Female Chronic Pelvic Pain (Female CPP)
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|ClinicalTrials.gov Identifier: NCT01255345|
Recruitment Status : Unknown
Verified October 2010 by Copenhagen University Hospital at Herlev.
Recruitment status was: Recruiting
First Posted : December 7, 2010
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment|
|Pelvic Pain Abdominal Pain Painful Bladder Syndrome Interstitial Cystitis Irritable Bowel Syndrome||Other: Chronic pelvic pain|
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.
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.
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 Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Observational Model:||Case Control|
|Official Title:||Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature|
|Study Start Date :||January 2011|
|Estimated Study Completion Date :||December 2012|
|Adult females with CPP living in Denmark||
Other: Chronic pelvic pain
A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255345
|Contact: Sys Loving, PT, ph.d.||0045 email@example.com|
|Department of Anaesthesiology, Herlev University Hospital||Recruiting|
|Herlev, Copenhagen, Denmark, 2730|
|Contact: Sys Loving, PT, ph.d.-student 0045 22128264 firstname.lastname@example.org|