women were aware of prolapse after mesh

repair, 18 % to 30 % would be aware of prolapse after native tissue repair. Repeat


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surgery for prolapse: This was probably more likely after native tissue repair (RR


evidence), suggesting that if 2 % of women needed repeat surgery after mesh

repair, 2 % to 7 % would do so after native tissue repair. Recurrent anterior

compartment prolapse: This was probably more likely after native tissue repair (RR


evidence), suggesting that if recurrent prolapse occurred in 13 % of women after

mesh repair, 32 % to 45 % would have recurrence after native tissue repair. Repeat

surgery for prolapse, SUI or mesh exposure (composite outcome): This was

probably less likely after native tissue repair (RR 0.59, 95 % CI: 0.41 to 0.83; 12

RCTs; 1,527 women; I2 = 45 %; moderate-quality evidence), suggesting that if 10 %

of women require repeat surgery after polypropylene mesh repair, 4 % to 8 % would

do so after native tissue repair. De novo SUI: Evidence suggested few or no

differences between groups (RR 0.67, 95 % CI: 0.44 to 1.01; 6 RCTs; 957 women;

I2 = 26 %; low-quality evidence). No evidence suggested a difference in rates of

repeat surgery for SUI. Dyspareunia (de novo): Evidence suggested few or no

differences between groups (RR 0.54, 95 % CI: 0.27 to 1.06; 8 RCTs; n = 583; I2 =

0 %; low-quality evidence). Native tissue versus absorbable mesh. Awareness of

prolapse: It is unclear whether results showed any differences between groups (RR

0.95, 95 % CI: 0.70 to 1.31; 1 RCT; n = 54; very low-quality evidence). Repeat

surgery for prolapse: It is unclear whether results showed any differences between

groups (RR 2.13, 95 % CI: 0.42 to 10.82; 1 RCT; n = 66; very low-quality evidence).

Recurrent anterior compartment prolapse: This is probably more likely after native

tissue repair (RR 1.50, 95 % CI: 1.09 to 2.06; 3 RCTs; n = 268; I2 = 0 %; moderate-

quality evidence), suggesting that if 27 % have recurrent prolapse after mesh repair,

29 % to 55 % would have recurrent prolapse after native tissue repair. SUI: It is

unclear whether results showed any differences between groups (RR 0.72, 95 % CI:

0.50 to 1.05; 1 RCT; n = 49; very low-quality evidence). Dyspareunia: No data were

reported. The authors concluded that biological graft repair or absorbable mesh

provided minimal advantage compared with native tissue repair. Native tissue repair

was associated with increased awareness of prolapse and increased risk of repeat

surgery for prolapse and recurrence of anterior compartment prolapse compared

with polypropylene mesh repair. However, native tissue repair was associated with

reduced risk of de-novo SUI, reduced bladder injury, and reduced rates of repeat

surgery for prolapse, SUI and mesh exposure (composite outcome). They stated

that current evidence does not support the use of mesh repair compared with native

tissue repair for anterior compartment prolapse owing to increased morbidity. Many

transvaginal polypropylenes meshes have been voluntarily removed from the

market,


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and newer light-weight transvaginal meshes that are available have not been

assessed by RCTs. These investigators stated that clinicians and women should be

cautious when utilizing these products, as their safety and effectiveness have not

been established.

Chughtai and associates (2017) stated that mesh (a synthetic graft) has been used

in POP repair and SUI to augment and strengthen weakened tissue. Polypropylene

mesh has come under scrutiny by the Food and Drug Administration (FDA). In an

observational cohort study, these researchers examined the rates of mesh

complications and invasive re-intervention following the placement of vaginal mesh

for POP repair or SUI surgery. Participants were women who underwent trans-

vaginal repair for POP or SUI with mesh between January 1, 2008, and December

31, 2012, and were followed-up through December 31, 2013. They were divided

into the following 4 groups based on the amount of mesh exposure: (i) trans-vaginal

POP repair surgery with mesh and concurrent sling use (vaginal mesh plus sling

group), (ii) transvaginal POP repair with mesh and no concurrent sling use

(vaginal mesh group), (iii) transvaginal POP repair without mesh but concurrent

sling use for SUI (POP sling group), and (iv) sling for SUI alone (SUI sling group).

The primary outcome was the occurrence of mesh complications and repeated

invasive intervention within 1 year after the initial mesh implantation. A time-to-

event analysis was performed to examine the occurrence of mesh erosions and

subsequent re-intervention. Secondary analyses of an age association (less than 65

versus greater than or equal to 65 years) were conducted. The study identified

41,604 women who underwent 1 of the 4 procedures. The mean (SD) age of women

at their initial mesh implantation was 56.2 (13.0) years. The highest risk of erosions

was found in the vaginal mesh plus sling group (2.72%; 95% CI, 2.31%-3.21%) and

the lowest in the SUI sling group (1.57 %; 95 % CI: 1.41 % to 1.74 %). The risk of

repeated surgery with concomitant erosion diagnosis was also the highest in the

vaginal mesh plus sling group (2.13 %; 95 % CI: 1.76 % to 2.56 %) and the lowest in

the SUI sling group (1.16 %; 95 % CI: 1.03 % to 1.31 %). The authors concluded

that the combined use of POP mesh and SUI mesh sling was associated with the

highest erosion and repeated intervention risk, while mesh sling alone had the

lowest erosion and repeated intervention risk. They stated that there is evidence for

a dose-response relationship between the amount of mesh used and subsequent

mesh erosions, complications, and invasive repeated intervention.


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Vaginal Tactile Imaging:

Egorov and colleagues (2010) noted that changes in the elasticity of the vaginal

walls, connective support tissues, and muscles are thought to play an important role

in the development of pelvic organ prolapse (POP). It creates 2 predominant

concerns specific to the biomechanical properties of pelvic support tissues: (i) how

does tissue elasticity affect the development of POP, and (ii) how can functional

elasticity be maintained through reconstructive surgery. These researchers

designed a prototype of vaginal tactile imager (VTI) for visualization and assessment

of elastic properties of pelvic floor tissues. In a pilot study (n =13), these

investigators analyzed applicability of VTI for evaluation of reconstructive surgery

results and characterization of normal and POP conditions. The authors concluded

that this trial demonstrated that VTI allowed imaging of vaginal walls with increased

rigidity due to implanted mesh grafts following reconstructive pelvic surgery and VTI

had the potential for prolapse characterization and detection.

van Raalte and Egorov (2015) stated that VTI records pressure patterns from vaginal

walls under an applied tissue deformation and during pelvic floor muscle (PFM)

contractions. These researchers validated VTI and muscle contraction parameters

(markers) sensitive to the female pelvic floor conditions. A total of 22 women with

normal and prolapse conditions were examined by a VTI probe. They identified 9

parameters that were sensitive to prolapse conditions (p < 0.05 for 1-way ANOVA

and/or p < 0.05 for t-test with correlation factor r from -0.73 to -0.56). The list of

parameters included pressure, pressure gradient and dynamic pressure response

during PFM at identified locations. The authors concluded that these parameters

may be used for biomechanical characterization of female pelvic floor conditions to

support an effective management of pelvic floor prolapse. Moreover, they stated that

further studies with larger sample sizes, investigating a variety of other pelvic floor

conditions, and use in the evaluation of interventions including physical therapy,

conservative management options and surgical correction are needed to further

explore diagnostic values of VTI.

The authors stated that this study had several drawbacks: (i) its small sample size

(n = 22), (ii) the lack of data to correlate PFM assessment with the site of

prolapse, degree of symptom severity for detected prolapse or associated

urinary or fecal continence symptoms. It was thought a sub-analysis may be

misleading given the limited sample size and should be reserved for future

studies. There may be very important differences in functional PFM recordings


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between a patient with a large distention defect of the vaginal wall versus a

primary apical defect, symptomatic versus asymptomatic prolapse or among

patients with associated urinary or rectal complaints. For future studies, it

would be important to evaluate symptom severity for pelvic floor disorders to

examine if there is a correlation between PFM evaluation, resting tone and

associated elasticity measurements of the underlying tissue. This may help

clinicians further differentiate types of pelvic floor conditions, their underlying

severity and how-to tailor treatments to best care for the individual patient, (iii)

the clinician obtaining the VTI measurements was not blinded to the POP

quantification system (POP-Q) measurements. The procedure for VTI recording

was standardized and would be difficult to bias the recording based on

expectations of the measurements, however this did remain a potential bias. To

diminish the potential influence of this bias, the images were evaluated, and

parameter values were extracted by another observer who did not have the

clinical information available until the data scaling versus prolapse stage, age

and parity.

Lucente and associates (2017) developed a new approach for the biomechanical

characterization of vaginal conditions, muscles, and connective tissues in the female

pelvic floor -- VTI allows biomechanical assessment of the soft tissue along the

entire length of the anterior, posterior, and lateral vaginal walls at rest, with manually

applied deflection pressures and with muscle contraction, muscle relaxation, and

Valsalva maneuver. Vaginal tactile imaging allows a large body of measurements to

evaluate individual variations in tissue elasticity, support defects, as well as pelvic

muscle function. Presuming that (i) the female pelvic floor organs are suspended

by ligaments against which muscles contract to open or close the outlets, and (ii)

damaged ligaments weaken the support and may reduce the force of muscle

contraction, these researchers made an attempt to characterize multiple pelvic floor

structures from VTI data. All of the 138 women enrolled in the study were

successfully examined with the VTI. The participants have had normal pelvic

support or POP (stages I to IV). The average age of this group of subjects was 60 ±

15 years. These investigators transposed a set of 31 VTI parameters into a

quantitative characterization of pelvic muscles and ligamentous structures.

Interpretation of the acquired VTI data for normal pelvic floor support and prolapse

conditions is proposed based on biomechanical assessment of the functional

anatomy. The authors concluded that VTI allowed biomechanical characterization of

female pelvic floor structures and tissues in-vivo, which may help to optimize


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treatment of the diseased conditions such as prolapse, incontinence, atrophy, and

some forms of pelvic pain.

The authors stated that among the VTI limitations were image dependence on

operator’s skill level, contact conditions, and probe size. In general, an examination

with a VTI probe is operator-dependent, similar to colonoscopy. Operator training is

needed to improve and standardize operator skills. Minimization or elimination of

the operator dependence is also achieved by intentional probe design, data

processing algorithms, and real-time feedback to the operator. The VTI intra- and

inter-operator measurement reproducibility study with 12 subjects demonstrated

intra-class correlation coefficients in the range from 0.80 to 0.92 and median tactile

image deviations from 6.6 % to 15.6 %. The lubrication helps to keep contact

conditions reproducible. Tactile imaging probes with different size and contact area

of 15 μm(2), and 20 cm(2) demonstrated different absolute values of P(x,y,z)

acquired for the same tissue. But comparison of the 2 image data sets revealed a

lot of similarity and common features; both probes showed close relative distribution

within P(x,y,z) and enabled similar tissue characterization.

In an observational, case-controlled clinical study, Egorov and co-workers (2017)

discussed a new approach for quantitative biomechanical characterization of the

vagina. Data were analyzed for 42 subjects with normal pelvic floor support. The

average age was 52 years (range of 26 to 90 years). These researchers introduced

8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force

to insertion (Newtons), (ii) insertion work (milliJoules), (iii) maximum stress-to-

strain ratio (elasticity; kiloPascals per millimeter), (iv) maximum pressure at rest

(kiloPascals), (v) anterior-posterior force a t rest (Newtons), (vi) left-right force at

rest (Newtons), (vii) maximum pressure at muscle contraction (kiloPascals), and

(viii) muscle contraction force (Newtons). These researchers observed low-to-

moderate correlation of these parameters with subject age and no correlation with

subject weight; 6 of 8 parameters demonstrated a p value of less than 0.05 for 2

subject subsamples divided by age (less than or equal to 52 versus greater than 52

years), which meant 6 VTI parameters change with age. The authors concluded

that VTI allowed biomechanical and functional characterization of the vaginal

conditions that can be used for (i) understanding "normal" vaginal conditions, (ii)

quantification of the deviation from normality, (iii) personalized treatment

(radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied

treatment outcome. Moreover, they stated that further research with a more

representative sample will show more comprehensive distributions and peculiar


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features for normal values. This study had 2 major drawbacks: (i) its relatively

small sample size (n = 42), and (ii) despite normal pelvic floor support (no

prolapse), some analyzed subjects came to the urogynecologic office with some

problematic conditions affecting the pelvic floor.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes covered if selection criteria are met:

Laparoscopic suture rectopexy - no specific code:

Dynamic magnetic resonance imaging (MRI) - no specific code:

57120 Colpocleisis (Le Fort type)

57280 Colpopexy, abdominal approach

57282 Colpopexy, vaginal; extra-peritoneal approach (sacrospinous,

iliococcygeus)

57425 Laparoscopy, surgical, colpopexy (suspension of vaginal apex)

CPT codes not covered for indications listed in the CPB:

0487T Biomechanical mapping, transvaginal, with report

+57267 Insertion of mesh or other prosthesis for repair of pelvic floor defect, each

site (anterior, posterior compartment), vaginal approach (List separately

in addition to code for primary procedure) info [with biologic graft]

57284 Paravaginal defect repair (including repair of cystocele, if performed);

open abdominal approach info [with biologic graft]

57285 Paravaginal defect repair (including repair of cystocele, if performed);

vaginal approach [with biologic graft]

81400 - 81479 Tier 2 Molecular Pathology Procedures

ICD-10 codes covered if selection criteria are met:

K62.2 - K62.3 Anal and rectal prolapse

N81.0 - N81.9 Female genital prolapse

ICD-10 codes not covered for indications listed in the CPB:

N39.41 -

N39.498

Other specified urinary incontinence

N95.2 Postmenopausal atrophic vaginitis


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Code Code Description

R10.2 Pelvic and perineal pain

R32 Unspecified urinary incontinence

R39.81 Functional urinary incontinence

The above policy is based on the following references:

Dynamic Magnetic Resonance Imaging

1. Barbaric ZL, Marumoto AK, Raz S. Magnetic resonance imaging of the

perineum and pelvic floor. Top Magn Reson Imaging.2001;12(2):83-92.

2. Boyadzhan L, Raman SS, Raz S. Role of static and dynamic MR imaging in

surgical pelvic floor dysfunction. Radiographics.2008;28(4):949-967.

3. Comiter CV, Vasavada SP, Barbaric ZL, at al. Grading pelvic prolapse and

pelvic floor relaxation using dynamic magnetic resonance imaging. Urology.

1999;54(3):454-457.

4. Delamarre JB, Kruyt RH, Doornbos J, et al. Anterior rectocele: Assessment

with radiographic defecography, dynamic magnetic resonance imaging,

and physical examination. Dis Colon Rectum. 1994;37(3):249-259.

5. Dohke M, Mitchell DG, Vasavada SP. Fast magnetic resonance imaging of

pelvic organ prolapse. Tech Urol. 2001;7(2):133-138.

6. Goodrich MA, Webb MJ, King BF, et al. Magnetic resonance imaging of

pelvic floor relaxation: Dynamic analysis and evaluation of patients before

and after surgical repair. Obstet Gynecol. 1993;82(6):883-891.

7. Guffler H, DeGregorio G, Dohnicht S, et al. Dynamic MRI after surgical

repair for pelvic organ prolapse. J Comput Assist Tomogr. 2002;26(5):734-

739.

8. Hodroff MA, Stolpen AH, Denson MA, et al. Dynamic magnetic resonance

imaging of the female pelvis: The relationship with the Pelvic Organ

Prolapse quantification staging system. J Urol. 2002;167(3):1353-1355.

9. Macura KJ. Magnetic resonance imaging of pelvic floor defects in women.

Top Magn Reson Imaging. 2006;17(6):417-426.

10. Marinkovic SP, Stanton SL. Incontinence and voiding difficulties associated

with prolapse. J Urol.2004;171(3):1021-1028.


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11. Pannu HK. Dynamic MR imaging of female organ prolapse. Radiol Clin

North Am. 2003;41(2):409-423.

12. Pannu HK, Kaufman HS, Cundiff GW, et al. Dynamic MR imaging of pelvic

organ prolapse: Spectrum of abnormalities. Radiographics. 2000;20

(6):1567-1682.

13. Rodriguez LV, Raz S. Diagnostic imaging of pelvic floor dysfunction. Curr

Opin Urol.2001;11(4):423-428.

14. Savoye-Collet C, Koning E, Dacher JN. Radiologic evaluation of pelvic floor

disorders. Gastroenterol Clin North Am. 2008;37(3):553-567.

15. Singh K, Reid WM, Berger LA. Assessment and grading of pelvic organ

prolapse by use of dynamic magnetic resonance imaging. Am J Obstet

Gynecol.2001;185(1):71-77.

16. Weidner AC, Low VHS. Imaging studies of the pelvic floor. Obstet Gynecol

Clin North Am. 1998;25(4):825-848.

17. Yang A, Mostwin JL, Rosenshein NB, Zerhouni EA. Pelvic floor descent in

women: Dynamic evaluation with fast MR imaging and cinematic display.

Radiology.1991;179(1):25-33.

Laparoscopic Suture Retropexy

1. Akbari RP Read TE. Laparoscopic rectal surgery: Rectal cancer, pelvic pouch

surgery, and rectal prolapse. Surg Clin North Am. 2006;86(4):899-914.

2. Benoist S, Taffinder N, Gould S, et al. Functional results two years after

laparoscopic rectopexy. Am J Surg. 2001;182(2):168-173.

3. Byrne CM, Smith SR, Solomon MJ, et al. Long-term functional outcomes

after laparoscopic and open rectopexy for the treatment of rectal prolapse.

Dis Colon Rectum. 2008;51(11):1597-1604.

4. Felt-Bersma RJ, Tiersma ES, Cuesta MA. Rectal prolapse, rectal

intussusception, rectocele, solitary rectal ulcer syndrome, and enterocele.

Gastroenterol Clin North Am. 2008;37(3):645-668.

5. Graf W, Stefansson T, Arvidsson D, Pahlman L. Laparoscopic suture

rectopexy. Dis Colon Rectum.1995;38(2):211-212.

6. Heah SM, Hartley JE, Hurley J, et al. Laparoscopic suture rectopexy without

resection is effective treatment for full-thickness rectal prolapse. Dis Colon

Rectum. 2000;43(5):638-643.

7. Hsu A, Brand MI, Saclarides TJ. Laparoscopic rectopexy without resection: A

worthwhile treatment for rectal prolapse in patients without prior

constipation. Am Surg. 2007;73(9):858-861.


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8. Lechaux D, Trebuchet G, Siproudhis L, Campion JP. Laparoscopic rectopexy

for full-thickness rectal prolapse: A single-institution retrospective study

evaluating surgical outcome. Surg Endosc. 2005;19(4):514-518.

9. Madiba TE, Baig MK, Wexner SD. Surgical management of rectal prolapse.

Arch Surg. 2005;140(1):63-73.

10. McNevin MS. Overview of pelvic floor disorders. Surg Clin North Am.

2010;90(1):195-205.

11. Senagore AJ. Management of rectal prolapse: The role of laparoscopic

approaches. Semin Laparosc Surg. 2003;10(4):197-202.

12. Tou S, Brown SR, Malik AI, Nelson RL. Surgery for complete rectal prolapse

in adults. Cochrane Database Syst Rev. 2008;(4):CD001758.

LeFort Colpocleisis

1. Current Obstetric & Gynecologic Diagnosis & Treatment. 9th Edition. 2003.

2. Danforth’s Obstetrics and Gynecology. 8th Edition. 1999.

3. Ryan; Kistner’s Gynecology & Women’s Health. 7th Edition. 1999.

4. TeLinde’s Operative Gynecology. 8th Edition. 1997.

5. Vaginal Surgery. 4th Edition. 1996.

6. Wang X, Chen Y, Hua K. Pelvic symptoms, body image, and regret after

LeFort colpocleisis: A long-term follow-up. J Minim Invasive Gynecol.

2017;24(3):415-419.

7. Buchsbaum GM, Lee TG. Vaginal obliterative procedures for pelvic organ

prolapse: A systematic review. Obstet Gynecol Surv. 2017;72(3):175-183.

Genetic Testing for Pelvic Organ Prolapse

1. Levin PJ, Visco AG, Shah SH, et al. Characterizing the phenotype of

advanced pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2012;18

(5):299-302.

2. Wu JM, Visco AG, Grass EA, et al. Comprehensive analysis of LAMC1 genetic

variants in advanced pelvic organ prolapse. Am J Obstet Gynecol. 2012;206

(5): 447.e1-e6.

3. Ward RM, Velez Edwards DR, Edwards T, et al. Genetic epidemiology of

pelvic organ prolapse: A systematic review. Am J Obstet Gynecol. 2014;211

(4):326-335.


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4. Cartwright R, Kirby AC, Tikkinen KA, et al. Systematic review and

metaanalysis of genetic association studies of urinary symptoms and

prolapse in women. Am J Obstet Gynecol. 2015;212(2): 199.e1-e24.

5. Khadzhieva MB, Kolobkov DS, Kamoeva SV, Salnikova LE. Expression

changes in pelvic organ prolapse: A systematic review and in silico study.

Sci Rep. 2017;7(1):7668.

Bilateral Abdominal Sacrocolpopexy with Polyvinylidene Fluoride Mesh

1. Rajshekhar S, Mukhopadhyay S, Morris E. Early safety and efficacy

outcomes of a novel technique of sacrocolpopexy for the treatment of

apical prolapse. Int J Gynaecol Obstet. 2016;135(2):182-186.

Biologic Graft

1. Schimpf MO, Abed H, Sanses T, et al; Society of Gynecologic Surgeons

Systematic Review Group. Graft and mesh use in transvaginal prolapse

repair: A systematic review. Obstet Gynecol. 2016;128(1):81-91.

Sacrocolpopexy

1. Alas AN, Anger JT. Management of apical pelvic organ prolapse. Curr Urol

Rep. 2015;16(5):33.

2. Costantini E, Brubaker L, Cervigni M, et al. Sacrocolpopexy for pelvic organ

prolapse: Evidence-based review and recommendations. Eur J Obstet

Gynecol Reprod Biol. 2016; 205:60-65.

3. Kenton K. Pelvic organ prolapse in women: Surgical repair of apical

prolapse (uterine or vaginal vault prolapse). UpToDate Inc., Waltham, MA.

Last reviewed July 2016.

4. Jelovsek JE. Pelvic organ prolapse in women: Choosing a primary surgical

procedure. UpToDate Inc., Waltham, MA. Last reviewed July 2016.

5. Wagner L, Meurette G, Vidart A, et al. Laparoscopic sacrocolpopexy for

pelvic organ prolapse: Guidelines for clinical practice. Prog Urol. 2016;26

Suppl 1: S27-S37.

Surgical Treatment of Primary Pelvic Organ Prolapse:

1. Le Normand L, Cosson M, Cour F, et al. Clinical practice guidelines:

Synthesis of the guidelines for the surgical treatment of primary pelvic


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organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP.

J Gynecol Obstet Biol Reprod (Paris). 2016;45(10):1606-1613.

Trans-Labial Ultrasound for the Assessment of Levator AniDefects and Levator Ani Biometry in Women with Pelvic Organ Prolapse:

1. Fashokun TB, Rogers RG. Pelvic organ prolapse in women: Diagnostic

evaluation. UpToDate Inc., Waltham, MA. Last reviewed July 2017.

2. Notten KJ, Vergeldt TF, van Kuijk SM, et al. Diagnostic accuracy and clinical

implications of translabial ultrasound for the assessment of levator ani

defects and levator ani biometry in women with pelvic organ prolapse: A

systematic review. Female Pelvic Med Reconstr Surg. 2017;23(6):420-428.

Use of Mesh Repair for Anterior Compartment Prolapse:

1. Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior

compartment prolapse. Cochrane Database Syst Rev. 2016;11:CD004014.

2. Chughtai B, Barber MD, Mao J, et al. Association between the amount of

vaginal mesh used with mesh erosions and repeated surgery after

repairing pelvic organ prolapse and stress urinary incontinence. JAMA Surg.

2017;152(3):257-263.

Vaginal Tactile Imaging:

1. Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans

Biomed Eng. 2010;57(7):1736-1744.

2. van Raalte H, Egorov V. Tactile imaging markers to characterize female

pelvic floor conditions. Open J Obstet Gynecol. 2015;5(9):505-515.

3. Lucente V, van Raalte H, Murphy M, Egorov V. Biomechanical paradigm and

interpretation of female pelvic floor conditions before a treatment. Int J

Womens Health. 2017; 9:521-550.

4. Egorov V, Murphy M, Lucente V, et al. Quantitative assessment and

interpretation of vaginal conditions. Sex Med. 2017 Dec 19 [Epub ahead of

print].


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0858 Organ Prolapse:

Selected Procedures

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania annual 04/01/2019

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http://www.aetnabetterhealth.com/pennsylvania

prior authorization review panel mco policy …...cpb 0858 organ prolapse: selected procedures...

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