Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-06-26

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Onabotulinumtoxin A (BoNT)

Intervention Type DRUG

belladonna

Intervention Type DRUG

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

Morphine

Intervention Type 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

Intervention Type DRUG

belladonna 16.2mg and morphine 7.5mg

Placebo suppository

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

Group Type PLACEBO_COMPARATOR

Onabotulinumtoxin A (BoNT)

Intervention Type DRUG

Placebo

Intervention Type DRUG

matching placebo to B\&O suppository

Interventions

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Onabotulinumtoxin A (BoNT)

Intervention Type DRUG

belladonna

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Placebo

matching placebo to B\&O suppository

Intervention Type DRUG

Active B&O suppository of belladonna

belladonna 16.2mg and morphine 7.5mg

Intervention Type DRUG

Other Intervention Names

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Botox Allergan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No