Status:
RECRUITING
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Lead Sponsor:
Region Stockholm
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Chronic Pelvic Pain Syndrome
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06115083
Start Date
December 1 2023
End Date
December 1 2026
Last Update
April 16 2024
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 141 86