Stress Urinary IncontinencePhase 4NCT00744198
Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
A Phase 4 study testing Autologous transobturator tape procedure, Synthetic transobturator tape procedure and Biological transobturator tape procedure in people with Stress Urinary Incontinence, run by University Magna Graecia at 1 site in Italy.
Trial summary
The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT). 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?
- Autologous transobturator tape procedure, Synthetic transobturator tape procedure and Biological transobturator tape procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2012to Aug 2014
- 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
- Genuine stress urinary incontinence by self report, examination and test
- Urethral hypermobility
- Eligible for all three 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.
Stefano Palomba, MD contact
Italy1 site, 1 recruiting
- Recruiting
"Pugliese" Hospital
Catanzaro, Catanzaro, 88100
Ingrid Tomaino, MD, 39-096-188-3234, angela.falbo@libero.it
Stefano Palomba, MD
About this study
Official title: A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling
The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).
To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.
Read the detailed description
Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .
All eligible patients 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
- Autologous transobturator tape procedure, Synthetic transobturator tape procedure, Biological transobturator tape procedure
- Keywords
- Autologous, Biological, Mesh, Polypropylene, Sling, Synthetic, Stress incontinence, Surgery, TOT, Treatment
- 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.
Autologous transobturator tape procedureProcedure or surgery
A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles
Synthetic transobturator tape procedureProcedure or surgery
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.
Biological transobturator tape procedureProcedure or surgery
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Autologous sling Receives: Procedure: Autologous transobturator tape procedure |
| 2 | Active comparator | Synthetic sling Receives: Procedure: Synthetic transobturator tape procedure |
| 3 | Active comparator | Biological sling Receives: Procedure: Biological transobturator tape procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
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 posted29 Aug 2008 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
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
- 8 participants (estimated)
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
- NCT00744198
- Sponsor's protocol ID
- 02/2008
- Status last verified
- Apr 2013
- First submitted
- 26 Aug 2008
- Last updated
- 8 Apr 2013
- Results posted
- No
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 in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling
- ClinicalTrials.gov ID
- NCT00744198
- Acronym / sponsor ID
- 02/2008
- Conditions
- Stress Urinary Incontinence
- Keywords
- Autologous, Biological, Mesh, Polypropylene, Sling, Synthetic, Stress incontinence, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- First posted
- 29 Aug 2008 (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.
The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).
To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.
Detailed description
Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .
All eligible patients 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Autologous transobturator tape procedureAutologous sling |
| 2 | Active comparator | Procedure: Synthetic transobturator tape procedureSynthetic sling |
| 3 | Active comparator | Procedure: Biological transobturator tape procedureBiological sling |
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)
- Genuine stress urinary incontinence by self report, examination and test
- Urethral hypermobility
- Eligible for all three 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 |
|---|---|---|
| Autologous transobturator tape procedureA strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles | Procedure or surgery | 1 |
| Synthetic transobturator tape procedureSmall incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles. | Procedure or surgery | 2 |
| Biological transobturator tape procedureSmall incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle | Procedure or surgery | 3 |
Primary outcome
Cure rate
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
Results are not available in the source record.
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 contact
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 Autologous transobturator tape procedure, Synthetic transobturator tape procedure and Biological 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Palomba, MD (stefanopalomba@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (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.