Chronic Pelvic Pain Syndrome
Conditions
Keywords
Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging
Brief summary
Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail. We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.
Interventions
DEVICEcombined sono-electro-magnetic therapy (Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
DEVICEplacebo therapy (Placebo Sonodyn Medico Star)
twice a day for 10 minutes during 12 weeks
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CPSS III * symptomatic \>3 months * NIH-CPSI total score =/\>15 * NIH-CPSI pain =/\>8
Exclusion criteria
* post void residual \>100mL * urinary tract infection * urethral stricture * prostate cancer * age \<18 years * claustrophobia * pacemaker, neurostimulator, insulin / pain pump
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) | before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Brain activity assessed by functional MRI | before treatment, after 12 weeks of treatment |
| Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database | before treatment |
Countries
Switzerland
Outcome results
None listed