Urinary Stress IncontinenceMUSTNCT02480231
Mid-Urethral Sling Tensioning Trial
A study testing Retropubic Midurethral Sling in people with Urinary Stress Incontinence, run by University of Calgary at 1 site in Canada.
Trial summary
Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Retropubic Midurethral Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Women who have elected for surgical management of symptomatic urinary incontinence
- Ability to read \& write in English
- Other prolapse surgery at time of sling placement is allowed
- Must consent to participation in trial
Who cannot join
- Women with a prior incontinence procedure
- Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
- Declines participation in trial
- Women with existing urinary retention or significant overactive bladder (requiring medication)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Foothills Hospital, University of Calgary
Calgary, Alberta, T2N 4J8
About this study
Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Retropubic Midurethral Sling
- Keywords
- Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retropubic Midurethral SlingDevice
Also called Tension free Vaginal Tape
| Study group | Role | What they receive |
|---|---|---|
| Babcock tensioning technique | Active comparator | Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp. Receives: Device: Retropubic Midurethral Sling |
| Scissor spacer technique | Active comparator | Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer. Receives: Device: Retropubic Midurethral Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal Bladder Function
Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation.
Measured: 1 year post operative
Secondary outcomes (5)
Rate of discharge from hospital with on-going need for catheterization
Measured: 12 months
Duration of catheterization after surgery
Measured: 12 months
Questionnaire scores
standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire)
Measured: 12 months
Pad test
Standardized 1 hour pad test values
Measured: 12 month
Uroflow parameters
Maximum urine flow rate, post void residual
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- 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
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Erin Brennand, University of Calgary
- Investigators
- Erin A Brennand, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480231
- Sponsor's protocol ID
- REB15-0455
- Acronym
- MUST
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2015
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brennand EA, Chai J, Cummings S, Huang B, Hughes T, Edwards A, Ramirez AC; Calgary Women's Pelvic Health Research Group. Babcock versus Scissor Tensioning for Retropubic Mid-Urethral Slings: Comparing Two Intra-Operative Techniques Through 5 Years of Follow-Up. Int Urogynecol J. 2025 Feb;36(2):279-287. doi: 10.1007/s00192-024-05916-y. Epub 2024 Oct 1.
PubMed 39352429Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.
PubMed 32769657
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Urethral Sling Tensioning Trial
- ClinicalTrials.gov ID
- NCT02480231
- Acronym / sponsor ID
- MUST / REB15-0455
- Conditions
- Urinary Stress Incontinence
- Keywords
- Tension-Free Vaginal Tape, Suburethral Slings, Midurethral Slings, Mid-urethral sling, urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Sep 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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.
Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babcock tensioning technique | Active comparator | Device: Retropubic Midurethral SlingGroup for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp. |
| Scissor spacer technique | Active comparator | Device: Retropubic Midurethral SlingGroup for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Women who have elected for surgical management of symptomatic urinary incontinence
- Ability to read \& write in English
- Other prolapse surgery at time of sling placement is allowed
- Must consent to participation in trial
Key exclusion criteria (4 listed)
- Women with a prior incontinence procedure
- Clinically obvious, but non-symptomatic stress urinary incontinence (latent stress incontinence)
- Declines participation in trial
- Women with existing urinary retention or significant overactive bladder (requiring medication)
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 |
|---|---|---|
| Retropubic Midurethral SlingAlso: Tension free Vaginal Tape | Device | Babcock tensioning technique, Scissor spacer technique |
Primary outcome
Abnormal Bladder Function
Time frame: 1 year post operative
Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation.
5 secondary outcomes
Rate of discharge from hospital with on-going need for catheterization
Time frame: 12 months
Duration of catheterization after surgery
Time frame: 12 months
Questionnaire scores
Time frame: 12 months
Pad test
Time frame: 12 month
Uroflow parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Derived from this study: PubMed 39352429Brennand EA, Chai J, Cummings S, Huang B, Hughes T, Edwards A, Ramirez AC; Calgary Women's Pelvic Health Research Group. Babcock versus Scissor Tensioning for Retropubic Mid-Urethral Slings: Comparing Two Intra-Operative Techniques Through 5 Years of Follow-Up. Int Urogynecol J. 2025 Feb;36(2):279-287. doi: 10.1007/s00192-024-05916-y. Epub 2024 Oct 1.
- Derived from this study: PubMed 32769657Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Erin A Brennand, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retropubic Midurethral Sling in people with Urinary Stress Incontinence, run by University of Calgary at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal Bladder Function (time frame: 1 year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480231, which also lists 2 linked publications.
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 1 Apr 2020.