Comparative Efficacy of Tadalafil and Amitriptyline in Female Interstitial Cystitis/Bladder Pain Syndrome: Double-Blind Randomized Trial
Abstract
Introduction and hypothesis: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic debilitating disorder of unclear etiology that impairs quality of life; physically, emotionally, and sexually. Up till now, no standard effective therapy has existed. Phosphodiesterase-5 inhibitors are vasodilatory and anti-inflammatory. We studied the efficacy and safety of tadalafil, amitriptyline, and their combination in female IC/BPS patients.
Methods: In this study, 132 female patients were randomized into three groups. Assessments were performed at baseline and at 4, 8, and 12 weeks using voiding diary, uroflowmetry, the visual analog scale (VAS), the Interstitial Cystitis Symptom Index (ICSI), and the Interstitial Cystitis Problem Index (ICPI). Global Response Assessment (GRA) and correlations between VAS and voided volume were analyzed at the end. Statistical analysis was performed using the Kruskal-Wallis test.
Results: Tadalafil and combination improved daytime voids more than amitriptyline (tadalafil vs amitriptyline p = 0.0005, amitriptyline vs combination p < 0.0001, tadalafil vs combination p = 0.0009). Night-time voids improved notably in tadalafil and combination vs amitriptyline (p < 0.0001). Maximum urinary flow rate (Qmax) increased in combination and tadalafil vs amitriptyline (p = 0.0004) and (p = 0.0294) respectively. Voided volume was higher in combination vs amitriptyline (p = 0.0041). ICSI, ICPI, and VAS scores decreased in all groups (p < 0.0001).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 132 participants or records.
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