Stress Urinary IncontinenceMOTOTNCT06924450
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
A study testing 1.2 cm Mesh TOT and 1.0 cm Mesh TOT in people with Stress Urinary Incontinence and Female Urinary Incontinence, run by Izzet Celegen at 1 site in Turkey (Türkiye).
Trial summary
This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Female Urinary Incontinence, Pelvic Floor Dysfunction
- What is being tested?
- 1.2 cm Mesh TOT and 1.0 cm Mesh TOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2025to 12 Nov 2025
- 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
- Female patients aged 18 years or older
- Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
- Positive stress test (urine leakage on coughing with a comfortably full bladder)
- Q-tip test showing urethral hypermobility (>30 degrees)
- Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
- Eligible for transobturator tape (TOT) surgery
- Body mass index (BMI) less than 35 kg/m²
- Able to provide informed consent and follow postoperative instructions
Who cannot join
- History of prior midurethral sling surgery
- Mixed urinary incontinence or urge-dominant symptoms
- Pelvic organ prolapse stage > II according to the POP-Q system
- Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
- Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
- Pregnant or planning to become pregnant within the next 12 months
Show all 9Show fewer
- Severe comorbid conditions (e.g., uncontrolled diabetes mellitus, active malignancy, pelvic radiotherapy)
- Use of medications that significantly affect bladder function (e.g., anticholinergics, diuretics)
- Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Regional Training and Research Hospital, Department of Obstetrics and Gynecology
Van, 65090
Yusuf Başkıran, MD, +90 432 215 76 02, yusuf.baskiran@istinye.edu.tr
Yusuf Başkıran, MD
About this study
This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.
Read the detailed description
This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).
The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.
Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.
Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.
- Being tested
- 1.2 cm Mesh TOT, 1.0 cm Mesh TOT
- Keywords
- Urinary Incontinence, Stress Urinary Incontinence (SUI), Female Pelvic Health, Transobturator Tape (TOT) Procedure, Pelvic Floor Surgery, Surgical Mesh, Randomized Controlled Trial, Urogynecology
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.2 cm Mesh TOTDevice
Patients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications.
1.0 cm Mesh TOTDevice
Patients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width.
| Study group | Role | What they receive |
|---|---|---|
| 1.2 cm Mesh (Intervention Group) | Experimental | Participants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. Receives: Device: 1.2 cm Mesh TOT |
| 1.0 cm Mesh (Control Group) | Active comparator | Participants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure. Receives: Device: 1.0 cm Mesh TOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cure Rate Based on Negative Stress Test
Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.
Measured: 6 months postoperatively
Secondary outcomes (4)
Change in ICIQ-SF Score
Change in total score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), measured before surgery and at 6 months postoperatively. The ICIQ-SF ranges from 0 to 21, with higher scores indicating worse symptom severity and greater impact on quality of life.
Measured: 6 months postoperatively
Incidence of Mesh-Related Complications
Incidence of mesh-related complications including mesh erosion, bladder outlet obstruction, infection, and pain. Complications will be assessed by physical examination and patient-reported symptoms during follow-up visits.
Measured: 6 months postoperatively
Recurrence of Stress Urinary Incontinence
Proportion of patients who present with recurrence of stress urinary incontinence, defined as a positive cough stress test or self-reported symptoms of urine leakage during physical activity.
Time Frame: 6 months postoperatively
Measured: 6 months postoperatively
Patient Satisfaction Score
Patient satisfaction will be measured using a structured questionnaire that includes a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. Assessment will be conducted at the 6-month follow-up visit.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start12 May 2025
- Primary completion12 Nov 2025 (estimated)
- Study completion12 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary 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
- Model description
- This randomized, single-blind parallel-group study compares the surgical outcomes of two mesh widths (1.2 cm vs. 1.0 cm) used in transobturator tape (TOT) surgery for women with stress urinary incontinence (SUI).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izzet Celegen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izzet Celegen, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924450
- Sponsor's protocol ID
- YB-MESH-2025-VAN001
- Other IDs
- EK-090523
- Acronym
- MOTOT
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to confidentiality policies and institutional regulations. Summary-level results may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery
- ClinicalTrials.gov ID
- NCT06924450
- Acronym / sponsor ID
- MOTOT / YB-MESH-2025-VAN001
- Keywords
- Urinary Incontinence, Stress Urinary Incontinence (SUI), Female Pelvic Health, Transobturator Tape (TOT) Procedure, Pelvic Floor Surgery, Surgical Mesh, Randomized Controlled Trial, Urogynecology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Izzet CelegenUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 12 Nov 2025 (estimated)
- Study completion
- 12 Nov 2025 (estimated)
- First posted
- 11 Apr 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 study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.
Detailed description
This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).
The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.
Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.
Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized, single-blind parallel-group study compares the surgical outcomes of two mesh widths (1.2 cm vs. 1.0 cm) used in transobturator tape (TOT) surgery for women with stress urinary incontinence (SUI).
| Arm | Type | Receives |
|---|---|---|
| 1.2 cm Mesh (Intervention Group) | Experimental | Device: 1.2 cm Mesh TOTParticipants in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. |
| 1.0 cm Mesh (Control Group) | Active comparator | Device: 1.0 cm Mesh TOTParticipants in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which represents the standard procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged 18 years or older
- Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
- Positive stress test (urine leakage on coughing with a comfortably full bladder)
- Q-tip test showing urethral hypermobility (>30 degrees)
- Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
Key exclusion criteria (9 listed)
- History of prior midurethral sling surgery
- Mixed urinary incontinence or urge-dominant symptoms
- Pelvic organ prolapse stage > II according to the POP-Q system
- Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
- Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
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 |
|---|---|---|
| 1.2 cm Mesh TOTPatients in this group will undergo transobturator tape (TOT) surgery using a 1.2 cm monofilament polypropylene mesh. The modified mesh width is being evaluated for its effect on surgical success, symptom improvement, and postoperative complications. | Device | 1.2 cm Mesh (Intervention Group) |
| 1.0 cm Mesh TOTPatients in this group will undergo transobturator tape (TOT) surgery using a 1.0 cm monofilament polypropylene mesh, which is the standard procedure. This group serves as a comparator to assess the impact of the modified mesh width. | Device | 1.0 cm Mesh (Control Group) |
Primary outcome
Objective Cure Rate Based on Negative Stress Test
Time frame: 6 months postoperatively
Objective cure will be defined as the absence of urinary leakage during a standardized cough stress test with a comfortably full bladder. The test will be performed by a blinded assessor at 6 months postoperatively.
4 secondary outcomes
Change in ICIQ-SF Score
Time frame: 6 months postoperatively
Incidence of Mesh-Related Complications
Time frame: 6 months postoperatively
Recurrence of Stress Urinary Incontinence
Time frame: 6 months postoperatively
Patient Satisfaction Score
Time frame: 6 months postoperatively
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 11 Jul 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to confidentiality policies and institutional regulations. Summary-level results may be shared upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.2 cm Mesh TOT and 1.0 cm Mesh TOT in people with Stress Urinary Incontinence and Female Urinary Incontinence, run by Izzet Celegen 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 8 inclusion and 9 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 11 Jul 2025. 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?
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 Yusuf Başkıran, Doctor (+905419523468, yusuf.baskiran@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cure Rate Based on Negative Stress Test (time frame: 6 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 11 Jul 2025.