A Randomized, Placebo-Controlled Study to Assess Safety and Efficacy of Vardenafil 10 mg and Tamsulosin 0.4 mg vs. Tamsulosin 0.4 mg Alone in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Gacci, Mauro; Vittori, Gianni; Tosi, Nicola; Siena, Giampaolo; Rossetti, M; Lapini, A.; Vignozzi, Linda; Serni, Sergio; Maggi, Mario; Carini, Marco

doi:10.1111/j.1743-6109.2012.02718.x

Cited by 68 publications

(51 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…One double-blinded trial ( n = 60) compared vardenafil 10 mg daily combined with tamsulosin 0.4 mg to tamsulosin monotherapy over 12 wk [52]. The overall RoB was moderate.…”

Section: Evidence Synthesismentioning

confidence: 99%

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

et al. 2017

View full text Add to dashboard Cite

Context Alpha-blockers (ABs) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Recently, newer drugs have shown promise for this indication. Objective To assess the comparative effectiveness and adverse effects (AEs) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta-analysis. Evidence acquisition Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases (through June 2016) were hand searches for references of relevant studies. Eligible studies included randomized controlled trials published in English of newer ABs, antimuscarinics, a beta-3 adrenoceptor agonist, phosphodiesterase type-5 inhibitors, or combination therapy with one of these medications as an active comparator. Observational studies of the same agents with a duration ≥1 yr that reported AEs were also included. Evidence synthesis We synthesized evidence from 43 randomized controlled trials as well as five observational studies. Based on improvement of mean International Prostate Symptom Score and quality of life scores, the effectiveness of the newer ABs was not different from the older ABs (moderate strength of evidence [SOE]), but had more AEs (low SOE). Antimuscarinics/AB combination therapy had similar outcomes as AB monotherapy (all moderate SOE), but often had more AEs. Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone. Evidence was insufficient for the beta-3 adrenoceptor agonist. For all newer agents, the evidence was generally insufficient to assess long-term efficacy, prevention of symptom progression, or AEs. Conclusions None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment. Given the lack of superior outcomes, the studies’ short time-horizon, and less assurance of their safety, their current value in treating LUTS attributable to BPH appears low. Patient summary In this paper, we reviewed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate. We found none of the new drugs to be better but there was more concern about side effects.

show abstract

“…One double-blinded trial ( n = 60) compared vardenafil 10 mg daily combined with tamsulosin 0.4 mg to tamsulosin monotherapy over 12 wk [52]. The overall RoB was moderate.…”

Section: Evidence Synthesismentioning

confidence: 99%

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

et al. 2017

View full text Add to dashboard Cite

show abstract

“…They concluded that patients in combination therapy group experienced no serious adverse events and this regimen was significantly more effective than tamsulosin alone in improving urinary symptoms (9). Another randomized parallel placebo controlled clinical trial confirmed that tadalafil or tamsulosin has significant and numerically similar effects on improvement of LUTS when comparing to placebo.…”

Section: Discussionmentioning

confidence: 67%

“…Some previous studies confirmed that combination therapy with 5-phosphodiesterase inhibitors and ɑ-adrenergic blockers resulted in significant improvement of LUTS (7)(8)(9). Recently, a meta-analysis of the cross sectional data from twelve articles depicted that 5-phosphodiesterase inhibitors can significantly improve LUTS secondary to BPH in patients with or without erectile dysfunction (10) but there is no obvious data about the role of 5-phosphodiesterase inhibitors in AUR when administered as combination therapy with ɑ-blocker agents.…”

Section: Introductionmentioning

confidence: 78%

“…Even though, only tadalafil was effective in patients with LUTS and erectile dysfunction (26). There are some previous reports regarding the safety and efficacy of sildenafil (25 or 50mg/day) in decreasing of IPSS as monotherapy or in combination with alpha blocker (7)(8)(9). A recent systematic review of the prospective and cross sectional studies on 3214 patients suggested that 5-phosphodiesterase inhibitors can significantly improve obstructive urinary symptoms secondary to BPH (10).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Does sildenafil enhance the effect of tamsulosin in relieving acute urinary retention?

et al. 2014

View full text Add to dashboard Cite

ARTICLE INFO ______________________________________________________________ ______________________Objective: To compare the safety and efficacy of combined therapy using sildenafil and tamsulosin for management of acute urinary retention (AUR) with tamsulosin alone in patients with benign prostate hyperplasia (BPH). Materials and Methods: 101 patients were enrolled in a randomized placebo-controlled study from June 2009 to April 2012. Patients presenting with an initial episode of spontaneous AUR underwent urethral catheterization and then prospectively randomized to receive tamsulosin 0.4mg plus sildenafil 50mg in group A and tamsulosin 0.4mg plus placebo in group B for three days. Urethral catheter was removed three days after medical treatment and patient's ability to void assessed at the day after catheter removal and seven days later. Patients who voided successfully were followed at least for three months. Results: Mean age of patients was 59.64 ± 3.84 years in group A and 60.56 ± 4.12 years in group B (p value = 0.92). Mean prostate volume and mean residual urine were comparable between both groups (p value = 0.74 and 0.42, respectively). Fifteen patients in group A (success rate: 70%) and nineteen patients in group B (success rate: 62.7%) had failed trial without catheter (TWOC) at 7th day following AUR (p value = 0.3). No significant difference was noted between both groups regarding the rate of repeated AUR at one month and three month follow-up period (p = 0.07 and p = 0.45, respectively). Conclusion: It seems that combination therapy by using 5-phosphodiesterase inhibitor and tamsulosin has no significant advantages to improve urinary retention versus tamsulosin alone.

show abstract

“…However, as BPH-BOO involves both the prostate and bladder, it remains undetermined whether the prostate, the bladder, or both, is the target of PDE5 inhibition. Specifically, studies that demonstrated PDE5Is’ beneficial effects almost all showed improvements in both the obstructive and irritative types of LUTS 2–7 . Since the obstructive and the irritative types of LUTS are concerned with different tissue sites (e.g., bladder neck vs. bladder body), the abovementioned clinical data make it difficult to identify a definitive site of action for PDE5Is.…”

Section: Bladder: Clinical Studiesmentioning

confidence: 99%

Phosphodiesterase-5 Expression and Function in the Lower Urinary Tract: A Critical Review

Lin

Albersen

Xin

et al. 2013

Urology

View full text Add to dashboard Cite

A Randomized, Placebo-Controlled Study to Assess Safety and Efficacy of Vardenafil 10 mg and Tamsulosin 0.4 mg vs. Tamsulosin 0.4 mg Alone in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Cited by 68 publications

References 35 publications

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

Does sildenafil enhance the effect of tamsulosin in relieving acute urinary retention?

Phosphodiesterase-5 Expression and Function in the Lower Urinary Tract: A Critical Review

Contact Info

Product

Resources

About