Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Edgar LeClaire, MD26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Onabotulinumtoxin A (BoNT)DRUG

belladonnaDRUG

Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.

MorphineDRUG

Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and intraoperative

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: Intraoperative

Postoperative Voiding Trial Results

Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.

Time frame: 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.

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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