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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Female Stress Urinary Incontinence
• Intervention / Treatment: Procedure: laparoscopic Burch colposuspension; Procedure: Trans obturator tape fixation

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt
      • Cairo University Hospitals
    • Giza, Giza Governorate, Egypt
      • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A laparoscopic Burch; laparoscopic Burch colposuspension	Procedure: laparoscopic Burch colposuspension; laparoscopic Burch colposuspension for female stress urinary incontinence
Active Comparator: group B TOT; Trans obturator tape	Procedure: Trans obturator tape fixation; mid urethral sling for female stress urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test	at 1, 3 and 6 months post operative

Secondary Outcome Measures

Outcome Measure	Time Frame
operative time	day 1 post operative
complicatio rate	till 6 months post operative
hospital stay	2 days post operative

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute
• Investigators: Study Director: Hussein A Hussein, professor of urology, professor of urology , Faculty of medicine , Cairo university; Study Chair: Ahmed I Kamel, professor of urology, professor of urology , Theodor Bilharz Research Institute; Study Chair: Ahmed H Abo-Zamel, assistant professor of urology, assistant professor of urology , Faculty of medicine , Cairo university; Study Chair: Ahmed S Kamel, lecturer of urology, lecturer of urology , Faculty of medicine , Cairo university

Publications and helpful links

General Publications

• Freites J, Stewart F, Omar MI, Mashayekhi A, Agur WI. Laparoscopic colposuspension for urinary incontinence in women. Cochrane Database Syst Rev. 2019 Dec 10;12(12):CD002239. doi: 10.1002/14651858.CD002239.pub4.
• Brasoveanu S, Balulescu L, Grigoras D, Erdelean D, Olaru F, Bardan R, Balint O, Margan MM, Alexandru A, Cristiana-Smaranda I, Pirtea L. Evaluating Patient Preferences and Clinical Outcomes for Modified Laparoscopic Burch Colposuspension and Transobturator Tape Procedures in Stress Urinary Incontinence Treatment. Life (Basel). 2024 Mar 14;14(3):380. doi: 10.3390/life14030380.
• D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): January 2, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stress urinary incontinence; SUI; TOT; Female Stress Urinary Incontinence; trans obturator tape; laparoscopic Burch; colposuspension
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: MD-94-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: all the IPD will be available from date of publication and for 6 months
• IPD Sharing Access Criteria: All urologists and gynecologists interested in stress incontinence via the contact information of the principle investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No