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.
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)
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.
Parallel
Pelvic floor re-education using bio-feedback and home training
Other interventionPelvic floor re-education using bio-feedback and home training
Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
Change in total score, range from 0-43 points. Higher score indicates worse symptoms.
Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
Sub score according to the domains; pain 0-21, urological symptoms 0-10 points and quality of life impact 0-12 points. Higher score indicates worse symptoms in all three domains.
Changes in global voiding function using free flow non-invasive urodynamic testing
Changes in global voiding function using free flow non-invasive urodynamic testing with electromyogram. Global assessment where combined results from maximum urinary flow rate, voided volume, post voiding residual volume, pelvic floor activity during voiding and the shape of the curve are used to define types of voiding patterns. * Normal flow * Asymmetrical obstructive flow * Symmetrical low flow * Irregular curve, straining flow * Plateau low flow As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
Changes in global storing function of the bladder using invasive urodynamics, cystometry
Changes in global bladder function using invasive urodynamics with cystometry with electromyogram. Global assessment where combined results from sensory input, cystometric capacity, detrusor activity, compliance and pelvic floor activity are combined to define different patterns. * Normal cystometry * Abnormal sensory input * Detrusor activity * Abnormal compliance * Abnormal bladder capacity As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
Changes in global voiding function using invasive urodynamics, pressure-flow study
Changes in global voiding function using invasive urodynamics, pressure-flow study with electromyogram. Global assessment where combined results from detrusor contractility, urinary flow and pelvic floor activity are combined to define different patterns. * Normal flow * Under-active flow * Obstructed flow As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.
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Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator
