Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Overactive Bladder Clinical Trial

— ROBIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600715
• Other study ID #: STUDY00003056
• Secondary ID: 15-051
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: June 26, 2017

Study information

• Verified date: June 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Onabotulinumtoxin A (BoNT)

• belladonna
Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
• Morphine
Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
• Placebo
matching placebo to B&O suppository
• Active B&O suppository of belladonna
belladonna 16.2mg and morphine 7.5mg

Locations

Country	Name	City	State
United States	University of Kansas School of Medicine - Wichita	Wichita	Kansas
United States	Wichita Women's Pelvic Surgery Center at Associates in Women's Health	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Edgar LeClaire, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)