Overactive BladderNCT03547518
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
A study testing PTNS treatment in people with Overactive Bladder, run by Corewell Health East at 1 site in United States.
Trial summary
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement. 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 treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 17 Nov 2022
- Phase
- Interventional
- 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
- Women and men > 18 years of age
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- An above normal urinary frequency as recorded on initial 3-day voiding diary
- Self-reported bladder symptoms greater than or equal to 3 months
- On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks
- Capable of giving informed consent
- Ambulatory and able to use toilet independently without difficulty
- Capable and willing to follow all study-related procedures
Who cannot join
- Pregnant or planning to become pregnant during study duration
- Diagnosis of neurogenic bladder
- Botox use in bladder or pelvic floor muscles within past 12 months
- Pacemakers or implantable defibrillators
- Current urinary tract infection
- Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.
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- Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs
- Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening.
- Use of investigational drug/device therapy within past 4 weeks
- Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
- Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results
- Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospitals
Royal Oak, Michigan, 48073
About this study
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.
Read the detailed description
Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.
- Conditions
- Overactive Bladder
- Being tested
- PTNS treatment, Sham treatment
- Keywords
- Urinary Urgency, Urinary Frequency, 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.
PTNS treatmentDevice
Also called Urgent PC Neuromodulation System
One-week induction consisting of three active PTNS treatments, each 2 hours long
Sham treatmentDevice
Also called Simulated treatment
One-week induction consisting of three active PTNS treatments, each 2 hours long
| Study group | Role | What they receive |
|---|---|---|
| Active PTNS treatment | Experimental | One-week induction consisting of three active PTNS treatments, each 2 hours long Receives: Device: PTNS treatment |
| Sham treatment | Sham comparator | One-week induction consisting of three sham treatments, each 2 hours long Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in GRA for Overall Bladder Symptoms
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
Measured: One week post induction (+/- 3 days)
Secondary outcomes (5)
Change From Baseline Urinary Frequency on 3 Day Voiding Diary
Change in number of total voids as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urinary frequency from baseline, negative change means increase in urinary frequency from baseline.
Measured: Baseline and 1 week post induction (+/- 3 days)
Change From Baseline Nocturia in 3 Day Voiding Diary
Change in number of total night time urinary voids over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in number of night time voids. Negative change means increase in number of night time voids.
Measured: Baseline and one week post induction (+/- 3 days)
Change From Baseline in Degree of Urgency in 3 Day Voiding Diary
Change in number of urinary voids recorded as urgent over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (end of treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.
Measured: Baseline and 1 week post induction (+/- 3 days)
Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary
Change in number of urge incontinence episodes over three days as measured by 3-day voiding diary, between pre-induction (baseline) and post-induction (post-treatment). Positive change means reduction in urge incontinence episodes. Negative change means increase in urge incontinence episodes.
Measured: Baseline and one week post induction (+/- 3 days)
Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)
Change from baseline in total score on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal. Score range 0-100. Higher score equals worse overactive bladder symptoms. Positive change means improvement in OAB symptoms. Negative change means worsening of OAB symptoms.
Measured: Baseline and 1 week post induction (+/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start13 Mar 2018
- Primary completion12 May 2022
- Study completion17 Nov 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single blind parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547518
- Sponsor's protocol ID
- 2017-497
- Status last verified
- Jul 2023
- First submitted
- 24 May 2018
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
- ClinicalTrials.gov ID
- NCT03547518
- Acronym / sponsor ID
- 2017-497
- Conditions
- Overactive Bladder
- Keywords
- Urinary Urgency, Urinary Frequency, Urge Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.
Detailed description
Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single blind parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Active PTNS treatment | Experimental | Device: PTNS treatmentOne-week induction consisting of three active PTNS treatments, each 2 hours long |
| Sham treatment | Sham comparator | Device: Sham treatmentOne-week induction consisting of three sham treatments, each 2 hours long |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women and men > 18 years of age
- Self-reported failed conservative care of behavioral modifications and/or oral medications
- An above normal urinary frequency as recorded on initial 3-day voiding diary
- Self-reported bladder symptoms greater than or equal to 3 months
- On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks
Key exclusion criteria (12 listed)
- Pregnant or planning to become pregnant during study duration
- Diagnosis of neurogenic bladder
- Botox use in bladder or pelvic floor muscles within past 12 months
- Pacemakers or implantable defibrillators
- Current urinary tract 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 |
|---|---|---|
| PTNS treatmentAlso: Urgent PC Neuromodulation SystemOne-week induction consisting of three active PTNS treatments, each 2 hours long | Device | Active PTNS treatment |
| Sham treatmentAlso: Simulated treatmentOne-week induction consisting of three active PTNS treatments, each 2 hours long | Device | Sham treatment |
Primary outcome
Improvement in GRA for Overall Bladder Symptoms
Time frame: One week post induction (+/- 3 days)
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
5 secondary outcomes
Change From Baseline Urinary Frequency on 3 Day Voiding Diary
Time frame: Baseline and 1 week post induction (+/- 3 days)
Change From Baseline Nocturia in 3 Day Voiding Diary
Time frame: Baseline and one week post induction (+/- 3 days)
Change From Baseline in Degree of Urgency in 3 Day Voiding Diary
Time frame: Baseline and 1 week post induction (+/- 3 days)
Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary
Time frame: Baseline and one week post induction (+/- 3 days)
Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)
Time frame: Baseline and 1 week post induction (+/- 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS treatment in people with Overactive Bladder, run by Corewell Health East 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 8 inclusion and 12 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 14 Aug 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). 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?
Improvement in GRA for Overall Bladder Symptoms (time frame: One week post induction (+/- 3 days)). 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 14 Aug 2023.