Overactive Bladder SyndromeNCT03559946
Condensed Percutaneous Tibial Nerve Stimulation (PTNS) Protocol
A study testing percutaneous tibial nerve stimulation (PTNS) in people with Overactive Bladder Syndrome, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- percutaneous tibial nerve stimulation (PTNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2018to 30 Mar 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment.
Who cannot join
- Patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis).
- Pregnant women or women who are planning to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook Medicine Women's Pelvic Health And Continence Center
Stony Brook, New York, 11733
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of a Condensed (Twice Weekly) Protocol to the Standard (Once Per Week) Protocol of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Overactive Bladder Syndrome (OAB)
The purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome.
Read the detailed description
This study aims to evaluate the impact of the periodicity of the PTNS treatments on the efficacy of treating patients with OAB. We will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of PTNS therapy.
Objective #1 (6-wk CP vs. 12-wk SP) is to show that 6 weeks of the condensed protocol (CP) will yield a higher efficacy compared to the standard 12-week protocol (SP). If this 6-week CP is proven effective, candidates for PTNS treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. Objective #2 (12-wk CP vs. 12-wk SP) is to show that 12 weeks of the CP will have a higher efficacy compared to the 12-week SP. If the superiority of this 12-week CP is proven, it could be beneficial in treating patients with refractory OAB.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- percutaneous tibial nerve stimulation (PTNS), Sham procedure
- Keywords
- Overactive Bladder Syndrome, Percutaneous Tibial Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous tibial nerve stimulation (PTNS)Device
The PTNS and the sham treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
Sham procedureDevice
The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Standard Protocol (SP) group | Sham comparator | The patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks Receives: Device: percutaneous tibial nerve stimulation (PTNS); Device: Sham procedure |
| Condensed Protocol (CP) group | Experimental | The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks. Receives: Device: percutaneous tibial nerve stimulation (PTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment (GRA)
GRA asks the patents to rate how their urinary symptoms have changed since the start of the treatment on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, and markedly improved)
Measured: At week 6 and week 12
Secondary outcomes (1)
Incontinence impact questionnaire-7 (IIQ-7)
IIQ-7 contains 7 questions to assess how accidental urine loss has affected the patients' activities, relationships, and feelings.
Measured: At week 0, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start8 Jun 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Terminated due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- We will be recruiting 66 patients, who will be randomized (1:1) to either the Standard Protocol (SP) group or the Condensed Protocol (CP) group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Responsible party
- Principal investigator, Jason Kim, Stony Brook University
- Investigators
- Jason Kim, M.D., Principal investigator, Stony Brook University Hospital, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559946
- Sponsor's protocol ID
- 1180838
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
PubMed 20171677Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.
PubMed 20850833
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of a Condensed (Twice Weekly) Protocol to the Standard (Once Per Week) Protocol of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Overactive Bladder Syndrome (OAB)
- ClinicalTrials.gov ID
- NCT03559946
- Acronym / sponsor ID
- 1180838
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder Syndrome, Percutaneous Tibial Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to COVID-19 pandemic
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Jun 2018 (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 purpose of this study is to understand how the frequency of PTNS sessions impacts their efficacy in the treatment of over active bladder syndrome.
Detailed description
This study aims to evaluate the impact of the periodicity of the PTNS treatments on the efficacy of treating patients with OAB. We will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of PTNS therapy.
Objective #1 (6-wk CP vs. 12-wk SP) is to show that 6 weeks of the condensed protocol (CP) will yield a higher efficacy compared to the standard 12-week protocol (SP). If this 6-week CP is proven effective, candidates for PTNS treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. Objective #2 (12-wk CP vs. 12-wk SP) is to show that 12 weeks of the CP will have a higher efficacy compared to the 12-week SP. If the superiority of this 12-week CP is proven, it could be beneficial in treating patients with refractory OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- We will be recruiting 66 patients, who will be randomized (1:1) to either the Standard Protocol (SP) group or the Condensed Protocol (CP) group.
| Arm | Type | Receives |
|---|---|---|
| Standard Protocol (SP) group | Sham comparator | Device: percutaneous tibial nerve stimulation (PTNS), Device: Sham procedureThe patients in the SP group will receive one PTNS treatment and one sham treatment per week for 12 weeks |
| Condensed Protocol (CP) group | Experimental | Device: percutaneous tibial nerve stimulation (PTNS)The patients in the CP group will receive 2 PTNS treatments per week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving PTNS treatment.
Key exclusion criteria (2 listed)
- Patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis).
- Pregnant women or women who are planning to become pregnant during the course of the study.
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 |
|---|---|---|
| percutaneous tibial nerve stimulation (PTNS)The PTNS and the sham treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot. | Device | Condensed Protocol (CP) group, Standard Protocol (SP) group |
| Sham procedureThe sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation | Device | Standard Protocol (SP) group |
Primary outcome
Global Response Assessment (GRA)
Time frame: At week 6 and week 12
GRA asks the patents to rate how their urinary symptoms have changed since the start of the treatment on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, and markedly improved)
1 secondary outcome
Incontinence impact questionnaire-7 (IIQ-7)
Time frame: At week 0, 6 and 12
Results and safety
The study was stopped early (reason given: Terminated due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 20171677Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
- Background: PubMed 20850833Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010 Nov;184(5):2001-6. doi: 10.1016/j.juro.2010.06.113. Epub 2010 Sep 20.
- 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.
Jason Kim, M.D. principal investigator
Stony Brook University Hospital, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous tibial nerve stimulation (PTNS) in people with Overactive Bladder Syndrome, run by Stony Brook University 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 1 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: stopped early, as of the sponsor's last update on 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Terminated due to COVID-19 pandemic). Results are not available in the source record.
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?
Global Response Assessment (GRA) (time frame: At week 6 and week 12). 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 NCT03559946, which also lists 2 linked publications.
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 14 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.