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Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study.
BJU Int. 2014 Oct; 114(4):568-75.BI

Abstract

OBJECTIVES

To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week, randomised, double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH).

PATIENTS AND METHODS

After a 4-week placebo lead-in period, men aged ≥45 years with an International Prostate Symptom Score (IPSS) of ≥13 and a maximum urinary flow rate of ≥4 to ≤15 mL/s received placebo (172 men), tadalafil 5 mg (171), or tamsulosin 0.4 mg (168) once daily for 12 weeks. Treatment Satisfaction Scale-BPH (TSS-BPH) responses were assessed based on median treatment differences using the van Elteren test.

RESULTS

Overall treatment satisfaction was greater for tadalafil vs placebo (P = 0.005), based on greater satisfaction with efficacy (P = 0.003); neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo (P ≥ 0.409). For individual questions, 66.5% of men rated tadalafil treatment as 'effective/very effective' (Question 1, Q1) vs placebo (P = 0.011), 72.6% would 'definitely/probably recommend their treatment' (Q3; P = 0.043), 71.8% were generally 'very satisfied/satisfied with their medication' (Q8; P < 0.003), and 65.0% would 'definitely/probably continue therapy' (Q10; P = 0.035). With tamsulosin, differences vs placebo were not statistically significant. Subgroup analyses of overall TSS-BPH by baseline age (≤65/>65 years), history of erectile dysfunction (yes/no), LUTS/BPH severity (IPSS</≥20), total testosterone level (<300/≥300 ng/dL), and age-specific predicted prostate volume (<40/≥40 mL) showed no statistically significant treatment-subgroup interactions. Men with recent prior α-blocker therapy reported greater treatment satisfaction with tadalafil vs placebo, with only borderline difference for men without prior therapy.

CONCLUSION

Treatment satisfaction was greater with tadalafil vs placebo, with no significant difference between tamsulosin and placebo.

Authors+Show Affiliations

Department of Urology, Hannover Medical School, Hannover, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24612148

Citation

Oelke, Matthias, et al. "Treatment Satisfaction With Tadalafil or Tamsulosin Vs Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH): Results From a Randomised, Placebo-controlled Study." BJU International, vol. 114, no. 4, 2014, pp. 568-75.
Oelke M, Giuliano F, Baygani SK, et al. Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study. BJU Int. 2014;114(4):568-75.
Oelke, M., Giuliano, F., Baygani, S. K., Melby, T., & Sontag, A. (2014). Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study. BJU International, 114(4), 568-75. https://doi.org/10.1111/bju.12733
Oelke M, et al. Treatment Satisfaction With Tadalafil or Tamsulosin Vs Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH): Results From a Randomised, Placebo-controlled Study. BJU Int. 2014;114(4):568-75. PubMed PMID: 24612148.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study. AU - Oelke,Matthias, AU - Giuliano,François, AU - Baygani,Simin K, AU - Melby,Thomas, AU - Sontag,Angelina, PY - 2014/3/12/entrez PY - 2014/3/13/pubmed PY - 2014/12/15/medline KW - patient satisfaction KW - phosphodiesterase type 5 inhibitors KW - randomised controlled trial KW - tadalafil KW - tamsulosin KW - treatment satisfaction SP - 568 EP - 75 JF - BJU international JO - BJU Int VL - 114 IS - 4 N2 - OBJECTIVES: To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week, randomised, double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS: After a 4-week placebo lead-in period, men aged ≥45 years with an International Prostate Symptom Score (IPSS) of ≥13 and a maximum urinary flow rate of ≥4 to ≤15 mL/s received placebo (172 men), tadalafil 5 mg (171), or tamsulosin 0.4 mg (168) once daily for 12 weeks. Treatment Satisfaction Scale-BPH (TSS-BPH) responses were assessed based on median treatment differences using the van Elteren test. RESULTS: Overall treatment satisfaction was greater for tadalafil vs placebo (P = 0.005), based on greater satisfaction with efficacy (P = 0.003); neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo (P ≥ 0.409). For individual questions, 66.5% of men rated tadalafil treatment as 'effective/very effective' (Question 1, Q1) vs placebo (P = 0.011), 72.6% would 'definitely/probably recommend their treatment' (Q3; P = 0.043), 71.8% were generally 'very satisfied/satisfied with their medication' (Q8; P < 0.003), and 65.0% would 'definitely/probably continue therapy' (Q10; P = 0.035). With tamsulosin, differences vs placebo were not statistically significant. Subgroup analyses of overall TSS-BPH by baseline age (≤65/>65 years), history of erectile dysfunction (yes/no), LUTS/BPH severity (IPSS</≥20), total testosterone level (<300/≥300 ng/dL), and age-specific predicted prostate volume (<40/≥40 mL) showed no statistically significant treatment-subgroup interactions. Men with recent prior α-blocker therapy reported greater treatment satisfaction with tadalafil vs placebo, with only borderline difference for men without prior therapy. CONCLUSION: Treatment satisfaction was greater with tadalafil vs placebo, with no significant difference between tamsulosin and placebo. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/24612148/Treatment_satisfaction_with_tadalafil_or_tamsulosin_vs_placebo_in_men_with_lower_urinary_tract_symptoms__LUTS__suggestive_of_benign_prostatic_hyperplasia__BPH_:_results_from_a_randomised_placebo_controlled_study_ L2 - https://doi.org/10.1111/bju.12733 DB - PRIME DP - Unbound Medicine ER -