Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - Not specified
Sex eligible: Female
Healthy volunteers: Accepted
Participants: 310 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This trial studies pelvic floor dysfunction and quality of life in uterine cancer survivors. Using questionnaires may help researchers learn more about the sexual function and quality of life in uterine cancer survivors.

Read the full description

PRIMARY OBJECTIVE:

I. To estimate and compare the prevalence of pelvic floor dysfunction in uterine cancer survivors by modality of treatment and to compare with a control group with no history of cancer using the Pelvic Floor Distress Inventory (PFDI).

SECONDARY OBJECTIVES:

I. To compare the degree of sexual dysfunction in uterine cancer survivors by modality of treatment using the Female Sexual Function Index (FSFI) as a continuous measure, and to compare to a non-cancer control group.

II. To compare the long term quality of life (QoL) (using the FSFI, the Pelvic Floor Impact Questionnaire \[PFIQ\], Functional Assessment of Cancer Therapy-Endometrial Cancer \[FACT-En\], Brief Pain Inventory \[BPI\], Alzheimer's Disease Assessment Scale \[ADAS\]/Cancer Rehabilitation Evaluation System for Research \[CARES\] dating scale and Menopausal survey) of patients who were treated with surgery and radiotherapy versus surgery alone (with or without chemotherapy), and to compare to a control group with no history of cancer.

III. To evaluate associations between dose volume parameters of organs at risk and pelvic floor symptoms using the PFIQ and PFDI.

IV. To evaluate associations between the radiation and surgical technique and quality of life (including pelvic symptoms and sexual function using the FSFI, PFIQ, PFDI, and FACT-En).

OUTLINE:

Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Patients with uterine cancer (including endometrial and uterine carcinoma or sarcoma) treated with surgery +/- radiation at MD Anderson between 2006 and 2017

Eligible surgeries include laparoscopic or robotic assisted abdominal total hysterectomy, total abdominal hysterectomy, and vaginal hysterectomy with or without pelvic node dissection, with or without omentectomy or omental biopsies
In addition, patients must have had all WITH bilateral-salpingo-oophorectomy (BSO), either during their surgery or in a previous or subsequent (within 3 months of endometrial cancer diagnosis) surgery
Patients have had at least one year of follow-up
Patients have not had any recurrence of disease
Patients must be able to complete the survey of their own volition
Patients must be able to read and speak English fluently
CONTROL GROUP: Patients have never been diagnosed with any cancer other than non-melanomatous skin cancers
CONTROL GROUP: Patient has undergone hysterectomy/BSO for benign reasons between 2006 and 2017
CONTROL GROUP: Patients must be able to complete the survey of their own volition
CONTROL GROUP: Patients must be able to speak and read English fluently

Exclusion Criteria:

Patients with cancer recurrence, as this will affect their current quality of life
Patients with additional pelvic surgery at the time of their hysterectomy (for example pelvic exenteration, urostomy placement, etc.)
Patients with a secondary primary cancer (including cervical cancer), as this will affect their current quality of life. Patients may have either squamous cell or basal cell carcinoma of the skin
Neurocognitive deficits that render patients unable to complete the survey on their own
Patients who have not yet had removal of their bilateral ovaries
Preoperative radiotherapy prior to hysterectomy

Study population

Patients with uterine cancer treated with surgery +/- radiation at MD Anderson between 2006 and 2017 and patients who have never been diagnosed with any cancer other than non-melanomatous skin cancers and have undergone hysterectomy/bilateral-salpingo-oophorectomy (BSO) for benign reasons between 2006 and 2017

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

Observational (questionnaires)

Patients complete questionnaires over 45-60 minutes consisting of demographic, treatment, lifestyle, disease, and comorbidity questions, as well as multiple study instruments assessing quality of life as it pertains to common toxicities of uterine cancer treatment.

Other: Questionnaire Administration

Questionnaire Administration OTHER

Complete questionnaires

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Pelvic floor distress (PFD)

Time frame: Up to 1 year

Measured by the Pelvic Floor Distress Inventory-20. Descriptive statistics (i.e. frequencies, percentages, medians, ranges, means, standard deviations, measures of skewness and kurtosis), including 95% confidence intervals (CIs) will be computed for the measures derived by study cohort. Prevalence estimates along with exact 95% CIs will be computed. Logistic regression analysis will be used to assess the odds of PFD for treatment cohorts relative to the cohort of patient controls.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

1 locations

M D Anderson Cancer CenterHouston, Texas, United StatesStatus unknown

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Study team and timeline

Lead sponsor: M.D. Anderson Cancer Center
Study start: Jan 9, 2020 Actual
Primary completion: Apr 11, 2027 Estimated
Study completion: Apr 11, 2027 Estimated
First posted: Nov 18, 2020 Actual
Last updated: Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Pelvic Floor Dysfunction and Quality of Life in Uterine Cancer Survivors

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026