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Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05733052
Enrollment
36
Registered
2023-02-17
Start date
2022-06-01
Completion date
2023-06-01
Last updated
2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Pelvic Floor Disorders

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

Interventions

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

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Urine loss on coughing controlled by hemostat behind symphysis

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Curing effect of the suturation6 monthsThe 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

Countries

Turkey (Türkiye)

Contacts

Primary ContactAHMET AKIN SIVASLIOGLU, Prof.
akinsivaslioglu@gmail.com+905322770618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026