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Clinical Trials/NCT03595215
NCT03595215
Completed
N/A

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

Theranova, L.L.C.1 site in 1 country18 target enrollmentSeptember 10, 2018
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ConditionsOveractive Bladder

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Theranova, L.L.C.
Enrollment
18
Locations
1
Primary Endpoint
Change in Urge Incontinence Episodes
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2018
End Date
September 17, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Change in Urge Incontinence Episodes

Time Frame: Baseline and 8 weeks

Secondary Outcomes

  • Change in Micturitions Per Day(Baseline and 8 weeks)
  • Change in Health-related Quality of Life (HRQL)(Baseline and 8 weeks)

Study Sites (1)

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