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

• 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: Edgar LeClaire, MD
• Information provided by (Responsible Party): Edgar LeClaire, MD, University of Kansas Medical Center

Tracking Information

• First Submitted Date: October 29, 2015
• First Posted Date: November 9, 2015
• Results First Submitted Date: June 26, 2018
• Results First Posted Date: September 20, 2018
• Last Update Posted Date: September 20, 2018
• Study Start Date: November 2015
• Actual Primary Completion Date: June 26, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Overactive Bladder
• Urinary Urge Incontinence
• Urinary Bladder, Neurogenic
• Painful Bladder Syndrome

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2015): 26
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 26, 2017
• Actual Primary Completion Date: June 26, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02600715
• Other Study ID Numbers: 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

• 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: Edgar LeClaire, MD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Edgar LeClaire, MD, FACOG; University of Kansas Medical Center

• PRS Account: University of Kansas Medical Center
• Verification Date: June 2018