Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: PTNS treatment; Device: Sham treatment

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active PTNS treatment; One-week induction consisting of three active PTNS treatments, each 2 hours long	Device: PTNS treatment; One-week induction consisting of three active PTNS treatments, each 2 hours long; Other Names: Urgent PC Neuromodulation System
Sham Comparator: Sham treatment; One-week induction consisting of three sham treatments, each 2 hours long	Device: Sham treatment; One-week induction consisting of three active PTNS treatments, each 2 hours long; Other Names: Simulated treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in GRA for Overall Bladder Symptoms	Number of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions	One week post induction (+/- 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline and 1 week post induction (+/- 3 days)

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Kenneth Peters, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Urinary Urgency; Urinary Frequency; Urge Incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: 2017-497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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