Tadalafil monotherapy in management of chronic prostatitis/chronic pelvic pain syndrome: a randomized double-blind placebo controlled clinical trial

Abstract

Purpose In this placebo-controlled trial, we aimed to evaluate the clinical results of using PDE-5 inhibitor, tadalafil 5 mg OD, for management of CP/CPPS. Patients and methods 140 patients ≤ 45 years old with moderate/severe CP/CPPS associated with ED (IIEF-5 < 22) were randomly divided and received either tadalafil 5 mg OD (tadalafil-group) or placebo (control-group) for 6 weeks. Post-treatment CPSI scores were compared to baseline and to placebo. Clinically significant responders (≥ 25% reduction from baseline score) were calculated. Tadalafil-induced changes in IIE-5 were evaluated in correlation to that of CPSI scores. Results By the 6th week, 59 and 56 patients were available in both groups respectively. Compared to baseline, tadalafil-group patients showed significant improvement in total, pain, urinary and Qol domains of CPSI (19.1 ± 5.26, 10.42 ± 3.55, 4.2 ± 1.72 and 4.47 ± 1.64 vs. 24.21 ± 5.05, 12.14 ± 3.57, 6.08 ± 1.53 and 6.22 ± 1.76), p < 0.5. When compared to placebo, all 6th week CPSI domains scores, except for pain, were significantly better in tadalafil-group (p < 0.05). Post-treatment pain score didn't significantly differ between both groups (10.42 ± 3.55, vs. 11.71 ± 3.9, p > 0.05). Clinically significant responders were 30 patients (50.8%) in tadalafil-group vs. 3 patients (5.4%) in control. Tadalafil-induced changes in IIEF-5 score had weak but significant correlation to Qol domain (r = − 0.28, p < 0.05). Conclusion Tadalafil 5 mg OD can significantly improve all CPSI domains as compared to baseline. Post-treatment CPSI scores, except for pain, were better than placebo. About 50.8% of patients can develop ≥ 25% reduction in their total CPSI scores after treatment. Apart from Qol domain, these changes are not significantly correlated to tadalafil-induced IIEF-5 scores changes.

Treatment of Chronic Prostatitis with Phosphodiesterase Type 5 Inhibitors

“…UTI was the common exclusion criterion of the selected studies. Detailed characteristics are mentioned in Table 1 [22][23][24][25][26][27][28][29][30] .…”

“…Yamanishi et al [28] (2020) [29] (2022) Case: 39.9±3.9, Control: 39.7±4. 7 Type III Not reported 17.6±2.2 24.21±5.05…”

“…So, overall two studies scored 5 points, two scored 4, one study scored 3 points while one scored at least 2 points. The highest score was observed as 7 in Tawfik's study and focused on set of all the points to minimize the risk of bias [29] .…”

Bladder pain syndrome in men

“…They improve lower urinary tract symptoms in men with benign prostatic hyperplasia, pulmonary arterial hypertension, complex regional pain syndrome and erectile dysfunction by relaxing the smooth muscle fibres of the prostate through modulation of nitric oxide cyclic guanosine monophosphate signalling. Studies have shown promising reductions in symptoms 15,16 …”

“…Studies have shown promising reductions in symptoms. 15,16 Third-line: intravesical options Intravesical treatments include instillations of lidocaine, sodium hyaluronic acid, chondroitin sulphate, dimethyl sulfoxide (DMSO) and heparin, either alone or as combinations. They are usually given as a course, with more frequent instillations initially.…”