Trial Outcomes & Findings for Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home (NCT NCT03595215)

NCT ID: NCT03595215

Last Updated: 2021-05-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2021-05-21

Participant Flow

Participant milestones

Measure	TENS Treatment Arm This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation
Overall Study STARTED	18
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TENS Treatment Arm n=18 Participants This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation
Age, Continuous	70.7 Years STANDARD_DEVIATION 11.7 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
UUI	5.6 Episodes STANDARD_DEVIATION 4.6 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	TENS Treatment Arm n=10 Participants This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation
Change in Urge Incontinence Episodes	3.9 UUI Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Mean number of urinary voids per day (taken over a 3-day period)

Outcome measures

Measure	TENS Treatment Arm n=10 Participants This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation
Change in Micturitions Per Day	5.6 voids per day Standard Deviation 13.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TENS Treatment Arm n=10 Participants This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation
Change in Health-related Quality of Life (HRQL)	-19.5 units on a scale Standard Deviation 14.5

Adverse Events

TENS Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Associate

TheraNova

Phone: 415-926-8616

Email: akrajcevska@theranova.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place