Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01370122
First received: June 2, 2011
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Pelvic Floor dysfunction affects the quality of life of women. However, the prevalence and risk factors for pelvic floor disorders (PFD) in survivors of gynecologic malignancies are not known. The investigators plan to perform an observational study including survivors of gynecologic malignancies. Questionnaires for diagnosis of pelvic floor disorders will be mailed to survivors to generate prevalence rates and risk factors for PFD in women with a history of a gynecologic cancer diagnosis.


Condition Intervention
Uterine Cancer
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Cervical Cancer
Vulvar Cancer
Other: Survey

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prevalence and Predictive Factors of Pelvic Floor Disorders in Gynecologic Malignancy Survivors

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Urinary incontinence [ Designated as safety issue: No ]
    Urinary incontinence is the most common outcome of all symptomatic pelvic floor disorders in women


Study Start Date: May 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects exposed to radiation Other: Survey
Subjects not exposed to radiation Other: Survey

Detailed Description:

Pelvic floor disorders negatively impact the quality of life of those afflicted by pelvic organ prolapse, lower urinary tract symptoms, defecatory or sexual dysfunction, or pain. Women who present for routine gynecologic care often have undiagnosed pelvic floor disorders, and physicians may not specifically question women to elicit pelvic floor symptoms. In the United States 24% of women report at least one pelvic floor disorder, which increases with age, parity , obesity. Gynecologic cancer survivors are a unique population who undergo a variety treatment regimens including surgery, chemotherapy, and radiation. Radical hysterectomy, a common surgical treatment for gynecologic cancers, is a well-established cause for lower urinary tract dysfunction. In contrast, data are lacking regarding risk factors for pelvic organ prolapse or fecal incontinence. Survivors of gynecologic malignancies may be at increased risk for symptomatic pelvic floor disorders, but may not be diagnosed due to lack of inquiry of these symptoms by practitioners. In addition, a recent qualitative study found that survivors of gynecologic malignancies believed that pelvic floor symptoms were an inevitable, untreatable corollary to treatment for their cancer and thus did not seek treatment. Furthermore, the study participants reported that they felt healthy despite these symptoms because of their oncologists assessment of their remission status. The lack of diagnosis and treatment of pelvic floor disorders has clinical and quality of life implications for the growing numbers of gynecologic malignancy survivors. The objective of this study is to identify the prevalence of an risk factors for pelvic floor disorders in women after treatment for gynecologic cancer. Our rationale for this project is that the investigators believe that pelvic floor disorders affect the quality of life of gynecologic cancer survivors and should be quantified. Successful completion of this study will provide evidence for practitioners to screen and treat pelvic floor disorders in gynecologic malignancy survivors.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women over the age of 20 with a history of uterine, ovarian, fallopian tube, peritoneal, cervical, or vulvar cancers.

Criteria

Inclusion Criteria:

  • Women with documented surgery for gynecologic malignancies at any of the three UPHS associated hospitals in center city Philadelphia (e.g., HUP, Pennsylvania hospital) and an accessible electronic medical record from the time of cancer diagnosis and beyond.
  • Gynecologic cancer survivors at least 20 years of age diagnosed and treated for uterine, ovarian, peritoneal, fallopian tube, cervical, or vulvar tumors between 2008 to July 2010 will be included

Exclusion Criteria:

  • Women who are pregnant, with benign tumors, those lost to follow-up, or deceased will be excluded from this study.
  • Patients unable to complete a written survey due to physical or mental disabilities will also be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370122

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01370122     History of Changes
Other Study ID Numbers: UPCC 35810
Study First Received: June 2, 2011
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Women over the age of 20

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Vulvar Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on April 23, 2014