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Behavioural Intervention
TENS Treatment Arm for Overactive Bladder (OAB Aim 2 Trial)
N/A
Waitlist Available
Research Sponsored by Theranova, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Awards & highlights
Summary
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
Eligible Conditions
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Health-related Quality of Life (HRQL)
Change in Micturitions Per Day
Trial Design
1Treatment groups
Experimental Treatment
Group I: TENS Treatment ArmExperimental Treatment1 Intervention
This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENS
2011
Completed Phase 2
~2040
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,492,376 Total Patients Enrolled
Theranova, L.L.C.Lead Sponsor
11 Previous Clinical Trials
451 Total Patients Enrolled
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