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

NCT06617676 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-09-27

No results posted yet for this study

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\'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.

Conditions

  • Overactive Bladder Syndrome
  • Urinary Incontinence, Urge
  • Nocturia

Interventions

DEVICE

Transcutaneous tibial nerve stimulation

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.

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center Shreveport

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-10-31
Completion
2026-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617676 on ClinicalTrials.gov