Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

NCT05733052 | Unknown

• 1 other identifier: 11/VII
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Polyester suture arm

EXPERIMENTAL

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.

Other: Polyester suture

Interventions

Polyester suture OTHER

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

Polyester suture arm

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Urine loss on coughing controlled by hemostat behind symphysis

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Training and Research Hospital

Muğla, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

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; Pregnancy Complications

Study Officials

• AHMET AKIN SIVASLIOGLU, Prof

  Mugla SITKI KOÇMAN UNİVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMET AKIN SIVASLIOGLU, Prof.

CONTACT

+905322770618; akinsivaslioglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 17, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)