Fixed or Adjustable Sling in the Treatment of Male Stress Urinary Incontinence

Results From a Large Cohort Study

Tanja Hüsch; Alexander Kretschmer; Alice Obaje; Ruth Kirschner-Hermanns; Ralf Anding; Tobias Pottek; Achim Rose; Roberto Olianas; Alexander Friedl; Roland Homberg; Jesco Pfitzenmaier; Rudi Abdunnur; Fabian Queissert; Carsten M. Naumann; Josef Schweiger; Carola Wotzka; Joanne Nyarangi-Dix; Torben Hofmann; Kurt Ulm; Wilhelm Hübner; Ricarda M. Bauer; Axel Haferkamp

Disclosures

Transl Androl Urol. 2020;9(3):1099-1107.

Methods

The study was approved by the local ethics committee of Frankfurt university hospital (ethic vote number 442/13). We conducted a multicenter single arm cohort study including a total of 470 patients who have received a fixed or adjustable MS for male stress urinary incontinence in the study centers between 2010 and 2012. Patients were enrolled retrospectively in Germany and Austria, thus, selection criteria for a fixed or adjustable sling was not standardized. Baseline characteristics, perioperative data and complication rates were collected retrospectively according the medical record. Standardised and validated questionnaires were prospectively completed by the patients at time of enrolment. A signed informed consent was mandatory for this investigation. The following questionnaires were used: "Incontinence – Quality of Life"^[9] (I-QoL; scale: 0–100, a higher score represents better QoL), "Patient Global Impression – Improvement"^[10] (PGI-I; range 1–7, very much better to very much worse), "International Consultation on Incontinence Questionnaire – Short Form"^[11,12] (ICIQ-SF; range: 0–21, 0: no incontinence, 1–5: slight, 6–12: moderate, 13–18: severe, 19–21: very severe), "Verbal Rating Scale of Pain" (VRS; range 0–10, a higher score represents more pain). Furthermore, the number of pads used per day and a 24-hour pad test were evaluated. Complications were evaluated according the Clavien Dindo Classification.^[13] Results were compared between the fixed and adjustable MS group. Functional outcome of fixed and adjustable MS group was additionally correlated with the confounders grade of incontinence,^[1–3] history of pelvic irradiation and prior surgery for urethral stricture disease. Additional subgroup analysis was performed in case of significant differences between the groups to identify confounder by utilized device. Quantitative variables were not grouped. Missing data have been handled in an available cases analysis approach.

Statistical Analysis

Statistical analysis was performed by IBM SPSS (Armonk, New York, United States) Statistics Version 22 for Macintosh. Descriptive statistic was applied for presentation of population characteristics, complication rates and outcome. A chi²-test for categorical and independent t-test for continuous variables was performed to identify heterogeneity between the groups. Correlations of baseline categorial variables with continence outcome were performed by the chi²-test. A significance level of 5% was determined.

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Table 1. Patients' baseline characteristics compared between fixed and adjustable slings
Variable	Fixed slings	Adjustable slings	P value
Age, years, mean ± SD (range)	69.4±6.8 (49–100)	69.9±6.8 (48–84)	0.529
BMI, kg/m², mean ± SD (range)	27.5±3.8 (18.2–38.4)	27.3±3.1 (20.9–36.9)	0.610
Weight of the 24 h-pad test, g, mean ± SD (IQR)	313.1±286.9 (5–1,200)	471.7±533.4 (15–3,500)	0.124
Number of pads preoperative, mean ± SD (IQR)	3.8±2.2 (1–15)	5.8±2.7 (1–20)	<0.001*
Grade of incontinence, mean ± SD (IQR)	1.9±0.5 (1–3)	2.3±0.5 (2–3)	<0.001*
Origin of incontinence, n (%)			-
Radical prostatectomy	279 (94.9)	157 (89.2)
TUR-Prostate	15 (5.1)	16 (9.1)
Brachytherapy	0	1 (0.6)
Prostate adenomenucleation	0	2 (1.1)
Diabetes mellitus, n (%)	37 (12.6)	35 (19.9)	0.033*
History of pelvic irradiation, n (%)	34 (11.6)	40 (22.7)	0.001*
Prior surgery for SUI, n (%)	17 (5.8)	40 (22.7)	<0.001*
Prior surgery for urethral stricture, n (%)	41 (13.9)	38 (21.6)	0.032*

*, significance P<0.05.

Table 2. Postoperative complications in comparison between fixed and adjustable slings
Variable	Fixed slings	Adjustable slings	P value
Clavien Dindo grade I, n (%)
Bleeding	0	2 (1.1)	0.067
Urinary retention	23 (7.8)	13 (7.4)	0.863
Clavien Dindo grade II, n (%)
Impaired wound healing	2 (0.7)	5 (2.8)	0.061
DeNovo Urge	22 (7.5)	6 (3.4)	0.071
Clavien Dindo grade III, n (%)
Urethral erosion	0	1 (0.6)	0.196
Infection	0	4 (2.3)	0.009*
Clavien Dindo grade I and III, n (%)
Pain	5 (1.7)	21 (11.9)	<0.001*

*, significance P<0.05.

Table 3. Results of the questionnaires in comparison to fixed and adjustable slings
Variable	Fixed slings	Adjustable slings	P-value
ICIQ-SF score, mean (SD)	8.0 (5.6)	8.6 (4.8)	0.444
I-QoL score, mean (SD)
Subscales, mean (SD)	84.5 (22.4)	84.1 (21.2)	0.897
Avoidance and limiting behaviour	30.0 (8.0)	30.4 (7.7)	0.376
Psychosocial impacts	36.0 (9.4)	34.8 (9.4)	0.415
Social embarrassment	18.5 (5.8)	19.2 (5.1)	0.784
PGI-I, mean (SD)	2.2 (1.5)	1.7 (1.0)	0.059
Better, (%)	81.5	93.4
No change, (%)	9.7	3.9
Worse, (%)	8.9	2.6
IPSS, mean (SD)	5.1 (0.5)	4.4 (0.5)	0.574
VRS Pain, mean (SD)
Perineum	0.3 (0.9)	1.1 (1.5)	<0.001*
Genitals	0.3 (0.8)	0.8 (1.3)	0.002*
Symphysis	0.2 (0.5)	0.5 (0.9)	<0.001*
Inguinal groin	0.2 (0.7)	0.7 (1.1)	<0.001*
Number of pads/day, mean (SD)	1.5 (1.4)	1.5 (1.3)	0.751
24 h pad test, g, mean (SD)	54.9 (151.3)	66.6 (163.5)	0.681

ICIQ-SF, International Consultation on Incontinence Questionnaire –Short Form; I-QoL, Incontinence – Quality of Life; PGI-I, Patient Global Impression of Improvement; IPSS, International Prostate Symptome Score; VRS, Verbale Rating Scale of Pain. SD, standard deviation. *, significance P<0.05.

Authors and Disclosures

Tanja Hüsch^1,2, Alexander Kretschmer^3,4, Alice Obaje⁵, Ruth Kirschner-Hermanns⁶, Ralf Anding⁶, Tobias Pottek⁷, Achim Rose⁸, Roberto Olianas⁹, Alexander Friedl¹⁰, Roland Homberg¹¹, Jesco Pfitzenmaier¹², Rudi Abdunnur¹³, Fabian Queissert¹⁴, Carsten M. Naumann¹⁵, Josef Schweiger¹⁶, Carola Wotzka¹⁷, Joanne Nyarangi-Dix¹⁸, Torben Hofmann¹⁹, Kurt Ulm²⁰, Wilhelm Hübner²¹, Ricarda M. Bauer³ and Axel Haferkamp¹; Debates On Male Incontinence (DOMINO)-Project

¹Department of Urology and Pediatric Urology, University Medical Center of Johannes Gutenberg University, Mainz, Germany; ²Promedon GmbH, Clinical Research, Kolbermoor, Germany; ³Department of Urology, Ludwig-Maximilians-University, Munich, Germany; ⁴Vancouver Prostate Center, University of British Columbia, Vancouver, Canada; ⁵Department of Urology, St. Bernward Hospital Hildesheim, Hildesheim, Germany; ⁶Neuro-Urology/Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany; ⁷Reconstructive Urology, Vivantes Hospital, Berlin, Germany; ⁸Department of Urology and Pediatric Urology, Helios Hospital Duisburg, Duisburg, Germany; ⁹Department of Urology, Hospital Luneburg, Luneburg, Germany; ¹⁰Department of Urology, Merciful Sisters Hospital, Vienna, Austria; ¹¹Department of Urology and Pediatric Urology, St. Barbara Hospital Hamm GmbH, Hamm, Germany; ¹²Department of Urology, Evangelic Hospital Bielefeld, Bielefeld, Germany; ¹³Department of Urology and Pediatric Urology, Helios Hospital Schwelm, Schwelm, Germany; ¹⁴Department of Urology, University Hospital Muenster, Muenster, Deutschland; ¹⁵Department of Urology and Pediatric Urology, Marienhaus Hospital Neuwied, Neuwied, Germany; ¹⁶Department of Urology and Pediatric Urology, Catholic Hospital St. Johann Nepomuk, Erfurt, Germany; ¹⁷Department of Urology, Diakonie Hospital Stuttgart, Stuttgart, Germany; ¹⁸Department of Urology and Pediatric Urology, University Hospital Heidelberg, Heidelberg, Germany; ¹⁹Department of Urology, Diakonie Hospital Schwaebisch Hall, Schwaebisch Hall, Germany; ²⁰Institute of medical Statistic and Epidemiology, Technical University Munich, Munich, Germany; ²¹Department of Urology, Hospital Weinviertel Korneuburg, Korneuburg, Austria

Correspondence to
Tanja Hüsch, MD. Department of Urology and Pediatric Urology, University Medical Center of Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131 Mainz, Germany. Email: tanjahuesch@gmail.com.

Contributions
(I) Conception and design: T Hüsch, A Kretschmer, A Obaje, R Anding, R Kirschner-Hermanns, T Pottek, A Rose, R Olianas, A Friedl, W Hübner, R Homberg, J Pfitzenmaier, R Abdunnur, F Queissert, CM Naumann, J Schweiger, C Wotzka, J Nyarangi-Dix, T Hofmann, K Ulm, RM Bauer, A Haferkamp; (II) Administrative Support: A Kretschmer; (III) Provision of study materials or patients: A Obaje, R Anding, R Kirschner-Hermanns, T Pottek, A Rose, R Olianas, A Friedl, W Hübner, R Homber, J Pfitzenmaier, R Abdunnur, F Queissert, CM Naumann, J Schweiger, C Wotzka, J Nyarangi-Dix, T Hofmann, RM Bauer, A Haferkamp; (IV) Collection and assembly of data: T Hüsch, A Kretschmer; (V) Data analysis and interpretation: T Hüsch, K Ulm; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Conflict of Interest
All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tau-19-852). TH reports personal fees from Promedon, outside the submitted work. TP reports personal fees from Teleflex, personal fees from Zephyr, personal fees from AMS, outside the submitted work. RA reports personal fees and other from Boston Scientific, personal fees and other from Promedon, outside the submitted work. CMN reports personal fees and other from Coloplast, outside the submitted work. WH reports non-financial support and other from Uromedia, non-financial support and other from Promedon, outside the submitted work. RMB reports personal fees and other from Boston Scientific, personal fees and other from Promedon, outside the submitted work. The other authors have no conflicts of interest to declare.