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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07398144
Enrollment
60
Registered
2026-02-09
Start date
2025-05-01
Completion date
2026-03-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Stress Urinary Incontinence

Keywords

laparoscopic Burch, trans obturator tape, TOT, Female Stress Urinary Incontinence, colposuspension, SUI, stress urinary incontinence

Brief summary

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

Detailed 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).

Interventions

laparoscopic Burch colposuspension for female stress urinary incontinence

PROCEDURETrans obturator tape fixation

mid urethral sling for female stress urinary incontinence

Sponsors

Theodor Bilharz Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
success rateat 1, 3 and 6 months post operativethe absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test

Secondary

MeasureTime frame
operative timeday 1 post operative
complicatio ratetill 6 months post operative
hospital stay2 days post operative

Countries

Egypt

Contacts

STUDY_DIRECTORHussein A Hussein, professor of urology

professor of urology , Faculty of medicine , Cairo university

STUDY_CHAIRAhmed I Kamel, professor of urology

professor of urology , Theodor Bilharz Research Institute

STUDY_CHAIRAhmed H Abo-Zamel, assistant professor of urology

assistant professor of urology , Faculty of medicine , Cairo university

STUDY_CHAIRAhmed S Kamel, lecturer of urology

lecturer of urology , Faculty of medicine , Cairo university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026