Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06115083

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Stockholm, Sweden, 141 86

Actively Recruiting

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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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