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

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Bladder, Neurogenic; Painful Bladder Syndrome; Urinary Urge Incontinence
• Intervention / Treatment: Drug: Onabotulinumtoxin A (BoNT); Drug: belladonna; Drug: Morphine; Drug: Active B&O suppository of belladonna; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Wichita, Kansas, United States, 67214
      • University of Kansas School of Medicine - Wichita
    • Wichita, Kansas, United States, 67208
      • Wichita Women's Pelvic Surgery Center at Associates in Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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: Active B&O suppository of belladonna; belladonna 16.2mg and morphine 7.5mg
Placebo Comparator: Placebo suppository; Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.	Drug: Onabotulinumtoxin A (BoNT); Other Names: Botox; Allergan; Drug: Placebo; matching placebo to B&O suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bladder Injection Pain	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.	Baseline and intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-analgesia Pain Score	Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).	Baseline
Post-operative Pain Score	Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).	Postoperative (within 10 minutes of the end of the BoNT procedure)
Number of Participants Declining to Complete Procedure Due to Pain Intolerance	Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.	Intraoperative
Postoperative Voiding Trial Results	Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.	Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)
Post Void Residual (PVR)	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.	2 Weeks
Number of Participants With Evidence of Infection or Positive Urine Culture	Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.	2 Weeks
Participant Satisfaction With Pain Control	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.'	Postoperative (within 10 minutes of the end of the BoNT procedure)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 26, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urination Disorders; Urinary Incontinence; Cystitis; Urinary Bladder, Overactive; Cystitis, Interstitial; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA; Morphine
• Other Study ID Numbers: STUDY00003056; 15-051 (Wichita Medical Research and Education Foundation IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No