Neurourology and Urodynamics 35:44–47 (2016)

Update on 2-Year Outcomes of the TOMSTM Transobturator Male Sling for the Treatment of Male Stress Urinary Incontinence € tow, Juliette Parisot, Odile Lingombet, Deborah Augustin, Alexandre de la Taille, Rene Yiou,* Zentia Bu Laurent Salomon, and Etienne Audureau

Assistance Publique des Ho^pitaux de Paris, Henri Mondor Teaching Hospital-Urology Department and CRCDC, Creteil, France Aims: To update the 2-year outcomes of the TOMSTM transobturator male sling for treating post-prostatectomy urinary incontinence (pRP-UI) in a group of patients previously evaluated at 1 year. Methods: We prospectively followed 40 patients with pRP-UI before and 6, 12, and 24 months after implantation of the TOMSTM transobturator male sling. Urinary symptoms were evaluated using the following questionnaires: USP, ICIQ, UCLA-PCI (urinary bother domain), PGI-I, and daily pad use. Success was defined as patients wearing no or only one security pad. We also report on any other surgical procedures for treating persistent incontinence during the follow-up period. Results: Of 40 patients included in the 1-year follow-up, seven required additional surgical treatment. In the remaining patients (n ¼ 33), significant improvement (P < 0.001) compared to baseline was seen, and a subsequent tendency (non-significant) toward impairment was noted throughout the three postoperative follow-ups for the ICIQ (14.4  4.4 [baseline], 7.6  5.7 [6 months], 8.1  5.6 [12 months], 8.9  5.5 [24 months]), USP-stress urinary (6.7  2.2, 2.8  2.4, 2.8  2.4, 3.2  2.8), ULCA-PCI-urinary bother (10.0  12.5, 66.0  33.0, 64.0  31.5, 62.0  30.7) scores, and pad use (2.5  1.2, 0.7  1.1, 0.8  1.2, 0.9  1.2). Significant impairment in postoperative PGI-I (6.2  0.9, 6.1  0.9, 5.8  1.1, P ¼ 0.028) and USPoveractive bladder symptoms scores (5.4  3.6 [6 months] vs. 6.6  3.7 [24 months], P ¼ 0.046) were noted. A total of 18 (54.5%), 17 (51.5%), and 15 (45.5%) patients wore no postoperative pad, respectively. Conclusion: Approximately half of the patients continue to wear no pad 2 years after TOMSTM transobturator male sling implantation. However, a tendency toward impaired continence, possibly associated with overactive bladder symptoms, was noted. Neurourol. Urodynam. 35:44–47, 2016. # 2014 Wiley Periodicals, Inc. Key words: male sling; overactive bladder; radical prostatectomy; urinary incontinence INTRODUCTION

The transobturator male sling is the standard treatment for moderate post-radical prostatectomy urinary incontinence (pRP-UI).1 Few studies have reported a follow-up longer than 1 year; in several of these studies, only one postoperative continence assessment was reported.2–4 Therefore, there is a lack of information concerning the stability of the effects of the transobturator male sling. We recently described the prospective results of 40 patients treated for pRP-UI using the TOMSTM transobturator male sling with a 1-year follow-up.5 Here we report the 2-year follow-up of the same group of patients. The aim was to investigate the stability of the results of this device.

MATERIALS AND METHODS

We completed a prospective 24-month evaluation of the 40 patients referred to our department between January 2010 and January 2012 for pRP-UI who were treated with the TOMSTM transobturator male sling as previously described.5 The mean age at the time of implantation was 67.7  7.0 years. We used the following questionnaires at baseline and at 6, 12, and 24 months postoperatively to assess the effects of the sling implantation: (1) UCLA Prostate Cancer Index (UCLA-PCI) Urinary Bother Item/Domain (score range, 0–100, with 0 corresponding to the poorest value).6 (2) ICIQ-SF (score range, 0–21).7 #

2014 Wiley Periodicals, Inc.

(3) Patient’s Global Impression of Improvement (PGI-I; score range, 1–7)8 assessed after surgery. (4) USP to evaluate stress urinary incontinence (SUI; score range, 0–9), overactive bladder (OAB; score range, 0–21), and urinary obstructive symptoms (score range, 0–9).9 (5) The number of pads used daily was recorded at each visit. Success at the 2-year follow-up was defined as the patient either not wearing pads or using one security pad but remaining dry most days. Improvement was defined as the patient using 2 pads/day and a minimum 50% reduction in the number of pads used. We also reported any other surgical procedures used to treat persistent incontinence in the followup period. No patients were lost to follow-up and the actual attrition rate was null. Statistical analyses were performed using Stata v12.1 (StataCorp, College Station, TX). Descriptive results are presented as means (standard deviation). Comparisons between repeated paired measures at baseline and at 6, 12, and Dirk De Ridder led the peer-review process as the Associate Editor responsible for the paper. R Yiou is consultant for CL Medical, AMS and Laborie.  Correspondence to: Rene Yiou, Assistance Publique des H^ opitaux de Paris, Henri Mondor Teaching Hospital-Urology Department and CRCDC, 51 av Marechal de Lattre de Tassigny, Creteil 94010, France. E-mail: [email protected] Received 13 April 2014; Accepted 15 July 2014 Published online 12 October 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.22668

TOMSTM Transobturator Male Sling 24 months (M6, M12, and M24, respectively) were performed globally using Skillings–Mack tests completed when significant by post-hoc pairwise Wilcoxon signed rank tests between baseline and M6, M6 and M12, M12 and M24, and baseline and M24, correcting for multiple comparisons using the Benjamini– Hochberg procedure. The Mann–Whitney rank-sum test was used to compare continuous variables between independent groups (patients requiring further surgery after male sling implantation versus not requiring further surgery). A X2 test was used to compare the percentage of patients cured/not cured at M6 and M24. P values