Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01370122
Collaborator
(none)
225
1
76.1
3

Study Details

Study Description

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 Phase
  • 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 Design

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 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Subjects exposed to radiation

Other: Survey

Subjects not exposed to radiation

Other: Survey

Outcome Measures

Primary Outcome Measures

  1. Urinary incontinence []

    Urinary incontinence is the most common outcome of all symptomatic pelvic floor disorders in women

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01370122
Other Study ID Numbers:
  • UPCC 35810
First Posted:
Jun 9, 2011
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2020