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A Randomized Comparison of Transobturator Tape With the Plication of Urethral Ligaments in the Treatment of Stress Urinary Incontinence

NCT06232525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-04-03

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of transobturator tape (TOT) operation and urethral ligament plication operation in stress incontinence patients. The main question:

* Which operation is more effective in treatment of stress incontinence?
* Which operation has less complication and risks? Participants will be followed about 5 days, 2.5 months, 6 months and 1 year after the operation and asked about the continence status and complications.

Conditions

  • Stress Incontinence, Female

Interventions

PROCEDURE

transobturator tape operation (TOT)

TOT surgery: With an 18 French Foley urinary catheter, the sling passes through the skin in the groin, the obturator foramen, the back of the adductor longus tendon, and the midurethral vaginal incision; extends 1 cm below the midpoint of the urethra, the tape is held in place without sutures by its interface with the patient's tissue. After the mesh is placed, the incision in the suburethral midline is closed.

PROCEDURE

urethral ligament plication

Urethral ligament plication: With an 18 French Foley urinary catheter, a vertical incision of approximately 3 cm is made in the anterior-lateral wall sulcus of the vagina on the right and left lines, 2 cm laterally from the midline, with the urethral meatus remaining in the midline, and external urethral ligaments on both sides inferolateral to the urethra, sutured in the midline by using 2-0 or 3-0 polyester sutures on both sides separately. The incised anterior vaginal tissue is closed one by one with 2-0 rapid Vicryl.

Sponsors & Collaborators

  • Alev Esercan

    lead OTHER_GOV

Principal Investigators

  • Peter Emanuel Petros, Prof. · retired

  • Alev Esercan, MD · Sanliurfa Education and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-02-01
Completion
2025-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232525 on ClinicalTrials.gov