Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Change of Life impact of Pelvic Floor Dysfunction (PFD) will be assessed by the PFIQ-7 Spanish version.
研究概览
简要总结
OBJECTIVE: To evaluate the effectiveness of an individualized pelvic floor physiotherapy programme combined with lifestyle education compared with lifestyle education alone in women with stage I or II pelvic organ prolapse (POP).
DESIGN: Randomized controlled clinical trial with blinded outcome assessment. A total of 120 women were randomly allocated to an experimental group receiving an individualized pelvic floor physiotherapy programme plus lifestyle education or to a control group receiving lifestyle education alone. Assessments were performed at baseline, immediately after the intervention, and at 3, 6, and 12 months.
PRIMARY OUTCOMES: Pelvic floor symptoms and their impact on daily life, assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7).
SECONDARY OUTCOMES: Anatomical pelvic organ prolapse stage and pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale and by perineal manometry.
DATA ANALYSIS: Treatment effectiveness will be evaluated by comparing changes over time between groups throughout the 12-month follow-up.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.
排除标准
- •Stage III or IV POP according to the POP-Q system.
- •Previous conservative treatment or surgery for POP. Neurological, gynecological, or urological conditions that could interfere with the intervention or outcome assessment.
- •Urinary tract infection or recurrent hematuria.
- •Current pregnancy or vaginal delivery within the previous 6 months.
- •Cognitive or language limitations that could prevent participants from understanding the study procedures, providing informed consent, completing the study questionnaires, or adequately participating in the intervention.
研究组 & 干预措施
Control group
Participants allocated to this group will receive an educational intervention consisting of six weekly sessions (40-45 minutes per session). The programme will include education on pelvic floor anatomy and pelvic organ function using printed materials and anatomical models, together with advice on modifiable lifestyle factors associated with pelvic floor symptoms, including weight management, heavy lifting, high-impact activities, constipation, smoking, and caffeine intake. Participants will also receive advice on appropriate toileting habits and will be taught the Knack manoeuvre to be performed before and during activities that increase intra-abdominal pressure.
干预措施: Educational strategy (Behavioral)
Physiotherapy group
Participants allocated to this group will receive an individualized pelvic floor physiotherapy programme consisting of 16 sessions (45-50 minutes per session), delivered twice weekly for 8 weeks, in addition to the educational intervention described for the control group. The physiotherapy programme will include pelvic floor muscle training (PFMT), individualized according to pelvic floor muscle function assessed by vaginal palpation, biofeedback-assisted exercises, and hypopressive exercises. From the eighth session onwards, participants will also be instructed to perform the prescribed exercises daily at home.
干预措施: Physical therapy + educational strategy (Other)
结局指标
主要结局
Change of Life impact of Pelvic Floor Dysfunction (PFD) will be assessed by the PFIQ-7 Spanish version.
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
Change of pelvis floor muscles (PFM) condition by vaginal palpation using Oxford Test
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
Oxford test range from 0 to 5, according to the muscles strength
Change of Pelvic Floor Muscle (PFM) strength will be measured by dynamometry
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
Three maximum PFM contractions will be requested and will be used the mean value. For the dynamometry (gr) a two-arms speculum ("Pelvimeter Phenix", Montpellier, France) in mid-sagittal plane, and in close position will be utilized.
Change of pelvis floor muscles (PFM) condition by vaginal palpation Levator Any Test (LAT)
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
LAT range from 0 to 5, according to the muscles strength and endurance
Change of Pelvic Floor Muscle (PFM) strength will be measured by manometry
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
Three maximum PFM contractions will be requested and will be used the mean value. For the manometry (cm2O2), an air-filled probe will be used ("Peritron", Melbourne, Australia)
Change of Symptoms and Quality of life (QoL) will be assessed by P-QOL & PFDI-20 Spanish versions
时间窗: 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention.
P-QOL assess the symptom severity and its impact on the quality of life in women with POP; and the PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress (QoL) caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse QoL. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20)
时间窗: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
The PFDI-20 is a 20-item patient-reported outcome measure assessing symptom distress related to pelvic floor disorders. It comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6). Each subscale is scored from 0 to 100, with higher scores indicating greater symptom distress. The total PFDI-20 score ranges from 0 to 300, with higher scores indicating greater overall pelvic floor symptom distress.
Change in the impact of pelvic floor symptoms on daily activities assessed with the Spanish version of the Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
时间窗: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
The PFIQ-7 is a 21-item patient-reported outcome measure comprising three 7-item subscales: the Urinary Impact Questionnaire-7 (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire-7 (POPIQ-7), and Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7). Each subscale is scored from 0 to 100, with higher scores indicating greater impact of pelvic floor symptoms on daily activities. The total PFIQ-7 score ranges from 0 to 300, with higher scores indicating greater overall impact.
次要结局
- Change in pelvic floor muscle strength assessed by perineal manometry(5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.)
- Change in pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale(5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.)
- Change in pelvic organ prolapse stage assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system(Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.)
研究者
Maria Torres Lacomba
Professor
University of Alcala