STUDY DESIGN, MATERIALS AND METHODS

SUB URETHRAL SLING FOR MALE URINARY INCONTINENCE: RANDOMIZED CLINIC TRIAL OF TWO SLINGS

Lima JPC, Pompeo ACL, Bezerra CA

Comparison of Argus® sling and AdVance® sling for male urinary

incontinence in the mid-term (12 months) follow up.

HYPOTHESIS / AIMS OF STUDY

From December 2010 to December 2011, 42 male patients with urinary

incontinence were recruited and 22 were randomized through computer random

table to sub urethral sling with Argus® (Promedon) or AdVance® (A.M.S.). All

patients were evaluated, before surgery, with multichannel urodynamic study, 24

hour pad test, QoL questionnaires (ICIQ – SF), voiding diary and clinical

examination including insertion of a 14 FR catheter to rule out urethral stenosis. All

patients had minimum six months after surgery which caused incontinence.

Patients with neurologic conditions, detrusor overactivity and urethral stenosis

were excluded. Protocol was approved by institution’s Ethical Committee and

patients agreed to sign informed consent. Surgery was performed as

recommended by manufacturers and follow up was planned in 7 days and 1, 6, 12

and 18 months post operatory. During follow up patients were submitted to pad

tests, voiding diaries and QoL questionnaires. Patients with urinary leaks after

Argus® were submitted to re-adjust of sling and followed as others. Success were

defined as cured (no leaks in pad test or voiding diary and 80% reduction in QoL

scores), improved (at least 50% reduction in leaks episodes or pad test weight and

reduction of more than 50% in QoL scores) or failed (none of the previous

conditions). Minimum 12 months follow up is presented. Results were analysed

statistically with Fisher’s exact test, Kolmogorov-Smirnov test, Friedman’s non

parametric test or Mann-Whitney test, according to the type of variable studied.

Patients were comparable between age, time after surgery which cause

incontinence, risk of cancer return according to Damico’s criteria, intensity of

incontinence, etc. Two patients (one in each group) did not complete 12 month

follow up (both died for other cause not related to surgery, cancer or incontinence).

The most important results are presented in the following table. Only one patient

was cured in the Advance group and two patients were cured in the Argus group. In

regard to improvement, both slings resulted in best QoL (see table). But in pad

tests and pad changes, Argus group provided better results. When we looked up

over incontinence episodes on voiding diaries both groups were statistically similar

with a better result favouring Argus group, where two patients were submitted to

readjustment. One patient were submitted to explantation of sling due to non-

treatable perineal pain. There were no other complications.

Variable Surgery Follow up n Medium sd min max p*

QoL

Advance

Baseline 10 19,10 1,97 16,00 21,00

0,004 6 m. 10 12,00 8,41 0,00 21,00

12 m. 10 12,90 7,61 0,00 21,00

Argus

Baseline 10 17,80 3,39 11,00 21,00

0,015 6 m. 10 9,10 7,98 0,00 21,00

12 m. 10 10,20 6,99 0,00 21,00

PAD

test

Advance

Baseline 10 619,30 445,46 50,00 1334,00

0,110 6 m. 10 480,10 726,45 0,00 1913,00

12 m. 10 284,40 331,04 0,00 880,00

Argus

Baseline 10 686,20 721,06 100,00 2550,00

0,017 6 m. 10 173,00 297,36 0,00 893,00

12 m. 10 70,00 110,64 0,00 343,00

Incontinent

Episodes

Advance

Baseline 10 3,25 3,04 0,00 7,30

0,430 6 m. 10 1,86 3,32 0,00 9,00

12 m. 10 6,89 8,35 0,00 20,00

Argus

Baseline 10 4,10 3,70 0,00 10,00

0,159 6 m. 10 1,56 2,25 0,00 7,00

12 m. 10 1,19 1,93 0,00 5,00

Pad

changes

Advance

Baseline 10 3,91 2,73 2,00 11,00

6 m. 10 3,13 4,05 0,00 12,00 0,349

12 m. 10 2,55 3,51 0,00 11,60

Argus

Baseline 10 4,17 2,38 1,30 9,00

6 m. 10 1,90 2,81 0,00 8,00 0,013

12 m. 10 1,69 2,30 0,00 7,30

(*) Friedman’s non parametric test

Results for several variables

Results according do DAMICO classification of risk

Our results show that both slings improve QoL in male patients with urinary

incontinence. Argus were better than AdVance in reduction of pad tests weight and

pad changes and tended to be better in reduction of incontinence episodes. This

suggests that QoL does not necessarily reflect objective improvement and authors

should look forward seeing closer the effects of this kind of surgery. In addition we

observed that results were similar between patients with mild/moderate

incontinence severity (< 400 ml/24h) in comparison with severe incontinence (> =

400 ml/24h). This suggests that slings may be tried in all patients before artificial

urinary sphincter. Finally, we also observed that patients with high risk of

recurrence, according to D'Amico's criteria have poor results. In spite this was

thought before, this is the first time it is demonstrated with data. We should

address these new insights in future research on this field

Argus tended to be better than Advance in male urinary incontinence in the mid-

term follow up.

Variable Risk Follow up n Medium sd min max p* min

QoL

low

Baseline 5 18,40 2,51 16,00 21,00 18,00

0,011 6 m. 5 9,40 6,80 0,00 17,00 12,00

12 m. 5 10,60 7,13 0,00 18,00 14,00

Medium

Baseline 9 17,44 3,24 11,00 21,00 17,00

0,013 6 m. 9 6,33 7,47 0,00 21,00 4,00

12 m. 9 8,56 6,33 0,00 21,00 8,00

High

Baseline 6 20,00 1,67 17,00 21,00 21,00

0,178 6 m. 6 17,83 5,19 8,00 21,00 20,50

12 m. 6 16,83 6,65 6,00 21,00 21,00

PAD test

low

Baseline 5 698,60 1039,51 100,00 2550,00 270,00

0,104 6 m. 5 139,20 135,33 0,00 300,00 150,00

12 m. 5 142,40 123,17 0,00 300,00 138,00

Medium

Baseline 9 613,44 393,15 100,00 1334,00 645,00

0,003 6 m. 9 226,00 633,27 0,00 1913,00 0,00

12 m. 9 86,78 231,63 0,00 703,00 0,00

High

Baseline 6 673,50 424,70 50,00 1200,00 743,50

0,738 6 m. 6 633,50 617,03 0,00 1630,00 629,00

12 m. 6 341,83 344,70 0,00 880,00 241,50

(*) Friedman’s non parametric test

RESULTS

INTERPRETATION OF RESULTS

CONCLUDING MESSAGE