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

Overactive Bladder Clinical Trial

— OAB Aim 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595215
• Other study ID #: CRD-12-1076
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: April 2021
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 17, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Theranova, L.L.C.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urge Incontinence Episodes		Baseline and 8 weeks
Secondary	Change in Micturitions Per Day	Mean number of urinary voids per day (taken over a 3-day period)	Baseline and 8 weeks
Secondary	Change in Health-related Quality of Life (HRQL)	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.	Baseline and 8 weeks