An interventional study of Pelvic floor re-education using bio-feedback and home training in Chronic Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome and Chronic Prostatitis, sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Region Stockholm · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Intervention with pelvic floor re-education using bio-feedback and home training for 6 months, with a follow up visit after an additional period of 6 months
Other: Pelvic floor re-education using bio-feedback and home training
No intervention during 6 months after inclusion. After the 6 month follow-up evaluation the study subjects are offered to participate in the interventional arm.
Pelvic 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.
Time frame: Measured 3, 6 and 12 months after inclusion
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.
Time frame: Measured 3, 6 and 12 months after inclusion
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.
Time frame: Measured 6 and 12 months after inclusion
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.
Time frame: Measured 6 and 12 months after inclusion
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.
Time frame: Measured 6 and 12 months after inclusion
Changes in urethral pressure using invasive urodynamics, urethral pressure profile
Changes in urethral pressure using invasive urodynamics, urethral pressure profile. * Maximum urethral pressure (cmH2O) * Maximum urethral closure pressure (cmH2O) As described in Urodynamics (third edition) by P. Abrams.
Time frame: Measured 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.
Pelvic floor muscle assessment according to test specifics by Frawley et al 2021 1. Assessment of muscle tone - Decreased / normal / increased 2. Assessment of voluntary contraction - No contraction / correct contraction / contraction only with help from other muscles / uncertain / straining 3. Assessment of relaxation post contraction - Yes / partial or delayed / no 4. Assessment of tenderness * Yes / No * If yes location is noted and severity of pain is graded according to numeric rating scale, 0-10, with higher value indicatinge more severe pain. Modified Oxford Scale for assessment of pelvic floor muscle power, graded from 0-5 with higer value indicating stronger power.
Time frame: Measured 3, 6 and 12 months after inclusion
Correlation between subjective and objective measurements
Correlation between subjective measurements using the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire and objective findings on urodynamic testing and pelvic floor assessment.
Time frame: Measured 3, 6 and 12 months after inclusion
Plan to share: No
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Region Stockholm