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Reduction of Bladder Injection Pain With Belladonna Opiate Suppository (ROBIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600715
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Edgar LeClaire, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE October 29, 2015
First Posted Date  ICMJE November 9, 2015
Results First Submitted Date  ICMJE June 26, 2018
Results First Posted Date  ICMJE September 20, 2018
Last Update Posted Date September 20, 2018
Study Start Date  ICMJE November 2015
Actual Primary Completion Date June 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
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 midway pain score minus the preoperative pain score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • Pre-analgesia Pain Score [ Time Frame: Baseline ]
    Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
  • Post-operative Pain Score [ Time Frame: Postoperative (within 10 minutes of the end of the BoNT procedure) ]
    Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
  • Number of Participants Declining to Complete Procedure Due to Pain Intolerance [ Time Frame: Intraoperative ]
    Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
  • Postoperative Voiding Trial Results [ Time Frame: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure) ]
    Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.
  • Post Void Residual (PVR) [ Time Frame: 2 Weeks ]
    Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment.
  • Number of Participants With Evidence of Infection or Positive Urine Culture [ Time Frame: 2 Weeks ]
    Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
  • Participant Satisfaction With Pain Control [ Time Frame: Postoperative (within 10 minutes of the end of the BoNT procedure) ]
    Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
  • Pre-analgesia pain score [ Time Frame: Baseline ]
    Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
  • Post-operative pain score [ Time Frame: Postoperative (within 10 minutes of the end of the BoNT procedure) ]
    Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
  • Number of participants declining to complete procedure due to pain intolerance [ Time Frame: Intraoperative ]
    Patient declines to proceed secondary to pain or discomfort.
  • Postoperative voiding trial results [ Time Frame: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure) ]
    Volume in ml of post-void residual urine obtained via catheter.
  • Post void residual (PVR) [ Time Frame: 2 Weeks ]
    Volume in ml of post-void residual urine obtained via catheter.
  • Number of participants with evidence of infection or positive urine culture [ Time Frame: 2 Weeks ]
    Urinalysis results showing evidence of infection or positive urine culture.
  • Participant satisfaction with pain control [ Time Frame: Postoperative (within 10 minutes of the end of the BoNT procedure) ]
    Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Official Title  ICMJE Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Overactive Bladder
  • Urinary Urge Incontinence
  • Urinary Bladder, Neurogenic
  • Painful Bladder Syndrome
Intervention  ICMJE
  • Drug: Onabotulinumtoxin A (BoNT)
    Other Names:
    • Botox
    • Allergan
  • Drug: belladonna
    Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
  • Drug: Morphine
    Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
  • Drug: Placebo
    matching placebo to B&O suppository
  • Drug: Active B&O suppository of belladonna
    belladonna 16.2mg and morphine 7.5mg
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Onabotulinumtoxin A (BoNT)
    • Drug: belladonna
    • Drug: Morphine
    • Drug: Active B&O suppository of belladonna
  • Placebo Comparator: Placebo suppository
    Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
    Interventions:
    • Drug: Onabotulinumtoxin A (BoNT)
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2015)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 26, 2017
Actual Primary Completion Date June 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02600715
Other Study ID Numbers  ICMJE STUDY00003056
15-051 ( Other Identifier: Wichita Medical Research and Education Foundation IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Edgar LeClaire, MD, University of Kansas Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Edgar LeClaire, MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edgar LeClaire, MD, FACOG University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP