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

NCT06232525 | Completed

• 1 other identifier: SEAH-63
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transobturator tape; urethral ligament plication

Outcome Measures

Primary Outcomes (2)

• Subjective finding of no urinary incontinence

  The patient has no urinary incontinence and a significant decrease in the UDI-6 score.

  After the first day of the operation day and all of the follow-up (postoperative 5th day, 2.5 th month, 6th month and first year)

• Objective finding of no urinary incontinence

  Tap test negativity (if the patient's bladder is filled with 300cc physiological saline and the patient is made to cough and no urine leakage is observed, it is considered negative)

  After the first day of the operation day and all of the follow-up(postoperative 5th day, 2.5 th month, 6th month and first year)

Secondary Outcomes (1)

• complications

  postoperative 5th day, 2.5 th month, 6th month and first year

Study Arms (2)

transobturator tape operation group

ACTIVE COMPARATOR

Patients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo TOT surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not).

Procedure: transobturator tape operation (TOT)

urethral ligament plication group

ACTIVE COMPARATOR

Patients who are decided to undergo surgery due to stress urinary incontinence are the group who will undergo urethral ligament plication surgery through a lottery system where the computer program will decide on the surgeon who will perform the surgery, without being told which surgery they will have (both surgeries will be performed through the mid-urethral approach and the patient will not be told whether mesh is used or not).

Procedure: urethral ligament plication

Interventions

transobturator tape operation (TOT) PROCEDURE

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.

transobturator tape operation group

urethral ligament plication PROCEDURE

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.

urethral ligament plication group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female urinary incontinence study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years or older
• Presence of stress urinary incontinence symptoms
• Agreeing to have surgery

You may not qualify if:

• Pregnancy
• Being under 18 years of age
• Suspicion of malignancy
• History of previous mid-urethral sling or urinary incontinence surgery
• Being diagnosed with intrinsic sphincter (urethral) insufficiency
• Urinary incontinence due to neurological bladder

Sponsors & Collaborators

• Alev Esercan: lead

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, 63250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

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 Petros, Prof.

  retired

  STUDY DIRECTOR

• Alev Esercan, MD

  Sanliurfa Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients who are decided to have surgery due to stress urinary incontinence will undergo TOT surgery and urethral plication surgery, without being told which surgery they will have (both surgeries will be performed with the mid-urethral approach and the patient will not be told whether mesh is used or not), with a draw system in which the computer program will decide on the surgeon who will perform the surgery. The surgeon will always be the same person (Esercan A), and on the morning of the surgery, he will be told about the surgery he will perform and will be asked not to share it with the patient. At the end of the 5th day, 2.5 months, 6 months and 1 year after the surgery, patients will be called for a check-up and examined by the same doctor, different from the doctors who performed the surgery and wrote the publication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrics and Gynecologist, MD

Model Details: In the double-blind study, one group of patients with stress urinary incontinence will undergo transobturator tape surgery and the other group of patients will undergo urethral ligament plication surgery.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 30, 2024
• Study Start: January 2, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2024-01

Locations

TU (1)