Female Chronic Pelvic Pain

• Conditions: Pelvic Pain; Abdominal Pain; Painful Bladder Syndrome; Interstitial Cystitis; Irritable Bowel Syndrome
• Interventions: Other: Chronic pelvic pain

• Registration Number: NCT01255345
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Study Start: 2011-01
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult females with CPP living in Denmark	Chronic pelvic pain	-

Trial Locations

Locations (1)

Department of Anaesthesiology, Herlev University Hospital; 🇩🇰 Herlev, Copenhagen, Denmark