Stress Urinary Incontinence in WomenNCT07312617
Short-Term Outcomes of TOT, TVT, and Burch Surgery Assessed by Transperineal Ultrasound
A study testing Transobturator Tape (TOT) Procedure, Tension-Free Vaginal Tape (TVT) Procedure and Burch Colposuspension Procedure in people with Stress Urinary Incontinence in Women and Pelvic Floor Disorders, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence in Women, Pelvic Floor Disorders
- What is being tested?
- Transobturator Tape (TOT) Procedure, Tension-Free Vaginal Tape (TVT) Procedure and Burch Colposuspension Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older
- Diagnosis of stress urinary incontinence based on clinical evaluation
- Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension
- Ability to provide written informed consent
- Willingness to participate in the study and comply with follow-up visits
Who cannot join
- Mixed or urge-predominant urinary incontinence
- Previous anti-incontinence or pelvic floor surgery
- Neurogenic bladder disorders
- Active urinary tract infection at the time of evaluation
- Pregnancy or planned pregnancy during the study period
- Known pelvic malignancy
- Inability to undergo transperineal ultrasonographic evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children Diseases Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Anatomical and Subjective Short-term Outcomes of TOT, TVT, and Burch Colposuspension: A Randomized Controlled Trial Using Transperineal Ultrasound
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.
The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.
The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
- Being tested
- Transobturator Tape (TOT) Procedure, Tension-Free Vaginal Tape (TVT) Procedure, Burch Colposuspension Procedure
- Keywords
- sui, tpus
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator Tape (TOT) ProcedureProcedure or surgery
Also called tot
Placement of a synthetic tape beneath the mid-urethra via the transobturator route.
Tension-Free Vaginal Tape (TVT) ProcedureProcedure or surgery
Placement of a synthetic tape beneath the mid-urethra using a retropubic approach.
Burch Colposuspension ProcedureProcedure or surgery
Suspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| tot | Active comparator | Participants underwent mid-urethral sling surgery for the treatment of stress urinary incontinence. Receives: Procedure: Transobturator Tape (TOT) Procedure |
| tvt | Active comparator | Participants in this arm underwent tension-free vaginal tape (TVT) surgery for the treatment of stress urinary incontinence. Receives: Procedure: Tension-Free Vaginal Tape (TVT) Procedure |
| Burch Colposuspension | Active comparator | Participants in this arm underwent Burch colposuspension surgery for the treatment of stress urinary incontinence. Receives: Procedure: Burch Colposuspension Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery.
Measured: Baseline (preoperative) and 3 months postoperatively
Secondary outcomes (1)
Subjective Improvement in Stress Urinary Incontinence Symptoms
Subjective outcomes were assessed using the Urogenital Distress Inventory-Short Form (UDI-6) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). For both scales, scores range from 0 to 100, where higher scores indicate a greater impact of symptoms and worse quality of life.
Measured: Baseline and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Apr 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence in WomenStudies 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
- Model description
- Participants were assigned to one of three parallel intervention groups (TOT, TVT, or Burch colposuspension), and each participant received only one type of surgical intervention. Outcomes were assessed and compared between groups during the same follow-up period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem boz izceyhan, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312617
- Sponsor's protocol ID
- 37/2023
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anatomical and Subjective Short-term Outcomes of TOT, TVT, and Burch Colposuspension: A Randomized Controlled Trial Using Transperineal Ultrasound
- ClinicalTrials.gov ID
- NCT07312617
- Acronym / sponsor ID
- 37/2023
- Keywords
- sui, tpus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 31 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.
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.
The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.
The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants were assigned to one of three parallel intervention groups (TOT, TVT, or Burch colposuspension), and each participant received only one type of surgical intervention. Outcomes were assessed and compared between groups during the same follow-up period.
| Arm | Type | Receives |
|---|---|---|
| tot | Active comparator | Procedure: Transobturator Tape (TOT) ProcedureParticipants underwent mid-urethral sling surgery for the treatment of stress urinary incontinence. |
| tvt | Active comparator | Procedure: Tension-Free Vaginal Tape (TVT) ProcedureParticipants in this arm underwent tension-free vaginal tape (TVT) surgery for the treatment of stress urinary incontinence. |
| Burch Colposuspension | Active comparator | Procedure: Burch Colposuspension ProcedureParticipants in this arm underwent Burch colposuspension surgery for the treatment of stress urinary incontinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18 years or older
- Diagnosis of stress urinary incontinence based on clinical evaluation
- Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension
- Ability to provide written informed consent
- Willingness to participate in the study and comply with follow-up visits
Key exclusion criteria (7 listed)
- Mixed or urge-predominant urinary incontinence
- Previous anti-incontinence or pelvic floor surgery
- Neurogenic bladder disorders
- Active urinary tract infection at the time of evaluation
- Pregnancy or planned pregnancy during the study period
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 |
|---|---|---|
| Transobturator Tape (TOT) ProcedureAlso: totPlacement of a synthetic tape beneath the mid-urethra via the transobturator route. | Procedure or surgery | tot |
| Tension-Free Vaginal Tape (TVT) ProcedurePlacement of a synthetic tape beneath the mid-urethra using a retropubic approach. | Procedure or surgery | tvt |
| Burch Colposuspension ProcedureSuspension of the anterior vaginal wall to the iliopectineal (Cooper's) ligament using non-absorbable sutures. | Procedure or surgery | Burch Colposuspension |
Primary outcome
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
Time frame: Baseline (preoperative) and 3 months postoperatively
The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery.
1 secondary outcome
Subjective Improvement in Stress Urinary Incontinence Symptoms
Time frame: Baseline and 3 months postoperatively
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 8 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator Tape (TOT) Procedure, Tension-Free Vaginal Tape (TVT) Procedure and Burch Colposuspension Procedure in people with Stress Urinary Incontinence in Women and Pelvic Floor Disorders, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 7 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 8 Jan 2026. 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 Turkey (Türkiye). 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?
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound (time frame: Baseline (preoperative) and 3 months postoperatively). 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 8 Jan 2026.