N/A
N=168
Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
Urinary Incontinence, Stress
Bottom Line
View on ClinicalTrials.gov: NCT02506309 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants With Negative Cough Stress Test (CST) — 86.4; 83.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TOT - inside-out trans-obturator tape/sling (Device); SIS - Innovative fixation single incision sling (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Brno University Hospital
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Negative Cough Stress Test (CST) |
86.4; 83.1 | — |
| PRIMARY Patient Global Impression of Improvement (PGI-I) Score |
1.4; 1.3 | — |
| SECONDARY Number of Participants With Major Perioperative Complications |
0; 0 | — |
| SECONDARY Number of Participants With Major Postoperative Complications |
0; 0 | — |
Summary
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
Eligibility Criteria
Inclusion Criteria
Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.
Exclusion Criteria
- patients with predominant urge incontinence
- patients with intrinsic sphincter deficiency (MUCP 2)
- previous urinary incontinence surgery
- previous pelvic organ prolapse surgery
- presence of other pelvic organ pathology.
Data sourced from ClinicalTrials.gov (NCT02506309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.