N/A N=18 Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT03595215 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Change in Urge Incontinence Episodes — 3.9 UUI

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TENS (Device)
Age: Adult, Older Adult · 55+ yrs
Sex: Female
Sponsor: Theranova, L.L.C.
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Urge Incontinence Episodes	3.9	—
SECONDARY Change in Micturitions Per Day	5.6	—
SECONDARY Change in Health-related Quality of Life (HRQL)	-19.5	—

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.

Eligibility Criteria

Inclusion Criteria

Females
55-100 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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03595215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.