An interventional study of PTNS maintenance in Overactive Bladder, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Not applicable, Interventional, and Treatment
The overall objective of this study is to compare the efficacy of the standard monthly maintenance therapy for percutaneous tibial nerve stimulation (PTNS), to sessions as the patient needs (prn) between 2 weeks and 12 weeks, based on overactive bladder symptoms. This is study is to help determine feasibility for conducting a larger trial that is appropriately powered to provide meaningful data.
Patient will be recruited from the Urogynecology clinic on the first floor of the hospital. Patients who have completed 12 weeks of PTNS therapy will be identified by the clinic nurse or nurse practitioner and then a member of the research team will approach the patient regarding involvement in the study. Patients will be asked if they would like to take part in this study and will be given the human bill of rights and well as consent forms in their preferred language (English or Spanish) if they agree to participate. Once they agree to participate, they will be asked to sign the consent forms in a private patient room.
This is a pilot study for feasibility designed as an equivalence and cost analysis study. Patients will be recruited at the 12th session of PTNS (conclusion of treatment and before maintenance therapy starts).
Patients will be from the Urogynecology clinic at Harbor UCLA Medical Center who have OAB and who have been treated with the standard 12 sessions of PTNS. Patients will be randomized to "every month PTNS maintenance" or "as needed PTNS maintenance (Q2-12 weeks)." At enrollment, questions will be read to patients in either Spanish or English based on patient's preferred language and study staff will fill out the surveys for the patient. The patient with the study staff will complete the validated questionnaires, Overactive Bladder Questionnaire (OAB-q), the Benefit, Satisfaction and Willingness to Continue the Treatment questionnaire (BSW) and the Visual analogue scale for satisfaction with treatment. Urinary symptoms will be measured by the validated Overactive Bladder Symptom Scale (OAB-SS) and a modified voiding diary. All patients will have a urine dip completed at this visit to rule out a bladder infection. Finally patients, with the help of study staff, will answer open ended questions. All of these measures will be repeated 3 months after enrollment and one year from enrollment. After the yearlong study, participants can continue treatment which will be decided by the patient and treating clinician. A cost analysis will compare the cost to patients and the cost to the clinic between the monthly PTNS maintenance group and the patient prn maintenance group. All of the above measures will be recorded at enrollment, 3 months from enrollment and 1 year from enrollment. This will be done in person with the help of the study staff at enrollment and either in person, via the phone or in writing at 3 month and 1 year follow up. No payment and no other recruitment methods will be used.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 37 is below 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients return for PTNS maintenance monthly.
Other: PTNS maintenance
Patients return for PTNS as needed (2-12 weeks).
Other: PTNS maintenance
The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)
Quality of Life - change
The primary aim is patient reported quality of life. A validated quality of life questionnaire specific to overactive bladder (OAB) (OAB-q).
Time frame: 3 months and 12 months from enrollment
Patient Satisfaction- change
The secondary aim is patient satisfaction which will be measured by the validated questionnaire, Benefit, Satisfaction and Willingness to Continue the Treatment questionnaire (BSW).
Time frame: 3 months and 12 months from enrollment
Urinary Symptoms - change
The tertiary aim is urinary symptoms which will be measured by the validated Overactive Bladder Symptom Scale (OAB-SS).
Time frame: 3 months and 12 months from enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in May 2018, 19 months.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 19 months is below that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. 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