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Clinical Trials/NCT01255345
NCT01255345
Unknown
N/A

Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature

Copenhagen University Hospital at Herlev1 site in 1 country2,500 target enrollmentJanuary 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Pain
Sponsor
Copenhagen University Hospital at Herlev
Enrollment
2500
Locations
1
Last Updated
14 years ago

Overview

Brief 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, 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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2012
Last Updated
14 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Copenhagen University Hospital at Herlev

Eligibility Criteria

Inclusion Criteria

  • Women ≥ 18 years
  • Living in Copenhagen Country (Region H)
  • Capable of reading, writing and speaking Danish

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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