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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in Egypt

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).
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 groups in NCT07398144
Study groupRoleWhat they receive
group A laparoscopic BurchActive comparatorlaparoscopic Burch colposuspension
Receives: Procedure: laparoscopic Burch colposuspension
group B TOTActive comparatorTrans 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.

  1. 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)
  1. operative time

    Measured: day 1 post operative

  2. complicatio rate

    Measured: till 6 months post operative

  3. 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.

  1. First posted9 Feb 2026
  2. Study start1 May 2025
  3. Primary completion2 Jan 2026
  4. Study completionMar 2026 (estimated)

Resources

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)
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 31821550
  • 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.

    PubMed 38541705
  • 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.

    PubMed 30681183

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.

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