NCT00710073

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2006

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

Study Start

First participant enrolled

May 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

July 3, 2008

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

July 2, 2008

Last Update Submit

July 2, 2008

Conditions

Chronic Pelvic Pain Syndrome

Keywords

Chronic pelvic pain syndromeNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Pain visual analogue scale

    before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment

Study Arms (1)

A

EXPERIMENTAL

Combined sono-electro-magnetic therapy

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

Interventions

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

twice a day for 10 minutes during 6 or 12 weeks

Also known as: Sonodyn Medico Star
A

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
  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Bern University Hospital

Bern, Switzerland

Location

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 3, 2008

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 3, 2008

Record last verified: 2008-07

Locations

CH(1)