Tadalafil Improves Symptoms, Erectile Function and Quality of Life in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (KYU-PRO Study)

Low Urin Tract Symptoms. 2018 Jan;10(1):76-83. doi: 10.1111/luts.12143. Epub 2016 Nov 5.

Abstract

Objectives: Effect of tadalafil on lower urinary tract symptoms (LUTS), erectile function and quality of life (QoL) were prospectively evaluated in patients with benign prostatic hyperplasia (BPH) at multicenter.

Methods: Eligible men were ≥40 years who had no treatment with alpha-blocker for BPH, with total International Prostate Symptom Score (IPSS) ≥8, IPSS-QOL ≥2 and prostate volume ≥20 mL. Data were collected on age, body mass index (BMI), and prostate specific antigen (PSA). Patients were asked to complete a self-reported questionnaire regarding the IPSS, Overactive Bladder Symptom Score (OABSS), International Index of Erectile Function 5 (IIEF5), and Medical Outcome Study 8-Item Short-Form Health Survey (SF-8). These measures were assessed at baseline, 4-, 8-, 12-week of tadalafil treatment. In addition, uroflowmetry was also performed at baseline, and 12-week end point visit.

Results: Thirty five patients with mean age 67.3 years, mean BMI 23.6 kg/m2 , mean prostate volume 36 mL, and mean PSA 3.4 ng/mL were enrolled. Treatment with tadalafil significantly improved IPSS total score, IPSS voiding subscore, IPSS storage subscore, OABSS and IPSS-QoL score after 4 weeks and these improvements were maintained for 12-week treatment period. IIEF5 score and general health in SF-8 are significantly improved with the treatment of tadalafil. However, maximum flow rate and postvoiding residual volume were not significantly changed. There were not any serious adverse events.

Conclusions: These results indicate that tadalafil 5 mg once daily would be effective and well tolerated treatment in Japanese men with BPH-LUTS.

Keywords: benign prostatic hyperplasia; erectile function; lower urinary tract symptoms; phosphodiesterase 5 inhibitor; quality of life.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Humans
  • Lower Urinary Tract Symptoms / drug therapy*
  • Lower Urinary Tract Symptoms / etiology
  • Lower Urinary Tract Symptoms / physiopathology
  • Male
  • Middle Aged
  • Penile Erection / drug effects*
  • Phosphodiesterase 5 Inhibitors / pharmacology
  • Phosphodiesterase 5 Inhibitors / therapeutic use*
  • Prospective Studies
  • Prostatic Hyperplasia / complications
  • Prostatic Hyperplasia / drug therapy*
  • Quality of Life
  • Severity of Illness Index
  • Symptom Assessment
  • Tadalafil / pharmacology
  • Tadalafil / therapeutic use*
  • Urination / drug effects*
  • Urodynamics / drug effects

Substances

  • Phosphodiesterase 5 Inhibitors
  • Tadalafil