Clinical trial NCT03547518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Urinary Urgency
Urinary Frequency
Urge Incontinence
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single blind parallel assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in GRA for Overall Bladder Symptoms
timeFrame: One week post induction (+/- 3 days)
Secondary outcomes:
measure: Change From Baseline Urinary Frequency on 3 Day Voiding Diary
timeFrame: Baseline and 1 week post induction (+/- 3 days)
measure: Change From Baseline Nocturia in 3 Day Voiding Diary
timeFrame: Baseline and one week post induction (+/- 3 days)
measure: Change From Baseline in Degree of Urgency in 3 Day Voiding Diary
timeFrame: Baseline and 1 week post induction (+/- 3 days)
measure: Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary
timeFrame: Baseline and one week post induction (+/- 3 days)
measure: Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)
timeFrame: Baseline and 1 week post induction (+/- 3 days)
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospitals
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: