Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00688506
First received: May 29, 2008
Last updated: July 2, 2012
Last verified: July 2012

May 29, 2008
July 2, 2012
November 2009
July 2012   (final data collection date for primary outcome measure)
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) [ Time Frame: before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688506 on ClinicalTrials.gov Archive Site
  • Brain activity assessed by functional MRI [ Time Frame: before treatment, after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database [ Time Frame: before treatment ] [ Designated as safety issue: No ]
Brain activity assessed by functional MRI [ Time Frame: before treatment, after 12 weeks of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Pelvic Pain Syndrome
  • Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)
    twice a day for 10 minutes during 12 weeks
    Other Name: Sonodyn Medico Star
  • Device: placebo therapy (Placebo Sonodyn Medico Star)
    twice a day for 10 minutes during 12 weeks
    Other Name: Placebo Sonodyn Medico Star device
  • Experimental: 1
    Combined sono-electro-magnetic therapy
    Intervention: Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)
  • Placebo Comparator: 2
    placebo therapy
    Intervention: Device: placebo therapy (Placebo Sonodyn Medico Star)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00688506
KEK 292/07, 1492
No
Thomas M. Kessler, MD, Department of Urology, University of Bern, 3010 Bern
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Thomas M Kessler, MD Department of Urology, University of Bern, 3010 Switzerland
University Hospital Inselspital, Berne
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP