Long-term Outcomes of Urethral and Uterosacral Ligament Plication

NCT07384117 | Active Not Recruiting

• 1 other identifier: SEAH-USL/ULP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.

Conditions

Incontinence Stress; Incontinence, Urge

Keywords

stress urinary incontinence; urge urinary incontinence

Outcome Measures

Primary Outcomes (1)

• The success (continence) rates after the operations

  Urinary incontinence status will be evaluated by Integral Theory Questionnaire and examinations at postoperative first and second year

  At postoperative first and second year

Secondary Outcomes (1)

• The complications

  At second postoperative year

Study Arms (2)

Urinary incontinent patients will have surgeries according to their incontinence type "stress"

EXPERIMENTAL

Urethral plication surgery (ULP) will be done for stress incontinence

Procedure: uterosacral ligament plication, urethral ligament plication

Urinary incontinent patients will have surgeries according to their incontinence type "urge"

EXPERIMENTAL

USL for urge urinary incontinence will be done.

Procedure: uterosacral ligament plication, urethral ligament plication

Interventions

uterosacral ligament plication, urethral ligament plication PROCEDURE

Urethral ligament plication: With an 18-inch French Foley catheter inserted, a vertical incision of approximately 3 cm is made in the sulcus of the anterior-lateral vaginal wall, 2 cm laterally on each side of the midline, ensuring the urethral meatus remains midline. The external urethral ligaments are located inferolateral to the urethra on both sides, the urethral portion of the pubourethral ligament (PUL) is located midline, and the lateral portion of the PUL is located laterally. Using 2-0 polyester sutures, the ligaments are sutured separately on both sides to form a loop. The incised anterior vaginal tissue is then closed individually with 2-0 rapid polyglactin sutures. Uterosacral ligament plication: A 18F Foley catheter inserted, in the lithotomy position; the posterior cervical lip is grasped with a tenaculum, and elevated outwards and upwards. Leaving rectovaginal fascia and rectum posterior; suturing the both uterosacral ligament by 2-0 polyester sutures in the midline.

Urinary incontinent patients will have surgeries according to their incontinence type "stress"; Urinary incontinent patients will have surgeries according to their incontinence type "urge"

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women with urinary incontinence at any ages
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)
• Agreement to undergo surgery
• No contraindications for anesthesia for surgery

You may not qualify if:

• Pregnancy
• Being under 18 years of age
• Suspicion of malignancy
• Urinary incontinence due to neurogenic bladder
• Presence of intrinsic sphincter (urethral) insufficiency

Sponsors & Collaborators

• Alev Esercan: lead

Study Sites (1)

Sanliurfa Education and Training Hospital

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Emanuel Papa Petros, Prof.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 1 March 2026, the data will be available.
• Access Criteria: Data sharing site and doi will be shared if it is asked to access.

Locations

TU (1)