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NCT Number: NCT07398144

Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence.

The goal of this prospective interventional study is to compare the effectiveness of laparoscopic Burch colposuspension versus trans obturator tape in the treatment of stress urinary incontinence in adult females. The success rate will be compared between the two proceudres at 1, 3 and 6 months post operatively. Operative times, hospital stay and perioperative complications will be evaluated in both arms

Participants will be asked to:

* complete the ICIQ-UI-SF questionnaire pre operatively and at 1, 3 and 6 months post operatively * undergo a pelvic examination pre operatively * undergo cough stress test pre operatively and at 1, 3 and 6 months post operatively * undergo a pressure flow study test pre operatively * undergo pelviabdominal ultrasound with post void residual urine measurement pre operatively and at 1, 3 and 6 months post operatively * undergo uroflowmetry at 1 month post operatively

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospitals, Giza, Giza Governorate, Egypt

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About this study

This is a prospective randomized study that is conducted at Theodor Bilharz research institute and Cairo university hospital. the study will include 60 female patients with genuine stress urinary incontinence allocated randomly to 2 groups; group A will undergo laparoscopic Burch colposuspension and group B which will undergo trans obturator tape fixation.

The investigators aim to evaluate the success rates of laparoscopic Burch colposuspension and TOT procedures in treatment of female SUI. Objective cure rates, assessed by cough stress test or pad weight test. ( A cure is defined as the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test. operation time and length of hospital stay as well as early outcomes, complications and continence rates at 1 month, 3 months and 6 months will be recorded and compared.

Inclusion criteria

  • Clinical Diagnosis of SUI: Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
  • Documented stress urinary incontinence by physical examination and urodynamic testing.
  • Adult female patients typically aged 18 years or older.
  • Completed Non-Surgical Management:

Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.

  • Willingness to Undergo Surgery

Exclusion criteria

  • Mixed urinary Incontinence
  • Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
  • Previous Anti-Incontinence Surgery
  • Neurological Conditions:

Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.

  • Pregnancy
  • Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
  • Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
  • Previous history of radiotherapy to the pelvis.
  • Contraindications to surgery such as uncorrectable coagulation disorders

Methodology All patients will provide oral and written consent before participating in any study-related procedures.

Preoperative Assessment:

  • History ((using validated questionnaire (International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) and physical examination to confirm stress incontinence and exclude overactive bladder syndrome.
  • Pelvic examination to rule out pelvic organ prolapse.
  • Routine preoperative labs (CBC, coagulation profile, electrolytes)
  • Urodynamic studies to confirm SUI
  • Pelvi-abdominal Ultrasonography to measure PVR.
  • Urine culture and sensitivity to exclude urinary tract infection. post operative work up:
  • Catheter removal after 24 hours.and monitoring for urine retention and catheterization if required
  • follow up scheduled at 1 month, 3 months and 6 months postoperatively targeting success rate, PVR and complications. (uroflowmetry at 1 month-visit)

Primary Outcomes:

Objective cure rates, assessed by cough stress test or pad weight test ( we use the pad test when the cough test is negative but the patient reports leakage during daily activities or patient is still has leakage after operation to compare the number of pads preoperatively and post-operatively ). ( A cure is defined as the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test.)

Secondary Outcomes:

  • Improvement in SUI symptoms (e.g., using validated questionnaires (International Consultation on Incontinence Questionnaire).
  • Comparing Peri-operative and early outcomes (e.g. hemoglobin loss, operation time, and length of hospital stay.).
  • Intraoperative and early complications (e.g. Bladder injury, infection, De novo urge incontinence, and Acute Urinary Retention, post-void residual volume).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Diagnosis of SUI:

Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.

  • Documented stress urinary incontinence by physical examination and urodynamic testing.
  • Adult female patients typically aged 18 years or older.
  • Completed Non-Surgical Management:

Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.

  • Willingness to Undergo Surgery

Exclusion criteria

  • virgin female
  • mixed urinary Incontinence
  • Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
  • Previous Anti-Incontinence Surgery
  • Neurological Conditions:

Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.

  • Pregnancy
  • Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
  • Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
  • Previous history of radiotherapy to the pelvis.
  • Contraindications to surgery such as uncorrectable coagulation disorders

Treatment and study plan

Laparoscopic Burch Colposuspension

Procedure

laparoscopic Burch colposuspension for female stress urinary incontinence

Trans obturator tape fixation

Procedure

mid urethral sling for female stress urinary incontinence

Primary outcomes

  1. success rate

    Time frame: at 1, 3 and 6 months post operative

    the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test

Secondary outcomes

  1. operative time

    Time frame: day 1 post operative

  2. complicatio rate

    Time frame: till 6 months post operative

  3. hospital stay

    Time frame: 2 days post operative

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study title

Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence. A Prospective Randomized Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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