Laparoscopic Burch Colposuspension
Procedurelaparoscopic Burch colposuspension for female stress urinary incontinence
NCT Number: NCT07398144
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
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Cairo university hospitals, Giza, Giza Governorate, Egypt
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
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
Exclusion criteria
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
Methodology All patients will provide oral and written consent before participating in any study-related procedures.
Preoperative Assessment:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
Exclusion criteria
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
laparoscopic Burch colposuspension for female stress urinary incontinence
mid urethral sling for female stress urinary incontinence
Time frame: at 1, 3 and 6 months post operative
the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test
Time frame: day 1 post operative
Time frame: till 6 months post operative
Time frame: 2 days post operative
Theodor Bilharz Research Institute
Other
Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence. A Prospective Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07530484
Female Stress Urinary Incontinence, Female Urogenital Diseases
Taipei, Taiwan
View Trial DetailsNCT05534269
Female Stress Urinary Incontinence, Female Urogenital Diseases
Zurich, Canton of Zurich, Switzerland
View Trial DetailsNCT06599190
Female Stress Urinary Incontinence, Female Urogenital Diseases
New Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT01032265
Female Stress Urinary Incontinence, Female Urogenital Diseases
Umeå, Sweden
View Trial Details