Overactive Bladder
Conditions
Keywords
overactive bladder, OAB, PTNS, percutaneous tibial nerve stimulation, TTNS, transcutaneous tibial nerve stimulation, county hospital, underserved
Brief summary
The goal of this clinical trial is to study whether transcutaneous tibial nerve stimulation (TTNS) is a feasible and satisfactory treatment for overactive bladder in Urogynecology patients who receive their care at a county hospital. Researchers will compare outcomes with TTNS to patients who undergo percutaneous tibial nerve stimulation (PTNS). The main questions it aims to answer are: * Is TTNS non-inferior to PTNS in terms of OAB symptom severity? * Are patients as satisfied with TTNS as they are with PTNS? * Are patients' symptoms improved with TTNS? Participants will: * either undergo PTNS or be taught how to do TTNS therapy at home * complete surveys about their bladder symptoms and satisfaction with treatment
Detailed description
Patients who consent to this study will be randomly assigned to either receive PTNS in clinic weekly, or TTNS every other day at home. The severity of their overactive bladder symptoms and satisfaction with treatment will be assessed before starting treatment as well as 6 weeks, 12 weeks and 6 months after starting treatment. The results of these surveys will be compared between groups to determine whether TTNS is non-inferior to PTNS in this particular patient population.
Interventions
DEVICETibial nerve stimulation
neuromodulation therapy for overactive bladder that targets the posterior tibial nerve
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
After randomization, patients and care providers will not be blinded, however investigators will be blinded to the results of the survey instruments.
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* age between 18 - 90 years old * patient of the Urogynecology clinic at Harbor UCLA medical center * diagnosis of overactive bladder * patient elects non-pharmacologic treatment of overactive bladder * English or Spanish speaking * able to consent and participate in research
Exclusion criteria
* cognitive impairment or diagnosis of dementia * diagnosis of neurogenic bladder * prior midurethral sling procedure * use of an electronic pacemaker * current pregnancy * incarcerated persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICIQ-OAB score | Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation | OAB symptom severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 weeks, 12 weeks, 6 months post treatment initiation | Patient satisfaction with the intervention (Y/N; would you recommend it to others?) |
| PGI-I | 6 weeks, 12 weeks, 6 months post treatment initiation | Patient global assessment of overall improvement, graded on a scale of 1-7 |
| Compliance | 6 months post treatment initiation | Number and percentage of PTNS visits (PTNS arm); Patient reported number of self-administered TTNS treatments per week |
Countries
United States
Outcome results
None listed