Pubourethral Ligament Plication for the Surgical Treatment of Stress Urinary Incontinence

Muğla Sıtkı Koçman University

Status: Enrolling

Conditions: Pelvic Floor Disorders; Urinary Incontinence

Treatments: Other: Polyester suture

Study type: Interventional

Funder types: Other

Identifiers

NCT05733052

11/VII

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urine loss on coughing controlled by hemostat behind symphysis

Exclusion criteria

• No exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Polyester suture arm

Experimental group

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.

Treatment:

Other: Polyester suture