Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence, Pelvic Floor Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Polyester suture
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: Urine loss on coughing controlled by hemostat behind symphysis Exclusion Criteria: No exclusion criteria
Sites / Locations
- Muğla Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polyester suture arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05733052
First Posted
December 27, 2022
Last Updated
February 16, 2023
Sponsor
Muğla Sıtkı Koçman University
1. Study Identification
Unique Protocol Identification Number
NCT05733052
Brief Title
Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence
Official Title
Pubourethral Plication Procedure (PPP) Cures Stress Urinary Incontinence Without Tapes- First Report.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Floor Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polyester suture arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Polyester suture
Intervention Description
A No2 polyester suture will be used for tying special anatomical structures fr telieving the symptom. of stress urinary incontinence
Primary Outcome Measure Information:
Title
Curing effect of the suturation
Description
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
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urine loss on coughing controlled by hemostat behind symphysis
Exclusion Criteria:
No exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHMET AKIN SIVASLIOGLU, Prof.
Phone
+905322770618
Email
akinsivaslioglu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMET AKIN SIVASLIOGLU, Prof
Organizational Affiliation
Mugla SITKI KOÇMAN UNİVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muğla Training and Research Hospital
City
Muğla
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burcu Harmandar, Assoc.Prof.
Email
burucuharmandar@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence
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