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NCT01784588 · ClinicalTrials.gov registry record · NA
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 281
- Enrollment target
NCT01784588: Completed NA study, sponsored by Boston Scientific Corporation.
NCT01784588 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 281 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01784588, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 281 participants
- Enrollment target
Study 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.
Primary Outcome
An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little bette
Interventions
- DEVICE Solyx Single Incision Sling System
- DEVICE Obtryx II Sling System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-01-17 |
| Phase | NA |
What the finished NCT01784588 record still lists
NCT01784588 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Solyx Single Incision Sling System is the first listed.
NCT01784588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01784588 about?
NCT01784588 is a clinical study titled "Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence". 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.
What is the current status of trial NCT01784588?
This trial is currently completed. It is a NA study. The enrollment target is 281 participants. The study started on 2013-06. Estimated completion is 2018-01-17.
What interventions are being tested in trial NCT01784588?
The interventions under investigation include: Solyx Single Incision Sling System (DEVICE), Obtryx II Sling System (DEVICE).
Who is sponsoring clinical trial NCT01784588?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01784588's enrollment target sits among peer trials
281 380th of 2000 higher than 1,621 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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