Pelvic PainFemale CPPNCT01255345
Female Chronic Pelvic Pain
An observational study of Pelvic Pain and Abdominal Pain, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Abdominal Pain, Painful Bladder Syndrome
- What is being tested?
- Chronic pelvic pain
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Dec 2012
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark
Who may be able to join
- Women ≥ 18 years
- Living in Copenhagen Country (Region H)
- Capable of reading, writing and speaking Danish
Who cannot join
- Pain limited solely to the perineal skin or introitus (vulvodynia)
- Pregnancy, cancer, active pelvic inflammatory disease
- Operation in the pelvic during the last 6 months
- Cognitively impaired individuals
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology, Herlev University Hospital
Herlev, Copenhagen, 2730
Sys Loving, PT, ph.d.-student, 0045 22128264, sylo@heh.regionh.dk
About this study
Official title: Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
The purpose of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.
Read the detailed description
Introduction:
The aim of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.
Methods:
The study is designed as a cross-sectional, questionnaire-based survey and two randomly selected age stratified groups of the responding participating women, one with or one without pain, will receive a clinical examination by a specialist physiotherapist for abnormal muscular finding in the pelvic, lower abdominal or inguinal area.
Results:
Descriptive characteristics will be obtained by univariate analysis and presented as means with standard deviations, or percentages. T test and the Mann-Whitney test will be used to analyze continuous data with and without normal distribution, respectively, and the Chi-square test or Fisher's exact test will be used to analyze categorical data, as appropriate. Correlation between self-reported CPP and abnormal muscular findings will be analysed. Logistic regression analysis will be used to identify the independent variables significantly associated with CPP. For logistic regression analysis, we will select only those findings that are significant as determined by Fisher's exact or the Chi-square test, with values of 0 and 1 assigned to the absence and presence, respectively, of each variable in each subject.
- Conditions
- Pelvic Pain, Abdominal Pain, Painful Bladder Syndrome, Interstitial Cystitis, Irritable Bowel Syndrome
- Being tested
- Chronic pelvic pain
- Keywords
- Physiotherapy, Multidisciplinary Pain Centers, Pain measurements, Physical activity, Quality of life
- Medical subject headings
- Pelvic Pain, Abdominal Pain, Cystitis, Interstitial, Irritable Bowel Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic pelvic painOther
A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.
| Study group | Role | What they receive |
|---|---|---|
| Adult females with CPP living in Denmark | Not described Receives: Other: Chronic pelvic pain |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255345
- Sponsor's protocol ID
- H-1-2010-037
- Acronym
- Female CPP
- Status last verified
- Oct 2010
- First submitted
- 6 Dec 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
- ClinicalTrials.gov ID
- NCT01255345
- Acronym / sponsor ID
- Female CPP / H-1-2010-037
- Conditions
- Pelvic Pain, Abdominal Pain, Painful Bladder Syndrome, Interstitial Cystitis, Irritable Bowel Syndrome
- Keywords
- Physiotherapy, Multidisciplinary Pain Centers, Pain measurements, Physical activity, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Dec 2010 (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.
The purpose of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.
Detailed description
Introduction:
The aim of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.
Methods:
The study is designed as a cross-sectional, questionnaire-based survey and two randomly selected age stratified groups of the responding participating women, one with or one without pain, will receive a clinical examination by a specialist physiotherapist for abnormal muscular finding in the pelvic, lower abdominal or inguinal area.
Results:
Descriptive characteristics will be obtained by univariate analysis and presented as means with standard deviations, or percentages. T test and the Mann-Whitney test will be used to analyze continuous data with and without normal distribution, respectively, and the Chi-square test or Fisher's exact test will be used to analyze categorical data, as appropriate. Correlation between self-reported CPP and abnormal muscular findings will be analysed. Logistic regression analysis will be used to identify the independent variables significantly associated with CPP. For logistic regression analysis, we will select only those findings that are significant as determined by Fisher's exact or the Chi-square test, with values of 0 and 1 assigned to the absence and presence, respectively, of each variable in each subject.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult females with CPP living in Denmark | – | Other: Chronic pelvic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark
Key inclusion criteria (3 listed)
- Women ≥ 18 years
- Living in Copenhagen Country (Region H)
- Capable of reading, writing and speaking Danish
Key exclusion criteria (4 listed)
- Pain limited solely to the perineal skin or introitus (vulvodynia)
- Pregnancy, cancer, active pelvic inflammatory disease
- Operation in the pelvic during the last 6 months
- Cognitively impaired individuals
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 |
|---|---|---|
| Chronic pelvic painA physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP. | Other | Adult females with CPP living in Denmark |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain and Abdominal Pain, run by Copenhagen University Hospital at Herlev 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sys Loving, PT, ph.d. (0045 22128264, sylo@heh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Jun 2011.