Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. (Anticholinergic; Solifenacin 10 mg) using validated symptoms questionnaires.

In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Mirabegron; Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• Adult patients (aged 19-80 years)

• Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.

Exclusion Criteria:

• Patients with neurogenic bladder, OAB syndrome, and neurological and psychiatric diseases

• Residual ureteral or renal stones after the procedure

• Preoperative febrile UTI

• pregnancy or breastfeeding

• Bilateral ureteroscopic surgery

• Single kidney

• Chronic kidney disease

• Cardiovascular or cerebrovascular disease

• Hepatic dysfunction

• History of pelvic surgery or irradiation

• History of bladder or prostate surgery

• Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL

• Preoperative indwelling of ureteral stent for relief of stone-related pain or sepsis