Phase 4
Completed N=26
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Overactive Bladder · Urinary Urge Incontinence · Urinary Bladder, Neurogenic · Painful Bladder Syndrome
Source: ClinicalTrials.gov NCT02600715 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Change in Bladder Injection Pain — 5; 4; 5 units on a scale — p=0.94
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bladder Injection Pain |
5; 4; 5 | 0.94 |
| SECONDARY Pre-analgesia Pain Score |
0; 0; 0 | — |
| SECONDARY Post-operative Pain Score |
2; 3; 2 | — |
| SECONDARY Number of Participants Declining to Complete Procedure Due to Pain Intolerance |
0; 0; 0 | — |
| SECONDARY Postoperative Voiding Trial Results |
3; 5; 8 | — |
| SECONDARY Post Void Residual (PVR) |
2; 3; 5 | — |
| SECONDARY Number of Participants With Evidence of Infection or Positive Urine Culture |
2; 4; 6 | — |
| SECONDARY Participant Satisfaction With Pain Control |
0; 1; 1; 2; 1; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02600715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.