Chronic Pelvic Pain SyndromeNCT00688506
Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
A study testing combined sono-electro-magnetic therapy (Sonodyn Medico Star) in people with Chronic Pelvic Pain Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- combined sono-electro-magnetic therapy (Sonodyn Medico Star)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CPSS III
- symptomatic >3 months
- NIH-CPSI total score =/>15
- NIH-CPSI pain =/>8
Who cannot join
- post void residual >100mL
- urinary tract infection
- urethral stricture
- prostate cancer
- age <18 years
- claustrophobia
- pacemaker, neurostimulator, insulin / pain pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
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.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- combined sono-electro-magnetic therapy (Sonodyn Medico Star), placebo therapy (Placebo Sonodyn Medico Star)
- Keywords
- Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined sono-electro-magnetic therapy (Sonodyn Medico Star)Device
Also called Sonodyn Medico Star
twice a day for 10 minutes during 12 weeks
placebo therapy (Placebo Sonodyn Medico Star)Device
Also called Placebo Sonodyn Medico Star device
twice a day for 10 minutes during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Combined sono-electro-magnetic therapy Receives: Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star) |
| 2 | Placebo comparator | placebo therapy Receives: Device: placebo therapy (Placebo Sonodyn Medico Star) |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
Measured: 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
Measured: 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
Measured: before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startNov 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Thomas M Kessler, MD, Principal investigator, Department of Urology, University of Bern, 3010 Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688506
- Sponsor's protocol ID
- KEK 292/07
- Other IDs
- 1492
- Status last verified
- Jul 2012
- First submitted
- 29 May 2008
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25546177
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00688506
- Acronym / sponsor ID
- KEK 292/07
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- Chronic pelvic pain syndrome, Neuromodulation, Brain effects, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: combined sono-electro-magnetic therapy (Sonodyn Medico Star)Combined sono-electro-magnetic therapy |
| 2 | Placebo comparator | Device: placebo therapy (Placebo Sonodyn Medico Star)placebo therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CPSS III
- symptomatic >3 months
- NIH-CPSI total score =/>15
- NIH-CPSI pain =/>8
Key exclusion criteria (7 listed)
- post void residual >100mL
- urinary tract infection
- urethral stricture
- prostate cancer
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined sono-electro-magnetic therapy (Sonodyn Medico Star)Also: Sonodyn Medico Startwice a day for 10 minutes during 12 weeks | Device | 1 |
| placebo therapy (Placebo Sonodyn Medico Star)Also: Placebo Sonodyn Medico Star devicetwice a day for 10 minutes during 12 weeks | Device | 2 |
Primary outcome
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
2 secondary outcomes
Brain activity assessed by functional MRI
Time frame: 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
Time frame: before treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
- Derived from this study: PubMed 25546177Kessler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Kessler, MD principal investigator
Department of Urology, University of Bern, 3010 Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined sono-electro-magnetic therapy (Sonodyn Medico Star) in people with Chronic Pelvic Pain Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00688506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.