Long-Term Effects of Pelvic Floor Training Using Bio-feedback and Home Exercises
in Men with Chronic Pelvic Pain
Measuring Symptom Improvement and Pelvic Floor Function
Led by Region Stockholm · Updated on 2024-04-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to understand the long-term effects of pelvic floor re-education using biofeedback and home training in men with chronic pelvic pain. The study focuses on whether this approach can provide lasting symptom improvement measured by a validated symptom score, the National Institute of Health - Chronic Prostatitis Symptom Index NIH-CPSI, and if these symptom changes relate to objective pelvic floor function measurements. The trial compares men undergoing pelvic floor training to a control group maintaining their usual treatment.
Participants in the intervention group will perform short daily pelvic floor exercises at home for six months, supplemented by four biofeedback sessions during the initial months. They receive personalized instructions based on an initial pelvic floor assessment and report their exercises in a digital diary. The control group will continue their current treatment unchanged for six months, after which they are offered the same pelvic floor training program.
Participants will complete symptom questionnaires and undergo pelvic floor muscle assessments and urodynamic evaluations at baseline, three, six, and twelve months. The study measures changes in symptoms, bladder function, and pelvic floor muscle performance over time. The total participation period includes a six-month intervention phase followed by an additional six-month follow-up, allowing researchers to evaluate both early and sustained effects of the training.
CONDITIONS
Brief Title
Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Research Team
L
Lotta Renström Koskela, M.D
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Diagnosed with Chronic Primary Pelvic Pain Syndrome (CPPPS) based on 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 such as bladder exstrophy or myelomeningocele
Transsexual males (biologically female at birth)
Diseases affecting nerve function to the pelvis or lower limbs, or treatments impacting study outcomes
Inability to participate in testing or follow training instructions due to mental incapacity or language difficulties
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants in the intervention group perform daily pelvic floor muscle training at home for six months combined with four bio-feedback sessions during the first months. Participants receive individual instruction based on baseline assessments and report their training in a digital diary.
4 bio-feedback sessions and daily home training
Follow-up
Duration - 6 months after treatment
Participants are re-evaluated at 3, 6, and 12 months with assessments including symptom scoring and pelvic floor muscle evaluation. Control group participants are offered the treatment after 6 months.
Visits at 3, 6, and 12 months for assessments
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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Published Research Related To This Trial
Long-term effects of pelvic floor training in male chronic pelvic pain, correlation between subjective and objective outcomes: a study protocol for a randomised controlled trial.
Helena Hallencreutz Grape, Birgitta Nordgren, Lotta Renström Koskela