Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- botulinum toxin type A (BoNT/A)
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Enrollment
- 134
- Locations
- 7
- Primary Endpoint
- Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male at least 50 years of age.
- •Voided volume =\> 125 ml.
- •Maximum urinary flow \< 15 ml/sec.
- •AUA symptom severity score =\>
- •Patient signed informed consent prior to the performance of any study procedures.
- •Patient able to complete the study protocol in the opinion of the investigator.
Exclusion Criteria
- •Any prior surgical intervention for BPH.
- •Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
- •Overactive bladder without bladder outlet obstruction.
- •Enrolled in another treatment trial for any disease within the past 30 days.
- •Men interested in future fertility.
- •Previous exposure to botulinum toxin.
- •On alpha-blocker within the past 48 hours.
- •On any 5-alpha-reductase inhibitor within the past month.
- •Post void residual \> 350 ml.
- •On phenylephrine, pseudoephedrine, imipramine, an anticholinergic, or cholinergic medication within the past 2 weeks.
Arms & Interventions
1
100 units botulinum toxin type A (BoNT/A)
Intervention: botulinum toxin type A (BoNT/A)
2
300 units botulinum toxin type A (BoNT/A)
Intervention: botulinum toxin type A (BoNT/A)
Outcomes
Primary Outcomes
Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.
Time Frame: 12 weeks
The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) \>=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.