Urinary Bladder, OveractivePhase 4NCT01194999
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
A Phase 4 study testing Pubovaginal sling procedure in people with Urinary Bladder, Overactive, run by Barrie Urology Associates at 1 site in Canada.
Trial summary
Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Pubovaginal sling procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-pubovaginal sling patient.
- Complete agreement and signing of Informed Consent Form.
Who cannot join
- Currently taking antimuscarinics or α1 blockers.
- Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Barrie Urology Associates - The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1
About this study
Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.
As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Pubovaginal sling procedure
- Keywords
- OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence, UUI, Pubovaginal Sling, PVS, Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pubovaginal sling procedureDevice
The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.
| Study group | Role | What they receive |
|---|---|---|
| Pubovaginal sling procedure | Experimental | Patients undergoing pubovaginal slings for stress urinary incontinence. Receives: Device: Pubovaginal sling procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OAB Symptoms Post Pubovaginal Sling Operation
Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.
Measured: Baseline to final follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barrie Urology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Canada, Inc.
- Responsible party
- Principal investigator, Dr. Joseph Zadra, Barrie Urology Associates
- Investigators
- Joseph A Zadra, MD CM FRCSC, Principal investigator, Barrie Urology Associates - The Male/Female Health and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194999
- Sponsor's protocol ID
- ARC-2010-04
- Status last verified
- Aug 2012
- First submitted
- 2 Sep 2010
- Last updated
- 20 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD. Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12.
PubMed 19002645Koch YK, Zimmern P. A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5.
PubMed 18520757Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6.
PubMed 17574730Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF. Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.
PubMed 20339833Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
PubMed 18995887
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
- ClinicalTrials.gov ID
- NCT01194999
- Acronym / sponsor ID
- ARC-2010-04
- Conditions
- Urinary Bladder, Overactive
- Keywords
- OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Barrie Urology AssociatesUniversity, hospital or other
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Posted 20 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.
As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pubovaginal sling procedure | Experimental | Device: Pubovaginal sling procedurePatients undergoing pubovaginal slings for stress urinary incontinence. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Post-pubovaginal sling patient.
- Complete agreement and signing of Informed Consent Form.
Key exclusion criteria (2 listed)
- Currently taking antimuscarinics or α1 blockers.
- Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
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 |
|---|---|---|
| Pubovaginal sling procedureThe procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure. | Device | Pubovaginal sling procedure |
Primary outcome
Change in OAB Symptoms Post Pubovaginal Sling Operation
Time frame: Baseline to final follow-up.
Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19002645Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD. Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12.
- Background: PubMed 18520757Koch YK, Zimmern P. A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5.
- Background: PubMed 17574730Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6.
- Background: PubMed 20339833Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF. Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.
- Background: PubMed 18995887Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
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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.
Joseph A Zadra, MD CM FRCSC principal investigator
Barrie Urology Associates - The Male/Female Health and Research Centre
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 Pubovaginal sling procedure in people with Urinary Bladder, Overactive, run by Barrie Urology Associates at 1 site in Canada.
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 2 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 20 Sep 2012. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in OAB Symptoms Post Pubovaginal Sling Operation (time frame: Baseline to final follow-up.). 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 NCT01194999, which also lists 5 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 20 Sep 2012.