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Clinical Trials/NCT00688506
NCT00688506
Completed
N/A

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country60 target enrollmentNovember 2009
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ConditionsChronic Pelvic Pain Syndrome

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pelvic Pain Syndrome
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
60
Locations
1
Primary Endpoint
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
July 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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