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Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial

NCT05842005 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-03

No results posted yet for this study

Summary

The goal of this pilot study is to report the safety and efficacy of a suture-suspended mesh-reduced sling for treating stress urinary incontinence (SUI) in women.

The main question\[s\] it aims to answer are:

* investigate the efficacy of this mesh-reduced suture-based surgical technique for improving SUI symptoms
* investigate the efficacy of this mesh-reduced suture-based surgical technique on key urethral support defects observed with 3D ultrasound Participants will consent to participate following which they will complete pre-operative assessments according to our routine clinical pathway. The participant will then undergo surgery and will be followed up to 12 months post-operatively via symptom assessment and pelvic exam.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Mesh-reduced Sling

In this proposed study, the investigators aim to evaluate the role of using a ¾ x ⅜ inch cm polypropylene mesh suspended by sutures as a mesh-reduced solution for SUI.

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Henry Chill, MD · Endeavor Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842005 on ClinicalTrials.gov