N/A
Completed N=18
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Source: ClinicalTrials.gov NCT03595215 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change in Urge Incontinence Episodes — 3.9 UUI
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.
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 | — |
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
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. Informational only — not medical advice.