Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

Not Applicable

Recruiting

• Conditions: Urinary Incontinence; Pelvic Floor Disorders
• Interventions: Other: Polyester suture

• Registration Number: NCT05733052
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

To test efficacy and safety at six months of the proposed Pubourethral Plication Procedure (PPP) for cure of stress urinary incontinence - reinforcing pubourethral ligaments (PUL) with large diameter polyester sutures.

Detailed Description

Full thickness vaginal incisions will be made in the suburethral sulci extending from bladder neck to urethral meatus. The operation space is 2.5cm2 space. A No2 or 3 polyester suture will be inserted into PUL, immediately lateral to midurethra, into PUL origin, external urethral ligament, laterally into m.pubococcygeus, then will be tied, but not tightly. The vaginal incisions will be closed with vicryl sutures. All women will be discharged on day of surgery. During the regular follow ups the healing at stress urinary incontinence will be evaluated

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-12-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Urine loss on coughing controlled by hemostat behind symphysis

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polyester suture arm	Polyester suture	A No 3 polyester suture will be inserted into the external urethral ligament, into the uurethral part of pubourethral ligament and into the pubic part of the pubourethral lgament then will be tied, but not tightly. The interventions will be carried on either side of the urethra that will be opened up by an 2.5 cm incision in the periurethral sulci.

Primary Outcome Measures

Name	Time	Method
Curing effect of the suturation	6 months	The plication of pubourethral ligaments with a polyester suture will lead to a neoligament formation; so that the pubourethral ligaments will get strenghened. If the pubourethral ligaments get strengthened woman will not loose urine upon stressful activities such as coughing. Hence the stress test will be negative. And the rate of negative stress test within the cohort will show us the efficinecy of operation in curing urinary incontinence

Trial Locations

Locations (1)

Muğla Training and Research Hospital; 🇹🇷 Muğla, Turkey