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Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1 , SK Madiraju 2 , KG Tayon 2 , MS Gross 3 , RE Carrion 1 , PE Perito 4 1) USF Urology Morsani School of Medicine Tampa, FL 2) Charles E Schmidt College of Medicine of FAU Boca Raton, FL 3) Dartmouth-Hitchcock Medical Center Lebanon, NH 4) Perito Urology Coral Gables, FL

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Page 1: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Durasphere as New Agent for the Treatment

of Hypermobile glans.

JJ Wallen1, SK Madiraju2, KG Tayon2, MS Gross3, RE Carrion1,

PE Perito4

1) USF Urology Morsani School of Medicine Tampa, FL

2) Charles E Schmidt College of Medicine of FAU Boca Raton, FL

3) Dartmouth-Hitchcock Medical Center Lebanon, NH

4) Perito Urology Coral Gables, FL

Page 2: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Outline

Relevant anatomy and physiology

Defining hypermobile glans

Goals of intervention

The “How To” of Subcoronal Injection

Outcomes and single institution

retrospective data

Page 3: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Treatment Paradigm

(Bickell, et al.,2016)

Page 4: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

New Treatment Paradigm

Distal penoplasty or

glanulopexy and/or

Durasphere bulking

augmentation

Page 5: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Anatomy

8

(Bickell, et al., 2016)

(Clement, Giuliano, 2015)

(Yiee & Baskin, 2010)

("The Penis - Human Anatomy", 2016)("Penis Anatomy", 2016)

Page 6: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Physiology

(Lasker, Pankey, & Kadowitz, 2013) ("Sexual Response Cycle", 2016)

Page 7: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Glans Penis

Is a sensory organ for sexual stimuli.

Appropriate shape for vaginal dilatation and for

easy introduction of the penis into the vagina.

If the glans size is too small compared to a

thicker shaft [or if true hypermobility exists]

introduction is not as easy or effective.

The cushion effects prevent both vaginal trauma

and injury of the distal penis.

(Moon, Kwak, & Kim, 2015)

Page 8: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Hypermobile Glans

Exists in the setting of properly sized and

positioned implant

Requires evaluation by an experienced

prosthetic urologist

Signs and symptoms:– Sensation of soft glans penis

– Pain during intercourse due to cylinder tip pressure

– Appearance of droopy glans penis with maximal

inflation

Page 9: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Goal of intervention

Stabilize glandular

tissue

Provide bulking

“bumper” effect

Recreate glandular

engorgement

Page 10: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Prevalence of hypermobility

Prosthetic erection does not include glanular tumescence

13-15% of partners quote soft or short glans as etiology of

dissatisfaction

Dissatisfied patients undergoing lipectomy, girth fat

grafting, and glans injection report satisfaction

(Montague 2007)

(Lledó‐García, et al., 2015)

(Shaeer, 2010)

Page 11: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Prevalence of hypermobility

In the 2015 JSM article Lledo-Garcia et al published their

original research on 149 patients whom underwent either

primary implantation or revision penile prosthesis surgery:

– Reported an overall patient satisfaction rate of 79% and 80%

respectively (very or moderately satisfied)

– 74% and 80% of their partners reported satisfaction

– However, there was a 13% and 15% rate for revision surgery of

partners quoting softness or shortness of the glans as the main

cause of their dissatisfaction.

Page 12: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Prevalence of hypermobility

In the 2010 JSM article Shaeer published his experience

with 18 patients whom reported dissatisfaction after 1

year of regular sexual practice after prosthesis

implantation and met follow up and exclusion critera:

– 7 patients were satisfied after counselling.

– 11 under went some combination of elongation with suprapubic

lipectomy, girth enhancement with dermal fat grafting, or glans

injection with polyacrelamide gel.

– Reported 47.6% and 21% gains in length and girth respectively

Page 13: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

(2) 17 Gauge Tuohy needles

(2) 1 cc Durasphere injection syringes

Sterile prep (chloraprep) and drape kit

4x4 Gauze

Intraoperative Supplies

Page 14: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Subcoronal Injection

Post Injection

Page 15: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Subcoronal Injection

Pre-op

Hypermobility

Post Injection

Bevel down

to avoid

tattooing

glans

Page 16: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Results

16 patients, total of 61 injections (mean 3.6,

range 2-8).

15 documented follow-up on average 50.5 weeks

86.6 % satisfaction rate

Reduced or absent pain during intercourse,

would do injection again, and subjectively

improved stability.

Page 17: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Results

3 adverse events.

– 2 minor

• thinning of skin

• ecchymosis and swelling of glans/penis

– 1 necrotic glans wound

All resolved with local wound care

Page 18: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

Conclusions

Durasphere has a safe history in treatment of ISD

Our initial data suggests that similarly successful results

are obtainable for glanular hypermobility

We believe subcoronal Durasphere injections should be a

viable option in the armamentarium of treatments for

glanular hypermobility due to high patient satisfaction,

ease of intervention, and low adverse events.

Page 19: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

References

1. Bickell, M., Manimala, N., Parker, J., Steixner, B., Wiegand, L., & Carrion, R. (2016). Floppy Glans Syndrome:

Pathogenesis and Treatment. Sexual Medicine Reviews, 4(2), 149-156. doi:10.1016/j.sxmr.2015.12.001

2. Clement, P., & Giuliano, F. (2015). Chapter 3 Anatomy and Physiology of Genital Organs - Men. In Handbook of

Clinical Neurology: Neurology of Sexual and Bladder disorders (Vol. 130, 3rd, pp. 19-37). Elsevier.

3. Lasker, G. F., Pankey, E. A., & Kadowitz, P. J. (2013). Modulation of Soluble Guanylate Cyclase for the

Treatment of Erectile Dysfunction. Physiology, 28(4), 262-269. doi:10.1152/physiol.00001.2013

4. Lledó‐García, E., Jara‐Rascón, J., Iribarren, I. M., Piñero‐Sánchez, J., Aragón‐Chamizo, J., &

Hernández‐Fernández, C. (2015). Penile Prosthesis First and Replacement Surgeries: Analysis of Patient and

Partner Satisfaction. The Journal of Sexual Medicine, 12(7), 1646-1653. doi:10.1111/jsm.12932

5. Montague, D. K. (2007). Penile Prosthesis Implantation: Size Matters. European Urology, 51(4), 887-888.

doi:10.1016/j.eururo.2006.10.027

6. Moon, D. G., Kwak, T. I., & Kim, J. J. (2015). Glans Penis Augmentation Using Hyaluronic Acid Gel as an

Injectable Filler. World J Mens Health The World Journal of Men's Health, 33(2), 50.

doi:10.5534/wjmh.2015.33.2.50

7. Penis Anatomy. (n.d.). Retrieved October 16, 2016, from http://cephalicvein.com/2016/07/penis-anatomy/

8. Sexual Response Cycle. (n.d.). Retrieved October 16, 2016, from

http://www1.appstate.edu/~hillrw/SexualDysfuntions/Treatments.htm

9. Shaeer, O. (2010). Supersizing the Penis Following Penile Prosthesis Implantation. The Journal of Sexual

Medicine, 7(7), 2608-2616. doi:10.1111/j.1743-6109.2010.01723.x

10. The Penis - Human Anatomy. (2016). Retrieved October 16, 2016, from

http://www.theodora.com/anatomy/the_penis.html

11. Yiee, J. H., & Baskin, L. S. (2010). Penile Embryology and Anatomy. The Scientific World JOURNAL, 10, 1174-

1179. doi:10.1100/tsw.2010.112

Page 20: Durasphere as New Agent for the Treatment of Hypermobile ... · Durasphere as New Agent for the Treatment of Hypermobile glans. JJ Wallen 1, SK Madiraju2, KG Tayon2, MS Gross3, RE

“If I have been able to see farther, it is

because I have stood on the shoulders of

giants.”

~ Sir Issac Newton