Overactive Bladder SyndromeBUTTONNCT03535857
Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
A study testing PTNS in people with Overactive Bladder Syndrome and Urinary Incontinence, Urge, run by Gnankang Sarah Napoe at 2 sites in United States.
Trial summary
This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Urinary Incontinence, Urge
- What is being tested?
- PTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2018to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
- Patients who consent to participate in the study
- Patients on pharmacologic therapy at the time of recruitment can continue their treatment
Who cannot join
- Pregnant patients
- Patients with pacemakers of implantable defibrillators
- Patients with neurogenic bladder
- Patients who have received Botox or have an implant for sacral nerve stimulation
- Patients with uncontrolled bleeding disorder
- Patients with unhealed ulcers or with leg edema surrounding medial malleolus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gnankang Sarah Napoe
Pittsburgh, Pennsylvania, 15203
WIHRI
Providence, Rhode Island, 02905
About this study
This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
Read the detailed description
Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary
- Being tested
- PTNS
- Keywords
- overactive bladder, OAB, urge urinary incontinence, PTNS
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNSDevice
Use of PTNS on the ankle for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Unilateral PTNS | Active comparator | 34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period Receives: Device: PTNS |
| Bilateral PTNS | Experimental | 34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period Receives: Device: PTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores.
The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.
Measured: 12 weeks or last measurement
Secondary outcomes (4)
Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement
The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids.
Measured: 12 weeks or last measurement
Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement
Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes.
Measured: 12 weeks or last measurement
Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement
Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids.
Measured: 12 weeks or last measurement
Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement
The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life.
Measured: 12 weeks or last measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start17 Apr 2018
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Why it stopped: Challenges with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gnankang Sarah Napoe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gnankang Sarah Napoe, University of Pittsburgh
- Investigators
- G. Sarah Napoe, MD, Principal investigator, University of PittsburghKyle Wohlrab, MD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535857
- Sponsor's protocol ID
- STUDY19100230
- Acronym
- BUTTON
- Status last verified
- Apr 2025
- First submitted
- 8 May 2018
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Publications
Napoe GS, Hall E, Dasgupta P, Myers DL, Wohlrab KJ. Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive bladder. World J Urol. 2025 Dec 4;44(1):15. doi: 10.1007/s00345-025-06107-0.
PubMed 41342952
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence
- ClinicalTrials.gov ID
- NCT03535857
- Acronym / sponsor ID
- BUTTON / STUDY19100230
- Keywords
- overactive bladder, OAB, urge urinary incontinence, PTNS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges with recruitment
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gnankang Sarah NapoeUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
Detailed description
Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral PTNS | Active comparator | Device: PTNS34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period |
| Bilateral PTNS | Experimental | Device: PTNS34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy
- Patients who consent to participate in the study
- Patients on pharmacologic therapy at the time of recruitment can continue their treatment
Key exclusion criteria (6 listed)
- Pregnant patients
- Patients with pacemakers of implantable defibrillators
- Patients with neurogenic bladder
- Patients who have received Botox or have an implant for sacral nerve stimulation
- Patients with uncontrolled bleeding disorder
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 |
|---|---|---|
| PTNSUse of PTNS on the ankle for 30 minutes | Device | Bilateral PTNS, Unilateral PTNS |
Primary outcome
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement
Time frame: 12 weeks or last measurement
Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation.
4 secondary outcomes
Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement
Time frame: 12 weeks or last measurement
Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement
Time frame: 12 weeks or last measurement
Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement
Time frame: 12 weeks or last measurement
Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement
Time frame: 12 weeks or last measurement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41342952Napoe GS, Hall E, Dasgupta P, Myers DL, Wohlrab KJ. Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive bladder. World J Urol. 2025 Dec 4;44(1):15. doi: 10.1007/s00345-025-06107-0.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Overactive Bladder Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence
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.
G. Sarah Napoe, MD principal investigator
University of Pittsburgh
Kyle Wohlrab, MD principal investigator
Women and Infants Hospital of Rhode Island
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS in people with Overactive Bladder Syndrome and Urinary Incontinence, Urge, run by Gnankang Sarah Napoe at 2 sites 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 3 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: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement (time frame: 12 weeks or last measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03535857, which also lists 1 linked publication.
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 15 Apr 2025.