Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

NCT03595215 | Completed Results FDA Device

• 1 other identifier: CRD-12-1076
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.

Conditions

Overactive Bladder

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

• Change in Urge Incontinence Episodes

  Baseline and 8 weeks

Secondary Outcomes (2)

• Change in Micturitions Per Day

  Baseline and 8 weeks

• Change in Health-related Quality of Life (HRQL)

  Baseline and 8 weeks

Study Arms (1)

TENS Treatment Arm

EXPERIMENTAL

This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.

Device: TENS

Interventions

TENS DEVICE

Transcutaneous electrical nerve stimulation

TENS Treatment Arm

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• years old
• Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
• Have self-reported bladder symptoms of more than 3 months
• Are ambulatory and able to use the toilet independently
• Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
• Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
• Able to provide informed consent
• Capable and willing to follow all study-related procedures

You may not qualify if:

• Have primary complaint of stress urinary incontinence
• Have a pacemaker or implantable defibrillator
• Had botox injections in the bladder or pelvic floor muscles in the past 12 months
• Have a current urinary tract or vaginal infection
• Have an active implantable SNS device (InterStim \& Bion)
• Have been diagnosed with peripheral neuropathy or nerve damage
• Currently pregnant
• Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Clinical Research Associate
• Organization: TheraNova

akrajcevska@theranova.com

415-926-8616

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 23, 2018
• Study Start: September 10, 2018
• Primary Completion: July 10, 2019
• Study Completion: September 17, 2019
• Last Updated: May 21, 2021
• Results First Posted: January 3, 2020

Record last verified: 2021-04

Locations

US (1)