Female Stress Urinary IncontinenceNCT07398144
Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence.
A study testing laparoscopic Burch colposuspension and Trans obturator tape fixation in people with Female Stress Urinary Incontinence, run by Theodor Bilharz Research Institute at 2 sites in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- laparoscopic Burch colposuspension and Trans obturator tape fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2025to Mar 2026
- 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
- Clinical Diagnosis of SUI:
- Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
- Documented stress urinary incontinence by physical examination and urodynamic testing.
- Adult female patients typically aged 18 years or older.
- Completed Non-Surgical Management:
- Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
- Willingness to Undergo Surgery
Who cannot join
- virgin female
- mixed urinary Incontinence
- Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
- Previous Anti-Incontinence Surgery
- Neurological Conditions:
- Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
Show all 11Show fewer
- Pregnancy
- Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
- Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
- Previous history of radiotherapy to the pelvis.
- Contraindications to surgery such as uncorrectable coagulation disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo university hospitals
Giza, Giza Governorate
Theodor Bilharz Research Institute
Giza, Giza Governorate
About this study
Official title: Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence. A Prospective Randomized Study
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
Read the detailed description
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.
- Documented stress urinary incontinence by physical examination and urodynamic testing.
- Adult female patients typically aged 18 years or older.
- Completed Non-Surgical Management:
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
- Willingness to Undergo Surgery
Exclusion criteria:
- Mixed urinary Incontinence
- Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
- Previous Anti-Incontinence Surgery
- Neurological Conditions:
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
- Pregnancy
- Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
- Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
- Previous history of radiotherapy to the pelvis.
- Contraindications to surgery such as uncorrectable coagulation disorders
Methodology All patients will provide oral and written consent before participating in any study-related procedures.
Preoperative Assessment:
- History ((using validated questionnaire (International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) and physical examination to confirm stress incontinence and exclude overactive bladder syndrome.
- Pelvic examination to rule out pelvic organ prolapse.
- Routine preoperative labs (CBC, coagulation profile, electrolytes)
- Urodynamic studies to confirm SUI
- Pelvi-abdominal Ultrasonography to measure PVR.
- Urine culture and sensitivity to exclude urinary tract infection. post operative work up:
- Catheter removal after 24 hours.and monitoring for urine retention and catheterization if required
- follow up scheduled at 1 month, 3 months and 6 months postoperatively targeting success rate, PVR and complications. (uroflowmetry at 1 month-visit)
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:
- Improvement in SUI symptoms (e.g., using validated questionnaires (International Consultation on Incontinence Questionnaire).
- Comparing Peri-operative and early outcomes (e.g. hemoglobin loss, operation time, and length of hospital stay.).
- Intraoperative and early complications (e.g. Bladder injury, infection, De novo urge incontinence, and Acute Urinary Retention, post-void residual volume).
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- laparoscopic Burch colposuspension, Trans obturator tape fixation
- Keywords
- laparoscopic Burch, trans obturator tape, TOT, Female Stress Urinary Incontinence, colposuspension, SUI, stress urinary incontinence
- 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
laparoscopic Burch colposuspension for female stress urinary incontinence
Trans obturator tape fixationProcedure or surgery
mid urethral sling for female stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| group A laparoscopic Burch | Active comparator | laparoscopic Burch colposuspension Receives: Procedure: laparoscopic Burch colposuspension |
| group B TOT | Active comparator | Trans obturator tape Receives: Procedure: Trans obturator tape fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test
Measured: at 1, 3 and 6 months post operative
Secondary outcomes (3)
operative time
Measured: day 1 post operative
complicatio rate
Measured: till 6 months post operative
hospital stay
Measured: 2 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 May 2025
- Primary completion2 Jan 2026
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathi Mohamed Ahmed Badr-El-Din, Theodor Bilharz Research Institute
- Investigators
- Hussein A Hussein, professor of urology, Study director, professor of urology , Faculty of medicine , Cairo universityAhmed I Kamel, professor of urology, Study chair, professor of urology , Theodor Bilharz Research InstituteAhmed H Abo-Zamel, assistant professor of urology, Study chair, assistant professor of urology , Faculty of medicine , Cairo universityAhmed S Kamel, lecturer of urology, Study chair, lecturer of urology , Faculty of medicine , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398144
- Sponsor's protocol ID
- MD-94-2025
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31821550Brasoveanu 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.
PubMed 38541705D'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.
PubMed 30681183
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07398144
- Acronym / sponsor ID
- MD-94-2025
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- laparoscopic Burch, trans obturator tape, TOT, Female Stress Urinary Incontinence, colposuspension, SUI, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
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
Detailed description
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.
- Documented stress urinary incontinence by physical examination and urodynamic testing.
- Adult female patients typically aged 18 years or older.
- Completed Non-Surgical Management:
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
- Willingness to Undergo Surgery
Exclusion criteria:
- Mixed urinary Incontinence
- Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
- Previous Anti-Incontinence Surgery
- Neurological Conditions:
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
- Pregnancy
- Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
- Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
- Previous history of radiotherapy to the pelvis.
- Contraindications to surgery such as uncorrectable coagulation disorders
Methodology All patients will provide oral and written consent before participating in any study-related procedures.
Preoperative Assessment:
- History ((using validated questionnaire (International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) and physical examination to confirm stress incontinence and exclude overactive bladder syndrome.
- Pelvic examination to rule out pelvic organ prolapse.
- Routine preoperative labs (CBC, coagulation profile, electrolytes)
- Urodynamic studies to confirm SUI
- Pelvi-abdominal Ultrasonography to measure PVR.
- Urine culture and sensitivity to exclude urinary tract infection. post operative work up:
- Catheter removal after 24 hours.and monitoring for urine retention and catheterization if required
- follow up scheduled at 1 month, 3 months and 6 months postoperatively targeting success rate, PVR and complications. (uroflowmetry at 1 month-visit)
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:
- Improvement in SUI symptoms (e.g., using validated questionnaires (International Consultation on Incontinence Questionnaire).
- Comparing Peri-operative and early outcomes (e.g. hemoglobin loss, operation time, and length of hospital stay.).
- Intraoperative and early complications (e.g. Bladder injury, infection, De novo urge incontinence, and Acute Urinary Retention, post-void residual volume).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A laparoscopic Burch | Active comparator | Procedure: laparoscopic Burch colposuspensionlaparoscopic Burch colposuspension |
| group B TOT | Active comparator | Procedure: Trans obturator tape fixationTrans obturator tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical Diagnosis of SUI:
- Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
- Documented stress urinary incontinence by physical examination and urodynamic testing.
- Adult female patients typically aged 18 years or older.
- Completed Non-Surgical Management:
Key exclusion criteria (11 listed)
- virgin female
- mixed urinary Incontinence
- Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
- Pregnancy
- Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
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 colposuspensionlaparoscopic Burch colposuspension for female stress urinary incontinence | Procedure or surgery | group A laparoscopic Burch |
| Trans obturator tape fixationmid urethral sling for female stress urinary incontinence | Procedure or surgery | group B TOT |
Primary outcome
success rate
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
3 secondary outcomes
operative time
Time frame: day 1 post operative
complicatio rate
Time frame: till 6 months post operative
hospital stay
Time frame: 2 days post operative
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 12 Feb 2026.
- Results publication: PubMed 31821550Freites 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.
- Results publication: PubMed 38541705Brasoveanu 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.
- Results publication: PubMed 30681183D'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.
- Individual participant dataSharing planned: Yes
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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.
Hussein A Hussein, professor of urology study director
professor of urology , Faculty of medicine , Cairo university
Ahmed I Kamel, professor of urology study chair
professor of urology , Theodor Bilharz Research Institute
Ahmed H Abo-Zamel, assistant professor of urology study chair
assistant professor of urology , Faculty of medicine , Cairo university
2 sites 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 Trans obturator tape fixation in people with Female Stress Urinary Incontinence, run by Theodor Bilharz Research Institute at 2 sites 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
success rate (time frame: at 1, 3 and 6 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 NCT07398144, which also lists 3 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 12 Feb 2026.