Overactive BladderNCT03136601
Percutaneous Tibial Nerve Stimulation Maintenance: Monthly Therapy or Per Patient Requested Need
A study testing PTNS maintenance in people with Overactive Bladder, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- PTNS maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 1 May 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be eligible if they have completed 12 session of PTNS treatment and agree to continue with maintenance therapy.
- Inclusion criteria is Women >=18 years of age, Completed 12 weeks of PTNS and desire to continue,
- Capable of giving informed consent, primary language of English or Spanish,
- Ambulatory and able to use toilet independently without difficulty, Capable and willing to follow all study-related procedures, OAB
Who cannot join
- Exclusion criteria includes Botox® use in bladder or pelvic floor muscles within past one year,
- Current urinary tract infection, Male, under 18 years old, non-English or Spanish speaking, patients who are unable to consent for themselves, prisoners, pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor UCLA Medical Center
Torrance, California, 90509
About this study
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.
Read the detailed description
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.
- Conditions
- Overactive Bladder
- Being tested
- PTNS maintenance
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNS maintenanceOther
The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)
| Study group | Role | What they receive |
|---|---|---|
| PTNS monthly | Active comparator | Patients return for PTNS maintenance monthly. Receives: Other: PTNS maintenance |
| PTNS as needed | Experimental | Patients return for PTNS as needed (2-12 weeks). Receives: Other: PTNS maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months and 12 months from enrollment
Secondary outcomes (1)
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).
Measured: 3 months and 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Oct 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tajnoos Yazdany, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136601
- Sponsor's protocol ID
- 30996-01
- Status last verified
- May 2018
- First submitted
- 7 Apr 2017
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation Maintenance: Monthly Therapy or Per Patient Requested Need
- ClinicalTrials.gov ID
- NCT03136601
- Acronym / sponsor ID
- 30996-01
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 2 May 2017 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS monthly | Active comparator | Other: PTNS maintenancePatients return for PTNS maintenance monthly. |
| PTNS as needed | Experimental | Other: PTNS maintenancePatients return for PTNS as needed (2-12 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be eligible if they have completed 12 session of PTNS treatment and agree to continue with maintenance therapy.
- Inclusion criteria is Women >=18 years of age, Completed 12 weeks of PTNS and desire to continue,
- Capable of giving informed consent, primary language of English or Spanish,
- Ambulatory and able to use toilet independently without difficulty, Capable and willing to follow all study-related procedures, OAB
Key exclusion criteria (2 listed)
- Exclusion criteria includes Botox® use in bladder or pelvic floor muscles within past one year,
- Current urinary tract infection, Male, under 18 years old, non-English or Spanish speaking, patients who are unable to consent for themselves, prisoners, pregnant patients.
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 |
|---|---|---|
| PTNS maintenanceThe intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs) | Other | PTNS as needed, PTNS monthly |
Primary outcome
Quality of Life - change
Time frame: 3 months and 12 months from enrollment
The primary aim is patient reported quality of life. A validated quality of life questionnaire specific to overactive bladder (OAB) (OAB-q).
1 secondary outcome
Patient Satisfaction- change
Time frame: 3 months and 12 months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS maintenance in people with Overactive Bladder, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - change (time frame: 3 months and 12 months from enrollment). 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 20 Jan 2026.