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Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial.
J Urol. 2013 Jan; 189(1 Suppl):S135-40.JU

Abstract

PURPOSE

We explored the impact of once daily tadalafil on urodynamic measures in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia via invasive and noninvasive urodynamic studies.

MATERIALS AND METHODS

We conducted a multicenter, randomized, double blind, placebo controlled clinical trial comparing once daily tadalafil 20 mg vs placebo during 12 weeks in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia with or without bladder outlet obstruction. Invasive and noninvasive urodynamics, International Prostate Symptom Score and general safety were assessed. The primary study end point was change in detrusor pressure at maximum urinary flow rate.

RESULTS

Urodynamic measures remained largely unchanged during the study with no statistically significant or clinically adverse difference between tadalafil and placebo in change in detrusor pressure at maximum urinary flow rate (mean difference between treatments -2.2 cm H(2)O, p = 0.33) or any other urodynamic parameter assessed including maximum urinary flow rate, maximum detrusor pressure, bladder outlet obstruction index or bladder capacity (all measures p ≥0.13). Treatment with tadalafil resulted in significant improvements in International Prostate Symptom Score (mean difference between treatments -4.2, p <0.001). Tadalafil was generally well tolerated with the majority of adverse events being mild to moderate in severity and few patients discontinuing due to adverse events (tadalafil 2.0%, placebo 1.0%).

CONCLUSIONS

Treatment with tadalafil once daily for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia showed no negative impact on bladder function as measured by detrusor pressure at maximum urinary flow rate or on any other urodynamic parameter assessed. Nonetheless men receiving tadalafil reported significant improvements in International Prostate Symptom Score with an adverse events profile similar to other recent studies of tadalafil for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia.

Authors+Show Affiliations

Department of Urology, Vanderbilt University, Nashville, TN 37232, USA. roger.dmochowski@Vanderbilt.EduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23234619

Citation

Dmochowski, Roger, et al. "Urodynamic Effects of once Daily Tadalafil in Men With Lower Urinary Tract Symptoms Secondary to Clinical Benign Prostatic Hyperplasia: a Randomized, Placebo Controlled 12-week Clinical Trial." The Journal of Urology, vol. 189, no. 1 Suppl, 2013, pp. S135-40.
Dmochowski R, Roehrborn C, Klise S, et al. Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial. J Urol. 2013;189(1 Suppl):S135-40.
Dmochowski, R., Roehrborn, C., Klise, S., Xu, L., Kaminetsky, J., & Kraus, S. (2013). Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial. The Journal of Urology, 189(1 Suppl), S135-40. https://doi.org/10.1016/j.juro.2012.11.025
Dmochowski R, et al. Urodynamic Effects of once Daily Tadalafil in Men With Lower Urinary Tract Symptoms Secondary to Clinical Benign Prostatic Hyperplasia: a Randomized, Placebo Controlled 12-week Clinical Trial. J Urol. 2013;189(1 Suppl):S135-40. PubMed PMID: 23234619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial. AU - Dmochowski,Roger, AU - Roehrborn,Claus, AU - Klise,Suzanne, AU - Xu,Lei, AU - Kaminetsky,Jed, AU - Kraus,Stephen, PY - 2009/06/10/received PY - 2012/12/14/entrez PY - 2012/12/19/pubmed PY - 2013/2/12/medline SP - S135 EP - 40 JF - The Journal of urology JO - J. Urol. VL - 189 IS - 1 Suppl N2 - PURPOSE: We explored the impact of once daily tadalafil on urodynamic measures in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia via invasive and noninvasive urodynamic studies. MATERIALS AND METHODS: We conducted a multicenter, randomized, double blind, placebo controlled clinical trial comparing once daily tadalafil 20 mg vs placebo during 12 weeks in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia with or without bladder outlet obstruction. Invasive and noninvasive urodynamics, International Prostate Symptom Score and general safety were assessed. The primary study end point was change in detrusor pressure at maximum urinary flow rate. RESULTS: Urodynamic measures remained largely unchanged during the study with no statistically significant or clinically adverse difference between tadalafil and placebo in change in detrusor pressure at maximum urinary flow rate (mean difference between treatments -2.2 cm H(2)O, p = 0.33) or any other urodynamic parameter assessed including maximum urinary flow rate, maximum detrusor pressure, bladder outlet obstruction index or bladder capacity (all measures p ≥0.13). Treatment with tadalafil resulted in significant improvements in International Prostate Symptom Score (mean difference between treatments -4.2, p <0.001). Tadalafil was generally well tolerated with the majority of adverse events being mild to moderate in severity and few patients discontinuing due to adverse events (tadalafil 2.0%, placebo 1.0%). CONCLUSIONS: Treatment with tadalafil once daily for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia showed no negative impact on bladder function as measured by detrusor pressure at maximum urinary flow rate or on any other urodynamic parameter assessed. Nonetheless men receiving tadalafil reported significant improvements in International Prostate Symptom Score with an adverse events profile similar to other recent studies of tadalafil for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/23234619/Urodynamic_effects_of_once_daily_tadalafil_in_men_with_lower_urinary_tract_symptoms_secondary_to_clinical_benign_prostatic_hyperplasia:_a_randomized_placebo_controlled_12_week_clinical_trial_ L2 - https://www.jurology.com/doi/full/10.1016/j.juro.2012.11.025?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -