Trial Outcomes & Findings for Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS (NCT NCT02550561)
NCT ID: NCT02550561
Last Updated: 2023-07-27
Results Overview
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.
COMPLETED
NA
16 participants
Visit 6 at 6 weeks and Visit 12 at 12 weeks
2023-07-27
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Lost to Follow-up
|
5
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
Baseline characteristics by cohort
| Measure |
Posterior Tibial Nerve Stimulation
n=16 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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14 Participants
n=5 Participants
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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16 participants
n=5 Participants
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VAS score
|
4.2 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
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Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) questionnaire score
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17.5 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
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O'Leary-Sant IC Symptom Index (ICSI) score
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11.2 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
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O'Leary-Sant IC Problem Index (ICPI) score
|
10.2 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
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24 hour voiding frequency
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12.2 voids/24 hours
STANDARD_DEVIATION 6.8 • n=5 Participants
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PRIMARY outcome
Timeframe: Visit 6 at 6 weeks and Visit 12 at 12 weeksPopulation: 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
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.
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation
n=10 Participants
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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Posterior Tibial Nerve Stimulation Week 12
Scores and standard deviations for questionnaires and 24 hour voiding frequency by participants by week 12.
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|---|---|---|
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Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale
Responders by Visit 6
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4 Participants
|
—
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Primary Outcome Measure: Percentage of Subjects Improved Global Response Assessment Scale
Responders by Visit 12
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3 Participants
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—
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SECONDARY outcome
Timeframe: At baseline then validated at follow-up (12-14 weeks)Population: Questionnaire means and standard deviations was analyzed and reported.
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.
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation
n=10 Participants
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.
|
Posterior Tibial Nerve Stimulation Week 12
n=10 Participants
Scores and standard deviations for questionnaires and 24 hour voiding frequency by participants by week 12.
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|---|---|---|
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Composite Secondary Self-Reported Outcome Measures - Questionnaires
Visual Analog Scale (VAS)
|
3.4 score on a scale
Standard Deviation 2.2
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3.2 score on a scale
Standard Deviation 2.0
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Composite Secondary Self-Reported Outcome Measures - Questionnaires
Pelvis Pain and Urgency/Frequency Patient Symptom Scale (PUF)
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15.5 score on a scale
Standard Deviation 4.7
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16.1 score on a scale
Standard Deviation 3.7
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Composite Secondary Self-Reported Outcome Measures - Questionnaires
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
|
8.3 score on a scale
Standard Deviation 3.8
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7.8 score on a scale
Standard Deviation 3.6
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|
Composite Secondary Self-Reported Outcome Measures - Questionnaires
O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)
|
8.3 score on a scale
Standard Deviation 4.3
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8.6 score on a scale
Standard Deviation 3.6
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SECONDARY outcome
Timeframe: At baseline then validated at follow-up (12-14 weeks)Population: Means and standard deviations along with 24-h voiding frequency was analyzed and reported.
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)
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation
n=10 Participants
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.
|
Posterior Tibial Nerve Stimulation Week 12
n=10 Participants
Scores and standard deviations for questionnaires and 24 hour voiding frequency by participants by week 12.
|
|---|---|---|
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Secondary Self-Reported Outcome Measures - 24 Hour Voiding Frequency
|
10.3 number of voids
Standard Deviation 5.0
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11.6 number of voids
Standard Deviation 5.4
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Adverse Events
Posterior Tibial Nerve Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place