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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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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.
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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Tibial Nerve Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 6 at 6 weeks and Visit 12 at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felicia Lane, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Irvine Medical Center | Orange | California | 92868 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Posterior Tibial Nerve Stimulation | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posterior Tibial Nerve Stimulation | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 21 patients met eligibility for enrollment. 16 subjects enrolled and began treatment with PTNS. Ten subjects completed 12 sessions while six patients were lost to follow up. Of those who were lost to follow up, only one case withdrew due to bladder worsening pain after four sessions | Posted | Count of Participants | Participants | Visit 6 at 6 weeks and Visit 12 at 12 weeks |
The adverse event data were collected over the period of 12 weeks of PTNS treatment.
Definitions did not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posterior Tibial Nerve Stimulation | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phuong Linh Huynh, CRC | University of California, Irvine | 7144566155 | plhuynh@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2017 | Feb 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| 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) | At baseline then validated at follow-up (12-14 weeks) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| VAS score | Visual Analog Scale (VAS) ranges from 0 to 10 with higher values representing a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) questionnaire score | The Pelvic Pain and Urgency/Frequency Patient Symptom Scale contains 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. Scores with higher values represent a worse outcome. The total score sum is reported and ranges from 0 to 35. | Mean | Standard Deviation | units on a scale |
|
| O'Leary-Sant IC Symptom Index (ICSI) score | O'Leary-Sant Interstitial Cystitis Symptom Index score is a sum of responses ranging from 0 to 5 for four questions, totaling from 0 to 20. Higher values represent worse outcome. | Mean | Standard Deviation | units on a scale |
|
| O'Leary-Sant IC Problem Index (ICPI) score | O'Leary-Sant Interstitial Cystitis Problem Index score is a sum of responses ranging from 0 to 4 for four questions, totaling from 0 to 16. Higher values represent worse outcome. | Mean | Standard Deviation | units on a scale |
|
| 24 hour voiding frequency | The amount of voids in a 24 hour period. | Mean | Standard Deviation | voids/24 hours |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Posterior Tibial Nerve Stimulation | 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. |
|
|
|
| Secondary | 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. | Questionnaire means and standard deviations was analyzed and reported. | Posted | Mean | Standard Deviation | score on a scale | At baseline then validated at follow-up (12-14 weeks) |
|
|
|
|
| Secondary | 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) | Means and standard deviations along with 24-h voiding frequency was analyzed and reported. | Posted | Mean | Standard Deviation | number of voids | At baseline then validated at follow-up (12-14 weeks) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) |
|
| O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) |
|
| 0.17 |
| Other |
| The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) | paired t-test | .08 | Other |
| The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) | paired t-test | 0.51 | Other |
| The mean change in 24-h urinary frequency | paired t-test | 0.22 | Other |