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

Alev Esercan

Status: Active, not recruiting

Conditions: Incontinence, Urge; Incontinence Stress

Treatments: Procedure: uterosacral ligament plication, urethral ligament plication

Study type: Interventional

Funder types: Other

Identifiers

NCT07384117

SEAH-USL/ULP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Procedure: uterosacral ligament plication, urethral ligament plication

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

Experimental group

Description:

USL for urge urinary incontinence will be done.

Treatment:

Procedure: uterosacral ligament plication, urethral ligament plication