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

Not Applicable

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT03595215
• Lead Sponsor: Theranova, L.L.C.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-23
• Study Start: 2018-09-10
• Primary Completion: 2019-07-10
• Study Completion: 2019-09-17
• Results First Submitted: 2019-11-13
• Results First Submitted QC: 2019-12-16
• Results First Posted: 2020-01-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

1. Females
2. 55-100 years old
3. Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
4. Have self-reported bladder symptoms of more than 3 months
5. Are ambulatory and able to use the toilet independently
6. 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
7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
8. Able to provide informed consent
9. Capable and willing to follow all study-related procedures

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Urge Incontinence Episodes	Baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Micturitions Per Day	Baseline and 8 weeks	Mean number of urinary voids per day (taken over a 3-day period)
Change in Health-related Quality of Life (HRQL)	Baseline and 8 weeks	Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States