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NCT Number: NCT06115083

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

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.

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Key information

Conditions

Chronic Pelvic Pain Syndrome Chronic Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pelvic Floor; Relaxation Prostatic Diseases Prostatitis Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location status: Recruiting

Location contact

Lotta R Koskela, MD

CONTACT

[email protected]

+46724694888

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Change in symptom score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire

    Time frame: Measured 3, 6 and 12 months after inclusion

    Change in total score, range from 0-43 points. Higher score indicates worse symptoms.

Secondary outcomes

  1. Change in sub score on the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire

    Time frame: Measured 3, 6 and 12 months after inclusion

    Sub score according to the domains; pain 0-21, urological symptoms 0-10 points and quality of life impact 0-12 points. Higher score indicates worse symptoms in all three domains.

  2. Changes in global voiding function using free flow non-invasive urodynamic testing

    Time frame: Measured 6 and 12 months after inclusion

    Changes in global voiding function using free flow non-invasive urodynamic testing with electromyogram.

    Global assessment where combined results from maximum urinary flow rate, voided volume, post voiding residual volume, pelvic floor activity during voiding and the shape of the curve are used to define types of voiding patterns.

    • Normal flow
    • Asymmetrical obstructive flow
    • Symmetrical low flow
    • Irregular curve, straining flow
    • Plateau low flow

    As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.

  3. Changes in global storing function of the bladder using invasive urodynamics, cystometry

    Time frame: Measured 6 and 12 months after inclusion

    Changes in global bladder function using invasive urodynamics with cystometry with electromyogram.

    Global assessment where combined results from sensory input, cystometric capacity, detrusor activity, compliance and pelvic floor activity are combined to define different patterns.

    • Normal cystometry
    • Abnormal sensory input
    • Detrusor activity
    • Abnormal compliance
    • Abnormal bladder capacity

    As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.

  4. Changes in global voiding function using invasive urodynamics, pressure-flow study

    Time frame: Measured 6 and 12 months after inclusion

    Changes in global voiding function using invasive urodynamics, pressure-flow study with electromyogram.

    Global assessment where combined results from detrusor contractility, urinary flow and pelvic floor activity are combined to define different patterns.

    • Normal flow
    • Under-active flow
    • Obstructed flow

    As described in the International Continence Society good urodynamic practices recommendations 2018 and Urodynamics (third edition) by P. Abrams.

  5. Changes in urethral pressure using invasive urodynamics, urethral pressure profile

    Time frame: Measured 6 and 12 months after inclusion

    Changes in urethral pressure using invasive urodynamics, urethral pressure profile.

    • Maximum urethral pressure (cmH2O)
    • Maximum urethral closure pressure (cmH2O)

    As described in Urodynamics (third edition) by P. Abrams.

  6. 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.

    Time frame: Measured 3, 6 and 12 months after inclusion

    Pelvic floor muscle assessment according to test specifics by Frawley et al 2021

    • Assessment of muscle tone
    • Decreased / normal / increased
    • Assessment of voluntary contraction
    • No contraction / correct contraction / contraction only with help from other muscles / uncertain / straining
    • Assessment of relaxation post contraction
    • Yes / partial or delayed / no
    • Assessment of tenderness
    • Yes / No
    • If yes location is noted and severity of pain is graded according to numeric rating scale, 0-10, with higher value indicatinge more severe pain.

    Modified Oxford Scale for assessment of pelvic floor muscle power, graded from 0-5 with higer value indicating stronger power.

  7. Correlation between subjective and objective measurements

    Time frame: Measured 3, 6 and 12 months after inclusion

    Correlation between subjective measurements using the National Institute of Health-Chronic Prostatitis Symptom Index questionnaire and objective findings on urodynamic testing and pelvic floor assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Lotta Renström Koskela, M.D

CONTACT

[email protected]

+46-8-12370000

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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