OAB Aim 2: Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

• Sponsor: Theranova, L.L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03595215
• Collaborator: Stanford University (Other)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Device: TENS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Jul 10, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: TENS; Transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcome Measures

1. Change in Urge Incontinence Episodes [Baseline and 8 weeks]

Secondary Outcome Measures

1. Change in Micturitions Per Day [Baseline and 8 weeks]

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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Theranova, L.L.C.
• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 7, 2019

More Information

Publications

None provided.

• Responsible Party: Theranova, L.L.C.
• ClinicalTrials.gov Identifier: NCT03595215
• Other Study ID Numbers: CRD-12-1076
• First Posted: Jul 23, 2018
• Last Update Posted: May 21, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Theranova, L.L.C.: TENS
• Additional relevant MeSH terms: Urinary Bladder, Overactive

Study Results

Participant Flow

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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
Period Title: Overall Study
STARTED	18
COMPLETED	10
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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 Participants	18
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.7 (11.7)
Sex: Female, Male (Count of Participants)
Female	18 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 27.8%
Not Hispanic or Latino	13 72.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5.6%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 11.1%
White	15 83.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
UUI (Episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Episodes]	5.6 (4.6)

Outcome Measures

1. Primary Outcome

Title	Change in Urge Incontinence Episodes
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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
Measure Participants	10
Mean (Standard Deviation) [UUI]	3.9 (4.0)

2. Secondary Outcome

Title	Change in Micturitions Per Day
Description	Mean number of urinary voids per day (taken over a 3-day period)
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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
Measure Participants	10
Mean (Standard Deviation) [voids per day]	5.6 (13.9)

3. Secondary Outcome

Title	Change in Health-related Quality of Life (HRQL)
Description	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.
Time Frame	Baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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
Measure Participants	10
Mean (Standard Deviation) [units on a scale]	-19.5 (14.5)

Adverse Events

Time Frame	Through study completion, an average of 8 weeks for each for each participant
Arm/Group Title	TENS Treatment Arm
Arm/Group Description	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
All Cause Mortality
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	TENS Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.