Which surgery stops leakage best? new study pits two procedures Head-to-Head
NCT ID NCT07398144
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two surgical treatments for stress urinary incontinence in women: laparoscopic Burch colposuspension and transobturator tape. Sixty adult women who have not improved with non-surgical treatments will be randomly assigned to one surgery. Researchers will check success rates, operation time, hospital stay, and complications at 1, 3, and 6 months after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgery (laparoscopic Burch colposuspension or transobturator tape)
- What this could lead to
- If successful, this could show which surgery works better for stopping urine leakage during activity, helping women choose the best option.
- What could go wrong
- This is a small, early-stage study with only 60 participants. Results may not apply to all women, and both surgeries carry risks like infection or failure to stop leakage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cairo university hospitals
Giza, Giza Governorate, Egypt
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Theodor Bilharz Research Institute
Giza, Giza Governorate, Egypt
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