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Radiation Therapy on Pelvic Floor Disorders in Women (RadPFD)

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Terminated

Conditions

Colorectal Cancer

Treatments

Other: REDCap Questionnaires

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04623515
P30CA012197 (U.S. NIH Grant/Contract)
WFBCCC 01620 (Other Identifier)
IRB00069825

Details and patient eligibility

About

Investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer

Full description

Primary Objective: To characterize the impact of radiation therapy on the lower urinary and bowel tract symptoms, (featuring urinary incontinence, irritative voiding symptoms, voiding dysfunction, bowel incontinence, and defecatory dysfunction) of female survivors of colorectal cancer 2-5 years after treatment.

Secondary Objectives:

  • To characterize sexual dysfunctions present in female colorectal cancer survivors 2-5 years after treatment and to determine the impact of radiation therapy compared to surgical treatment alone.
  • To examine the impact of radiation therapy on the sexual function of the partner of female survivors of colorectal cancer treated with radiation treatment.

Enrollment

49 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Living, female patients.
  • Age 18 or older with a diagnosis of colorectal cancer (current or past, regardless of Stage)-confirmed by pathology report - made between the years of 2015 and 2018.
  • History of treatment for colorectal cancer in the Wake Forest Baptist Health System.
  • Sexual partners of the above participants (subjects can participate even if they are not sexually active or if no sexual partner is available).
  • English speaking.

Exclusion criteria

  • No internet access.
  • Non-English speakers (validated instruments are only available in English).

Trial design

49 participants in 2 patient groups

Surgery Only Group
Description:
Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.
Treatment:
Other: REDCap Questionnaires
Surgery and Radiation Therapy Group
Description:
Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.
Treatment:
Other: REDCap Questionnaires

Trial contacts and locations

1

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Central trial contact

Sachin Vyas, PhD

Data sourced from clinicaltrials.gov

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