Chronic Pelvic PainCPPESWTNCT02042651
A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain
A study testing Low intensity extracorporeal shockwave therapy in people with Chronic Pelvic Pain, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Introduction: Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- Low intensity extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Feb 2016
- 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
- pelvic pain with a duration of more than 6 months
- be able to read and understand the study information
Who cannot join
- known etiology for pelvic pain eg. cancer, infection, inherent abnormalities.
- diagnosed with hemophilia
- receiving anti thrombotic therapy other than hearth magnyl
- diagnosed with thrombocytosis
- active cancer
- treated with IV glucocorticoids within the last 6 months
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- disease in the rectal area
- abnormal digital rectal exploration
- bacteriospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study
Introduction:
Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.
Read more
Methods:
All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.
The investigators anticipate to include 100 chronic pelvic pain patients in the study.
included patients will be randomized into two groups: active treatment or sham treatment.
All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.
A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.
Participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment.
Possible gains from this study:
The investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today.
Ethics, funding, and publication:
The study is performed in compliance with the Helsinki declaration. External funding have been applied for but not yet received. Participants will be informed of sources of external funding. The result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.
- Conditions
- Chronic Pelvic Pain
- Being tested
- Low intensity extracorporeal shockwave therapy, Sham low intensity extracorporeal shockwave therapy
- Keywords
- ESWT, Chronic pelvic pain, randomized, sham controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity extracorporeal shockwave therapyDevice
Also called Storz Duolith® SD1 T-TOP, CE 1275
Shockwaves will be applied to the perineum a total of 6 times once per week. The energy level applied will range between 0.25 and 0.40 mJ/mm2 with a frequency of 3 Hz for a total of 3000 shockwaves per treatment session
Sham low intensity extracorporeal shockwave therapyDevice
Also called Storz Duolith® SD1 T-TOP, CE 1275
Shockwaves will be applied to the perineum a total of 6 times once per week. The shockwaves will be blocked by a medium on the handheld applicator.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity extracorporeal shockwave therapy | Experimental | Active treatment with low intensity extracorporeal shockwave therapy applied to the perineum. Receives: Device: Low intensity extracorporeal shockwave therapy |
| Sham low intensity extracorporeal shockwave therapy | Sham comparator | Sham treatment with low intensity extracorporeal shockwave therapy applied to the perineum. Receives: Device: Sham low intensity extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIH-Chronic Prostatitis Symptom Index
A questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain, urinary symptoms, and quality of life.
Measured: Change from baseline to twelve weeks after final treatment
Secondary outcomes (3)
Change in The International Index of Erectile Function 5
Questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 25.
Measured: Change from baseline to twelve weeks after final treatment
Change in The International prostate symptom score
A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. scores range from 0 to 35.
Measured: Change from baseline to twelve weeks after final treatment
Global satisfaction score
One question designed to estimate treatment satisfaction on a four point Likert scale.
Measured: Twelve weeks after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: study stopped because of insuficient number of comparable patients available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Frey, Herlev Hospital
- Investigators
- Anders U Frey, Bach. Med., Principal investigator, Urological Research Unit, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042651
- Sponsor's protocol ID
- H-3-2013-178
- Other IDs
- HEH-2013-33
- Acronym
- CPPESWT
- Status last verified
- Mar 2015
- First submitted
- 10 Jan 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Extracorporeal Shockwave Therapy Against Chronic Pelvic Pain: a Randomized and Sham Controled Study
- ClinicalTrials.gov ID
- NCT02042651
- Acronym / sponsor ID
- CPPESWT / H-3-2013-178
- Conditions
- Chronic Pelvic Pain
- Keywords
- ESWT, Chronic pelvic pain, randomized, sham controlled
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study stopped because of insuficient number of comparable patients available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 23 Jan 2014 (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.
Introduction:
Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.
Methods:
All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.
The investigators anticipate to include 100 chronic pelvic pain patients in the study.
included patients will be randomized into two groups: active treatment or sham treatment.
All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.
A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.
Participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment.
Possible gains from this study:
The investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today.
Ethics, funding, and publication:
The study is performed in compliance with the Helsinki declaration. External funding have been applied for but not yet received. Participants will be informed of sources of external funding. The result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity extracorporeal shockwave therapy | Experimental | Device: Low intensity extracorporeal shockwave therapyActive treatment with low intensity extracorporeal shockwave therapy applied to the perineum. |
| Sham low intensity extracorporeal shockwave therapy | Sham comparator | Device: Sham low intensity extracorporeal shockwave therapySham treatment with low intensity extracorporeal shockwave therapy applied to the perineum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pelvic pain with a duration of more than 6 months
- be able to read and understand the study information
Key exclusion criteria (9 listed)
- known etiology for pelvic pain eg. cancer, infection, inherent abnormalities.
- diagnosed with hemophilia
- receiving anti thrombotic therapy other than hearth magnyl
- diagnosed with thrombocytosis
- active cancer
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 |
|---|---|---|
| Low intensity extracorporeal shockwave therapyAlso: Storz Duolith® SD1 T-TOP, CE 1275Shockwaves will be applied to the perineum a total of 6 times once per week. The energy level applied will range between 0.25 and 0.40 mJ/mm2 with a frequency of 3 Hz for a total of 3000 shockwaves per treatment session | Device | Low intensity extracorporeal shockwave therapy |
| Sham low intensity extracorporeal shockwave therapyAlso: Storz Duolith® SD1 T-TOP, CE 1275Shockwaves will be applied to the perineum a total of 6 times once per week. The shockwaves will be blocked by a medium on the handheld applicator. | Device | Sham low intensity extracorporeal shockwave therapy |
Primary outcome
Change in NIH-Chronic Prostatitis Symptom Index
Time frame: Change from baseline to twelve weeks after final treatment
A questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain, urinary symptoms, and quality of life.
3 secondary outcomes
Change in The International Index of Erectile Function 5
Time frame: Change from baseline to twelve weeks after final treatment
Change in The International prostate symptom score
Time frame: Change from baseline to twelve weeks after final treatment
Global satisfaction score
Time frame: Twelve weeks after final treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
Anders U Frey, Bach. Med. principal investigator
Urological Research Unit, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity extracorporeal shockwave therapy in people with Chronic Pelvic Pain, run by Herlev Hospital at 1 site in Denmark.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 24 Mar 2015. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in NIH-Chronic Prostatitis Symptom Index (time frame: Change from baseline to twelve weeks after final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.