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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06211894
• Other study ID #: e27
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2024
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Dysfunction
• Ultrasonography
• Urinary Incontinence

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Cemil Tascioglu City Hospital	Istanbul
Turkey	Prof.Dr.Cemil Tascioglu Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Primary	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)	6 months