Overactive Bladder SyndromeTTNSNCT06617676
Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women
A study testing Transcutaneous tibial nerve stimulation in people with Overactive Bladder Syndrome and Urinary Incontinence, Urge, run by Louisiana State University Health Sciences Center Shreveport.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Urinary Incontinence, Urge, Nocturia
- What is being tested?
- Transcutaneous tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
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\'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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Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Transcutaneous tibial nerve stimulation
- Keywords
- Overactive bladder syndrome, Transcutaneous sacral nerve stimulation, Falls, Urinary urgency, Urinary frequency, Nocturia
- Medical subject headings
- Urinary Incontinence, Urge, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous tibial nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous tibial nerve stimulation |
| No treatment group | No intervention | Treatment will be deferred after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
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.
Measured: From enrollment to the end of treatment at 12 weeks
Ambulation with empty bladder conditions
Participants will walk across an electronic pathway after emptying their bladder 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.
Measured: From enrollment to the end of treatment at 12 weeks
Three Day Bladder Diary
Participants will complete a three day voiding diary to determine urinary frequency, urinary urgency, and the number of nighttime voids. These will be completed at the initial clinic visit, 6-week follow up clinic visit, and 12-week follow up clinic visit.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Mahoney, Louisiana State University Health Sciences Center Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617676
- Sponsor's protocol ID
- STUDY00002713
- Acronym
- TTNS
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT06617676
- Acronym / sponsor ID
- TTNS / STUDY00002713
- Keywords
- Overactive bladder syndrome, Transcutaneous sacral nerve stimulation, Falls, Urinary urgency, Urinary frequency, Nocturia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| TTNS - two times per week | Experimental | Device: Transcutaneous tibial nerve stimulationParticipants 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. |
| TTNS - four times per week | Experimental | Device: Transcutaneous tibial nerve stimulationParticipants 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. |
| No treatment group | No intervention | –Treatment will be deferred after 12 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous tibial nerve stimulationTwo 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. | Device | TTNS - four times per week, TTNS - two times per week |
Primary outcome
Overactive Bladder Symptom Score (OABSS)
Time frame: From enrollment to the end of treatment at 12 weeks
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.
6 secondary outcomes
Geriatric Self-efficacy Index for Urinary Incontinence
Time frame: From enrollment to the end of treatment at 12 weeks
Activities-specific Balance Confidence Scale
Time frame: From enrollment to the end of treatment at 12 weeks
Timed Up and Go Test
Time frame: From enrollment to the end of treatment at 12 weeks
Ambulation with a strong desire to void
Time frame: From enrollment to the end of treatment at 12 weeks
Ambulation with empty bladder conditions
Time frame: From enrollment to the end of treatment at 12 weeks
Three Day Bladder Diary
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation in people with Overactive Bladder Syndrome and Urinary Incontinence, Urge, run by Louisiana State University Health Sciences Center Shreveport.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda T Mahoney, DPT, PT (318-813-2970, amanda.mahoney@lsuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder Symptom Score (OABSS) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.