Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Onabotulinumtoxin A (BoNT)
* Drug: belladonna
* Drug: Morphine
* Drug: Placebo
* Drug: Active B&O suppository of belladonna


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active B&O suppository of belladonna<br>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)<br> <br> * Other names: Allergan;Drug: belladonna<br>* Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.<br>Drug: Morphine<br>* Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.<br>Drug: Active B&O suppository of belladonna<br>* belladonna 16.2mg and morphine 7.5mg<br>|
| Placebo Comparator: Placebo suppository<br>Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. | Drug: Onabotulinumtoxin A (BoNT)<br> <br> * Other names: Allergan;Drug: Placebo<br>* matching placebo to B&O suppository<br>|

What is the study measuring?
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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) |