Urinary IncontinenceSASSINCT07276295
Synthetic Versus Autologous Sling For Stress Incontinence
A study testing autologous fascia sling and tension-free vaginal tape in people with Urinary Incontinence, run by University of British Columbia at 7 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- autologous fascia sling and tension-free vaginal tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 7 sitesCanada
- Study dates
- 12 Jan 2026to Dec 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females at birth (female anatomy, any gender)
- Aged 18 years or older (19 years or older for BC participants)
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
Kelowna General Hospital
Kelowna, British Columbia
Judy Fan, 604-806-9829, judy.fan@phc.ca
Jennifer Locke
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
Jessica Pudwell, 613-549-6666 ext. 3937, jessica.pudwell@queensu.ca
Sophia Badowski
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Teresa Flaxman, 613-761-4522, tflaxman@ohri.ca
Aisling Clancy
- Recruiting
St. Paul's Hospital; Saskatoon City Hospital
Saskatoon, Saskatchewan
Judy Fan, 604-806-9829, judy.fan@phc.ca
Garson Chan
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Judy Fan, 604-806-9829, judy.fan@phc.ca
Roxana Geoffrion
- Recruiting
Vancouver General Hospital; UBC Hospital
Vancouver, British Columbia
Judy Fan, 604-806-9829, judy.fan@phc.ca
Kate Anderson
- Recruiting
Victoria General Hospital
Victoria, British Columbia
Judy Fan, 604-806-9829, judy.fan@phc.ca
Emily Sandwith
About this study
Official title: Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial
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.
- Conditions
- Urinary Incontinence
- Being tested
- autologous fascia sling, tension-free vaginal tape
- Keywords
- autologous fascia sling, stress predominant urinary incontinence, tension-free vaginal tape
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fascia slingProcedure or surgery
Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence.
tension-free vaginal tapeProcedure or surgery
Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence.
| Study group | Role | What they receive |
|---|---|---|
| tension-free vaginal tape | Active comparator | Not described Receives: Procedure: tension-free vaginal tape |
| autologous fascia sling | Active comparator | Not described Receives: Procedure: autologous fascia sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective urinary incontinence status measured by standing cough test
Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no
Measured: 5 years post-op
Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale
Proportion of participants who report new abdominopelvic pain with an average intensity greater than 3 on a 0-10 Likert pain intensity scale over the past 6 months
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start12 Jan 2026
- Primary completionJun 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Roxana Geoffrion, University of British Columbia
- Investigators
- Roxana Geoffrion, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276295
- Sponsor's protocol ID
- H25-02899
- Acronym
- SASSI
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No