Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

Sponsor

Muğla Sıtkı Koçman University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05733052

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Pelvic Floor Disorders	Other: Polyester suture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polyester suture arm 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 A No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence

Arm

Intervention/Treatment

Experimental: Polyester suture arm

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Urine loss on coughing controlled by hemostat behind symphysis

Exclusion Criteria:

No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Muğla Training and Research Hospital	Muğla		Turkey

Sponsors and Collaborators

Muğla Sıtkı Koçman University

Investigators

Principal Investigator: AHMET AKIN SIVASLIOGLU, Prof, Mugla SITKI KOÇMAN UNİVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AHMET AKIN SIVASLIOĞLU, Professor, Muğla Sıtkı Koçman University

ClinicalTrials.gov Identifier:

NCT05733052

Other Study ID Numbers:

11/VII

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 17, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Pelvic Floor Disorders

Study Results

No Results Posted as of Feb 17, 2023