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

Theodor Bilharz Research Institute

Status

Active, not recruiting

Conditions

Female Stress Urinary Incontinence

Treatments

Procedure: laparoscopic Burch colposuspension

Procedure: Trans obturator tape fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT07398144

MD-94-2025

Details and patient eligibility

About

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

Full description

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).

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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