Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
Overview
- Phase
- Phase 4
- Intervention
- Onabotulinumtoxin A (BoNT)
- Conditions
- Overactive Bladder
- Sponsor
- Edgar LeClaire, MD
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change in Bladder Injection Pain
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.
Investigators
Edgar LeClaire, MD
Clinical Instructor
University of Kansas Medical Center
Eligibility Criteria
Inclusion Criteria
- •Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
- •No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
- •Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)
Exclusion Criteria
- •Currently pregnant
- •Currently nursing a baby
- •Anticipated geographic relocation within the first 3 months following treatment
- •Allergy to morphine, belladonna, or opiates
- •Patients will be excluded if participating in another research study
- •Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded
Arms & Interventions
Active B&O suppository of belladonna
Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: Onabotulinumtoxin A (BoNT)
Active B&O suppository of belladonna
Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: belladonna
Active B&O suppository of belladonna
Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: Morphine
Active B&O suppository of belladonna
Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: Active B&O suppository of belladonna
Placebo suppository
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: Onabotulinumtoxin A (BoNT)
Placebo suppository
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Bladder Injection Pain
Time Frame: Baseline and intraoperative
The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.
Secondary Outcomes
- Postoperative Voiding Trial Results(Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure))
- Number of Participants Declining to Complete Procedure Due to Pain Intolerance(Intraoperative)
- Post Void Residual (PVR)(2 Weeks)
- Pre-analgesia Pain Score(Baseline)
- Number of Participants With Evidence of Infection or Positive Urine Culture(2 Weeks)
- Post-operative Pain Score(Postoperative (within 10 minutes of the end of the BoNT procedure))
- Participant Satisfaction With Pain Control(Postoperative (within 10 minutes of the end of the BoNT procedure))