Results Summary
What was the research about?
Endometrial cancer, or cancer of the uterus, is a common cancer for women in the United States. More than half of women with this cancer also have stress urinary incontinence, or SUI. Women with SUI may leak urine when doing things like coughing, sneezing, or lifting heavy objects. Endometrial cancer and SUI can both be treated with surgery.
In this study, the research team looked at results for women who had surgery for SUI at the same time as cancer surgery, compared with women who had cancer surgery alone.
What were the results?
Women who had both surgeries were more likely to report better quality of life after one year than women who had cancer surgery alone.
Women who had both surgeries were more likely to need a foley catheter, a tube to drain their urine, when they left the hospital. The two groups also had small, but not meaningful, differences in
- The way surgery went, including the number of days until they had surgery or the length of their surgery
- How much blood they lost during surgery
The two groups didn’t differ in
- How many transfusions they had
- Problems from surgery including pain and infections
- How likely they were to need an intermittent catheter, a tube placed and removed several times a day to drain the bladder, when they left the hospital
- Sexual function
Who was in the study?
The study included 539 women with cancer of the uterus and SUI. All received care at one of eight hospitals across the United States. Of these women, 84 percent were white, 10 percent were African American, 4 percent were Hispanic, and 2 percent were another race or more than one race or ethnicity. The average age was 62.
What did the research team do?
When women went to see their cancer doctor, they were offered a visit with another doctor to talk about treating SUI. About half of the women went to this visit; about 21% of women in the study decided to have both surgeries at once. The others had cancer surgery alone and chose nonsurgical treatment or no treatment for SUI.
The research team surveyed women about quality of life and sexual function at the start of the study and again six weeks, six months, and one year after surgery. The team also reviewed women’s health records.
Women with past endometrial cancer, doctors, and a case manager helped plan the study.
What were the limits of the study?
Most women in the study were white. Results may differ for women of other races and ethnicities. Women who had worse bladder control problems were more likely to have both surgeries than women who had less severe problems. Fewer women had both surgeries than expected, making it hard to find differences in health outcomes.
Future research could look at results for more women who choose both surgeries at once.
How can people use the results?
Doctors and patients with cancer of the uterus can use the results when considering treatment for SUI.
Professional Abstract
Objective
To compare the effectiveness of concomitant surgery for uterine cancer and stress urinary incontinence (SUI) versus cancer surgery alone on improving quality of life (QOL), sexual function, and clinical outcomes among women with endometrial cancer and SUI
Study Design
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study |
| Population | 539 adult women diagnosed with stage I or II endometrial cancer or complex atypical hyperplasia who also had SUI; of these, 111 had concomitant surgery for cancer and SUI and 428 who had cancer surgery alone |
| Interventions/ Comparators |
|
| Outcomes |
QOL, sexual function, and clinical outcomes including time to surgery, length of hospital stay, operative time, estimated blood loss, transfusions, intraoperative injury, pain, postoperative infections, postoperative complications, return to the operating room, retained foley catheter, intermittent self-catheterization |
| Timeframe | 1-year follow-up for study outcomes |
This observational cohort study compared concomitant surgery to treat cancer and SUI versus cancer surgery alone to improve outcomes among women with early stage endometrial cancer or atypical hyperplasia.
Women in the study with uterine cancer were screened for SUI and offered a referral to a urogynecologist at their initial oncologist visit. Women who saw the urogynecologist were evaluated for SUI surgery, and, if appropriate, offered concomitant surgery. Women completed surveys about QOL and sexual function at their initial visit, and then again six weeks, six months, and one year after treatment. Researchers reviewed electronic medical records for clinical outcomes data.
The study included 539 women with endometrial cancer who also had SUI. Of these, 84% were white, 10% were African American, 4% were Hispanic, and 2% were another race or more than one race and ethnicity. The average age was 62. Women received care at one of eight clinically and geographically diverse hospitals across the United States.
Women with endometrial cancer, oncologists, urogynecologists, an obstetrician/gynecologist, and an oncology case manager helped design the study.
Results
Of women offered a referral to a urogynecologist, 47% followed up with a referral appointment. In total, 21% of women in the study chose to have concomitant surgery. Of these, 56% reported severe or very severe SUI symptoms, compared with 27% of women who chose not to have concomitant surgery.
One year after treatment, compared with women who had cancer surgery alone, women who had concomitant surgery were 20% more likely to have QOL scores above the median (risk ratio [RR]=1.20; 95% confidence interval [CI]: 1.02, 1.41). Women who had concomitant surgery also had a greater likelihood of having a retained foley catheter upon hospital discharge (p<0.0001). Although not clinically significant, they also had a greater number of days until surgery (p=0.0059), higher estimated blood loss (p=0.0001), and longer operative time (p<0.0001).
The two groups did not differ significantly in sexual function, transfusions, intraoperative injuries, pain, need for intermittent self-catheterization at the time of hospital discharge, and postoperative infections and complications.
Limitations
Most patients in the study were white. Results may differ for patients from other racial and ethnic groups. Women with worse SUI, who are more likely to benefit from surgery, were more likely to choose concomitant surgery, which could have accounted for the improvement in QOL for this group. The study was underpowered because fewer women chose to have concomitant surgery than researchers expected.
Conclusions and Relevance
In this study, women who had concomitant surgery had improved quality of life, but also a greater likelihood of having a retained foley catheter upon hospital discharge. Other study outcomes did not differ.
Future Research Needs
Future research could compare cancer surgery alone with concomitant cancer and SUI surgery among a larger, more diverse group of women.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for the makeup of the stakeholder panel and suggested that its makeup be compared with the racial and ethnic attributes of the study population. The researchers said that their stakeholder panel included 17 people: 11 physicians, 5 patients, and 1 oncology case manager who was also a cancer survivor. The researchers noted that the panelists included 14 women and 3 men, 2 African Americans and 1 Asian.
- The reviewers asked if including stage III and IV endometrial cancer patients had any impact on findings, noting that the researchers had not included such patients at the outset. The researchers explained that a substantial number of patients diagnosed with stage I cancer were found to have stage III or IV after pathological analysis, but they were included in analyses because their original clinical diagnoses were at stage I or II. This subset of patients was somewhat less likely to have chosen concomitant stress urinary incontinence (SUI) surgery with their cancer surgery and more likely to have lower quality of life, but the researchers said these differences were not statistically significant. Adjusting for the stage III and IV patients did not substantially alter the association between concomitant SUI surgery and improved quality of life.
- The reviewers asked about the process used to communicate with patients who did not speak English, noting that any adaptation of forms and questionnaires raises concerns about the reliability and validity of the translations. The researchers said their hospital’s professional translating services prepared a Spanish version of the consent form. The researchers found validated Spanish-speaking versions of the study surveys online, except for one survey which their hospital’s professional translating services had translated. The study’s Institutional Review Board approved all Spanish versions of the surveys. Each study site had bilingual staff who were able to answer questions for patients who spoke Spanish.
- The reviewers asked why patients were screened for SUI multiple times in their first oncology visit given that the oncologist and patient were most likely focused on cancer treatment. The reviewers explained that patients in their focus groups asked for this because they recalled feeling overwhelmed and wanting time to think about incontinence.
- Reviewers asked for an explanation regarding the treatment of Group 2, identified as non-surgical SUI treatment. The researchers explained that based on stakeholder input, women who saw a urogynecologist but did not have surgery would fit into this category, but did receive some type of treatment, such as behavioral interventions.