Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden
Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
BMJ Open. 2024 Nov 4;14(11):e087620. doi: 10.1136/bmjopen-2024-087620.
Chronic primary pelvic pain syndrome (CPPPS) is a condition characterised by pain in the pelvic area together with lower urinary tract symptoms. Pathophysiology remains largely unclear. Common treatment modalities show unsatisfactory results. This randomised controlled trial aims to establish the long-term effect of pelvic floor re-education using biofeedback and home training for men with CPPPS evaluated with the National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) and to explore if outcomes can be correlated to changes in objective urodynamic measures.
After inclusion all study participants will go through baseline testing consisting of urodynamic evaluation, assessment of the pelvic floor muscles and the NIH-CPSI questionnaire, thereafter, randomised to intervention or control group. Intervention consists of short daily session of pelvic floor muscle training, during 6 months. Parallelly with starting up, the intervention group will attend four bio-feedback sessions, to guide and facilitate the training. The training will initially aim on how to correctly activate and relax the pelvic floor muscles with functional enhancement further on. The control group will be offered to enter the intervention group after the 6-month assessment. The outcome will be assessed by repeating the baseline tests at 3, 6 and 12 months.To compare the primary outcome, the NIH-CPSI questionnaire between and within the two groups will be analysed. Secondary outcomes are the differences in sub-score reduction according to the domains in the NIH-CPSI questionnaire, the manual assessment of the pelvic floor muscles and numerical results from the urodynamic testing. The correlation between subjective and objective outcomes will be analysed.
The study obtained ethical approval from the Swedish Ethical Review Authority (2023-00286-01). The study result will be published in a peer-reviewed medical journal and presented at an international conference.
This trial is registered at Clinicaltrials.gov (NCT06115083).
慢性原发性盆腔疼痛综合征（CPPPS）是一种以盆腔区域疼痛伴下尿路症状为特征的疾病。其病理生理学仍很大程度上不清楚。常见的治疗方法效果并不理想。本随机对照试验旨在通过生物反馈和家庭训练来建立对 CPPPS 患者进行盆底再教育的长期效果，并用国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）进行评估，并探讨结果是否可以与客观尿动力学测量的变化相关。
所有研究参与者纳入后，将进行基线测试，包括尿动力学评估、盆底肌肉评估和 NIH-CPSI 问卷，然后随机分为干预组或对照组。干预组包括为期 6 个月的每天短暂盆底肌肉训练。同时，干预组将参加 4 次生物反馈课程，以指导和促进训练。训练最初旨在如何正确激活和放松盆底肌肉，并进一步进行功能增强。对照组将在 6 个月评估后被邀请进入干预组。通过在 3、6 和 12 个月时重复基线测试来评估结果。为了比较主要结局，将对两组之间和组内 NIH-CPSI 问卷进行分析。次要结局是根据 NIH-CPSI 问卷的各领域，减少亚评分的差异，手动评估盆底肌肉和尿动力学测试的数值结果。将分析主观和客观结果之间的相关性。
该研究已获得瑞典伦理审查局的伦理批准（2023-00286-01）。研究结果将发表在同行评议的医学期刊上，并在国际会议上展示。
本试验在 Clinicaltrials.gov 注册（NCT06115083）。
