The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.

NCT ID: NCT06211894

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-01-01

Brief 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. 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.

Conditions

Urinary Incontinence; Sexual Dysfunction; Ultrasonography

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

transobturator tape

Intervention Type: PROCEDURE

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.

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.

transobturator tape

Intervention Type: PROCEDURE

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.

Interventions

transobturator tape

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-Continent patients ages 18 to 45 who underwent mid-urethral sling (MUS) surgery due to isolated SUI were included in the study

Exclusion Criteria

• 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,
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

fatih sahin

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cemil Tascıoglu City Hospital

Istanbul, , Turkey (Türkiye)

Prof.Dr.Cemil Taşcıoğlu Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

e27

Identifier Type: -

Identifier Source: org_study_id