Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

NCT03547518 | Completed Results FDA Device

• 1 other identifier: 2017-497
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Keywords

Urinary Urgency; Urinary Frequency; Urge Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline Urinary Frequency on 3 Day Voiding Diary

  Baseline and 1 week post induction (+/- 3 days)

• Change From Baseline Nocturia in 3 Day Voiding Diary

  Baseline and one week post induction (+/- 3 days)

• Change From Baseline in Degree of Urgency in 3 Day Voiding Diary

  Baseline and 1 week post induction (+/- 3 days)

• Change From Baseline in Number of Urge Incontinence Episodes in 3 Day Voiding Diary

  Baseline and one week post induction (+/- 3 days)

• Change From Baseline in Overactive Bladder Questionnaire-short Form Symptom Bother (OABq-SF)

  Baseline and 1 week post induction (+/- 3 days)

Study Arms (2)

Active PTNS treatment

EXPERIMENTAL

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

Device: PTNS treatment

Sham treatment

SHAM COMPARATOR

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

Device: Sham treatment

Interventions

PTNS treatment DEVICE

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

Also known as: Urgent PC Neuromodulation System

Active PTNS treatment

Sham treatment DEVICE

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

Also known as: Simulated treatment

Sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Results Point of Contact

• Title: Jennifer Giordano, RN BSN Clinical Research Manager
• Organization: William Beaumont Hosptial

jennifer.giordano@corewellhealth.org

248-551-3517

Study Officials

• Kenneth Peters, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant blinded to interventional or sham treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Urology

Model Details: Randomized, single blind parallel assignment

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: March 13, 2018
• Primary Completion: May 12, 2022
• Study Completion: November 17, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)