Sono-Electro-Magnetic Therapy for Refractory Chronic Pelv... | NCT00710073

Studies
Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome

NCT00710073

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Jul 3, 2008Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Chronic Pelvic Pain Syndrome

Interventions

sono-electro-magnetic therapy (Sonodyn Medico Star)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Jul 2, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2008

Last Update Posted Date

Jul 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Combined sono-electro-magnetic therapy	Device: sono-electro-magnetic therapy (Sonodyn Medico Star)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sono-electro-magnetic therapy (Sonodyn Medico Star)	Device	twice a day for 10 minutes during 6 or 12 weeks	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)		before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Pain visual analogue scale		before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

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
age <18 years

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas M Kessler, MD	Department of Urology, University of Bern, 3010 Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Bern University Hospital		Bern			Switzerland