Prolonged bladder catheterization, the conventional management of urinary bladder dysfunction secondary to radical hysterectomy for gynecologic malignancies, is associated with patient discomfort, higher incidence of urinary tract infection, delayed ambulation and moderate cost.
OBJECTIVE: This study aimed to determine the efficacy and safety of solifenacin succinate in the decreasing mean duration of indwelling catheterization after radical hysterectomy.
METHODS: In this non-blinded, no placebo, randomized controlled trial, patients 19 years old and above, diagnosed with early stage cervical cancer and stage II endometrial cancer were randomized to 2 arms: control arm and treatment arm (given solifenacin succinate 5 mg once a day after radical hysterectomy). Bladder function testing on the 3rd postoperative day and weekly thereafter was done on all patients. The primary endpoint was the mean duration of indwelling catheterization until bladder function recovery was obtained. Patients were monitored for adverse drug reactions and development of urinary tract infection.
RESULTS: Each arm had 18 patients. The clinicopathologic profiles of the patients in the 2 arms were comparable. The mean duration of indwelling catheterization was significantly shorter in the treatment arm (13.33 days ± 10.50 SO) than in the control arm (21.33 days ± 11.66 SO) (P = 0.046). No adverse drug reactions were noted.
CONCLUSION: Solifenacin succinate effectively and safely reduced mean duration of indwelling catheterization among patients who underwent radical hysterectomy. Human ; Female ; Aged ; Middle Aged ; Adult ; Urinary Bladder ; Solifenacin Succinate ; Uterine Cervical Neoplasms ; Urinary Catheterization ; Hysterectomy ; Urinary Tract Infections ; Endometrial Neoplasms ; Drug-related Side Effects And Adverse Reactions