Overactive BladderPhase 4NCT01764893
Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
A Phase 4 study testing PTNS plus solifenacin in people with Overactive Bladder, run by Bay State Clinical Trials, Inc. at 1 site in United States.
Trial summary
The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire)… 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?
- PTNS plus solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- history of overactive bladder
- history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
- PTNS-naive
- willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
- able to swallow and retain oral medication
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- able and willing to participate in the full duration of the study
- able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
- OAB-q (items 1-8) score of 30 or higher
Who cannot join
- presence of cardiac pacemaker and/or defibrillator
- history of urinary retention
- history of gastric retention
- uncontrolled narrow angle glaucoma
- any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
- abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin > 3 times the upper limit of normal
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- history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- known hypersensitivity to solifenacin
- participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period
- pregnancy or trying to become pregnant
- breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder
The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.
- Conditions
- Overactive Bladder
- Being tested
- PTNS plus solifenacin, Placebo
- Keywords
- Overactive 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.
PTNS plus solifenacinOther
Also called Vesicare
12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug.
PlaceboOther
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
| Study group | Role | What they receive |
|---|---|---|
| PTNS and solifenacin | Active comparator | PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks Receives: Other: PTNS plus solifenacin |
| PTNS and placebo | Placebo comparator | PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Questionnaire, items 1-8 only
Measured: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
Overactive Bladder Questionnaire, items 1-8 only
Measured: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
Secondary outcomes (5)
3-day micturition diary
To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)
Measured: Change in Bladder diary from Baseline to 5 weeks.
3-day micturition diary
To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)
Measured: Change in Bladder diary from Baseline to 11 weeks.
3-day micturition diary
To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)
Measured: Change in Bladder diary from Baseline to 15 weeks.
Urgency Perception Scale (questionnaire)
Measured: Changes in Urgency Perception from Baseline to 11 weeks.
Urgency Perception Scale (questionnaire)
Measured: Changes in Urgency Perception from Baseline to 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bay State Clinical Trials, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H. David Mitcheson, MD, Principal investigator, Bay State Clinical Trials, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764893
- Sponsor's protocol ID
- BSU-SOL-001
- Status last verified
- May 2014
- First submitted
- 3 Jan 2013
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder
- ClinicalTrials.gov ID
- NCT01764893
- Acronym / sponsor ID
- BSU-SOL-001
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bay State Clinical Trials, Inc.University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jan 2013 (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 null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS and solifenacin | Active comparator | Other: PTNS plus solifenacinPTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks |
| PTNS and placebo | Placebo comparator | Other: PlaceboPTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- history of overactive bladder
- history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
- PTNS-naive
- willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
Key exclusion criteria (11 listed)
- presence of cardiac pacemaker and/or defibrillator
- history of urinary retention
- history of gastric retention
- uncontrolled narrow angle glaucoma
- any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
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 |
|---|---|---|
| PTNS plus solifenacinAlso: Vesicare12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug. | Other | PTNS and solifenacin |
| Placebo12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo. | Other | PTNS and placebo |
Primary outcome
Overactive Bladder Questionnaire, items 1-8 only
Time frame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
Overactive Bladder Questionnaire, items 1-8 only
Time frame: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
5 secondary outcomes
3-day micturition diary
Time frame: Change in Bladder diary from Baseline to 5 weeks.
3-day micturition diary
Time frame: Change in Bladder diary from Baseline to 11 weeks.
3-day micturition diary
Time frame: Change in Bladder diary from Baseline to 15 weeks.
Urgency Perception Scale (questionnaire)
Time frame: Changes in Urgency Perception from Baseline to 11 weeks.
Urgency Perception Scale (questionnaire)
Time frame: Changes in Urgency Perception from Baseline to 15 weeks.
Results and safety
The study was stopped early (reason given: Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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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.
H. David Mitcheson, MD principal investigator
Bay State Clinical Trials, 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 PTNS plus solifenacin in people with Overactive Bladder, run by Bay State Clinical Trials, 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 May 2014. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.). Results are not available in the source record.
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?
Overactive Bladder Questionnaire, items 1-8 only (time frame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.). The study lists 2 primary outcomes in all. 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 23 May 2014.