Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

NCT ID: NCT03547518

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2022-11-17

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active PTNS treatment

One-week induction consisting of three active PTNS treatments, each 2 hours long

Group Type: EXPERIMENTAL

PTNS treatment

Intervention Type: DEVICE

One-week induction consisting of three active PTNS treatments, each 2 hours long

Sham treatment

One-week induction consisting of three sham treatments, each 2 hours long

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: DEVICE

One-week induction consisting of three active PTNS treatments, each 2 hours long

Interventions

PTNS treatment

One-week induction consisting of three active PTNS treatments, each 2 hours long

Intervention Type: DEVICE

Sham treatment

One-week induction consisting of three active PTNS treatments, each 2 hours long

Intervention Type: DEVICE

Other Intervention Names

Urgent PC Neuromodulation System; Simulated treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Kenneth M Peters, MD

Professor and Chairman, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospitals

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-497

Identifier Type: -

Identifier Source: org_study_id