NCT00688506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 3, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

May 29, 2008

Last Update Submit

July 2, 2012

Conditions

Chronic Pelvic Pain Syndrome

Keywords

Chronic pelvic pain syndromeNeuromodulationBrain effectsNeuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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 Arms (2)

1

EXPERIMENTAL

Combined sono-electro-magnetic therapy

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

2

PLACEBO COMPARATOR

placebo therapy

Device: placebo therapy (Placebo Sonodyn Medico Star)

Interventions

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

twice a day for 10 minutes during 12 weeks

Also known as: Sonodyn Medico Star
1
placebo therapy (Placebo Sonodyn Medico Star)DEVICE

twice a day for 10 minutes during 12 weeks

Also known as: Placebo Sonodyn Medico Star device
2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CPSS III
  • symptomatic \>3 months
  • NIH-CPSI total score =/\>15
  • NIH-CPSI pain =/\>8

You may not qualify if:

  • post void residual \>100mL
  • urinary tract infection
  • urethral stricture
  • prostate cancer
  • age \<18 years
  • claustrophobia
  • pacemaker, neurostimulator, insulin / pain pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Kessler TM, Mordasini L, Weisstanner C, Juni P, da Costa BR, Wiest R, Thalmann GN. Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial. PLoS One. 2014 Dec 29;9(12):e113368. doi: 10.1371/journal.pone.0113368. eCollection 2014.

    PMID: 25546177DERIVED

Study Officials

  • Thomas M Kessler, MD

    Department of Urology, University of Bern, 3010 Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 3, 2008

Study Start

November 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 3, 2012

Record last verified: 2012-07

Locations

CH(1)