Female Chronic Pelvic Pain (Female CPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01255345
First received: December 6, 2010
Last updated: June 23, 2011
Last verified: October 2010
  Purpose

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 Intervention
Pelvic Pain
Abdominal Pain
Painful Bladder Syndrome
Interstitial Cystitis
Irritable Bowel Syndrome
Other: Chronic pelvic pain

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Estimated Enrollment: 2500
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 6, 2010
Last Updated: June 23, 2011
Health Authority: Denmark: The Danish Data Protection Agency

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

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

ClinicalTrials.gov processed this record on July 23, 2014