Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Patient Global Impression of Improvement (PGI-1)
研究概览
简要总结
The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.
详细描述
A randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. Assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. Surgical characteristics and adverse events during follow-up are also registered.
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
- None
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
- •women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor
- •height of perineum 2 cm or less.
- •A least 6 months post partum
- •stopped "exclusive breastfeeding"
- •no indication for other gynecological surgical procedure
排除标准
- •history of 4th degree laceration
- •connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome)
- •current use of systemic corticosteroids
- •diabetes mellitus
- •suspect occult sphincter tear on ultrasound
- •history of previous urogynecological operation
研究组 & 干预措施
Perineorraphy.
Secondary surgical repair of the perineal body. Operation is performed by a urogynecologist in an operation theater in local anesthesia. The operation aims to re-create the anatomy in the injured perineum using 2-4 sutures.
干预措施: Perineorraphy (Procedure)
Pelvic floor exercise.
Tutored pelvic floor exercise. A trained physio therapist evaluate the pelvic floor musculature and helps the patient to perform proper pelvic floor exercises using biofeedback. The patient receives a training scheme and meets the therapist regularly every second week during 4 months.
干预措施: Pelvic floor exercise (Other)
结局指标
主要结局
Patient Global Impression of Improvement (PGI-1)
时间窗: 6 months after intervention (operation or start of pelvic floor training)
Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1
次要结局
- Pelvic Floor Impact Questionnaire (PIFQ-7)(6 months after intervention (operation or start of pelvic floor training))
- Ultrasound of perineum(6 months after intervention (operation or start of pelvic floor training))
- Hospital Anxiety and Depression Scale (HAD)(6 months after intervention (operation or start of pelvic floor training))
- Vaginal symptoms(6 months after intervention (operation or start of pelvic floor training))
- Surgical complications(From surgery up to 6 months postoperatively)
- POP-Q (Pelvic organ Quantification System)(6 months after intervention (operation or start of pelvic floor training))
- Pelvic floor distress inventory (PFDI 20)(6 months after intervention (operation or start of pelvic floor training))
- Prolapse Incontinence Sexual Questionnaire (PISQ)(6 months after intervention (operation or start of pelvic floor training))
研究者
Marion Ek
M.D. Ph.D.
Stockholm South General Hospital