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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:
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.
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
• Willingness to Undergo Surgery
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A laparoscopic Burch | Active Comparator | laparoscopic Burch colposuspension |
|
| group B TOT | Active Comparator | Trans obturator tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic Burch colposuspension | Procedure | laparoscopic Burch colposuspension for female stress urinary incontinence |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | day 1 post operative | |
| complicatio rate | till 6 months post operative | |
| hospital stay |
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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.
• Willingness to Undergo Surgery
Exclusion Criteria:
virgin female
mixed urinary Incontinence
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university hospitals | Giza | Giza Governorate | Egypt | |||
| Theodor Bilharz Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31821550 | Result | 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. | |
| 38541705 | 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. |
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all the IPD will be available from date of publication and for 6 months
All urologists and gynecologists interested in stress incontinence via the contact information of the principle investigator
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| Trans obturator tape fixation | Procedure | mid urethral sling for female stress urinary incontinence |
|
| 2 days post operative |
| Giza |
| Giza Governorate |
| Egypt |
| 30681183 | 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. |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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