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

NCT06115083 | Recruiting

• 1 other identifier: K 2023-4671
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

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

  Measured 3, 6 and 12 months after inclusion

Secondary Outcomes (7)

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

  Measured 3, 6 and 12 months after inclusion

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

  Measured 6 and 12 months after inclusion

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

  Measured 6 and 12 months after inclusion

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

  Measured 6 and 12 months after inclusion

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

  Measured 6 and 12 months after inclusion

Study Arms (2)

Pelvic floor muscle re-education

EXPERIMENTAL

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

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

Standard Care

NO INTERVENTION

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.

Interventions

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

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

Pelvic floor muscle re-education

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 86, Sweden

RECRUITING

Related Publications (1)

• Hallencreutz Grape H, Nordgren B, Renstrom Koskela L. Long-term effects of pelvic floor training in male chronic pelvic pain, correlation between subjective and objective outcomes: a study protocol for a randomised controlled trial. BMJ Open. 2024 Nov 4;14(11):e087620. doi: 10.1136/bmjopen-2024-087620.

  PMID: 39496364 DERIVED

MeSH Terms

Conditions

Prostatitis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lotta Renström Koskela, M.D

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotta Renström Koskela, M.D

CONTACT

+46-8-12370000; lotta.renstrom-koskela@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The interpreter of the urodynamic evaluations will be blinded regarding intervention/control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 2, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)