Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
研究概览
简要总结
To find out the effectiveness of physical therapy associated with the surgical treatment over the simptoms and quality of life in III and IV grades of pelvic organ prolapse, patients will be randomly assigned to one of these groups: experimental group: pre-surgical and post-surgical physical therapy + behavioral education + surgical therapy. Control group: surgical treatment + behavioral education.
In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months post-surgery.
详细描述
Intervention in the experimental group, patients assigned to this group will receive:
- Pre-surgical physical therapy: 9 sessions of physical therapy aimed at correcting posture, to the awareness and the strengthening of the pelvic floor muscles. They will be also informed and instructed on hygienic and behavioral education to prevent pelvic organ prolapse and urinary incontinence. Each session will be about 45 minutes and 3 sessions will be held a week for 3 weeks.
- Post-surgical Physical Therapy:
-
Hospital discharge patients will receive the same fact sheet on sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence.
-
6th weeks after surgery: 8 physical therapy sessions (2 per week for 4 weeks) about 30 minutes to review hypopressive exercises and contractions of the pelvic floor.
Intervention in the control group, patients assigned to this group will receive:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive women diagnosed with grade III and IV pelvic organ prolapse, which would be operated for this reason at the Asturias Prince Hospital (Madrid-Spain).
排除标准
- •Women diagnosed with different III / IV grade of POP or a history of conservative treatment not from the subproject "Physiotherapy in the POP grades I and II", or a history of POP surgery, or concurrent conditions that would be affect the treatment (neurological, gynecological or urological), or recurrent urinary infection or hematuria, or those III / IV grades in POP which is contraindicated or not possible to perform surgery.
- •Pregnant women or women with a vaginal birth in the last six months.
- •Women with cognitive limitations to understand the information, answer questionnaires, consent and / or participate in the study.
研究组 & 干预措施
surgical treatment+behavior therapy+physical therapy
Including POP surgical treatment, and pre- post physical therapy to aim the posture, PFM awareness and the strengthening. They will be also informed and instructed on hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
干预措施: physical therapy (Other)
surgical treatment+behavior therapy+physical therapy
Including POP surgical treatment, and pre- post physical therapy to aim the posture, PFM awareness and the strengthening. They will be also informed and instructed on hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
干预措施: surgical treatment (Other)
surgical treatment+behavior therapy+physical therapy
Including POP surgical treatment, and pre- post physical therapy to aim the posture, PFM awareness and the strengthening. They will be also informed and instructed on hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
干预措施: behavior therapy (Other)
surgical treatment+behavior therapy
Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
干预措施: surgical treatment (Other)
surgical treatment+behavior therapy
Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
干预措施: behavior therapy (Other)
结局指标
主要结局
Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
时间窗: up to 24th months post-surgery.
The SF-12 Health Survey (SF-12) Spanish version
时间窗: up to 24th months post-surgery.
International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
时间窗: up to 24th months post-surgery.
次要结局
- Urinary symptoms (urinary frequency, nocturia, urgency, incontinence, coital incontinence, nocturnal enuresis, frequency of urinary tract infections, dysuria and urinary difficulty).(up to 24th months post-surgery.)
研究者
BEATRIZ SANCHEZ SANCHEZ
PHD
University of Alcala