Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Recruiting now · Not applicable
Conditions studied: Chronic Pelvic Pain Syndrome, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Pelvic Floor; Relaxation
In brief
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.
Key facts
- Study ID
- NCT06115083
- Run by
- Region Stockholm
- People needed
- 40
- Starts
- 2023-12-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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