Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

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Brief Title

Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

Official Title

The Prevalence and Predictive Factors of Pelvic Floor Disorders in Gynecologic Malignancy Survivors

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.
    

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


Primary Outcome

Urinary incontinence


Condition

Uterine Cancer

Intervention

Survey

Study Arms / Comparison Groups

 Subjects exposed to radiation
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

225

Start Date

May 2011

Completion Date

September 2017

Primary Completion Date

October 2012

Eligibility 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.
      

Gender

Female

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01370122

Organization ID

UPCC 35810


Responsible Party

Sponsor

Study Sponsor

Abramson Cancer Center of the University of Pennsylvania


Study Sponsor

, , 


Verification Date

April 2020