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

June 2, 2011
October 11, 2012
May 2011
October 2012   (final data collection date for primary outcome measure)
Urinary incontinence [ Designated as safety issue: No ]
Urinary incontinence is the most common outcome of all symptomatic pelvic floor disorders in women
Same as current
Complete list of historical versions of study NCT01370122 on ClinicalTrials.gov Archive Site
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Pelvic Floor Disorders in Survivors of Gynecologic Malignancies
The Prevalence and Predictive Factors of Pelvic Floor Disorders in Gynecologic Malignancy Survivors

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

  • Uterine Cancer
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Cervical Cancer
  • Vulvar Cancer
Other: Survey
  • Subjects exposed to radiation
    Intervention: Other: Survey
  • Subjects not exposed to radiation
    Intervention: Other: Survey
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01370122
UPCC 35810
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
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Abramson Cancer Center of the University of Pennsylvania
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP