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
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthetic Versus Autologous Sling For Stress Incontinence (SASSI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07276295
- Acronym / sponsor ID
- SASSI / H25-02899
- Conditions
- Urinary Incontinence
- Keywords
- autologous fascia sling, stress predominant urinary incontinence, tension-free vaginal tape
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tension-free vaginal tape | Active comparator | Procedure: tension-free vaginal tape |
| autologous fascia sling | Active comparator | Procedure: autologous fascia sling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous fascia slingParticipants will receive autologous fascia sling as surgery for stress predominant urinary incontinence. | Procedure or surgery | autologous fascia sling |
| tension-free vaginal tapeParticipants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence. | Procedure or surgery | tension-free vaginal tape |
Primary outcome
Objective urinary incontinence status measured by standing cough test
Time frame: 5 years post-op
Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no
Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale
Time frame: 6 months post-op
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roxana Geoffrion principal investigator
University of British Columbia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy Fan (604-806-9829, judy.fan@phc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective urinary incontinence status measured by standing cough test (time frame: 5 years post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.