NCT04623515

Radiation Therapy on Pelvic Floor Disorders in Women

Exploring the Impact of Radiation Therapy on Pelvic Floor Disorders in Women Treated for Colorectal Cancer (RadPFD)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	REDCap Questionnaires	Once consent is obtained, the participants will be routed to a REDCap secure link. Participants will complete a questionnaires regarding demographics and medical history. Participants will also complete validated questionnaires regarding their lower urinary and bowel tract function and sexual health- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Modified Manchester Health Questionnaire (MMHQ), PROMIS® v2.0 Brief Profile Sexual Function and Satisfaction (Female) and SF-12 ® .

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2020-11-10
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States