Clinical trial NCT06617676: Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women
Official title: Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Urinary Incontinence, Urge
Nocturia
Keywords: Overactive bladder syndrome
Transcutaneous sacral nerve stimulation
Falls
Urinary urgency
Urinary frequency
Nocturia
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of of the three groups in parallel for the duration of the study. The variable in the intervention will be the number of treatments they receive per week.
Primary purpose: TREATMENT

Brief summary: 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\&#39;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.

Detailed description: This study will improve standardization for the delivery of transcutaneous tibial nerve stimulation as a treatment modality for overactive bladder in post-menopausal women and contribute to lower cost care options within the home environment. This is a prospective randomized control trial where the participants' baseline conditions will be utilized for comparison with post-treatment. The independent variable is transcutaneous tibial nerve stimulation. The dependent variables are urinary frequency and urinary continence episodes based on three-day bladder diary, OAB-V8, Overactive Bladder Symptom Severity Score (OABSS), Activities-specific Balance Confidence Scale (ABC-16), Geriatric Self-efficacy Index for Urinary Incontinence (GSE-UI), and the Timed-Up and Go test (TUGT). Additional pre- and post- test variables that will be considered are spatiotemporal measurements of gait with both full and empty bladder conditions.

At the first session at the School of Allied Health Professions following screening and consent, participants will complete the OAB-SS, ABC-16, and the GSE-UI. Participants will be asked to start drinking water at the start of the first session. Once the participant notes a strong desire to void that is difficult to defer based on the urgency severity scale (USS), the participant will walk along the GaitRITE pathway to the restroom. Participant will void into a urine specimen collector and bladder volume will be recorded, but urine will not be retained. The participant will then walk back over the electronic pathway to collect empty bladder condition gait. Participant will then complete the TUGT. Following this testing, participants will be instructed in home use of the transcutaneous tibial nerve stimulation. Participants will place one electrode 3 finger widths above the medial malleolus with the other placed below the medial malleolus with the following parameters: 10 Hertz, 200 microseconds, for 30 minutes to a strong but comfortable level that is under the motor threshold. Participants will complete these sessions either two or four times per week for 12 weeks or will receive no treatment for the 12 weeks. Participants will be given a log for home use to document their compliance with the home treatment.

Participants will follow up at the School of Allied Health Professions at the 6-week mark to complete the gait testing and Activities-specific Balance Confidence Scale and the Geriatric Self-Efficacy Index for Urinary Incontinence. Participants will be given supplies to complete an additional three-day bladder diary to bring with them for the 12-week follow-up. Following 12 weeks of transcutaneous tibial nerve stimulation, participants will return to the School of Allied Health Professions to complete the procedure described above.

Eligibility criteria: Inclusion Criteria: Inclusion criteria include females over 60 years of age who score an 8 or greater on the OAB-V8 with no exclusion criteria.

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Exclusion Criteria: those who experience stress UI only, have a pacemaker, neurologic deficit (e.g. Parkinson\&#39;s disease, multiple sclerosis, spinal cord injury), current urinary tract infection, known active cancer, or current OAB medication use (Tolterdine, etc.) with consideration of a washout period, and inability to walk 30 meters.

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Primary outcomes:
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Geriatric Self-efficacy Index for Urinary Incontinence
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Timed Up and Go Test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Ambulation with a strong desire to void
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Ambulation with empty bladder conditions
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Three Day Bladder Diary
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
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