跳至主要内容
临床试验/NCT05391425
NCT05391425Unknown不适用

The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function in Premenopausal vs Postmenopausal Women: A Prospective Observational Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年6月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women

研究概览

简要总结

This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.

详细描述

Solifenacin is an anticholinergic drug that is commonly used for lower urinary tract symptoms such as urgency, frequency and urge urinary incontinence. Solifenacin use and sexual function improvement is presented in some research, but the correlation between the improvement in sexual function and LUTS symptoms is yet not investigated. Also the effect on sexual function in premenopausal vs postmenopausal women are unknown.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women presented in Arnavutkoy State Hospital Gynecology Clinic with lower urinary tract symptoms that are planned to start treatment with Solifenacin 5 mg (Vesicare 5mg).
  • Patients agreed to involve in the study, having discussed other treatment options and possible side effects of the medication.
  • Informed consent obtained

排除标准

  • urinary tract infection
  • stress urinary incontinence
  • urinary retention
  • grade 2 or above pelvic organ prolapse according to POP-Q scale
  • Solifenacin contraindications such as narrow angle glaucoma, allergy of Solifenacin or other components of the drug.

结局指标

主要结局

the effect of solifenasin used for lower urinary tract symptoms on sexual function in premenapausal vs postmenapausal women

时间窗: 6 months

The aim of this study is to determine whether Solifenacine used for lower urinary tract symptoms improve sexual function (measured by Female Sexual Function Index; higher scores meaning sexual dysfunction with the cut off value of 26.) and if so does this improvement differs between premenaupausal and postmenaupausal women.

the effect of solifenasin used for lower urinary tract symptoms on sexual function

时间窗: 6 months

Female Sexual Function Index (FSFI) scores change between in baseline, 3 and 6 months after Solifenacin use for lower urinary tract symptoms.

次要结局

  • the effect of Solifenacin treatment for lower urinary tract symptoms (LUTS) on sexual function and its correleation with the improvement in LUTS(3 and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

inci sema tas

MD

Istanbul University

研究点 (1)

Loading locations...

相似试验