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

NCT06617676 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00002713
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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\'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

Keywords

Overactive bladder syndrome; Transcutaneous sacral nerve stimulation; Falls; Urinary urgency; Urinary frequency; Nocturia

Outcome Measures

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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

• Geriatric Self-efficacy Index for Urinary Incontinence

  From enrollment to the end of treatment at 12 weeks

• Activities-specific Balance Confidence Scale

  From enrollment to the end of treatment at 12 weeks

• Timed Up and Go Test

  From enrollment to the end of treatment at 12 weeks

• Ambulation with a strong desire to void

  From enrollment to the end of treatment at 12 weeks

• Ambulation with empty bladder conditions

  From enrollment to the end of treatment at 12 weeks

Study Arms (3)

TTNS - two times per week

EXPERIMENTAL

Participants will receive transcutaneous tibial nerve stimulation for 30 minutes with a frequency of 12 Hz, pulse width of 300 microseconds, and to an intensity of the participant's tolerance under the motor threshold. This group will receive treatment two times per week.

Device: Transcutaneous tibial nerve stimulation

TTNS - four times per week

EXPERIMENTAL

Participants will receive transcutaneous tibial nerve stimulation for 30 minutes with a frequency of 12 Hz, pulse width of 300 microseconds, and to an intensity of the participant's tolerance under the motor threshold. This group will receive treatment four times per week.

Device: Transcutaneous tibial nerve stimulation

No treatment group

NO INTERVENTION

Treatment will be deferred after 12 weeks.

Interventions

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.

TTNS - four times per week; TTNS - two times per week

Eligibility Criteria

• Age: 60 Years - 85 Years
• Gender Eligibility Details: Cis-gender females, biological females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

MeSH Terms

Conditions

Urinary Incontinence, Urge; Nocturia

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amanda T Mahoney, DPT, PT

CONTACT

318-813-2970; amanda.mahoney@lsuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor - Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share