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Reduction of Bladder Injection Pain With Belladonna Opiate Suppository (ROBIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600715
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Edgar LeClaire, MD, University of Kansas Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Urge Incontinence Urinary Bladder, Neurogenic Painful Bladder Syndrome Drug: Onabotulinumtoxin A (BoNT) Drug: belladonna Drug: Morphine Drug: Placebo Drug: Active B&O suppository of belladonna Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
Study Start Date : November 2015
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : June 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
Drug Information available for: Belladonna

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Onabotulinumtoxin A (BoNT)
Other Names:
  • Botox
  • Allergan

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

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

Drug: Active B&O suppository of belladonna
belladonna 16.2mg and morphine 7.5mg
Placebo Comparator: Placebo suppository
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
 Drug: Onabotulinumtoxin A (BoNT)
Other Names:
  • Botox
  • Allergan

Drug: Placebo
matching placebo to B&O suppository


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.'


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600715


Locations
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United States, Kansas
Wichita Women's Pelvic Surgery Center at Associates in Women's Health
Wichita, Kansas, United States, 67208
University of Kansas School of Medicine - Wichita
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Edgar LeClaire, MD
Investigators
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Principal Investigator: Edgar LeClaire, MD, FACOG University of Kansas Medical Center
  Study Documents (Full-Text)

Documents provided by Edgar LeClaire, MD, University of Kansas Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 5, 2015
Informed Consent Form  [PDF] November 23, 2015

More Information
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Responsible Party: Edgar LeClaire, MD, Clinical Instructor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02600715    
Other Study ID Numbers: STUDY00003056
15-051 ( Other Identifier: Wichita Medical Research and Education Foundation IRB )
First Posted: November 9, 2015    Key Record Dates
Results First Posted: September 20, 2018
Last Update Posted: September 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Incontinence
Urination Disorders
Cystitis
Neurologic Manifestations
Nervous System Diseases
Morphine
Botulinum Toxins, Type A
 abobotulinumtoxinA
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Agents
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents