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A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
J Sex Med. 2014 Jan; 11(1):187-96.JS

Abstract

INTRODUCTION

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction are common disorders of advancing age.

AIM

To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH.

METHODS

In this prospective randomized study, 133 men complaining of LUTS due to BPH were included. Forty-five patients received tamsulosin 0.4 mg/day alone (Group A), 44 patients received tadalafil 10 mg/day (Group B), and combination therapy (tamsulosin and tadalafil both) was instituted in 44 patients (Group C). After a 2-week medication free run-in period, they were evaluated for International Prostatic Symptom Score (IPSS), International Index of Erectile Function score (IIEF5), quality of life (IPSS QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR) volume, and safety parameters before and at 3 months of treatment.

MAIN OUTCOME MEASURES

There were primary (IPSS, IPSS QoL index, Qmax, and PVR) and secondary (erectile function [EF] domain scores from IIEF5) efficacy end points. Safety assessment included laboratory tests and patient's reporting of adverse event.

RESULTS

A significant improvement in IPSS score was observed in all the 3 groups A, B, and C (-50.90%, P < 0.05; -33.50%, P < 0.05; and -53.90%, P < 0.05, respectively). IIEF5 score increased significantly in these three groups (+39.28%, P < 0.05; +45.96%, P < 0.05; and +60.23%, P < 0.05, respectively). A significant increase in Qmax and decrease in PVR were also observed (33.99%, P < 0.05; 29.78%, P < 0.05; and 37.04%, P < 0.05) and (-60.90%, P < 0.05; -49.45%, P < 0.05; and -62.97%, P < 0.05, respectively). The QoL scores improved significantly (-73.35%, P < 0.05; -70.26%, P < 0.05; and -79.65%, P < 0.05, respectively). Side effects were dyspepsia, heartburn, headache, flushing, myalgia, and backache. Adverse effect dropout was 3.7%. No participant experienced any severe or serious adverse events.

CONCLUSIONS

In patients with LUTS due to BPH, tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS. Their EF also improves with these medications. The improvement is better with combination therapy compared with single agent alone.

Authors+Show Affiliations

Department of Urology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24165272

Citation

Singh, Dig Vijay, et al. "A Comparative Randomized Prospective Study to Evaluate Efficacy and Safety of Combination of Tamsulosin and Tadalafil Vs. Tamsulosin or Tadalafil Alone in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia." The Journal of Sexual Medicine, vol. 11, no. 1, 2014, pp. 187-96.
Singh DV, Mete UK, Mandal AK, et al. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014;11(1):187-96.
Singh, D. V., Mete, U. K., Mandal, A. K., & Singh, S. K. (2014). A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. The Journal of Sexual Medicine, 11(1), 187-96. https://doi.org/10.1111/jsm.12357
Singh DV, et al. A Comparative Randomized Prospective Study to Evaluate Efficacy and Safety of Combination of Tamsulosin and Tadalafil Vs. Tamsulosin or Tadalafil Alone in Patients With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. J Sex Med. 2014;11(1):187-96. PubMed PMID: 24165272.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. AU - Singh,Dig Vijay, AU - Mete,Uttam Kumar, AU - Mandal,Arup Kumar, AU - Singh,Shrawan Kumar, Y1 - 2013/10/25/ PY - 2013/10/30/entrez PY - 2013/10/30/pubmed PY - 2014/10/4/medline KW - Benign Prostatic Hyperplasia KW - Erectile Dysfunction KW - Lower Urinary Tract Symptoms KW - Medical Therapy KW - Tadalafil KW - Tamsulosin SP - 187 EP - 96 JF - The journal of sexual medicine JO - J Sex Med VL - 11 IS - 1 N2 - INTRODUCTION: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction are common disorders of advancing age. AIM: To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH. METHODS: In this prospective randomized study, 133 men complaining of LUTS due to BPH were included. Forty-five patients received tamsulosin 0.4 mg/day alone (Group A), 44 patients received tadalafil 10 mg/day (Group B), and combination therapy (tamsulosin and tadalafil both) was instituted in 44 patients (Group C). After a 2-week medication free run-in period, they were evaluated for International Prostatic Symptom Score (IPSS), International Index of Erectile Function score (IIEF5), quality of life (IPSS QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR) volume, and safety parameters before and at 3 months of treatment. MAIN OUTCOME MEASURES: There were primary (IPSS, IPSS QoL index, Qmax, and PVR) and secondary (erectile function [EF] domain scores from IIEF5) efficacy end points. Safety assessment included laboratory tests and patient's reporting of adverse event. RESULTS: A significant improvement in IPSS score was observed in all the 3 groups A, B, and C (-50.90%, P < 0.05; -33.50%, P < 0.05; and -53.90%, P < 0.05, respectively). IIEF5 score increased significantly in these three groups (+39.28%, P < 0.05; +45.96%, P < 0.05; and +60.23%, P < 0.05, respectively). A significant increase in Qmax and decrease in PVR were also observed (33.99%, P < 0.05; 29.78%, P < 0.05; and 37.04%, P < 0.05) and (-60.90%, P < 0.05; -49.45%, P < 0.05; and -62.97%, P < 0.05, respectively). The QoL scores improved significantly (-73.35%, P < 0.05; -70.26%, P < 0.05; and -79.65%, P < 0.05, respectively). Side effects were dyspepsia, heartburn, headache, flushing, myalgia, and backache. Adverse effect dropout was 3.7%. No participant experienced any severe or serious adverse events. CONCLUSIONS: In patients with LUTS due to BPH, tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS. Their EF also improves with these medications. The improvement is better with combination therapy compared with single agent alone. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/24165272/A_comparative_randomized_prospective_study_to_evaluate_efficacy_and_safety_of_combination_of_tamsulosin_and_tadalafil_vs__tamsulosin_or_tadalafil_alone_in_patients_with_lower_urinary_tract_symptoms_due_to_benign_prostatic_hyperplasia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)30548-8 DB - PRIME DP - Unbound Medicine ER -