Long-term Outcomes of Urethral and Uterosacral Ligament Plication (ULP-USL)

Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Incontinence, Urge; Incontinence Stress
• Intervention / Treatment: Procedure: uterosacral ligament plication, urethral ligament plication

Detailed Description

For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated.

This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Sanliurfa, Turkey (Türkiye)
    • Sanliurfa Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)

  • Agreement to undergo surgery
  • No contraindications for anesthesia for surgery

Exclusion Criteria:

• Pregnancy

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urinary incontinent patients will have surgeries according to their incontinence type "stress"; Urethral plication surgery (ULP) will be done for stress incontinence	Procedure: uterosacral ligament plication, urethral ligament plication; 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.
Experimental: Urinary incontinent patients will have surgeries according to their incontinence type "urge"; USL for urge urinary incontinence will be done.	Procedure: uterosacral ligament plication, urethral ligament plication; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The complications	Any complication seen after until postoperative second year	At second postoperative year

Collaborators and Investigators

• Sponsor: Alev Esercan
• Investigators: Study Director: Peter Emanuel Papa Petros, Prof.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 10, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stress urinary incontinence; urge urinary incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: SEAH-USL/ULP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected during the study will be shared.
• IPD Sharing Time Frame: From 1 March 2026, the data will be available.
• IPD Sharing Access Criteria: Data sharing site and doi will be shared if it is asked to access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No