Urinary IncontinenceNCT06211894
The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.
An observational study of Urinary Incontinence and Sexual Dysfunction, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial summary
Urinary incontinence, commonly observed among women aged 30 to 60, encompasses Stress Urinary Incontinence (SUI), responsible for the majority of cases. This condition significantly affects the quality of life, influencing physical, emotional, and sexual aspects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Incontinence, Sexual Dysfunction, Ultrasonography
- What is being tested?
- transobturator tape
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Between January 2020 and January 2022, a total of 82 continent patients ages 18 to 45 who underwent MUS surgery due to isolated SUI were included in the study
Who may be able to join
- -Continent patients ages 18 to 45 who underwent mid-urethral sling (MUS) surgery due to isolated SUI were included in the study
Who cannot join
- Patients who experienced surgical failure in incontinence surgery,
- who had undergone previous vaginal surgeries, who had a history of hysterectomy,
- who underwent additional surgeries during the same session,
- who had pelvic organ prolapse, who had received radiation therapy,
- who had a diagnosis of malignancy,
- who were menopausal, who received external hormone treatment,
Show all 10Show fewer
- who were sexually inactive, whose partners had erectile dysfunction,
- who did not attend postoperative follow-up appointments,
- who became postoperatively pregnant,
- who had undergone non-synthetic mesh (autologous fascia) surgery for SUI were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cemil Tascıoglu City Hospital
Istanbul, 34320
Prof.Dr.Cemil Taşcıoğlu Hospital
Istanbul, 34320
About this study
Urinary incontinence, commonly observed among women aged 30 to 60, encompasses Stress Urinary Incontinence (SUI), responsible for the majority of cases. This condition significantly affects the quality of life, influencing physical, emotional, and sexual aspects. Severe cases impact libido and cause vaginal dryness, affecting not just sexual function but also relationships, leading to an overall decline in quality of life. Hence, examining sexual functions in those affected by SUI holds significance.
The study aimed to evaluate the impact of mesh-urethra distance on sexual functions using perineal ultrasound in continent patients post-transobturator tape (TOT) surgery for isolated SUI.
Read more
Patients achieving continence post-surgery were categorized based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and > 5 mm.
Questionnaires, including the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), were administered preoperatively and at the 6-month postoperative follow-up.
Read the detailed description
Urinary incontinence, often seen in women aged 30 to 60, involves Stress Urinary Incontinence (SUI) in most cases. It significantly affects life, impacting physical, emotional, and sexual well-being. Severe cases can lower sex drive and cause vaginal dryness, affecting not just the individual's sex life but also relationships, leading to a lower quality of life overall. That's why looking at how SUI affects sexual aspects is crucial.
The study aimed to see how the distance between the mesh and urethra after transobturator tape (TOT) surgery might affect sexual function in patients who no longer experienced incontinence. Patients were divided based on this distance, and surveys like the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) were used before and six months after surgery.
- Conditions
- Urinary Incontinence, Sexual Dysfunction, Ultrasonography
- Being tested
- transobturator tape
- Keywords
- Female stress incontinence, transobturator tape, transperineal ultrasound
- Medical subject headings
- Urinary Incontinence, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transobturator tapeProcedure or surgery
transobturator tape :The surgeon makes a small incision in the vagina and small incisions in the right and left groin. The surgical process is similar to the retropubic approach, but the mesh passes through the groin muscles rather than the abdominal wall. transperineal ultrasound: patients who underwent TOT and were evaluated with transperineal ultrasonography, women with incontinence 6 months after the surgery showed discrepancies in the movement of the urethra with the sling compared to continent women, along with asymmetry between the mesh arms, bladder neck descent, and varied sling positions.
| Study group | Role | What they receive |
|---|---|---|
| the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm | Patients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent. Receives: Procedure: transobturator tape | |
| the urethra at the bladder neck to the nearest proximal edge of the tape: > 5 mm | Patients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent. Receives: Procedure: transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the significance of postoperative FSFI scores on sexual functions in patients with continent status who underwent TOT surgery due to isolated SUI.
The primary outcome measure involves assessing the impact of postoperative FSFI (Female Sexual Function Index) scores specifically on the sexual functions of patients who have maintained continence status and underwent TOT (Transobturator Tape) surgery attributable to isolated Stress Urinary Incontinence (SUI)
Measured: 6 months
To assess the significance of sexual functions using The ICIQ-UI SF score in patients with continence status who underwent TOT surgery due to isolated SUI.
evaluating the relevance of sexual functions utilizing The ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score among patients maintaining continence status following Transobturator Tape (TOT) surgery due to isolated Stress Urinary Incontinence (SUI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2020
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatih sahin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211894
- Sponsor's protocol ID
- e27
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.
- ClinicalTrials.gov ID
- NCT06211894
- Acronym / sponsor ID
- e27
- Conditions
- Urinary Incontinence, Sexual Dysfunction, Ultrasonography
- Keywords
- Female stress incontinence, transobturator tape, transperineal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 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.
Urinary incontinence, commonly observed among women aged 30 to 60, encompasses Stress Urinary Incontinence (SUI), responsible for the majority of cases. This condition significantly affects the quality of life, influencing physical, emotional, and sexual aspects. Severe cases impact libido and cause vaginal dryness, affecting not just sexual function but also relationships, leading to an overall decline in quality of life. Hence, examining sexual functions in those affected by SUI holds significance.
The study aimed to evaluate the impact of mesh-urethra distance on sexual functions using perineal ultrasound in continent patients post-transobturator tape (TOT) surgery for isolated SUI.
Patients achieving continence post-surgery were categorized based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and > 5 mm.
Questionnaires, including the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), were administered preoperatively and at the 6-month postoperative follow-up.
Detailed description
Urinary incontinence, often seen in women aged 30 to 60, involves Stress Urinary Incontinence (SUI) in most cases. It significantly affects life, impacting physical, emotional, and sexual well-being. Severe cases can lower sex drive and cause vaginal dryness, affecting not just the individual's sex life but also relationships, leading to a lower quality of life overall. That's why looking at how SUI affects sexual aspects is crucial.
The study aimed to see how the distance between the mesh and urethra after transobturator tape (TOT) surgery might affect sexual function in patients who no longer experienced incontinence. Patients were divided based on this distance, and surveys like the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) were used before and six months after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm | – | Procedure: transobturator tapePatients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent. |
| the urethra at the bladder neck to the nearest proximal edge of the tape: > 5 mm | – | Procedure: transobturator tapePatients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Between January 2020 and January 2022, a total of 82 continent patients ages 18 to 45 who underwent MUS surgery due to isolated SUI were included in the study
Key inclusion criteria (1 listed)
- -Continent patients ages 18 to 45 who underwent mid-urethral sling (MUS) surgery due to isolated SUI were included in the study
Key exclusion criteria (10 listed)
- Patients who experienced surgical failure in incontinence surgery,
- who had undergone previous vaginal surgeries, who had a history of hysterectomy,
- who underwent additional surgeries during the same session,
- who had pelvic organ prolapse, who had received radiation therapy,
- who had a diagnosis of malignancy,
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 tapetransobturator tape :The surgeon makes a small incision in the vagina and small incisions in the right and left groin. The surgical process is similar to the retropubic approach, but the mesh passes through the groin muscles rather than the abdominal wall. transperineal ultrasound: patients who underwent TOT and were evaluated with transperineal ultrasonography, women with incontinence 6 months after the surgery showed discrepancies in the movement of the urethra with the sling compared to continent women, along with asymmetry between the mesh arms, bladder neck descent, and varied sling positions. | Procedure or surgery | the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm, the urethra at the bladder neck to the nearest proximal edge of the tape: > 5 mm |
Primary outcome
To evaluate the significance of postoperative FSFI scores on sexual functions in patients with continent status who underwent TOT surgery due to isolated SUI.
Time frame: 6 months
The primary outcome measure involves assessing the impact of postoperative FSFI (Female Sexual Function Index) scores specifically on the sexual functions of patients who have maintained continence status and underwent TOT (Transobturator Tape) surgery attributable to isolated Stress Urinary Incontinence (SUI)
To assess the significance of sexual functions using The ICIQ-UI SF score in patients with continence status who underwent TOT surgery due to isolated SUI.
Time frame: 6 months
evaluating the relevance of sexual functions utilizing The ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score among patients maintaining continence status following Transobturator Tape (TOT) surgery due to isolated Stress Urinary Incontinence (SUI)
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 18 Jan 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Sexual Dysfunction, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites 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 1 inclusion and 10 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To evaluate the significance of postoperative FSFI scores on sexual functions in patients with continent status who underwent TOT surgery due to isolated SUI. (time frame: 6 months). 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 18 Jan 2024.