Obstetric Perineal Trauma, Pelvic Floor Symptoms and Early Physiotherapy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
研究概览
简要总结
The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength. This will be achieved by an acknowledged/validated questionnaire sent electronically 6 weeks after first delivery. Women with symptomes of urinary incontinence according to the questionnaire will be offered participation in a single-blinded randomized intervention study to compare outcome after targeted physiotherapy with conventional advice and support. Intervention encompasses weekly pelvic floor training for 12 weeks. Pelvic strength will be measured and symptom information collected before and after intervention and 12 months postpartum in both groups.
Pelvic floor problems after delivery are common and often persistent, including urinary/fecal incontinence, pelvic organ prolapse and sexual problems. Such symptoms reduce QoL and handicap women in multiple ways, physically, psychologically and socially. More knowledge of whether interventions and guidelines in this field can improve health and QoL is required.
详细描述
Single-blind randomized controlled trial (RCT) to assess and compare the effects of early pelvic floor muscle training and present standard care/advice on pelvic floor muscle (PFM) strength, symptoms from the pelvic floor and bothersome symptoms (QoL) after obstetric perineal repair.
Procedure/Study design: Single-blind randomized controlled trial.
Details of test administration and data collection methods:
PFM strength will be measured with Myomed 932® (Enraf-Nonius, Delft, Netherlands) for squeeze pressure, vaginally and rectally.
Pelvic floor symptoms, (bladder/bowel function, prolapse symptoms, sexual function) and bothersomeness will be measured with the validated Icelandic version of the Australian Female Pelvic Floor Questionnaire.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy primiparas after delivery at LSH
- •≥18 years
- •Diagnosed with urinary incontinence according to the self administered Australian Pelvic floor Questionnaire (Icelandic version) 6 weeks post partum.
- •Able to attend intervention in the capital area
- •Answer the Australian Pelvic Floor Questionnaire
排除标准
- •Diseases or conditions that can interfere with pelvic floor function (other than childbirth), such as prior pelvic floor surgery or ability to benefit from the intervention
- •Women unable to understand Icelandic
- •Woman with cognitive disabilities.
研究组 & 干预措施
Physiotherapy intervention
Intensive pelvic floor muscle training (PFMT) given by a physiotherapist with vaginal/rectal pressure feedback once a week for 12 weeks.
干预措施: Physiotherapy intervention (Other)
No intervention
Standard care
结局指标
主要结局
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
时间窗: 16 weeks
Urinary incontinence rates measured by scores on the Australian Female PelvicFloor questionnaire
次要结局
- Quality of life measured by scores on the Australian Female PelvicFloor questionnaire(16 weeks)
- Sexual dysfunction measured by scores on the Australian Female PelvicFloor questionnaire(16 weeks)
- Fecal/flatal incontinence measured by scores on the Australian Female PelvicFloor questionnaire(16 weeks)