Clinical trial · Observational
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)
NCT04623515CI-TRIAL-00071086RadPFDterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB closure, slow accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| REDCap Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Surgery Only Group
- description
- Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.
- interventionNames
- Other: REDCap Questionnaires
- label
- Surgery and Radiation Therapy Group
- description
- Participants will complete a questionnaires regarding demographics and medical history on a secured REDCap link.
- interventionNames
- Other: REDCap Questionnaires
Primary outcomes (1)
- measure
- Urinary Dysfunction - International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
- timeFrame
- Up to 4 months
- description
- The ICIQ-FLUTS is a 12-item validated, self-administered questionnaire that is derived from the Bristol Female Lower Urinary Tract Symptoms (BF-LUTS) questionnaire and designed for use in women and to assess urinary symptoms and effects on quality of life. There are 3 subscales within this instrument to assess incontinence, voiding and filling. Investigators will specifically use the incontinence subscale as the primary outcome. The instrument is based on 5 questions, with possible answers on a 5-point scale (ranging from "never" to "all of the time"). Scoring is 0-48 with higher scores equaling to a greater bother with urinary dysfunction in participants.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.