title: Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women--a multicenter, randomized, open-label, controlled comparison study.
abstract: OBJECTIVE
  The aim of the study was to compare the effectiveness and safety of solifenacin succinate tablets alone or combined with local estrogen for overactive bladder treatment in postmenopausal women.
  
  
  METHODS
  This multicenter, randomized, open, parallel-controlled clinical trial enrolled 104 women between January 2012 and August 2013. Participants meeting the inclusion criteria were randomized 1:1 to 12 weeks of treatment with group A (solifenacin 5 mg qd + promestriene vaginal capsules intravaginally) or group B (solifenacin 5 mg qd). Before and after 12 weeks of treatment, symptoms (urinary urgency, frequency, and urge incontinence) were analyzed. Our primary outcome was the change from baseline to the end of treatment in the mean number of voids in 24 hours. Quality of life (QoL) was assessed using International Prostate Symptom Score and Overactive Bladder Symptom Score questionnaires and safety according to the incidence of adverse events. The t test or the Mann-Whitney U test was used to compare continuous variables, and the χ(2) test or Fisher's exact test was used to compare categorical variables.
  
  
  RESULTS
  The median decreases in the mean number of voids in 24 hours in groups A and B were 5.2. and 4.3, respectively, which were not significantly different. The median decreases in urgency episodes in groups A and B were 2.0 and 2.5, respectively. In addition, the QoL scores significantly changed in both groups (both P < 0.05). The most common adverse event was dry mouth (19.2% in both groups).
  
  
  CONCLUSIONS
  Solifenacin with or without local estrogen was effective and safe for overactive bladder treatment in postmenopausal women. The addition of local estrogen improved subjective feelings and QoL.
authors.affiliation: 1Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China 2Department of Epidemiology and Statistics Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and School of Basic Medicine, Peking Union Medical College, Beijing, China 3The Second Hospital, University of South China, Hengyang City, Hunan Province, China 4Department of Obstetrics and Gynecology, Tongji Hospital of Tongji University, Shanghai, China 5Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing, China 6Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Hubei, Wuhan, China 7Department of Obstetrics and Gynecology, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Jiang
authors.forename: Lan
authors.initials: L
authors.lastname: Zhu
authors.forename: Tao
authors.initials: T
authors.lastname: Xu
authors.forename: Mei-Ying
authors.initials: MY
authors.lastname: Gong
authors.forename: Yu-Liang
authors.initials: YL
authors.lastname: Huang
authors.forename: Huai-Fang
authors.initials: HF
authors.lastname: Li
authors.forename: Jian-Jun
authors.initials: JJ
authors.lastname: Wang
authors.forename: Xiao-Wen
authors.initials: XW
authors.lastname: Tong
authors.forename: Xiao-Xia
authors.initials: XX
authors.lastname: Cheng
authors.forename: Wen-Pei
authors.initials: WP
authors.lastname: Bai
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.forename: Xue-Xian
authors.initials: XX
authors.lastname: Xu
authors.forename: Hui-Cheng
authors.initials: HC
authors.lastname: Xu
mesh_terms: D000282:Administration, Intravaginal; D000368:Aged; D002681:China; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D017698:Postmenopause; D011788:Quality of Life; D000069464:Solifenacin Succinate / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D064804:Urological Agents
chemical_list: D004967:Estrogens; D018727:Muscarinic Antagonists; D064804:Urological Agents; D000069464:Solifenacin Succinate