Clinical Trials Logo
  1. Home
  2. Urinary Incontinence
  3. NCT05733052
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3