Treatment of Female Stress Urinary IncontinenceNCT04775186
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
A study testing Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) in people with Treatment of Female Stress Urinary Incontinence, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Treatment of Female Stress Urinary Incontinence
- What is being tested?
- Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
To compare the laparoscopic Burch colposuspension with the midurethral slings (TVT, TOT) for treatment of female stress urinary incontinence as regard efficacy and safety.
Read the 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).
- Being tested
- Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)Procedure or surgery
Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Burch colposuspension | Experimental | Not described Receives: Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) |
| midurethral sling | Experimental | Not described Receives: Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
● 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment of Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Aliaboeihayagan Ali Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775186
- Sponsor's protocol ID
- female stress incontinence
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abughanima MF, Elazab AS, Shalaby M, Aboelhayagan MA, Mohamed H, Mohamed T, Abdelrahman MA. Laparoscopic Burch Colposuspension Versus Transobturator Tape for the Treatment of Stress Urinary Incontinence in Egyptian Women: A 12-Month Randomized Controlled Trial. Neurourol Urodyn. 2026 Aug 11. doi: 10.1002/nau.70403. Online ahead of print.
PubMed 42578342
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04775186
- Acronym / sponsor ID
- female stress incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Burch colposuspension | Experimental | Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) |
| midurethral sling | Experimental | Procedure: Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) | Procedure or surgery | Laparoscopic Burch colposuspension, midurethral sling |
Primary outcome
● 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
Time frame: 1 year
● Accordingly. the patients will be classified into three groups: 1. Cured: patients who have negative cough stress test and the patient scores 0 on UDI-6. 2. Improved: patients who have more than 50% improvement in symptoms as determined by UDI-6. 3. Failed treatment: patients who have less than 50% improvement in symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 42578342Abughanima MF, Elazab AS, Shalaby M, Aboelhayagan MA, Mohamed H, Mohamed T, Abdelrahman MA. Laparoscopic Burch Colposuspension Versus Transobturator Tape for the Treatment of Stress Urinary Incontinence in Egyptian Women: A 12-Month Randomized Controlled Trial. Neurourol Urodyn. 2026 Aug 11. doi: 10.1002/nau.70403. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT) in people with Treatment of Female Stress Urinary Incontinence, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
● 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.