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Completed

NCT Number: NCT00688506

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

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.

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Key information

Conditions

Chronic Pelvic Pain Syndrome

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

combined sono-electro-magnetic therapy (Sonodyn Medico Star)

Device

twice a day for 10 minutes during 12 weeks

Other names: Sonodyn Medico Star

placebo therapy (Placebo Sonodyn Medico Star)

Device

twice a day for 10 minutes during 12 weeks

Other names: Placebo Sonodyn Medico Star device

Primary outcomes

  1. 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

Secondary outcomes

  1. Brain activity assessed by functional MRI

    Time frame: before treatment, after 12 weeks of treatment

  2. Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database

    Time frame: before treatment

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2008
Registry last updated
Jul 3, 2012

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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