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Completed

NCT Number: NCT02600715

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

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.

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Key information

Conditions

Overactive Bladder Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Painful Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urinary Urge Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas School of Medicine - Wichita, Wichita, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onabotulinumtoxin A (BoNT)

Drug

Other names: Botox, Allergan

belladonna

Drug

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

Morphine

Drug

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

Placebo

Drug

matching placebo to B&O suppository

Active B&O suppository of belladonna

Drug

belladonna 16.2mg and morphine 7.5mg

Primary outcomes

  1. Change in Bladder Injection Pain

    Time frame: 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 outcomes

  1. Pre-analgesia Pain Score

    Time frame: Baseline

    Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

  2. Post-operative Pain Score

    Time frame: 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).

  3. Number of Participants Declining to Complete Procedure Due to Pain Intolerance

    Time frame: Intraoperative

    Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.

  4. Postoperative Voiding Trial Results

    Time frame: 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.

  5. Post Void Residual (PVR)

    Time frame: 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.

  6. Number of Participants With Evidence of Infection or Positive Urine Culture

    Time frame: 2 Weeks

    Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.

  7. Participant Satisfaction With Pain Control

    Time frame: 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.'

Sponsors and collaborators

Lead sponsor

Edgar LeClaire, MD

Other

Registry information

Official study title

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

Acronym: ROBIN

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2015
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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