Urinary Bladder, OveractivePhase 4STEPNCT00928395
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
A Phase 4 study testing Urgent PC in people with Urinary Bladder, Overactive, run by Uroplasty, Inc at 12 sites in United States.
Trial summary
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Urgent PC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2009to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
- Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
- Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
- Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
- Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
- Subjects must remain off all antimuscarinics throughout participation in trial
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- Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
- Capable of giving informed consent
- Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years
Who cannot join
- Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
- Subjects who were not able or willing to follow original SUmiT Trial study schedule
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Capital Region Urological Surgeons, PLLC
Albany, New York, 12208
Gregory L. Davis, M.D., FACOG, Inc.
Chico, California, 95928
Urology Health Center, PC
Fremont, Nebraska, 68025
Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
Grand Rapids, Michigan, 49503
Alliance Urology Specialists
Greensboro, North Carolina, 27403
Greenwich Urological Associates, P.C.
Greenwich, Connecticut, 06830
Athena Urology
Issaquah, Washington, 98027
Mercy Health Partners at the Lakes
Muskegon, Michigan, 49444
Specialists in Urology
Naples, Florida, 34102
Virginia Urology
Richmond, Virginia, 23235
Beaumont Hospital
Royal Oak, Michigan, 48073
Central Missouri Women's Healthcare, LLC
White Plains, New York, 10604
About this study
Official title: Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Urgent PC
- Keywords
- Urgent PC, Overactive Bladder, SUmiT Trial, Overactive Urinary Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent PCDevice
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
| Study group | Role | What they receive |
|---|---|---|
| Urgent PC | Active comparator | The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). Receives: Device: Urgent PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
Measured: 36 months total
Secondary outcomes (3)
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Measured: every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.
Measured: every three months for 36 months
Change in Voiding Diary Parameters.
Measured: every three months for 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2012
- Study completionDec 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 (1)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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uroplasty, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Peters, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928395
- Sponsor's protocol ID
- UPC121908
- Acronym
- STEP
- Status last verified
- Apr 2013
- First submitted
- 24 Jun 2009
- Last updated
- 16 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
PubMed 22674493
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation
- ClinicalTrials.gov ID
- NCT00928395
- Acronym / sponsor ID
- STEP / UPC121908
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urgent PC, Overactive Bladder, SUmiT Trial, Overactive Urinary Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uroplasty, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urgent PC | Active comparator | Device: Urgent PCThe Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
- Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
- Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
- Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
- Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
Key exclusion criteria (2 listed)
- Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
- Subjects who were not able or willing to follow original SUmiT Trial study schedule
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 |
|---|---|---|
| Urgent PCThe Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). | Device | Urgent PC |
Primary outcome
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline
Time frame: 36 months total
The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).
3 secondary outcomes
GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.
Time frame: every three months for 36 months
Change in OAB-q and SF-36 Questionnaires.
Time frame: every three months for 36 months
Change in Voiding Diary Parameters.
Time frame: every three months for 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22674493Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
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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.
Kenneth Peters, MD principal investigator
Beaumont Hospital
12 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 Urgent PC in people with Urinary Bladder, Overactive, run by Uroplasty, Inc at 12 sites in United States.
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 9 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 16 May 2013). 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?
Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline (time frame: 36 months total). 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 NCT00928395, which also lists 1 linked publication.
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 16 May 2013.