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

Edgar LeClaire, MD

Status and phase: Completed; Phase 4

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

Treatments: Drug: Placebo; Drug: belladonna; Drug: Active B&O suppository of belladonna; Drug: Morphine; Drug: Onabotulinumtoxin A (BoNT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02600715

15-051

STUDY00003056

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Active B&O suppository of belladonna

Experimental group

Description:

Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.

Treatment:

Drug: Morphine

Drug: Onabotulinumtoxin A (BoNT)

Drug: Active B&O suppository of belladonna

Drug: belladonna

Placebo suppository

Placebo Comparator group

Description:

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

Treatment:

Drug: Onabotulinumtoxin A (BoNT)

Drug: Placebo