Interstitial Cystitis Bladder Pain Syndromes
Conditions
Keywords
Posterior Tibial Nerve Stimulation, Bladder
Brief summary
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.
Detailed description
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.
Interventions
DEVICENURO TM
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.
DEVICESham
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥18 years old with visual analog scale \> 5 * Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention * Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention. * Capable of giving informed consent * Ambulatory * Capable and willing to follow all study-relation procedures
Exclusion criteria
* Patients pregnant or planning to become pregnant during the study duration * Botox use in pelvic floor muscles within the last year * Current urinary or vaginal infections * Current use of Interstim device * History of a cardiac pacemaker * Diagnosis of neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 12 Weeks | Quality of Life Scores |
| O'Leary-Sant Pain Scores | 12 weeks | pain intensity, location of pain and associated symptoms |
| Over Active Bladder-Questionnaire (OAB-Q) | 12 Weeks | This will allow for evaluation of subjects with concomitant overactive bladder and painful bladder syndrome characteristics. |
| The SF-12 (Short Form) Health Scale | 12 Weeks | Used to evaluate quality of life of each subject at the three analysis intervals. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post Tibial Nerve Stimulation Group (PTNS) NURO TM: 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. | 18 |
| Sham Group Sham: 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. | 22 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Post Tibial Nerve Stimulation Group (PTNS) | Total | Sham Group |
|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 18.3 | 51.2 years STANDARD_DEVIATION 18.3 | 51.7 years STANDARD_DEVIATION 18.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 35 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 14 Participants | 31 Participants | 17 Participants |
| Region of Enrollment United States | 18 participants | 40 participants | 22 participants |
| Sex: Female, Male Female | 18 Participants | 40 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 0 / 18 | 0 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post Tibial Nerve Stimulation Group (PTNS) | Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 | 2 Participants |
| Sham Group | Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 | 4 Participants |
Secondary
O'Leary-Sant Pain Scores
pain intensity, location of pain and associated symptoms
Time frame: 12 weeks
Secondary
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
Secondary
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
Secondary
Visual Analog Scale (VAS)
Quality of Life Scores
Time frame: 12 Weeks