Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes

Region Stockholm

Status: Enrolling

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Pelvic Floor; Relaxation; Chronic Pelvic Pain Syndrome

Treatments: Other: Pelvic floor re-education using bio-feedback and home training

Study type: Interventional

Funder types: Other

Identifiers

NCT06115083

K 2023-4671

Details and patient eligibility

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Pelvic floor muscle re-education

Experimental group

Description:

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

Treatment:

Other: Pelvic floor re-education using bio-feedback and home training

Standard Care

No Intervention group

Description:

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.