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A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia.
Eur Urol. 2013 Mar; 63(3):496-503.EU

Abstract

BACKGROUND

Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH).

OBJECTIVE

To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study.

DESIGN, SETTING, AND PARTICIPANTS

A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥ 50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥ 12, total prostate volume (TPV) 30-100ml, and maximum flow rate (Q(max)) 5-15 ml/s.

INTERVENTION

Single transperineal (n=63) or transrectal (n=311) administration of placebo (n=94) or onabotulinumtoxinA 100 U (n=95), 200 U (n=94), or 300 U (n=97) into the prostate transition zone.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Q(max), TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed.

RESULTS AND LIMITATIONS

Significant improvements from baseline in IPSS, Q(max), TPV, and TZV were observed for all groups, including placebo, at week 12 (p<0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n=180) at week 12. AEs were comparable across all groups.

CONCLUSIONS

Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study.

TRIAL REGISTRATION

http://www.Clinical Trials.gov; NCT00284518.

Authors+Show Affiliations

Medical University of Vienna, Vienna, Austria. michael.marberger@A1.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23098762

Citation

Marberger, Michael, et al. "A Randomized Double-blind Placebo-controlled Phase 2 Dose-ranging Study of onabotulinumtoxinA in Men With Benign Prostatic Hyperplasia." European Urology, vol. 63, no. 3, 2013, pp. 496-503.
Marberger M, Chartier-Kastler E, Egerdie B, et al. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013;63(3):496-503.
Marberger, M., Chartier-Kastler, E., Egerdie, B., Lee, K. S., Grosse, J., Bugarin, D., Zhou, J., Patel, A., & Haag-Molkenteller, C. (2013). A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. European Urology, 63(3), 496-503. https://doi.org/10.1016/j.eururo.2012.10.005
Marberger M, et al. A Randomized Double-blind Placebo-controlled Phase 2 Dose-ranging Study of onabotulinumtoxinA in Men With Benign Prostatic Hyperplasia. Eur Urol. 2013;63(3):496-503. PubMed PMID: 23098762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. AU - Marberger,Michael, AU - Chartier-Kastler,Emmanuel, AU - Egerdie,Blair, AU - Lee,Kyu-Sung, AU - Grosse,Joachim, AU - Bugarin,Denise, AU - Zhou,Jihao, AU - Patel,Anand, AU - Haag-Molkenteller,Cornelia, Y1 - 2012/10/12/ PY - 2012/07/23/received PY - 2012/10/05/accepted PY - 2012/10/27/entrez PY - 2012/10/27/pubmed PY - 2013/7/17/medline SP - 496 EP - 503 JF - European urology JO - Eur. Urol. VL - 63 IS - 3 N2 - BACKGROUND: Botulinum toxin treatment has been investigated as a minimally invasive alternative to oral medications in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH). OBJECTIVE: To explore the efficacy of onabotulinumtoxinA 100 U, 200 U, and 300 U versus placebo in men with LUTS/BPH in a phase 2 dose-ranging study. DESIGN, SETTING, AND PARTICIPANTS: A multicenter double-blind randomized, placebo-controlled 72-wk study enrolled men ≥ 50 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥ 12, total prostate volume (TPV) 30-100ml, and maximum flow rate (Q(max)) 5-15 ml/s. INTERVENTION: Single transperineal (n=63) or transrectal (n=311) administration of placebo (n=94) or onabotulinumtoxinA 100 U (n=95), 200 U (n=94), or 300 U (n=97) into the prostate transition zone. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary efficacy end point was a change from baseline in IPSS at week 12. Secondary end points were Q(max), TPV, and transition zone volume (TZV). Analysis of covariance and the Cochran-Mantel-Haenszel method assessed the efficacy and proportion of IPSS responders. Adverse events (AEs) were assessed. RESULTS AND LIMITATIONS: Significant improvements from baseline in IPSS, Q(max), TPV, and TZV were observed for all groups, including placebo, at week 12 (p<0.001), with no significant differences between onabotulinumtoxinA and placebo. However, in an exploratory post hoc analysis, a significant reduction in IPSS versus placebo was observed with onabotulinumtoxinA 200 U in prior α-blocker users (n=180) at week 12. AEs were comparable across all groups. CONCLUSIONS: Reductions in LUTS/BPH symptoms were seen in all groups, including placebo, with no significant between-group differences owing to a large placebo effect from the injectable therapy. The findings from the post hoc analysis in men previously treated with α-blockers will be further explored in an appropriately designed study. TRIAL REGISTRATION: http://www.Clinical Trials.gov; NCT00284518. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/23098762/A_randomized_double_blind_placebo_controlled_phase_2_dose_ranging_study_of_onabotulinumtoxinA_in_men_with_benign_prostatic_hyperplasia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(12)01224-9 DB - PRIME DP - Unbound Medicine ER -