At a glance
ClinicalIndex Comparison RecordN/ACompleted· 281 enrolled
Drug / intervention
Solyx Single Incision Sling System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
In Brief
A clinical study evaluating Solyx Single Incision Sling System and Obtryx II Sling System for Stress Urinary Incontinence. Completed, enrolled 281 participants across 23 sites in 2 countries.
Detailed Summary
The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesAustralia, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartJun 2013
Primary CompletionJan 2018
TodayJul 2026
First PostedFeb 6, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.4 years ago
Interventions
Solyx Single Incision Sling Systemdevice
Solyx Single Incision Sling System
Obtryx II Sling Systemdevice
Standard outside-in transobturator sling