Pelvic floor training for men with chronic pelvic pain
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
This study is testing if pelvic floor exercises and biofeedback can help men with chronic pelvic pain feel better over six months compared to those who continue their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06115083 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study aims to evaluate the long-term effects of pelvic floor re-education through biofeedback and home training in men suffering from chronic pelvic pain. Participants will engage in daily pelvic floor exercises for six months, complemented by biofeedback sessions, while their symptoms will be assessed using the National Institute of Health - Chronic Prostatitis Symptom Index. The study will also correlate subjective symptom improvements with objective measurements of pelvic floor function. A control group will maintain their current treatment without any new interventions during the study period.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old residing in Sweden, diagnosed with Chronic Primary Pelvic Pain Syndrome.
Not a fit: Patients with cancer in the abdomen or pelvic organs, congenital anomalies affecting the pelvic region, or those unable to participate due to mental incapacity or language difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for men suffering from chronic pelvic pain by providing effective non-invasive treatment options.
How similar studies have performed: Other studies have shown promising results with pelvic floor training for chronic pelvic pain, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Lotta Renström Koskela, M.D — Karolinska University Hospital
- Study coordinator: Lotta Renström Koskela, M.D
- Email: lotta.renstrom-koskela@regionstockholm.se
- Phone: +46-8-12370000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.