Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain, Using Bio-feedback and Home Training - Subjective Outcomes in Correlation to Objective Measurements of the Lower Urinary Tract and Pelvic Floor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
研究概览
简要总结
The goal of this randomized controlled study is to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with chronic pelvic pain. The main questions it aims to answer are if pelvic floor re-education using bio-feedback and home training will give a long-lasting improvement in symptoms, assessed with a validated symptom score (the National Institute of Health - Chronic Prostatitis Symptom Index) and if an improvement in symptoms can be correlated to objective measurements of pelvic floor function. Participants will be asked to do pelvic floor exercises daily during six months with additional sessions of bio-feedback training. The control group will have no changes in their on-going treatment for their chronic pelvic pain and will be offered to enter the treatment group after six months.
详细描述
At baseline all included study subjects will fill in a validated symptom score, the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) and have an assessment of their pelvic floor muscles and undergo a urodynamic evaluation.
The intervention group will perform short daily session of pelvic floor muscle training at home during six months in combination with four bio-feedback sessions during the first months. The study subjects will receive an individual instruction based on the pelvic floor assessment from the baseline visit. The study subjects will report their training in a digital diary.
A reevaluation will be done at three, six and twelve months. At six and 12 months repeating the baseline tests. At three months a renewed assessment of muscle function and the NIH-CPSI questionnaire.
The control group will be instructed not to engage in any new treatment for their chronic pelvic pain during the study period. After the six months evaluation all participants in the control group will be offered to be enrolled in the treatment group, with the same set-up and follow-up as the treatment group.
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 (Investigator)
盲法说明
The interpreter of the urodynamic evaluations will be blinded regarding intervention/control group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over the age of 18, residents in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) (N41.1 (chronic prostatitis), N41.9 (Inflammatory disease of prostate, unspecified), N50.8F (Chronic Pelvic Pain Syndrome in men)
排除标准
- •Cancer in the abdomen or pelvic organs (current or previous)
- •Congenital anomalies affecting the pelvic region (Bladder exstrophy, Myelomeningocele etc.)
- •Transsexual male, (i.e. at birth biologically female)
- •Diseases affecting the nerve function to the pelvic and/or lower extremities, other disease or ongoing treatment that could have an impact on the outcome of the study.
- •Incapability to participate in testing or follow training instructions due to mental incapacity, language difficulties etc.
结局指标
主要结局
Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
时间窗: Measured 3, 6 and 12 months after inclusion
Change in total score, range from 0-43 points. Higher score indicates worse symptoms.
次要结局
- Changes in global storing function of the bladder using invasive urodynamics, cystometry(Measured 6 and 12 months after inclusion)
- Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire(Measured 3, 6 and 12 months after inclusion)
- Changes in global voiding function using free flow non-invasive urodynamic testing(Measured 6 and 12 months after inclusion)
- Changes in global voiding function using invasive urodynamics, pressure-flow study(Measured 6 and 12 months after inclusion)
- Changes in urethral pressure using invasive urodynamics, urethral pressure profile(Measured 6 and 12 months after inclusion)
- Correlation between subjective and objective measurements(Measured 3, 6 and 12 months after inclusion)
- Changes in pelvic floor muscle assessment according to test specifics by Frawley et al 2021 and the modified Oxford Scale according to Laycock et al 2001.(Measured 3, 6 and 12 months after inclusion)
研究者
Lotta Renström Koskela
Principal Investigator
Region Stockholm