title: Bethanechol chloride for the prevention of bladder dysfunction after radical hysterectomy in gynecologic cancer patients: a randomized controlled trial study.
abstract: BACKGROUND
  Bethanechol chloride is considered as a treatment in patients with high postvoid residual urine (PVR). It enhances detrusor muscle contraction, resulting in higher maximum flow rate, higher detrusor pressure at maximum flow, and lower PVR. The efficacy of this agent in patients after radical hysterectomy is unclear. We aim to evaluate the efficacy of bethanechol chloride compared with placebo for the prevention of bladder dysfunction after type III radical hysterectomy.
  
  
  METHODS
  Gynecologic cancer patients who underwent type III radical hysterectomy were randomized by computer-generated schedule to assign patients in a 1:1 ratio into 2 groups. The treatment group received bethanechol chloride (Ucholine 20 mg 3 times a day on the third to seventh postoperative day), and the control group received placebo. Patients and physicians were masked to treatment allocation. The primary end point was the rate of urethral catheter removal at 1 week postoperatively. If PVR was more than 30% of voided volume, the urethral catheter was reinserted, and medication would be continued but not for more than 1 month. This study was registered as ISRCTN92687416.
  
  
  RESULTS
  There were 31 patients in each group without significant difference in baseline characteristics. Twenty-one patients (67.7%) in the treatment group and 12 patients (38.7%) in the control group had the urethral catheter removed at 1 week postoperatively (P = 0.04). Median duration of urethral catheterization was shorter in the treatment group (7 and 14 days, P = 0.03). However, the PVR and the incidence of urinary tract infection at 1 month postoperatively were not significantly different. Nine patients (29%) in the treatment group had adverse events such as nausea, abdominal distension, and abdominal cramping, which was higher than the control group (1 patient, 3.2%; P = 0.01). However, no patients required any medical treatments.
  
  
  CONCLUSIONS
  Bethanechol chloride decreases the duration of urethral catheterization in patients who underwent type III radical hysterectomy with manageable adverse events.
authors.affiliation: Gynecologic Oncology Division and Urogynecology Division, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. T_manchana@hotmail.com
authors.forename: Tarinee
authors.initials: T
authors.lastname: Manchana
authors.forename: Chalisa
authors.initials: C
authors.lastname: Prasartsakulchai
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D018723:Bethanechol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000534:rehabilitation / Q000601:surgery*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy / Q000534:rehabilitation / Q000601:surgery*; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects / Q000534:rehabilitation; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010919:Placebos; D011182:Postoperative Care; D011183:Postoperative Complications / Q000517:prevention & control*; D001743:Urinary Bladder / Q000187:drug effects / Q000503:physiopathology; D001745:Urinary Bladder Diseases / Q000517:prevention & control*; D014554:Urination / Q000187:drug effects
chemical_list: D018721:Muscarinic Agonists; D010919:Placebos; D018723:Bethanechol