Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Last updated: August 24, 2018
Sponsor: Edgar LeClaire, MD
Overall Status: Completed

Phase

4

Condition

Interstitial Cystitis

Overactive Bladder

Enuresis

Treatment

N/A

Clinical Study ID

NCT02600715
STUDY00003056
15-051
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Met clinical criteria under outside care or during the Principal Investigator'sroutine 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 offeredenrollment into the study for either overactive bladder (OAB), neurogenic detrusoroveractivity (NDO), or refractory interstitial cystitis (IC)

Exclusion

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-upbladder testing (post-void residual) or data collection will also be excluded

Study Design

Total Participants: 26
Study Start date:
November 01, 2015
Estimated Completion Date:
June 26, 2017

Connect with a study center

  • University of Kansas School of Medicine - Wichita

    Wichita, Kansas 67214
    United States

    Site Not Available

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

    Wichita, Kansas 67208
    United States

    Site Not Available

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