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

NCT ID: NCT03595215

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2019-09-17

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

Transcutaneous electrical nerve stimulation

Interventions

TENS

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Theranova, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University Medical Center

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRD-12-1076

Identifier Type: -

Identifier Source: org_study_id