An interventional study of NURO TM and Sham in Interstitial Cystitis Bladder Pain Syndromes, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.
This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat analysis. The primary outcome measure will be the Patient Global Impression of Improvement (PGI-I) a single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint.
It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater improvement in both pain and quality of life scores, when compared with subjects who are randomized to the sham arm.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
Device: NURO TM
Device: Sham
The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
Also known as: Neuromodulation system, Medtronic Device Model # 3533, stimulator model NURO 100
A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The "grounding pad" from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded.
Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2
A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint. Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7
Time frame: 12 weeks
Visual Analog Scale (VAS)
Quality of Life Scores
Time frame: 12 Weeks
O'Leary-Sant Pain Scores
pain intensity, location of pain and associated symptoms
Time frame: 12 weeks
Over Active Bladder-Questionnaire (OAB-Q)
This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.
Time frame: 12 Weeks
The SF-12 (Short Form) Health Scale
Used to evaluate quality of life of each subject at the three analysis intervals.
Time frame: 12 Weeks
| Milestone | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group |
|---|---|---|
| Started | 18 | 22 |
| Completed | 11 | 18 |
| Not completed | 7 | 4 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
A single item questionnaire assessing overall impression of improvement over time at the initial 12 weeks endpoint. Patients are asked to describe their condition compared to how it was before intervention on a scale from 1 to 7: Very much better = 1 Much better = 2 A little better = 3 No change = 4 A little worse = 5 Much worse = 6 Very much worse = 7
| Participants | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group |
|---|---|---|
| Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 | 2 | 4 |
Quality of Life Scores
Results for this outcome have not been posted.
pain intensity, location of pain and associated symptoms
Results for this outcome have not been posted.
This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics.
Results for this outcome have not been posted.
Used to evaluate quality of life of each subject at the three analysis intervals.
Results for this outcome have not been posted.
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Post Tibial Nerve Stimulation Group (PTNS) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Sham Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group | Total |
|---|---|---|---|
| Mean | 50.7 ± 18.3 | 51.7 ± 18.2 | 51.2 ± 18.3 |
| Sex: Female, Male(Participants) | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group | Total |
|---|---|---|---|
| Female | 18 | 22 | 40 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 15 | 20 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 17 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 5 | 9 |
| Region of Enrollment(participants) | Post Tibial Nerve Stimulation Group (PTNS) | Sham Group | Total |
|---|---|---|---|
| United States | 18 | 22 | 40 |
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