Stress Urinary IncontinenceNCT05616481
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension
A study testing Laparoscopic Burch colposuspension and Modefied Burch (TOT - like) in people with Stress Urinary Incontinence and Burch Colposuspention, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Burch Colposuspention
- What is being tested?
- Laparoscopic Burch colposuspension and Modefied Burch (TOT - like)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Pregnancy
- Less than 12 months post-partum.
Show all 9Show fewer
- Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts)
- Genito-urinary malignancy.
- Current chemo or radiation therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Fawzy Salman
Cairo, Cairo Governorate
Mohamed Fawzy Salman, MD, +201111788996, prof_mohamed_fawzy@yahoo.com
About this study
Official title: Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)
- Conditions
- Stress Urinary Incontinence, Burch Colposuspention
- Being tested
- Laparoscopic Burch colposuspension, Modefied Burch (TOT - like)
- Keywords
- Stress urinary incontinence, Burch Colposuspension, TOT
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Burch colposuspensionProcedure or surgery
The original Burch procedure will be performed
Modefied Burch (TOT - like)Procedure or surgery
more lateral fixation to avoid post-operative voiding dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Burch | Active comparator | The original procedure will be performed Receives: Procedure: Laparoscopic Burch colposuspension |
| Laparoscopic modefied Burch procedur (TOT-like) | Active comparator | Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament. Receives: Procedure: Modefied Burch (TOT - like) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence
Measured: 3 months post operative
Secondary outcomes (3)
Post operative rates of voiding dysfunction (at 3 months).
Measured: at 3 months
Overall operative time
Measured: Intraoperative (measured from verrus needle insertion)
Complication rates of both techniques.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2022
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616481
- Sponsor's protocol ID
- Burch versus Modefied Burch
- Status last verified
- May 2025
- First submitted
- 7 Nov 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abrar S, Razzak L, Mohsin R. The practice of Burch Colposuspension versus Mid Urethral Slings for the treatment of Stress Urinary Incontinence in developing country. Pak J Med Sci. 2021 Sep-Oct;37(5):1359-1364. doi: 10.12669/pjms.37.5.4017.
PubMed 34475912Aleksandrov A, Meshulam M, Rabischong B, Botchorishvili R. Laparoscopic TOT-like Burch Colposuspension: Back to the Future? J Minim Invasive Gynecol. 2021 Jan;28(1):24-25. doi: 10.1016/j.jmig.2020.04.018. Epub 2020 Apr 24.
PubMed 32339752Carmel ME, Deng DY, Greenwell TJ, Zimmern PE. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus. 2016 Aug;2(3):231-237. doi: 10.1016/j.euf.2016.03.005. Epub 2016 Mar 26.
PubMed 28723368Kim A, Kim S, Kim HG. Current Overview of Surgical Options for Female Stress Urinary Incontinence. Int Neurourol J. 2020 Sep;24(3):222-230. doi: 10.5213/inj.2040052.026. Epub 2020 Sep 30.
PubMed 33017893Marquini GV, Bella ZIKJD, Sartori MGF. Burch Procedure: A Historical Perspective. Rev Bras Ginecol Obstet. 2022 May;44(5):511-518. doi: 10.1055/s-0042-1744312. Epub 2022 Feb 18.
PubMed 35181882
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05616481
- Acronym / sponsor ID
- Burch versus Modefied Burch
- Conditions
- Stress Urinary Incontinence, Burch Colposuspention
- Keywords
- Stress urinary incontinence, Burch Colposuspension, TOT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 15 Nov 2022 (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.
This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Burch | Active comparator | Procedure: Laparoscopic Burch colposuspensionThe original procedure will be performed |
| Laparoscopic modefied Burch procedur (TOT-like) | Active comparator | Procedure: Modefied Burch (TOT - like)Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Pregnancy
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 colposuspensionThe original Burch procedure will be performed | Procedure or surgery | Laparoscopic Burch |
| Modefied Burch (TOT - like)more lateral fixation to avoid post-operative voiding dysfunction | Procedure or surgery | Laparoscopic modefied Burch procedur (TOT-like) |
Primary outcome
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 operative
3 secondary outcomes
Post operative rates of voiding dysfunction (at 3 months).
Time frame: at 3 months
Overall operative time
Time frame: Intraoperative (measured from verrus needle insertion)
Complication rates of both techniques.
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: PubMed 34475912Abrar S, Razzak L, Mohsin R. The practice of Burch Colposuspension versus Mid Urethral Slings for the treatment of Stress Urinary Incontinence in developing country. Pak J Med Sci. 2021 Sep-Oct;37(5):1359-1364. doi: 10.12669/pjms.37.5.4017.
- Results publication: PubMed 32339752Aleksandrov A, Meshulam M, Rabischong B, Botchorishvili R. Laparoscopic TOT-like Burch Colposuspension: Back to the Future? J Minim Invasive Gynecol. 2021 Jan;28(1):24-25. doi: 10.1016/j.jmig.2020.04.018. Epub 2020 Apr 24.
- Results publication: PubMed 28723368Carmel ME, Deng DY, Greenwell TJ, Zimmern PE. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus. 2016 Aug;2(3):231-237. doi: 10.1016/j.euf.2016.03.005. Epub 2016 Mar 26.
- Results publication: PubMed 33017893Kim A, Kim S, Kim HG. Current Overview of Surgical Options for Female Stress Urinary Incontinence. Int Neurourol J. 2020 Sep;24(3):222-230. doi: 10.5213/inj.2040052.026. Epub 2020 Sep 30.
- Results publication: PubMed 35181882Marquini GV, Bella ZIKJD, Sartori MGF. Burch Procedure: A Historical Perspective. Rev Bras Ginecol Obstet. 2022 May;44(5):511-518. doi: 10.1055/s-0042-1744312. Epub 2022 Feb 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Burch colposuspension and Modefied Burch (TOT - like) in people with Stress Urinary Incontinence and Burch Colposuspention, run by Al-Azhar University at 1 site in Egypt.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fawzy Salman, MD (+201111788996, prof_mohamed_fawzy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 operative). 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 NCT05616481, which also lists 5 linked publications.
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 29 May 2025.