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NCT05733052 Clinical Trial

Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:
Pubourethral Plication Procedure (PPP) Cures Stress Urinary Incontinence Without Tapes- First Report.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05733052
Other study ID # 11/VII
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2023

Study information
Verified date February 2023
Source Mugla Sitki Koçman University
Contact AHMET AKIN SIVASLIOGLU, Prof.
Phone +905322770618
Email akinsivaslioglu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility Inclusion Criteria: - Urine loss on coughing controlled by hemostat behind symphysis Exclusion Criteria: - No exclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Polyester suture
A No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence

Locations
Country Name City State
Turkey Mugla Training and Research Hospital Mugla

Sponsors (1)
Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Curing effect of the suturation 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 6 months
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