Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The prolapse stage will be measured with Simplified POP-Q
研究概览
简要总结
The aim of this study is to search the effects of electrical stimulation on clinical symptoms such as pelvic floor muscle strength, stage of POP, symptoms of pelvic floor, quality of life and sexual function in women with pelvic organ prolapse (POP)
详细描述
This study is planned as a prospective, sham radomized controlled study. Individuals who volunteered to participate in the study, complying with the inclusion criteria and signed the consent paper will be randomly allocated into ES and Sham ES groups.
The study includes women aged 18-65 diagnosed with staged 1-2 POP by the physician.All patients were evaluated by the same doctor who performed the POP-Q measurement, who was blinded to the baseline results. The treatment of patients will be given by the same therapist. Measurements will be made 3 times at baseline (before treatment), interim period (4th week) and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being in the age range of 18-65 ,
- •Having stage1-2 symptomatic prolapse according to the POP-Q system,
- •Being a volunteer and literate
排除标准
- •Being pregnant,
- •being stage 3-4 prolapse, Those whose evaluation parameters are missing and who do not regularly participate,
- •Inadequate understanding and cooperation in treatment and evaluation parameters,
- •Have malignant disease, urinary infection,
- •accompanying neurological disease, diabetes mellitus and cardiopathy with complications,
- •have electronic and metal implant, loss of sensation, sacral peripheral nerve lesion
- •Patients with at least one of the kidney failure requiring hemodialysis
结局指标
主要结局
The prolapse stage will be measured with Simplified POP-Q
时间窗: Change from baseline prolapse stage at 4 weeks and 8 weeks
The measurements are taken when the Valsalva maneuver is performed while the patient is in the dorsal lithotomy position. According to the reference point of the hymen, It is measured at a total of 4 points: cervix, posterior fornix, anterior and posterior vaginal wall. The stage of prolapse is graded. Stage 0: There is no prolapse. Stage 1: The most distal part of the prolapse is more than 1 cm above the prolapse. Stage 2: The most distal part of the prolapse, between 1 cm above and 1 cm below the prolapse Stage 3: The most distal part of the prolapse protrudes more than 1 cm below the prolapse. Stage 4: Complete eversion of the lower genital tract
次要结局
- Pelvic floor muscle strength will be measured measured with PFX Perineometer device(Cardio Design Pty Ltd, Australia)(Change from baseline Pelvic floor muscle strength at 4 weeks and 8 weeks)
- The pelvic organ prolapse symptoms will be assessed by Pelvic Organ Prolapse Symptom Score(POP-SS).(Change from baseline the pelvic organ prolapse symptoms at 4 weeks and 8 weeks)
- Patients' quality of life will be assessed using the Prolapse Quality of Life Scale (P-QOL).(Change from baseline quality of life at 4 weeks and 8 weeks)
- The pelvic organ prolapse symptoms severity will be assessed by the Pelvic Floor Distress Inventory (PFDI-20) .(Change from baseline the pelvic organ prolapse symptoms severity at 4 weeks and 8 weeks)
- Patients' sexual function will be assessed by the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12)(Change from baseline sexual function at 4 weeks and 8 weeks)