Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-85
SponsorLouisiana State University Health Sciences Center Shreveport

About this trial

The goal of this clinical trial is to learn if surface tibial electrical stimulation (mild electrical signals on the inside of the ankle) helps women 60 years or older with urine leakage that happens on the way to the bathroom or at night time. The main questions it aims to answer are: 1). How many treatments per week over a 12-week period improve a person\'s bladder symptoms?; 2). Is a person more confident that they will not fall and / or leak urine on the way to the bathroom after the treatment with the electrical stimulation treatments; 3). Does the way a person walks when they need to go to the bathroom change after they have had the electrical stimulation? They will visit the clinic 3 times to complete several questionnaires and walk with a full bladder and empty bladder. On the first visit, the participant will be taught how to use the electrical stimulation device. Participants will either receive the treatment 2 or 4 times per week for 12 weeks or no treatment with the option to receive treatment following the 12 weeks. Participants will be given a bladder diary to complete at the start of treatment, at 6 weeks, then at 12 weeks and will be instructed in completion. They will drink water until they have a strong urge to urinate, then will walk along an electronic pathway and will go empty their bladder. After emptying, they will walk back along the electronic pathway again. They will also complete a Timed Up and Go test - stand up from a chair, walk 3 meters, then turn around, walk back, then sit down. At the 6th week follow up and the 12th week follow up, they will complete each questionnaire again and complete the walking tasks again.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous tibial nerve stimulation

    Device

    Two electrodes will be place over the tibial nerve over the medial ankle. The electrical stimulation will be turned up to patient tolerance at a sensory level only.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: TTNS - two times per weekExperimental treatment 1 intervention
Group B: TTNS - four times per weekExperimental treatment 1 intervention
Group C: No treatment groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overactive Bladder Symptom Score (OABSS)

Overactive Bladder Symptom Score is a self-reported outcome measure that will be collected at multiple time frames - initial day, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Geriatric Self-efficacy Index for Urinary Incontinence

The Geriatric Self-efficacy Index for Urinary Incontinence is a self-reported outcome measure that will be completed at the initial clinic visit, 6-week follow up clinic visit, 12-week follow up clinic visit.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Activities-specific Balance Confidence Scale

The Activities-specific Balance Confidence Scale is a self-reported outcome measure that will be completed at the initial clinic visit, 6-week follow up clinic visit, 12-week follow up clinic visit.

Time frame
From enrollment to the end of treatment at 12 weeks
3

Timed Up and Go Test

The Timed Up and Go Test is a walking test that will be performed at the initial clinic visit, 6-week follow up clinic visit, 12-week follow up clinic visit. Participants will rise from a chair, walk three meters, turn around, walk back to the chair, and sit back down for time.

Time frame
From enrollment to the end of treatment at 12 weeks
4

Ambulation with a strong desire to void

Participants will drink water until they reach the sensation of a strong desire to void. They will walk across an electronic pathway to determine gait velocity, step length, and step width. They will complete this at the initial clinic visit, 6-week follow up clinic visit, and 12-week follow up clinic visit.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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