Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
Primary Purpose
Treatment of Female Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Female Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 1- All Adult Female patients complaining of stress urinary incontinence attending the voiding dysfunction clinic at Asyut Urology and Nephrology hospital and willing to participate in the study.
Exclusion Criteria:
- 1- Recurrent SUI. 2- Significance Pelvic organ prolapse requiring surgical intervention. 3- Associated Neurologic disorders affecting the lower urinary tract e.g diabetes, spinal cord injury and others.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Laparoscopic Burch colposuspension
midurethral sling
Arm Description
Outcomes
Primary Outcome Measures
● the result of cough stress test. The outcome will be binary: either negative test meaning no leakage at all or positive meaning there is any sort of leakage on stress. The secondary outcome measures will be the scores
● Accordingly. the patients will be classified into three groups:
Cured: patients who have negative cough stress test and the patient scores 0 on UDI-6.
Improved: patients who have more than 50% improvement in symptoms as determined by UDI-6.
Failed treatment: patients who have less than 50% improvement in symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT04775186
First Posted
February 25, 2021
Last Updated
September 24, 2021
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04775186
Brief Title
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
Official Title
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare the laparoscopic Burch colposuspension with the midurethral slings (TVT, TOT) for treatment of female stress urinary incontinence as regard efficacy and safety.
Detailed Description
Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as an involuntary loss of urine on physical exertion, sneezing, or coughing (1). It occurs primarily in multiparous women (2).
The prevalence of UI among Egyptian women is high (55%). Aging, low educational level, menopause, higher parity (>3), vaginal delivery, and previous multiple abortions (>3) are significant risk factors for UI(3) Mid-urethral slings (TVT and TOT) are now the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence(4) (5) Mid-Urethral Slings have a very high satisfaction rate (85-90 %) (4) (6), with durability of satisfaction recently demonstrated out to 5-years (79-85 %) as well as a modest 5-year treatment success (43-51 %) (4, 7) Burch colposuspension is a well-accepted technique for surgical management of stress urinary incontinence (SUI), especially when it is associated with urethral hypermobility. it first description in 1961 (8) (9) Originally performed as an open surgical procedure and then Over time, Burch colposuspension has been adapted for laparoscopy, it was long considered as the "gold standard" for the treatment of SUI before emergent of midurethral slings (9) The cure rates for laparoscopic colposuspention is as high as 68.9% to 88.0% whereas recurrence rates remain low, however, it has been reported that the cure rate of retropubic suspension techniques in general decreases steadily from 90% at 1 year to about70% by 10 years postoperatively. After a decline, it seems to reach a plateau at 65-70% at a 20 year follow-up (9) After the Food and Drug Administration (FDA) issued a warning about the use of transvaginal meshes for pelvic organ prolapse (POP) in 2011, there has been much debate about the use of mesh in the MUS continence procedures. Concern is increasing that the use of transvaginal mesh devices to treat SUI and POP have exposed women to avoidable harms following complications such as infection, tissue extrusion, mesh exposure ,mesh shrinkage, and side effects such as severe pain, sexual dysfunction, and repeat surgical interventions (5).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Female Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Burch colposuspension
Arm Type
Experimental
Arm Title
midurethral sling
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
Intervention Description
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
Primary Outcome Measure Information:
Title
● the result of cough stress test. The outcome will be binary: either negative test meaning no leakage at all or positive meaning there is any sort of leakage on stress. The secondary outcome measures will be the scores
Description
● Accordingly. the patients will be classified into three groups:
Cured: patients who have negative cough stress test and the patient scores 0 on UDI-6.
Improved: patients who have more than 50% improvement in symptoms as determined by UDI-6.
Failed treatment: patients who have less than 50% improvement in symptoms.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1- All Adult Female patients complaining of stress urinary incontinence attending the voiding dysfunction clinic at Asyut Urology and Nephrology hospital and willing to participate in the study.
Exclusion Criteria:
1- Recurrent SUI. 2- Significance Pelvic organ prolapse requiring surgical intervention. 3- Associated Neurologic disorders affecting the lower urinary tract e.g diabetes, spinal cord injury and others.
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
We'll reach out to this number within 24 hrs