Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

NCT02600715 | Completed Phase 4 Results

• 2 other identifiers: STUDY0000305615-051
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pre-analgesia Pain Score

  Baseline

• Post-operative Pain Score

  Postoperative (within 10 minutes of the end of the BoNT procedure)

• Number of Participants Declining to Complete Procedure Due to Pain Intolerance

  Intraoperative

• Postoperative Voiding Trial Results

  Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)

• Post Void Residual (PVR)

  2 Weeks

Study Arms (2)

Active B&O suppository of belladonna

EXPERIMENTAL

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); Drug: belladonna; Drug: Morphine; Drug: Active B&O suppository of belladonna

Placebo suppository

PLACEBO COMPARATOR

Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Drug: Onabotulinumtoxin A (BoNT); Drug: Placebo

Interventions

Onabotulinumtoxin A (BoNT) DRUG

Also known as: Botox, Allergan

Active B&O suppository of belladonna; Placebo suppository

belladonna DRUG

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

Active B&O suppository of belladonna

Morphine DRUG

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

Active B&O suppository of belladonna

Placebo DRUG

matching placebo to B\&O suppository

Placebo suppository

Active B&O suppository of belladonna DRUG

belladonna 16.2mg and morphine 7.5mg

Active B&O suppository of belladonna

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Edgar LeClaire, MD: lead

Study Sites (2)

Wichita Women's Pelvic Surgery Center at Associates in Women's Health

Wichita, Kansas, 67208, United States

Location

University of Kansas School of Medicine - Wichita

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Bladder, Neurogenic; Cystitis, Interstitial

Interventions

Botulinum Toxins, Type A; Idoxuridine; Morphine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Neurologic Manifestations; Nervous System Diseases; Cystitis

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jennifer Duong, MPH, Research Associate
• Organization: University of Kansas School of Medicine-Wichita

jduong@kumc.edu

316-962-3126

Study Officials

• Edgar LeClaire, MD, FACOG

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)