N/A
Completed N=40
PTNS Versus Sham Efficacy in Treatment of BPS
Interstitial Cystitis Bladder Pain Syndromes
Source: ClinicalTrials.gov NCT02747420 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 — 2; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Patient Global Impression of Improvement (PG-I) Score = 1 or 2 |
2; 4 | — |
| SECONDARY Visual Analog Scale (VAS) |
— | — |
| SECONDARY O'Leary-Sant Pain Scores |
— | — |
| SECONDARY Over Active Bladder-Questionnaire (OAB-Q) |
— | — |
| SECONDARY The SF-12 (Short Form) Health Scale |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02747420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.