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

May 2, 2023 updated by: Henry Chill, NorthShore University HealthSystem

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women presenting to our tertiary urogynecology clinic with stress urinary incontinence symptoms based on their answers to PFDI-20 questionnaire and deciding to proceed with surgical treatment of SUI will be invited to participate in this study. Baseline screening will include our standard clinical pathway, which includes symptom review and standard questionnaires, standard vaginal and, urodynamic study and 3D pelvic floor ultrasound. If clinical and ultrasound imaging findings are consistent with SUI in setting of normal urethral closure pressure but lack of urethral support that is state of the art indication for mid-urethral sling procedure, patients will be offered this mesh-reduced mini-sling mesh-reduced sling for treating their condition.

For patients expressing interest, the study procedures and consent will be reviewed during this office visit. Consent will be signed at the following pre-op visit. This study will involve no additional pre-operative tests or questionnaires, beyond our routine clinical pathway for women presenting with SUI with or without pelvic prolapse.

Surgical method Patients participating in this study will undergo standard preoperative and peri-operative care, and anesthetic and pain management care, identical than that which occurs for any pelvic reconstructive surgery within our division. Coexisting pelvic prolapse repairs such as cystocele and rectocele repair, with or without hysterectomy, will be performed per routine.

For treating SUI, the dissection will be completely identical to mid-urethral sling. The difference will be instead of passing the mesh through the tunnels on each side of urethra and exiting through rectus fascia, the investigators will use a ¾ x ⅜ inch polypropylene mesh and place it under the mid urethral. This mesh will be suspended by two suspending permanent sutures on each side to the pubic rami periosteum. At this point sutures will be tied down and the vaginal skin closed with a 2-0 vicryl suture.

Postoperative care This procedure entails no additional or specific post-operative activity limitations or care in comparison to the existing baseline pelvic organ prolapse surgeries. The investigators anticipate that all patients will be discharged from the hospital consistent with normal patterns, either on the same day of surgery or after a brief hospital stay, depending on the meeting of postoperative milestones and discharge criteria.

Follow up Patients will return to the office for postoperative visits at 2 weeks, 2 months, and 12 months after surgery. During the 2-month and 12 month follow-up visits, a vaginal exam and pelvic floor ultrasound will be performed to evaluate healing and urethral motion.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Northshore University Health System
        • Contact:
        • Principal Investigator:
          • Henry Chill, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Symptomatic stress urinary incontinence

Exclusion Criteria:

  • Women of childbearing age (0-45 years)
  • Previous stress urinary incontinence surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh-reduced Sling
Mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFDI-20 score
Time Frame: 12 months post-op
Pelvic Floor Disability Index (PFDI-20) score indicating SUI symptom severity. Higher values indicate greater distress or worse outcome. The sub-scales score ranges from 0 to 100. The summary score ranges from 0 to 300.
12 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication measured by distal urethral swing angle
Time Frame: 12 months post-op

Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.

This will be measured by distal urethral swing angle during Valsalva measured via pelvic ultrasound.
12 months post-op
Complication measured by proximal urethral swing angle
Time Frame: 12 months post-op

Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.

This will be measured by proximal urethral swing angle during Valsalva measured via pelvic ultrasound.
12 months post-op
Complication measured by early and remote post-operative complications
Time Frame: 12 months post-op

Investigate the efficacy of this mesh-reduced suture based surgical technique on key urethral support defects observed with 3D ultrasound.

This will be measured by early and remote postoperative complications.
12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Investigators

  • Principal Investigator: Henry Chill, MD, Northshore University Healthsystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH22-464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared with other investigators listed in the study within NorthShore University Health System.

IPD Sharing Time Frame

Data will become available during data collection until after publication.

IPD Sharing Access Criteria

Other investigators within NorthShore University Health System who are listed on the study delegation log will receive individual participant data during data collection for use during data analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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