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

NCT06211894 | Completed

• 1 other identifier: e27
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Incontinence; Sexual Dysfunction; Ultrasonography

Keywords

Female stress incontinence; transobturator tape; transperineal ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Procedure: transobturator tape

Interventions

transobturator tape 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; the urethra at the bladder neck to the nearest proximal edge of the tape: > 5 mm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (2)

Cemil Tascıoglu City Hospital

Istanbul, 34320, Turkey (Türkiye)

Location

Prof.Dr.Cemil Taşcıoğlu Hospital

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Sexual Dysfunction, Physiological

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 18, 2024
• Study Start: January 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)