Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTNS treatment
Sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Urgency, Urinary Frequency, Urge Incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- William Beaumont Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active PTNS treatment
Sham treatment
Arm Description
One-week induction consisting of three active PTNS treatments, each 2 hours long
One-week induction consisting of three sham treatments, each 2 hours long
Outcomes
Primary Outcome Measures
Improvement in GRA for Overall Bladder Symptoms
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03547518
Brief Title
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Official Title
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Urinary Urgency, Urinary Frequency, Urge Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single blind parallel assignment
Masking
Participant
Masking Description
Participant blinded to interventional or sham treatment
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active PTNS treatment
Arm Type
Experimental
Arm Description
One-week induction consisting of three active PTNS treatments, each 2 hours long
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
One-week induction consisting of three sham treatments, each 2 hours long
Intervention Type
Device
Intervention Name(s)
PTNS treatment
Other Intervention Name(s)
Urgent PC Neuromodulation System
Intervention Description
One-week induction consisting of three active PTNS treatments, each 2 hours long
Intervention Type
Device
Intervention Name(s)
Sham treatment
Other Intervention Name(s)
Simulated treatment
Intervention Description
One-week induction consisting of three active PTNS treatments, each 2 hours long
Primary Outcome Measure Information:
Title
Improvement in GRA for Overall Bladder Symptoms
Description
Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions
Time Frame
One week post induction (+/- 3 days)
Secondary Outcome Measure Information:
Title
Change From Baseline Urinary Frequency on 3 Day Voiding Diary
Description
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.
Time Frame
Baseline and 1 week post induction (+/- 3 days)
Title
Change From Baseline Nocturia in 3 Day Voiding Diary
Description
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.
Time Frame
Baseline and one week post induction (+/- 3 days)
Title
Change From Baseline in Degree of Urgency in 3 Day Voiding Diary
Description
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.
Time Frame
Baseline and 1 week post induction (+/- 3 days)
Title
Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary
Description
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.
Time Frame
Baseline and one week post induction (+/- 3 days)
Title
Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)
Description
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.
Time Frame
Baseline and 1 week post induction (+/- 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospitals
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
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