Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

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. Identifier: NCT01370122
Recruitment Status : Active, not recruiting
First Posted : June 9, 2011
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment
Uterine Cancer Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Cervical Cancer Vulvar Cancer 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.

Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prevalence and Predictive Factors of Pelvic Floor Disorders in Gynecologic Malignancy Survivors
Study Start Date : May 2011
Actual Primary Completion Date : October 2012

Group/Cohort Intervention/treatment
Subjects exposed to radiation Other: Survey
Subjects not exposed to radiation Other: Survey

Primary Outcome Measures :
  1. Urinary incontinence
    Urinary incontinence is the most common outcome of all symptomatic pelvic floor disorders in women

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes 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.

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.

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 identifier (NCT number): NCT01370122

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

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01370122     History of Changes
Other Study ID Numbers: UPCC 35810
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Pelvic Floor Disorders
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fallopian Tube Diseases
Adnexal Diseases
Vulvar Diseases
Pregnancy Complications