Overactive BladderPhase 4OrBITNCT00448175
Overactive Bladder Innovative Therapy Trial (OrBIT)
A Phase 4 study testing Urgent PC Neuromodulation System and Tolterodine in people with Overactive Bladder, run by Uroplasty, Inc at 1 site in United States.
Trial summary
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Urgent PC Neuromodulation System and Tolterodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2008
- 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
- Is at least 18 years of age
- Experiences OAB with a voiding frequency of at least 8 times per day
- Is ambulatory and able to use a toilet independently and without difficulty
Who cannot join
- On OAB pharmacotherapy within the previous month
- Primary complaint is stress urinary incontinence
- Has pacemaker or implantable defibrillator
- Has history of heart problems
- Has nerve damage or neuropathy
- Has gastric or urinary retention
Show all 9Show fewer
- Has uncontrolled narrow-angle glaucoma
- Has known sensitivity to drug ingredients
- Is pregnant or planning to become pregnant during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overactive Bladder Innovative Therapy Trial
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
- Conditions
- Overactive Bladder
- Being tested
- Urgent PC Neuromodulation System, Tolterodine
- Keywords
- OAB symptoms of urgency, frequency, and urge incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent PC Neuromodulation SystemDevice
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).
TolterodineDrug
| Study group | Role | What they receive |
|---|---|---|
| Urgent PC treatment arm | Experimental | Not described Receives: Device: Urgent PC Neuromodulation System; Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Voids at 12 Weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
Measured: Baseline to 12 weeks
Secondary outcomes (4)
Urge Incontinence Episodes at 12 Weeks
Measured: 12 weeks
Volume Voided at 12 Weeks
Measured: 12 weeks
OAB Quality of Life at 12 Weeks
Measured: 12 weeks
Known Side Effects Through 12 Weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startJun 2006
- Primary completionOct 2008
- Study completionOct 2008
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.
- Other trials for Overactive BladderStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uroplasty, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megan O'Toole, Study director, Uroplasty, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448175
- Sponsor's protocol ID
- UPC032006
- Acronym
- OrBIT
- Status last verified
- Apr 2013
- First submitted
- 15 Mar 2007
- Last updated
- 16 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
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
- Overactive Bladder Innovative Therapy Trial
- ClinicalTrials.gov ID
- NCT00448175
- Acronym / sponsor ID
- OrBIT / UPC032006
- Conditions
- Overactive Bladder
- Keywords
- OAB symptoms of urgency, frequency, and urge incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Uroplasty, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Mar 2007 (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.
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urgent PC treatment arm | Experimental | Device: Urgent PC Neuromodulation System, Drug: Tolterodine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is at least 18 years of age
- Experiences OAB with a voiding frequency of at least 8 times per day
- Is ambulatory and able to use a toilet independently and without difficulty
Key exclusion criteria (9 listed)
- On OAB pharmacotherapy within the previous month
- Primary complaint is stress urinary incontinence
- Has pacemaker or implantable defibrillator
- Has history of heart problems
- Has nerve damage or neuropathy
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 PC Neuromodulation SystemThe 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 treatment arm |
| Tolterodine | Drug | Urgent PC treatment arm |
Primary outcome
Frequency of Voids at 12 Weeks
Time frame: Baseline to 12 weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
4 secondary outcomes
Urge Incontinence Episodes at 12 Weeks
Time frame: 12 weeks
Volume Voided at 12 Weeks
Time frame: 12 weeks
OAB Quality of Life at 12 Weeks
Time frame: 12 weeks
Known Side Effects Through 12 Weeks
Time frame: 12 weeks
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.
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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.
Megan O'Toole study director
Uroplasty, Inc
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 Urgent PC Neuromodulation System and Tolterodine in people with Overactive Bladder, run by Uroplasty, Inc at 1 site 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 3 inclusion and 9 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 1 site 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?
Frequency of Voids at 12 Weeks (time frame: Baseline to 12 weeks). 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 16 May 2013.