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

NCT07398144 | Active Not Recruiting DMC

• 1 other identifier: MD-94-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Female Stress Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• operative time

  day 1 post operative

• complicatio rate

  till 6 months post operative

• hospital stay

  2 days post operative

Study Arms (2)

group A laparoscopic Burch

ACTIVE COMPARATOR

laparoscopic Burch colposuspension

Procedure: laparoscopic Burch colposuspension

group B TOT

ACTIVE COMPARATOR

Trans obturator tape

Procedure: Trans obturator tape fixation

Interventions

laparoscopic Burch colposuspension PROCEDURE

laparoscopic Burch colposuspension for female stress urinary incontinence

group A laparoscopic Burch

Trans obturator tape fixation PROCEDURE

mid urethral sling for female stress urinary incontinence

group B TOT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (2)

Cairo university hospitals

Giza, Giza Governorate, Egypt

Location

Theodor Bilharz Research Institute

Giza, Giza Governorate, Egypt

Location

Related Publications (3)

• 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.

  PMID: 31821550 RESULT

• 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.

  PMID: 38541705 RESULT

• 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.

  PMID: 30681183 RESULT

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

• Hussein A Hussein, professor of urology

  professor of urology , Faculty of medicine , Cairo university

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology specialist

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 1, 2025
• Primary Completion: January 2, 2026
• Study Completion: March 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: all the IPD will be available from date of publication and for 6 months
• Access Criteria: All urologists and gynecologists interested in stress incontinence via the contact information of the principle investigator

Locations

EG (2)