Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Phase 4

Completed

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

• Registration Number: NCT02600715
• Lead Sponsor: Edgar LeClaire, MD

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 available

Study Timeline

• Study First Submitted: 2015-10-29
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2017-06-26
• Study Completion: 2017-06-26
• Status Verified: 2018-06
• Results First Submitted: 2018-06-26
• Results First Submitted QC: 2018-08-24
• Last Update Submitted: 2018-08-24
• Results First Posted: 2018-09-20
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active B&O suppository of belladonna	Onabotulinumtoxin A (BoNT)	Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Active B&O suppository of belladonna	belladonna	Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Active B&O suppository of belladonna	Morphine	Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Active B&O suppository of belladonna	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.
Placebo suppository	Onabotulinumtoxin A (BoNT)	Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Placebo suppository	Placebo	Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Primary Outcome Measures

Name	Time	Method
Change in Bladder Injection Pain	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Voiding Trial Results	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.
Number of Participants Declining to Complete Procedure Due to Pain Intolerance	Intraoperative	Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
Post Void Residual (PVR)	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.
Pre-analgesia Pain Score	Baseline	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 With Evidence of Infection or Positive Urine Culture	2 Weeks	Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
Post-operative Pain Score	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).
Participant Satisfaction With Pain Control	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.'

Trial Locations

Locations (2)

Wichita Women's Pelvic Surgery Center at Associates in Women's Health; 🇺🇸 Wichita, Kansas, United States

University of Kansas School of Medicine - Wichita; 🇺🇸 Wichita, Kansas, United States