Overactive BladderNCT07353944
TTNS vs PTNS in a County Hospital System.
A study testing Tibial nerve stimulation 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 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tibial nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2017to 30 Jun 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment or diagnosis of dementia
- diagnosis of neurogenic bladder
- prior midurethral sling procedure
- use of an electronic pacemaker
- current pregnancy
- incarcerated persons
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor UCLA Medical Center
Torrance, California, 90509
About this study
Official title: Assessment of Patient Satisfaction With Transcutaneous Tibial Nerve Stimulation in a County Hospital System
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).
Read more
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
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Tibial nerve stimulation
- Keywords
- overactive bladder, OAB, PTNS, percutaneous tibial nerve stimulation, TTNS, transcutaneous tibial nerve stimulation, county hospital, underserved
- 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.
Tibial nerve stimulationDevice
Also called PTNS, TTNS
neuromodulation therapy for overactive bladder that targets the posterior tibial nerve
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous tibial nerve stimulation (PTNS) | Active comparator | 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. Receives: Device: Tibial nerve stimulation |
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | 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. Receives: Device: Tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-OAB score
OAB symptom severity
Measured: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation
Secondary outcomes (3)
Patient satisfaction
Patient satisfaction with the intervention (Y/N; would you recommend it to others?)
Measured: 6 weeks, 12 weeks, 6 months post treatment initiation
PGI-I
Patient global assessment of overall improvement, graded on a scale of 1-7
Measured: 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
Measured: 6 months post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start18 Jan 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 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
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT07353944
- Sponsor's protocol ID
- 2023-32833-01
- Other IDs
- 2023
- Status last verified
- Mar 2019
- First submitted
- 16 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Satisfaction With Transcutaneous Tibial Nerve Stimulation in a County Hospital System
- ClinicalTrials.gov ID
- NCT07353944
- Acronym / sponsor ID
- 2023-32833-01
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, OAB, PTNS, percutaneous tibial nerve stimulation, TTNS, transcutaneous tibial nerve stimulation, county hospital, underserved
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Jan 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous tibial nerve stimulation (PTNS) | Active comparator | Device: Tibial nerve stimulationParticipants 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. |
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | Device: Tibial nerve stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- cognitive impairment or diagnosis of dementia
- diagnosis of neurogenic bladder
- prior midurethral sling procedure
- use of an electronic pacemaker
- current pregnancy
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 |
|---|---|---|
| Tibial nerve stimulationAlso: PTNS, TTNSneuromodulation therapy for overactive bladder that targets the posterior tibial nerve | Device | Percutaneous tibial nerve stimulation (PTNS), Transcutaneous tibial nerve stimulation (TTNS) |
Primary outcome
ICIQ-OAB score
Time frame: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation
OAB symptom severity
3 secondary outcomes
Patient satisfaction
Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation
PGI-I
Time frame: 6 weeks, 12 weeks, 6 months post treatment initiation
Compliance
Time frame: 6 months post treatment initiation
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 21 Jan 2026.
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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 Tibial nerve stimulation 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 6 inclusion and 6 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 21 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?
ICIQ-OAB score (time frame: Baseline, 6 weeks, 12 weeks, 6 months post treatment initiation). 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 21 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.