Stress Incontinence, FemaleaddedNCT06232525
A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
A study testing transobturator tape operation (TOT) and urethral ligament plication in people with Stress Incontinence, Female, run by Alev Esercan at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question: Which operation is more effective in treatment of stress incontinence? Which operation has less complication and risks?… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Incontinence, Female
- What is being tested?
- transobturator tape operation (TOT) and urethral ligament plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 1 Mar 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
- Being 18 years or older
- Presence of stress urinary incontinence symptoms
- Agreeing to have surgery
Who cannot join
- Pregnancy
- Being under 18 years of age
- Suspicion of malignancy
- History of previous mid-urethral sling or urinary incontinence surgery
- Being diagnosed with intrinsic sphincter (urethral) insufficiency
- Urinary incontinence due to neurological bladder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Education and Research Hospital
Sanliurfa, 63250
About this study
The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question:
- Which operation is more effective in treatment of stress incontinence?
- Which operation has less complication and risks? Participants will be followed about 5 days, 2.5 months, 6 months and 1 year after the operation and asked about the continence status and complications.
Read the detailed description
The study will be a double-blind, prospective experimental study. When examining patients with stress urinary incontinence complaints, POP-Q staging in terms of pelvic organ prolapse before surgery, symptom interrogation in the examination of the anterior/middle and posterior compartments based on the Integral Theory in the pelvic floor examination, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female sexual function scale (FSFI) scales will be filled in to evaluate sexual functions. One group of patients will undergo transobturator tape (TOT), and the other group will undergo urethral ligament plication surgery.
Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient.
At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, the patients were called for control and examined by the same doctor, different from the doctors who wrote the surgery and the publication. POP-Q staging was performed again in terms of pelvic organ prolapse, based on the Integral Theory in the pelvic floor examination. During the examination of the anterior/middle and posterior compartments, symptom inquiry, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female Sexual Function Scale (FSFI) scales will be filled in for the evaluation of sexual functions. The FSFI survey has 19 questions; It evaluates 6 main factors: sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and after multiplying the coefficients, the highest score is 36 and the lowest score is 2. Impact coefficients used to score the entire scale; It was determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction and pain/discomfort. A FSFI score below 26.55 is defined as compatible with sexual dysfunction. Additionally, if there are any complications, they will be recorded in detail.
- Conditions
- Stress Incontinence, Female
- Being tested
- transobturator tape operation (TOT), urethral ligament plication
- Keywords
- transobturator tape, urethral ligament plication
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transobturator tape operation (TOT)Procedure or surgery
TOT surgery: With an 18 French Foley urinary catheter, the sling passes through the skin in the groin, the obturator foramen, the back of the adductor longus tendon, and the midurethral vaginal incision; extends 1 cm below the midpoint of the urethra, the tape is held in place without sutures by its interface with the patient's tissue. After the mesh is placed, the incision in the suburethral midline is closed.
urethral ligament plicationProcedure or surgery
Urethral ligament plication: With an 18 French Foley urinary catheter, a vertical incision of approximately 3 cm is made in the anterior-lateral wall sulcus of the vagina on the right and left lines, 2 cm laterally from the midline, with the urethral meatus remaining in the midline, and external urethral ligaments on both sides inferolateral to the urethra, sutured in the midline by using 2-0 or 3-0 polyester sutures on both sides separately. The incised anterior vaginal tissue is closed one by one with 2-0 rapid Vicryl.
| Study group | Role | What they receive |
|---|---|---|
| transobturator tape operation group | Active comparator | Patients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo TOT surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not). Receives: Procedure: transobturator tape operation (TOT) |
| urethral ligament plication group | Active comparator | Patients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo urethral ligament plication surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not). Receives: Procedure: urethral ligament plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective finding of no urinary incontinence
The patient has no urinary incontinence and a significant decrease in the UDI-6 score.
Measured: After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)
Objective finding of no urinary incontinence
Tap test negativity (if the patient's bladder is filled with 300cc physiological saline and the patient is made to cough and no urine leakage is observed, it is considered negative)
Measured: After the first day of the operation day and all of the follow-up(postoperative 5th day, 2.5 th month, 6th month and first year)
Secondary outcomes (1)
complications
the presence of postoperative complications; Any complications such as presence of urinary incontinence, leg pain, inability to urinate, hematuria, pelvic organ injury
Measured: postoperative 5th day, 2.5 th month, 6th month and first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start2 Jan 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, FemaleStudies 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
- In the double-blind study, one group of patients with stress urinary incontinence will undergo transobturator tape surgery and the other group of patients will undergo urethral ligament plication surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alev Esercan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Alev Esercan, Sanliurfa Education and Research Hospital
- Investigators
- Peter Emanuel Petros, Prof., Study director, retiredAlev Esercan, MD, Principal investigator, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232525
- Sponsor's protocol ID
- SEAH-63
- Acronym
- added
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06232525
- Acronym / sponsor ID
- added / SEAH-63
- Conditions
- Stress Incontinence, Female
- Keywords
- transobturator tape, urethral ligament plication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Alev EsercanOther government
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Jan 2024 (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.
The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question:
- Which operation is more effective in treatment of stress incontinence?
- Which operation has less complication and risks? Participants will be followed about 5 days, 2.5 months, 6 months and 1 year after the operation and asked about the continence status and complications.
Detailed description
The study will be a double-blind, prospective experimental study. When examining patients with stress urinary incontinence complaints, POP-Q staging in terms of pelvic organ prolapse before surgery, symptom interrogation in the examination of the anterior/middle and posterior compartments based on the Integral Theory in the pelvic floor examination, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female sexual function scale (FSFI) scales will be filled in to evaluate sexual functions. One group of patients will undergo transobturator tape (TOT), and the other group will undergo urethral ligament plication surgery.
Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient.
At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, the patients were called for control and examined by the same doctor, different from the doctors who wrote the surgery and the publication. POP-Q staging was performed again in terms of pelvic organ prolapse, based on the Integral Theory in the pelvic floor examination. During the examination of the anterior/middle and posterior compartments, symptom inquiry, Urogenital Distress Inventory (UDI-6) for the evaluation of urinary incontinence and Female Sexual Function Scale (FSFI) scales will be filled in for the evaluation of sexual functions. The FSFI survey has 19 questions; It evaluates 6 main factors: sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain/discomfort. The highest total raw score that can be obtained in this scale is 95, the lowest raw score is 4, and after multiplying the coefficients, the highest score is 36 and the lowest score is 2. Impact coefficients used to score the entire scale; It was determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, and 0.4 for orgasm, satisfaction and pain/discomfort. A FSFI score below 26.55 is defined as compatible with sexual dysfunction. Additionally, if there are any complications, they will be recorded in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the double-blind study, one group of patients with stress urinary incontinence will undergo transobturator tape surgery and the other group of patients will undergo urethral ligament plication surgery.
| Arm | Type | Receives |
|---|---|---|
| transobturator tape operation group | Active comparator | Procedure: transobturator tape operation (TOT)Patients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo TOT surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not). |
| urethral ligament plication group | Active comparator | Procedure: urethral ligament plicationPatients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo urethral ligament plication surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years or older
- Presence of stress urinary incontinence symptoms
- Agreeing to have surgery
Key exclusion criteria (6 listed)
- Pregnancy
- Being under 18 years of age
- Suspicion of malignancy
- History of previous mid-urethral sling or urinary incontinence surgery
- Being diagnosed with intrinsic sphincter (urethral) insufficiency
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 operation (TOT)TOT surgery: With an 18 French Foley urinary catheter, the sling passes through the skin in the groin, the obturator foramen, the back of the adductor longus tendon, and the midurethral vaginal incision; extends 1 cm below the midpoint of the urethra, the tape is held in place without sutures by its interface with the patient's tissue. After the mesh is placed, the incision in the suburethral midline is closed. | Procedure or surgery | transobturator tape operation group |
| urethral ligament plicationUrethral ligament plication: With an 18 French Foley urinary catheter, a vertical incision of approximately 3 cm is made in the anterior-lateral wall sulcus of the vagina on the right and left lines, 2 cm laterally from the midline, with the urethral meatus remaining in the midline, and external urethral ligaments on both sides inferolateral to the urethra, sutured in the midline by using 2-0 or 3-0 polyester sutures on both sides separately. The incised anterior vaginal tissue is closed one by one with 2-0 rapid Vicryl. | Procedure or surgery | urethral ligament plication group |
Primary outcome
Subjective finding of no urinary incontinence
Time frame: After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)
The patient has no urinary incontinence and a significant decrease in the UDI-6 score.
Objective finding of no urinary incontinence
Time frame: After the first day of the operation day and all of the follow-up(postoperative 5th day, 2.5 th month, 6th month and first year)
Tap test negativity (if the patient's bladder is filled with 300cc physiological saline and the patient is made to cough and no urine leakage is observed, it is considered negative)
1 secondary outcome
complications
Time frame: postoperative 5th day, 2.5 th month, 6th month and first year
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 3 Apr 2025.
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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.
Peter Emanuel Petros, Prof. study director
retired
Alev Esercan, MD principal investigator
Sanliurfa Education and Research Hospital
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 operation (TOT) and urethral ligament plication in people with Stress Incontinence, Female, run by Alev Esercan 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 3 inclusion and 6 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 3 Apr 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?
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?
Subjective finding of no urinary incontinence (time frame: After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)). 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 3 Apr 2025.