Interstitial CystitisNCT02550561
Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
A study testing Posterior Tibial Nerve Stimulation in people with Interstitial Cystitis and Painful Bladder Syndrome, run by University of California, Irvine at 1 site in United States.
Trial summary
In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 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
- Interstitial Cystitis, Painful Bladder Syndrome
- What is being tested?
- Posterior Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of IC/PBS
- complaint of urinary urgency (sudden, compelling desire to pass urine which is difficult to defer) or urinary frequency (voiding >8 times per 24 hour period)
- female
- have undergone at least 1 course of a standard therapy for IC/PBS
- 18 years of age or older
Who cannot join
- not having undergone at least 1 course of a standard therapy for IC/PBS
- having a pacemaker or implantable defibrillator
- being prone to excessive bleeding
- having nerve damage that could impact the posterior tibial nerve
- pregnant or planning pregnancy during treatment course
- non-English speaking
- current malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Irvine Medical Center
Orange, California, 92868
About this study
Official title: Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM), involving a two stage surgical procedure and permanent device implantation. While the mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and peripheral mechanisms related to afferent signaling, causing modification of pain and lower urinary tract sensation.¹
Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks. The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS. The results of this study will suggest future directions and provide critical information to design studies to determine to what extent and in what situations PTNS may be effective.
The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary tract function before, during and after the treatments. At the completion of treatments, subjects will be asked to enroll in post-study follow up monitoring to understand the duration of symptom effect.
Read the detailed description
The overall objective of this prospective, pilot study is to determine if percutaneous tibial nerve stimulation (PTNS) is an effective treatment for interstitial cystitis/painful bladder syndrome (IC/PBS). Our specific aim is to evaluate how PTNS performs with regards to the reduction of symptoms in subjects with this disorder. The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS.
There will be a number of secondary outcome variables including: changes in a 24 hour voiding diary during the course of the interventions, ratings for bladder pain, urinary urgency and urinary frequency on standardized scales, the score on O'Leary-Sant IC Symptom and Problem Index, scores of validated questionnaires for pelvic floor and general health. The investigators will also collect and report any adverse events.
Subjects will be recruited during a routine visit to the University of California, Irvine (UCI) urogynecology division that the patient has scheduled to initiate or continue routine care for their complaints. If the provider feels that the patient may be appropriate for the study and meets the inclusion/exclusion criteria, she will offer to have a study investigator speak with patient at that time or at a later time at the patient's convenience. Once consents are signed, the subject will be provided with the following materials to complete before their first treatment visit:
- demographic and medical history survey
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
- urine pregnancy test (for premenopausal subjects)
The PTNS treatment visits will be administered in the standard fashion. This involves the placement of a thin needle (similar to an acupuncture needle) inserted near the posterior ankle. The needle is then connected to an electrode stimulator and the stimulation is adjusted until appropriate response (toe flex or fan) is obtained without patient discomfort. When at the appropriate level, the electrode is stimulated for 30 minutes per treatment session.
Study visits will be conducted in the UCI Ob/Gyn clinic with a nurse trained to administer PTNS. These treatments will occur weekly for 12 weeks. (See Section 2.4 for table outlining treatment visits.) At all visits, the nurse will inquire regarding any adverse reactions to treatment and the subject complete a VAS. After completion of the twelfth treatment visit, the subject will be requested to complete the following:
- 7-point global response assessment (GRA) scale and interval medical history questionnaire
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
These forms will be returned within two weeks and the subject will return to the clinic for a follow up visit with her provider. At this time, depending on their current symptoms and response to the treatment on the GRA scale, the subjects will be offered to continue with PTNS treatments at a maintenance interval or to pursue alternative care outside of the study protocol if no benefit was obtained. If subjects are planning to continue maintenance treatments, they will be asked if they wish to continue with an additional follow up 12-16 weeks after the final treatment visit. The information collected at that time will be as follows:
- 7-point global response assessment (GRA) scale and interval medical history questionnaire
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
- Post-study follow-up survey
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome
- Being tested
- Posterior Tibial Nerve Stimulation
- Keywords
- Posterior tibial nerve stimulation, PTNS, IC
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Tibial Nerve StimulationDevice
PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Tibial Nerve Stimulation | Experimental | PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots. If benefits are obtained, 12 weeks of treatment is followed by spaced maintenance sessions at timing of provider and patient discretion. Receives: Device: Posterior Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale
The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS. Responders are those that marked either moderately or markedly improved.
Measured: Visit 6 at 6 weeks and Visit 12 at 12 weeks
Secondary outcomes (2)
Composite Secondary Self-Reported Outcome Measures - Questionnaires
Scores with higher values represent a worse outcome for all measures. (1) Visual Analog Scale (VAS) rating of the severity of pain ranges from 0-10; (2) Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) Scale is the sum of symptom and bother scores. There is a total of 8 questions but, due to sub-questions, there are 11 answers about severity of condition coded in a range from 0 to 4 subscale for two questions and 0 to 3 for nine questions. The total score sum is reported and ranges from 0 to 35; (3) O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score is a sum of responses ranging from 0 to 5 for four questions, totaling from 0 to 20;. (4) O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score is a sum of responses ranging from 0 to 4 for four questions from 0 to 16.
Measured: At baseline then validated at follow-up (12-14 weeks)
Secondary Self-Reported Outcome Measures - 24 Hour Voiding Frequency
Scores with higher values represent a worse outcome for all measures. 24-Hour Voiding Diary includes frequency, fluid intake and void amount (ounces), leaks or accidents (yes or no), strong urge to urinate (yes or no), activity when you leaked or had an urge (description)
Measured: At baseline then validated at follow-up (12-14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionMar 2018
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.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Principal investigator, Felicia Lane, University of California, Irvine
- Investigators
- Felicia Lane, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550561
- Sponsor's protocol ID
- 2015-2010
- Status last verified
- Jul 2023
- First submitted
- 3 Sep 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT02550561
- Acronym / sponsor ID
- 2015-2010
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome
- Keywords
- Posterior tibial nerve stimulation, PTNS, IC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM), involving a two stage surgical procedure and permanent device implantation. While the mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and peripheral mechanisms related to afferent signaling, causing modification of pain and lower urinary tract sensation.¹
Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks. The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS. The results of this study will suggest future directions and provide critical information to design studies to determine to what extent and in what situations PTNS may be effective.
The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary tract function before, during and after the treatments. At the completion of treatments, subjects will be asked to enroll in post-study follow up monitoring to understand the duration of symptom effect.
Detailed description
The overall objective of this prospective, pilot study is to determine if percutaneous tibial nerve stimulation (PTNS) is an effective treatment for interstitial cystitis/painful bladder syndrome (IC/PBS). Our specific aim is to evaluate how PTNS performs with regards to the reduction of symptoms in subjects with this disorder. The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS.
There will be a number of secondary outcome variables including: changes in a 24 hour voiding diary during the course of the interventions, ratings for bladder pain, urinary urgency and urinary frequency on standardized scales, the score on O'Leary-Sant IC Symptom and Problem Index, scores of validated questionnaires for pelvic floor and general health. The investigators will also collect and report any adverse events.
Subjects will be recruited during a routine visit to the University of California, Irvine (UCI) urogynecology division that the patient has scheduled to initiate or continue routine care for their complaints. If the provider feels that the patient may be appropriate for the study and meets the inclusion/exclusion criteria, she will offer to have a study investigator speak with patient at that time or at a later time at the patient's convenience. Once consents are signed, the subject will be provided with the following materials to complete before their first treatment visit:
- demographic and medical history survey
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
- urine pregnancy test (for premenopausal subjects)
The PTNS treatment visits will be administered in the standard fashion. This involves the placement of a thin needle (similar to an acupuncture needle) inserted near the posterior ankle. The needle is then connected to an electrode stimulator and the stimulation is adjusted until appropriate response (toe flex or fan) is obtained without patient discomfort. When at the appropriate level, the electrode is stimulated for 30 minutes per treatment session.
Study visits will be conducted in the UCI Ob/Gyn clinic with a nurse trained to administer PTNS. These treatments will occur weekly for 12 weeks. (See Section 2.4 for table outlining treatment visits.) At all visits, the nurse will inquire regarding any adverse reactions to treatment and the subject complete a VAS. After completion of the twelfth treatment visit, the subject will be requested to complete the following:
- 7-point global response assessment (GRA) scale and interval medical history questionnaire
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
These forms will be returned within two weeks and the subject will return to the clinic for a follow up visit with her provider. At this time, depending on their current symptoms and response to the treatment on the GRA scale, the subjects will be offered to continue with PTNS treatments at a maintenance interval or to pursue alternative care outside of the study protocol if no benefit was obtained. If subjects are planning to continue maintenance treatments, they will be asked if they wish to continue with an additional follow up 12-16 weeks after the final treatment visit. The information collected at that time will be as follows:
- 7-point global response assessment (GRA) scale and interval medical history questionnaire
- 24 hour voiding diary
- visual analog scale (VAS) for bladder pain
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
- O'Leary-Sant IC Symptom and Problem Index
- Post-study follow-up survey
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior Tibial Nerve Stimulation | Experimental | Device: Posterior Tibial Nerve StimulationPTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots. If benefits are obtained, 12 weeks of treatment is followed by spaced maintenance sessions at timing of provider and patient discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis of IC/PBS
- complaint of urinary urgency (sudden, compelling desire to pass urine which is difficult to defer) or urinary frequency (voiding >8 times per 24 hour period)
- female
- have undergone at least 1 course of a standard therapy for IC/PBS
- 18 years of age or older
Key exclusion criteria (7 listed)
- not having undergone at least 1 course of a standard therapy for IC/PBS
- having a pacemaker or implantable defibrillator
- being prone to excessive bleeding
- having nerve damage that could impact the posterior tibial nerve
- pregnant or planning pregnancy during treatment course
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 |
|---|---|---|
| Posterior Tibial Nerve StimulationPTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots. | Device | Posterior Tibial Nerve Stimulation |
Primary outcome
Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale
Time frame: Visit 6 at 6 weeks and Visit 12 at 12 weeks
The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS. Responders are those that marked either moderately or markedly improved.
2 secondary outcomes
Composite Secondary Self-Reported Outcome Measures - Questionnaires
Time frame: At baseline then validated at follow-up (12-14 weeks)
Secondary Self-Reported Outcome Measures - 24 Hour Voiding Frequency
Time frame: At baseline then validated at follow-up (12-14 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Felicia Lane, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Tibial Nerve Stimulation in people with Interstitial Cystitis and Painful Bladder Syndrome, run by University of California, Irvine 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 5 inclusion and 7 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 27 Jul 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. 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 27 Jul 2023). 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?
Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale (time frame: Visit 6 at 6 weeks and Visit 12 at 12 weeks). 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 27 Jul 2023.