Female Chronic Pelvic Pain

Irritable Bowel Syndrome Clinical Trial

— Female CPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255345
• Other study ID #: H-1-2010-037
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2010
• Last updated: June 23, 2011
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2010
• Source: Copenhagen University Hospital at Herlev
• Contact: Sys Loving, PT, ph.d.
• Phone: 0045 22128264
• Email: sylo[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish Data Protection Agency
• Study type: Observational

Clinical 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, physical activity and abnormal muscular findings in the pelvic area.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abdominal Pain
• Cystitis, Interstitial
• Interstitial Cystitis
• Irritable Bowel Syndrome
• Painful Bladder Syndrome
• Pelvic Pain
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology, Herlev University Hospital	Herlev	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark,