Actively Recruiting
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Led by Region Stockholm · Updated on 2024-04-16
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Region Stockholm
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, over 18 years old
- Resident of Sweden
- Diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) according to ICD-10 codes N41.1, N41.9, or N50.8F
You will not qualify if you...
- Current or previous cancer in the abdomen or pelvic organs
- Congenital anomalies affecting the pelvic region (e.g., bladder exstrophy, myelomeningocele)
- Transsexual males (biologically female at birth)
- Diseases affecting nerve function to the pelvic area or lower extremities, or any other disease or ongoing treatment that might impact study outcomes
- Unable to participate in testing or follow training instructions due to mental incapacity or language difficulties
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Sweden, 141 86
Actively Recruiting
Research Team
L
Lotta Renström Koskela, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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