- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255345
Female Chronic Pelvic Pain (Female CPP)
Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sys Loving, PT, ph.d.
- Phone Number: 0045 22128264
- Email: sylo@heh.regionh.dk
Study Locations
-
-
Copenhagen
-
Herlev, Copenhagen, Denmark, 2730
- Recruiting
- Department of Anaesthesiology, Herlev University Hospital
-
Contact:
- Sys Loving, PT, ph.d.-student
- Phone Number: 0045 22128264
- Email: sylo@heh.regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult females with CPP living in Denmark
|
A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Urologic Diseases
- Urinary Bladder Diseases
- Pain
- Neurologic Manifestations
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Cystitis
- Irritable Bowel Syndrome
- Abdominal Pain
- Cystitis, Interstitial
- Pelvic Pain
Other Study ID Numbers
- H-1-2010-037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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