Long Term Effects of Pelvic Floor Re-education in Men With Chronic Pelvic Pain, Using Bio-feedback and Home Training - Subjective Outcomes in Correlation to Objective Measurements of the Lower Urinary Tract and Pelvic Floor

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Lotta Renström Koskela, M.D
lotta.renstrom-koskela@regionstockholm.se
+46-8-12370000
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: Pelvic floor muscle re-education
Intervention with pelvic floor re-education using bio-feedback and home training for 6 months, with a follow up visit after an additional period of 6 months
No_intervention: Standard Care
No intervention during 6 months after inclusion. After the 6 month follow-up evaluation the study subjects are offered to participate in the interventional arm.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska Institutet
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov