An interventional study of Tibial nerve stimulation in Overactive Bladder, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center is the lead sponsor of 67 studies on the registry; 1 is open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
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Exclusion Criteria:
Participants undergo weekly 30-minute percutaneous tibial nerve stimulation in our clinic. The PTNS device is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an acupuncture needle that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain.
Device: Tibial nerve stimulation
Participants receive a TENS unit and are taught how to conduct TTNS therapy at home at their recruitment visit. The TENS unit is a neuromodulation system comprised of an external signal generator attached to one electrode that is placed on the patient's foot, and the other to an electrode patch that is inserted in the patient's inner ankle. It delivers a low electrical signal (20 Hz, 200ms pulse width) to the posterior tibial nerve, adjusted to the participant's perception of stimulation without pain. They will be instructed to conduct this therapy every other day at home.
Device: Tibial nerve stimulation
neuromodulation therapy for overactive bladder that targets the posterior tibial nerve
Also known as: PTNS, TTNS
ICIQ-OAB score
OAB symptom severity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation
Patient satisfaction
Patient satisfaction with the intervention (Y/N; would you recommend it to others?)
Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation
PGI-I
Patient global assessment of overall improvement, graded on a scale of 1-7
Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation
Compliance
Number and percentage of PTNS visits (PTNS arm); Patient reported number of self-administered TTNS treatments per week
Time frame: 6 months post treatment initiation
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center