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

TheraNova

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: TENS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03595215

CRD-12-1076

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

TENS Treatment Arm

Experimental 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.

Treatment:

Device: TENS