Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

NCT ID: NCT05733052

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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

Conditions

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Urinary Incontinence Pelvic Floor Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Polyester suture

Intervention Type OTHER

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

Interventions

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Polyester suture

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Urine loss on coughing controlled by hemostat behind symphysis
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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AHMET AKIN SIVASLIOĞLU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHMET AKIN SIVASLIOGLU, Prof

Role: PRINCIPAL_INVESTIGATOR

Mugla SITKI KOÇMAN UNİVERSITY

Locations

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Muğla Training and Research Hospital

Muğla, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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AHMET AKIN SIVASLIOGLU, Prof.

Role: CONTACT

+905322770618

Facility Contacts

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Burcu Harmandar, Assoc.Prof.

Role: primary

Other Identifiers

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11/VII

Identifier Type: -

Identifier Source: org_study_id

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