Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Pain, Urology, Urology |
| Therapuetic Areas: | Musculoskeletal, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2015 |
| End Date: | March 2018 |
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.
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:
1. demographic and medical history survey
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. O'Leary-Sant IC Symptom and Problem Index
6. 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:
1. 7-point global response assessment (GRA) scale and interval medical history
questionnaire
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. 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:
1. 7-point global response assessment (GRA) scale and interval medical history
questionnaire
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. O'Leary-Sant IC Symptom and Problem Index
6. Post-study follow-up survey
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:
1. demographic and medical history survey
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. O'Leary-Sant IC Symptom and Problem Index
6. 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:
1. 7-point global response assessment (GRA) scale and interval medical history
questionnaire
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. 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:
1. 7-point global response assessment (GRA) scale and interval medical history
questionnaire
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. O'Leary-Sant IC Symptom and Problem Index
6. Post-study follow-up survey
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
Click here to add this to my saved trials
