Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAl-Azhar University
About this trial
This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with genuine stress urinary incontinence.
Mixed urinary incontinence with predominant stress element.
Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.
Disqualifiers
Mixed incontinence with predominant Urge urinary incontinence.
Recent pelvic surgery (less than 3 months).
Neurogenic lower urinary tract dysfunction.
Previous surgery for stress urinary incontinence.
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic Burch colposuspension
Procedure/SurgeryThe original Burch procedure will be performed
Modefied Burch (TOT - like)
Procedure/Surgerymore lateral fixation to avoid post-operative voiding dysfunction
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic BurchActive comparator 1 intervention
Group B: Laparoscopic modefied Burch procedur (TOT-like)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence
Time frame
3 months post operativeSecondary outcomes
1
Post operative rates of voiding dysfunction (at 3 months).
Time frame
at 3 months2
Overall operative time
Time frame
Intraoperative (measured from verrus needle insertion)3
Complication rates of both techniques.
Time frame
up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov