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Synthetic Versus Autologous Sling For Stress Incontinence

NCT ID: NCT07276295

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2032-12-31

Brief Summary

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This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.

Detailed Description

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Conditions

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Urinary Incontinence

Keywords

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autologous fascia sling stress predominant urinary incontinence tension-free vaginal tape

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tension-free vaginal tape

Group Type ACTIVE_COMPARATOR

tension-free vaginal tape

Intervention Type PROCEDURE

Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.

autologous fascia sling

Group Type ACTIVE_COMPARATOR

autologous fascia sling

Intervention Type PROCEDURE

Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.

Interventions

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autologous fascia sling

Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.

Intervention Type PROCEDURE

tension-free vaginal tape

Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult females at birth (female anatomy, any gender)
* Greater than or equal to 60 years old
* Have stress predominant urinary incontinence (spUI) eligible for both types of surgery (tension-free vaginal tape and autologous fascia sling)
* Exhausted conservative management options for UI (Kegel's exercises, physiotherapy, pessary)
* Completed childbearing
* Able to follow up with clinic visits for up to five years after surgery

Exclusion Criteria

* Clinical Frailty Score of 6 or more, as moderate frailty is likely associated with excessive postoperative deterioration
* Concurrent pelvic surgery
* Neurogenic bladder
* Previous UI surgery
* Previous pelvic radiation
* Previous mesh exposure
* Presence of pelvic pain for more than three months in the last five years
* Likely unable to follow up
* Immunocompromised individuals receiving immunosuppressive medications for at least 3 months
* Chronic systemic steroid use for at least 3 months for autoimmune diseases
* Unable to stop smoking for at least 3 months prior to surgery and at high risk of restart smoking post-operatively
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Roxana Geoffrion

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H25-02899

Identifier Type: -

Identifier Source: org_study_id