We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Female Chronic Pelvic Pain (Female CPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pelvic Pain Abdominal Pain Painful Bladder Syndrome Interstitial Cystitis Irritable Bowel Syndrome Other: Chronic pelvic pain

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 Design

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark
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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Sys Loving, PT, ph.d. 0045 22128264 sylo@heh.regionh.dk

Locations
Denmark
Department of Anaesthesiology, Herlev University Hospital Recruiting
Herlev, Copenhagen, Denmark, 2730
Contact: Sys Loving, PT, ph.d.-student    0045 22128264    sylo@heh.regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
More Information

Responsible Party: Sys Loving, PT, MSc, ph.d.-student, Multidisciplinary Pain Center, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01255345     History of Changes
Other Study ID Numbers: H-1-2010-037
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: October 2010

Keywords provided by Copenhagen University Hospital at Herlev:
Physiotherapy
Multidisciplinary Pain Centers
Pain measurements
Physical activity
Quality of life

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Pelvic Pain
Cystitis
Abdominal Pain
Cystitis, Interstitial
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Nervous System Diseases
Signs and Symptoms, Digestive