Back to results

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

Primary Purpose

Chronic Pelvic Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

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

placebo therapy (Placebo Sonodyn Medico Star)

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain Syndrome focused on measuring Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Urology, University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Combined sono-electro-magnetic therapy

placebo therapy

Outcomes

Primary Outcome Measures

National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)

Secondary Outcome Measures

Brain activity assessed by functional MRI

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

Full Information

NCT ID

NCT00688506

First Posted

May 29, 2008

Last Updated

July 2, 2012

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT00688506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pelvic Pain Syndrome

Keywords

Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Combined sono-electro-magnetic therapy

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo therapy

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Sonodyn Medico Star

Intervention Description

twice a day for 10 minutes during 12 weeks

Intervention Type

Device

Intervention Name(s)

placebo therapy (Placebo Sonodyn Medico Star)

Other Intervention Name(s)

Placebo Sonodyn Medico Star device

Intervention Description

twice a day for 10 minutes during 12 weeks

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Brain activity assessed by functional MRI

Time Frame

before treatment, after 12 weeks of treatment

Title

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

Time Frame

before treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas M Kessler, MD

Organizational Affiliation

Department of Urology, University of Bern, 3010 Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Urology, University of Bern

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25546177

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs