Clinical trial NCT06211894: The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.
Official title: The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Sexual Dysfunction
Ultrasonography
Keywords: Female stress incontinence
transobturator tape
transperineal ultrasound
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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.

Primary outcomes:
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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cemil Tascıoglu City Hospital
city: Istanbul
country: Turkey
facility: Prof.Dr.Cemil Taşcıoğlu Hospital
Study officials:
References: