Pelvic Floor Disorders in Survivors of Gynecologic Malignancies

NCT01370122 | Completed DMC

• 1 other identifier: UPCC 35810
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cancer; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Cervical Cancer; Vulvar Cancer

Keywords

Women over the age of 20

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence

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

Study Arms (2)

Subjects exposed to radiation

Other: Survey

Subjects not exposed to radiation

Other: Survey

Interventions

Survey OTHER

Subjects exposed to radiation; Subjects not exposed to radiation

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Uterine Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Cervical Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 9, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2017
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

US (1)