Stress Urinary IncontinencePhase 4NCT00573703
Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
A Phase 4 study testing Laparoscopic Burch colposuspension and Transobturator tape procedure in people with Stress Urinary Incontinence, run by University Magna Graecia at 1 site in Italy.
Trial summary
Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Laparoscopic Burch colposuspension and Transobturator tape procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 4
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant or genuine stress urinary incontinence by self report,examination and test
- Urethral hypermobility
- Eligible for both surgical procedures
- Ambulatory
Who cannot join
- Pregnancy
- <12 months post-partum
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
- Recent pelvic surgery
Show all 13Show fewer
- Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
- Previous pelvic or anti-incontinence surgery
- History of severe abdominopelvic infections
- Known extensive abdominopelvic adhesions
- Detrusor instability and/or intrinsic sphincter dysfunction
- Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
- BMI >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence
Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.
Read the detailed description
Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Laparoscopic Burch colposuspension, Transobturator tape procedure
- Keywords
- Laparoscopic Burch colposuspension, Stress incontinence, Surgery, TOT, Treatment, Predominant or genuine 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
Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.
Transobturator tape procedureProcedure or surgery
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: Procedure: Laparoscopic Burch colposuspension |
| Group B | Experimental | Not described Receives: Procedure: Transobturator tape procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective/subjective symptoms improvements
Measured: 12 months
Secondary outcomes (6)
Intra-operative complication rate
Measured: one day
Postoperative complications rate
Measured: 12 months
Failure rate
Measured: 12 months
Recurrence rate
Measured: 12 months
Quality of life
Measured: 12 months
Sexual function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
- Investigators
- Stefano Palomba, MD, Principal investigator, Chair of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroFulvio Zullo, MD, Study chair, Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573703
- Sponsor's protocol ID
- 02/2007
- Status last verified
- Apr 2013
- First submitted
- 12 Dec 2007
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT00573703
- Acronym / sponsor ID
- 02/2007
- Conditions
- Stress Urinary Incontinence
- Keywords
- Laparoscopic Burch colposuspension, Stress incontinence, Surgery, TOT, Treatment, Predominant or genuine stress urinary incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- First posted
- 14 Dec 2007 (estimated)
- 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.
Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.
Detailed description
Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Laparoscopic Burch colposuspension |
| Group B | Experimental | Procedure: Transobturator tape procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Predominant or genuine stress urinary incontinence by self report,examination and test
- Urethral hypermobility
- Eligible for both surgical procedures
- Ambulatory
Key exclusion criteria (13 listed)
- Pregnancy
- <12 months post-partum
- Systemic disease and/or drugs known to affect bladder function
- Current chemotherapy or radiation therapy
- Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
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 colposuspensionLapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique. | Procedure or surgery | Group A |
| Transobturator tape procedureSmall incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period. | Procedure or surgery | Group B |
Primary outcome
Objective/subjective symptoms improvements
Time frame: 12 months
6 secondary outcomes
Intra-operative complication rate
Time frame: one day
Postoperative complications rate
Time frame: 12 months
Failure rate
Time frame: 12 months
Recurrence rate
Time frame: 12 months
Quality of life
Time frame: 12 months
Sexual function
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
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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.
Stefano Palomba, MD principal investigator
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD study chair
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Burch colposuspension and Transobturator tape procedure in people with Stress Urinary Incontinence, run by University Magna Graecia at 1 site in Italy.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 8 Apr 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective/subjective symptoms improvements (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2013.