Clinical trial NCT06115083: Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Prostatitis
Pelvic Floor; Relaxation
Keywords: Chronic pelvic pain syndrome
Chronic prostatitis with chronic pelvic pain syndrome
Chronic prostatitis
Pelvic floor muscles
Urodynamics
Physiotherapy
Bio-feedback
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-11-02
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled single blinded clinical study with a study period of 12 months from inclusion until completion. The study subjects are then randomly assigned in a 1:1 ratio either to treatment or control group. After 6 months the study subjects in the control group are offered to be included in the intervention group.
Primary purpose: TREATMENT

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 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.

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 floor muscles and undergo a urodynamic evaluation.

The intervention group will perform short daily session of pelvic floor muscle training at home during six months in combination with four bio-feedback sessions during the first months. The study subjects will receive an individual instruction based on the pelvic floor assessment from the baseline visit. The study subjects will report their training in a digital diary.

A reevaluation will be done at three, six and twelve months. At six and 12 months repeating the baseline tests. At three months a renewed assessment of muscle function and the NIH-CPSI questionnaire.

The control group will be instructed not to engage in any new treatment for their chronic pelvic pain during the study period. After the six months evaluation all participants in the control group will be offered to be enrolled in the treatment group, with the same set-up and follow-up as the treatment group.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
timeFrame: Measured 3, 6 and 12 months after inclusion
Secondary outcomes:
measure: Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire
timeFrame: Measured 3, 6 and 12 months after inclusion
measure: Changes in global voiding function using free flow non-invasive urodynamic testing
timeFrame: Measured 6 and 12 months after inclusion
measure: Changes in global storing function of the bladder using invasive urodynamics, cystometry
timeFrame: Measured 6 and 12 months after inclusion
measure: Changes in global voiding function using invasive urodynamics, pressure-flow study
timeFrame: Measured 6 and 12 months after inclusion
measure: Changes in urethral pressure using invasive urodynamics, urethral pressure profile
timeFrame: Measured 6 and 12 months after inclusion
measure: Changes in pelvic floor muscle assessment according to test specifics by Frawley et al 2021 and the modified Oxford Scale according to Laycock et al 2001.
timeFrame: Measured 3, 6 and 12 months after inclusion
measure: Correlation between subjective and objective measurements
timeFrame: Measured 3, 6 and 12 months after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Lotta Renström Koskela, M.D
role: PRINCIPAL_INVESTIGATOR
References: