Urinary Stress IncontinencePhase 4NCT02886520
Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes
A Phase 4 study testing PVDF transobturator tape and Polypropylene transobturator tape in people with Urinary Stress Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 9 sites in Spain.
Trial summary
This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- PVDF transobturator tape and Polypropylene transobturator tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 9 sitesSpain
- Study dates
- Apr 2016to Apr 2019
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stress urinary incontinence.
- Women with stress-predominant mixed urinary incontinence.
Who cannot join
- Incapacity to understand the information or give their consent.
- Previous anti-incontinence surgery with slings.
- Low pressure urethra (MUCP < 20cmH2O).
- Neurogenic bladder.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital de Mataró
Barcelona
Hospital de Viladecans
Barcelona
Hospital General de Granollers
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Santa Caterina
Girona
Hospital General Riotinto
Huelva
Hospital Quiron Sagrado Corazon
Seville
Hospital Virgen del Rocío
Seville
About this study
Official title: Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.
- Conditions
- Urinary Stress Incontinence
- Being tested
- PVDF transobturator tape, Polypropylene transobturator tape
- Keywords
- Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVDF transobturator tapeDevice
Also called Dynamesh-SIS
Polypropylene transobturator tapeDevice
| Study group | Role | What they receive |
|---|---|---|
| PVDF transobturator tape | Active comparator | Transobturator tension-free suburethral tape made of polyvinylidene fluoride. Receives: Device: PVDF transobturator tape |
| PP transobturator tape | Active comparator | Transobturator tension-free suburethral tape made of polypropylene. Receives: Device: Polypropylene transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria:
- CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be "Very much better".
- IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be "Much better" or "A little better".
Measured: One year
Secondary outcomes (1)
Number of participants with adverse events
Comparison of the intra- and postoperative complications between both procedures.
Measured: Up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Granollers, Hospital Quiron Sagrado Corazon, Hospital de Mataró, Hospital Riotinto, Hospitales Universitarios Virgen del Rocío, Hospital Universitari de Bellvitge, Hospital de Viladecans, Hospital Santa Caterina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886520
- Sponsor's protocol ID
- PR(AMI)241-2015
- Status last verified
- Jul 2019
- First submitted
- 27 Aug 2016
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT02886520
- Acronym / sponsor ID
- PR(AMI)241-2015
- Conditions
- Urinary Stress Incontinence
- Keywords
- Urinary incontinence, Materials, Surgery, Transobturator tape, Polyvinylidene fluoride, Polypropylene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital de Granollers, Hospital Quiron Sagrado Corazon, Hospital de Mataró, Hospital Riotinto, Hospitales Universitarios Virgen del Rocío, Hospital Universitari de Bellvitge, Hospital de Viladecans, Hospital Santa Caterina
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 1 Sep 2016 (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.
This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVDF transobturator tape | Active comparator | Device: PVDF transobturator tapeTransobturator tension-free suburethral tape made of polyvinylidene fluoride. |
| PP transobturator tape | Active comparator | Device: Polypropylene transobturator tapeTransobturator tension-free suburethral tape made of polypropylene. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with stress urinary incontinence.
- Women with stress-predominant mixed urinary incontinence.
Key exclusion criteria (4 listed)
- Incapacity to understand the information or give their consent.
- Previous anti-incontinence surgery with slings.
- Low pressure urethra (MUCP < 20cmH2O).
- Neurogenic bladder.
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 |
|---|---|---|
| PVDF transobturator tapeAlso: Dynamesh-SIS | Device | PVDF transobturator tape |
| Polypropylene transobturator tape | Device | PP transobturator tape |
Primary outcome
Effectiveness
Time frame: One year
Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria: * CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be "Very much better". * IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be "Much better" or "A little better".
1 secondary outcome
Number of participants with adverse events
Time frame: Up to one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVDF transobturator tape and Polypropylene transobturator tape in people with Urinary Stress Incontinence, run by Hospital Universitari Vall d'Hebron Research Institute at 9 sites in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness (time frame: One year). 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 26 Jul 2019.