MP15-09 TADALAFIL VERSUS COMBINED TAMSOLUSIN AND CIPROFLOXACIN FOR TREATMENT OF CHRONIC PELVIC PAIN SYNDROME: A RANDOMIZED CONTROLLED TRIAL

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP15-09 TADALAFIL VERSUS COMBINED TAMSOLUSIN AND CIPROFLOXACIN FOR TREATMENT OF CHRONIC PELVIC PAIN SYNDROME: A RANDOMIZED CONTROLLED TRIAL Marwan Anas, Ahmed EL-Hefnawy, and Ahmed Shoma Marwan AnasMarwan Anas More articles by this author , Ahmed EL-HefnawyAhmed EL-Hefnawy More articles by this author , and Ahmed ShomaAhmed Shoma More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003235.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Chronic prostatitis /Chronic pelvic pain syndrome (CP/CPPS) is still presenting true considerable challenge to urologists .It is characterized by confluence of symptoms including mainly suprapubic or deep perineal pain, and voiding symptoms. The exact etiology and pathogenesis of CP/CPPS remain unknown up till now. A specific diagnostic test for CP/CPPS is still not yet determined. Until now, there are no proven therapies for CP/CPPS. A wide variety of pharmacologic and non-pharmacologic therapies have been studied in clinical trials, but most have shown limited curative efficacy in symptom alleviation. Our aim To assess the efficacy and safety of PDEI-5 (Tadalafil) for treatment of CP/CPPS. METHODS: It is a prospective randomized controlled single blinded phase III clinical trial. Between May 2020 and April 2022, 97 patients with a diagnosis of type IIIa chronic non-bacterial prostatitis were enrolled in the final analysis at the end of study. Forty-nine for tadalafil (group A), who received combined tadalafil 5 mg once daily before bed time and placebo (sugar pills) after meal once daily for 12 weeks and forty-eight for combined tamsulosin and ciprofloxacin (group B) who received ciprofloxacin 1000 mg once daily PO after meal and tamsulosin 0.4 mg before bed time for the same period. Patients were followed for 12 weeks after administration of treatment. Primary end point was pain relief which was assessed by NIH-CPSI at 12 weeks after treatment. RESULTS: Patients baseline characteristics were comparable in both groups. At the end of RCT, tadalafil-group patients showed significant improvement in total, pain, urinary and Qol domains of NIH-CPSI compared to baseline (17.92±2.3, 7.41±1.56, 4.96±0.86, 5.55±0.79 vs. 30.88±3.62, 14.67±2.2, 6.67±1.17, 9.53±1.15 respectively, p<0.0001). When compared to combined tamsulosin and ciprofloxacin, all 12th week NIH-CPSI domains scores, except for urinary, were significantly better in tadalafil group (p<0.0001). Side-effects among group B were much higher than in group A. The most common side-effects in group A were dyspepsia (8.2%) and back pain (6.1%) while in group B were retrograde ejaculation (18.8%) and dizziness (16.7%). By the end of 12th week, 39 (79.6%) patients in group A showed marked improvement in GRA, while in group B, 41 (85.4%) patients showed moderate improvement. CONCLUSIONS: Tadalafil is effective and safe treatment modality for CP/CPPS. It has the advantage of giving more pain relief and improvement of sexual function compared with combined tamsulosin and ciprofloxacin. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e195 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Marwan Anas More articles by this author Ahmed EL-Hefnawy More articles by this author Ahmed Shoma More articles by this author Expand All Advertisement PDF downloadLoading ...