Overactive BladderPhase 4NCT01605617
Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
A Phase 4 study testing Fesoterodine fumarate and Percutaneous Tibial Nerve Stimulation (PTNS) in people with Overactive Bladder, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators are studying two FDA-approved modalities used to treat overactive bladder to determine if they improve overactive bladder with or without urge incontinence when used together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and fesoterodine fumarate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Fesoterodine fumarate and Percutaneous Tibial Nerve Stimulation (PTNS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ages > 18 and < 100 years old without childbearing potential
- History of overactive bladder
- with or without urge incontinence)
- with or without a history of previous anticholinergic use
- At least 8 voids per 24 hours documented by history and physical and voiding diary
Who cannot join
- Has had PTNS modulation in the past
- Has a primary complaint of stress urinary incontinence
- History of an allergy or sensitivity to tolterodine tartrate tablets or its ingredients
- History of an allergy or sensitivity to fesoterodine tartrate tablets or its ingredients
- Has a recent positive urinalysis for infection
- Has taken anticholinergic medication in the last 4 weeks for overactive bladder
Show all 14Show fewer
- Has any of the following:
- pacemakers or implantable defibrillators
- excessive bleeding
- urinary or gastric retention
- nerve damage and/or neuropathy
- myasthenia gravis, uncontrolled narrow angle glaucoma
- liver disease or kidney disease
- QT prolongation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Arizona (MCSB and MCH)
Phoenix, Arizona, 85054
About this study
Official title: Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
The investigators are studying two FDA-approved modalities used to treat overactive bladder to determine if they improve overactive bladder with or without urge incontinence when used together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and fesoterodine fumarate.
Read the detailed description
Overactive bladder (OAB) is described as urinary urgency with or without urge incontinence, usually associated with urinary frequency and nocturia. The primary complaint is a strong desire to void without the ability to postpone micturition. Two treatments used in the treatment of OAB are pharmacotherapy and percutaneous tibial nerve stimulation (PTNS).
Pharmacotherapy for OAB is based on medications that block the muscarinic receptors of the detrusor muscle. These particular receptors are not unique to the bladder, however, and patients complain of bothersome side effects that are a result of systemic muscarinic receptor blockade. Medications are successful for many patients but compliance is poor and many patients discontinue the medications as a result of side effects, cost, and insufficient symptom improvement.
Percutaneous tibial nerve stimulation (PTNS) is a newer treatment modality that provides neuromodulation to the pelvic floor by stimulating the posterior tibial nerve. This nerve is accessed with a fine needle electrode that is inserted in the medial portion of the ankle. This area has long been recognized as having nerve projections to the sacral nerve plexus and can modulate bladder activity. Several studies have clearly demonstrated the effectiveness of neuromodulation to treat urge incontinence.
There have been studies comparing the efficacy of pharmacotherapy versus PTNS. In one study, 49% of subjects taking fesoterodine fumarate for urge incontinence reported an improvement in symptoms of overactive bladder. In other studies, 79.5% of patients undergoing PTNS reported improvement or cure. Although studies report similar improvement or cure between the two treatment modalities, there is no evidence of the efficacy of using both PTNS and pharmacotherapy concurrently. This study is aimed at proving synergy between the two treatment modalities when used together in an effort to administer smaller doses of anticholinergic agents, while obtaining comparable or improved urge incontinence.
- Conditions
- Overactive Bladder
- Being tested
- Fesoterodine fumarate, Placebo, Percutaneous Tibial Nerve Stimulation (PTNS)
- 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.
Fesoterodine fumarateDrug
Also called Toviaz
PTNS + 4mg of fesoterodine fumarate for 12 weeks
PlaceboDrug
PTNS + placebo for 12 weeks
Percutaneous Tibial Nerve Stimulation (PTNS)Procedure or surgery
PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate).
| Study group | Role | What they receive |
|---|---|---|
| PTNS + fesoterodine fumarate first, then PTNS + placebo | Active comparator | Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo. Receives: Drug: Fesoterodine fumarate; Drug: Placebo; Procedure: Percutaneous Tibial Nerve Stimulation (PTNS) |
| PTNS + placebo first, then PTNS + fesoterodine fumarate | Placebo comparator | Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate Receives: Drug: Fesoterodine fumarate; Drug: Placebo; Procedure: Percutaneous Tibial Nerve Stimulation (PTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy
Measured: From baseline to 12 weeks post treatment
Secondary outcomes (5)
Mean Change in Urinary Urge Incontinence Episodes in 24 Hours
Measured: Baseline, 12 weeks post treatment
Number of Voids Causing Waking
Measured: From baseline to 12 weeks post treatment
Volume Voided Per Day
Measured: From baseline to 12 weeks post treatment
Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)
The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.
Measured: baseline, 12 weeks post treatment
Change in Score on Overactive Bladder Questionnaire (QAB-q)
The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from "not at all" to "a very great deal." Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort).
Measured: Baseline, 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Low recruitment rate, and study patients were removed prior to completion
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.
- More trials run by Mayo ClinicThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Cornella, Mayo Clinic
- Investigators
- Jeffrey Cornella, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605617
- Sponsor's protocol ID
- 11-004589
- Status last verified
- Dec 2013
- First submitted
- 3 May 2012
- Last updated
- 5 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate
- ClinicalTrials.gov ID
- NCT01605617
- Acronym / sponsor ID
- 11-004589
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate, and study patients were removed prior to completion
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 5 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying two FDA-approved modalities used to treat overactive bladder to determine if they improve overactive bladder with or without urge incontinence when used together rather than separately, percutaneous tibial nerve stimulation (PTNS) versus PTNS and fesoterodine fumarate.
Detailed description
Overactive bladder (OAB) is described as urinary urgency with or without urge incontinence, usually associated with urinary frequency and nocturia. The primary complaint is a strong desire to void without the ability to postpone micturition. Two treatments used in the treatment of OAB are pharmacotherapy and percutaneous tibial nerve stimulation (PTNS).
Pharmacotherapy for OAB is based on medications that block the muscarinic receptors of the detrusor muscle. These particular receptors are not unique to the bladder, however, and patients complain of bothersome side effects that are a result of systemic muscarinic receptor blockade. Medications are successful for many patients but compliance is poor and many patients discontinue the medications as a result of side effects, cost, and insufficient symptom improvement.
Percutaneous tibial nerve stimulation (PTNS) is a newer treatment modality that provides neuromodulation to the pelvic floor by stimulating the posterior tibial nerve. This nerve is accessed with a fine needle electrode that is inserted in the medial portion of the ankle. This area has long been recognized as having nerve projections to the sacral nerve plexus and can modulate bladder activity. Several studies have clearly demonstrated the effectiveness of neuromodulation to treat urge incontinence.
There have been studies comparing the efficacy of pharmacotherapy versus PTNS. In one study, 49% of subjects taking fesoterodine fumarate for urge incontinence reported an improvement in symptoms of overactive bladder. In other studies, 79.5% of patients undergoing PTNS reported improvement or cure. Although studies report similar improvement or cure between the two treatment modalities, there is no evidence of the efficacy of using both PTNS and pharmacotherapy concurrently. This study is aimed at proving synergy between the two treatment modalities when used together in an effort to administer smaller doses of anticholinergic agents, while obtaining comparable or improved urge incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS + fesoterodine fumarate first, then PTNS + placebo | Active comparator | Drug: Fesoterodine fumarate, Drug: Placebo, Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo. |
| PTNS + placebo first, then PTNS + fesoterodine fumarate | Placebo comparator | Drug: Fesoterodine fumarate, Drug: Placebo, Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female ages > 18 and < 100 years old without childbearing potential
- History of overactive bladder
- At least 8 voids per 24 hours documented by history and physical and voiding diary
Key exclusion criteria (14 listed)
- Has had PTNS modulation in the past
- Has a primary complaint of stress urinary incontinence
- History of an allergy or sensitivity to tolterodine tartrate tablets or its ingredients
- History of an allergy or sensitivity to fesoterodine tartrate tablets or its ingredients
- Has a recent positive urinalysis for infection
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 |
|---|---|---|
| Fesoterodine fumarateAlso: ToviazPTNS + 4mg of fesoterodine fumarate for 12 weeks | Drug | PTNS + fesoterodine fumarate first, then PTNS + placebo, PTNS + placebo first, then PTNS + fesoterodine fumarate |
| PlaceboPTNS + placebo for 12 weeks | Drug | PTNS + fesoterodine fumarate first, then PTNS + placebo, PTNS + placebo first, then PTNS + fesoterodine fumarate |
| Percutaneous Tibial Nerve Stimulation (PTNS)PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate). | Procedure or surgery | PTNS + fesoterodine fumarate first, then PTNS + placebo, PTNS + placebo first, then PTNS + fesoterodine fumarate |
Primary outcome
Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy
Time frame: From baseline to 12 weeks post treatment
5 secondary outcomes
Mean Change in Urinary Urge Incontinence Episodes in 24 Hours
Time frame: Baseline, 12 weeks post treatment
Number of Voids Causing Waking
Time frame: From baseline to 12 weeks post treatment
Volume Voided Per Day
Time frame: From baseline to 12 weeks post treatment
Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)
Time frame: baseline, 12 weeks post treatment
Change in Score on Overactive Bladder Questionnaire (QAB-q)
Time frame: Baseline, 12 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Jeffrey Cornella, MD principal investigator
Mayo Clinic
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 Fesoterodine fumarate and Percutaneous Tibial Nerve Stimulation (PTNS) in people with Overactive Bladder, run by Mayo Clinic 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 5 inclusion and 14 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 5 Feb 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?
Yes. Results are posted in the registry (first posted 5 Feb 2014). 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?
Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy (time frame: From baseline to 12 weeks post treatment). 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 5 Feb 2014.