Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of KESS scale points
研究概览
简要总结
This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse
详细描述
Pelvic organ prolapse is a condition with impaired anatomic structure, which may result in defecatory disorders and usually considered as an indication for surgery. However, operation is not always possible. Existing data suggest that functional component may also be possible, despite on the anatomic impairment. The aim of the study is to evaluate the effect of complex conservative treatment of functional defecatory disorders in patients with mild to moderate grade of pelvic organ prolapse
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
- Double (Investigator, Outcomes Assessor)
盲法说明
After randomization eligible subjects are to receive one of the treatment option described in the Model Description according to the order placed in a closed envelope which is to be opened by person who perform biofeedback (BFT) and tibial neuromodulation (TNM). The investigator responsible for the study conduction, clinical assessment and high-resolution anorectal manometry measurements is not supposed to get the information about the number of procedures (BFT+TNM; or BFT+TNM + pelvic floor muscles training (PFMT); or BFT+TNM + PFMT + diet modification (DM)) that a certain subject receives
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate (signed informed consent form)
- •Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry
排除标准
- •rectocele III grade;
- •internal genitals prolapse;
- •history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);
- •gynecological surgery that may influence sensory or reservoir function of rectum;
- •history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;
- •start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and/or contractility
- •inability to understand and/or follow the instructions to perform all the procedures required per protocol
- •general condition of the patient that make her ineligible by the discretion of the investigator
研究组 & 干预措施
biofeedback and tibial neuromodulation (BFB+TNM)
干预措施: Biofeedback therapy (Procedure)
biofeedback and tibial neuromodulation (BFB+TNM)
干预措施: Tibial neuromodulation (Procedure)
BFB+TNM + pelvic floor muscles training (PFMT)
干预措施: Pelvic floor muscles training (Behavioral)
BFB+TNM + pelvic floor muscles training (PFMT)
干预措施: Biofeedback therapy (Procedure)
BFB+TNM + pelvic floor muscles training (PFMT)
干预措施: Tibial neuromodulation (Procedure)
BFB+TNM+PFMT+diet modification
干预措施: Biofeedback therapy (Procedure)
BFB+TNM+PFMT+diet modification
干预措施: Tibial neuromodulation (Procedure)
BFB+TNM+PFMT+diet modification
干预措施: Pelvic floor muscles training (Behavioral)
BFB+TNM+PFMT+diet modification
干预措施: Diet modification (Behavioral)
结局指标
主要结局
Change of KESS scale points
时间窗: at the end-point, 6 months after enrolment
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline values.
Change in Scale of bowel evacuatory function assessment
时间窗: at the end-point, 6 months after enrolment
A specialized validated questionnaire will be used before treatment and at the end of the study. "Change" is to be assessed as percentage decline from baseline v
Mean stool frequency
时间窗: A week
clinical outcome
Mean stool form value
时间窗: A week
clinical outcome, assessed with the use of the Bristol stool scale (BSS)
Mean defecation with difficult bowel emptying
时间窗: a week
patient-reported outcome, clinical
Average anal resting pressure
时间窗: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Maximum absolute anal squeeze pressure
时间窗: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average absolute anal squeeze pressure
时间窗: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Average incremental anal squeeze pressure
时间窗: at the end-point, 6 months after enrolmentat the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Residual push pressure
时间窗: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
Push relaxation percentage
时间窗: at the end-point, 6 months after enrolment
Values obtained during HR anorectal manometry
次要结局
未报告次要终点
研究者
Sergey Morozov
MD, PhD
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology