About one-fifth of people who undergo radical cystectomy are women, but little is known about the experience of this patient population after surgery. A collaborative team from UVA Health and the Cleveland Clinic is conducting the first-ever prospective clinical trial to study pelvic floor and sexual health outcomes in women after bladder removal surgery.
At UVA Health, the trial is being led by urologists Jacqueline Zillioux, MD, and David E. Rapp, MD, along with urologic oncologist Tracey Krupski, MD.
Surgery Has Wide-Ranging Effects on Pelvic Health
Radical cystectomy is most often done to treat bladder cancer. In women, besides removing the bladder and urethra, this procedure also involves removing other pelvic organs, including the ovaries, fallopian tubes, and uterus, and the part of the vaginal wall that is attached to the bladder. This can lead to a number of issues, such as a disruption of the nerves in the pelvic area and an increased risk of pelvic organ prolapse.
"We know that this surgery has wide-ranging effects on women's pelvic health," Zillioux says. "As part of this trial, we will conduct thorough evaluations before the patients have surgery as well as at several time points afterwards. We hope that in the long term, this will provide us with actual data we can use to better guide women on what to expect after this surgery."
Zillioux stresses the importance of this research, noting that one recent study found that only 18% of women are asked about or evaluated for pelvic organ prolapse after radical cystectomy. "We don't have good numbers on how common problems after surgery are or what the normal healing process is," she says.
Combining Expertise of Urologic Oncologists & Female Pelvic Reconstructive Surgeons
Zillioux did a urology residency at UVA Health under the mentorship of Rapp. The two of them conceived of the idea for this trial during that time. The trial was launched in 2021, while Zillioux was completing a fellowship in female pelvic medicine and reconstructive surgery (FPMRS) at the Cleveland Clinic.
Now that Zillioux has received an appointment at UVA Health, she aims to recruit more patients for the trial that requires strong collaborative relationships between urologic oncologists and female pelvic reconstructive surgeons.
"This research requires a lot of coordination from different perspectives and areas of expertise,” Zillioux says. "As an expert in FPMRS, I don't have the background in cancer surgery. Likewise, the urologic oncologists don't have the same training I have."
Looking for Opportunities to Improve Patient Care
The investigators hope to enroll 75 patients in the trial, about one-third of them at UVA Health. This observational study will consist of several points of data collection for each patient. Before surgery, patients receive a pelvic exam from a specialist in female pelvic reconstruction surgery. This exam helps to establish vaginal length and assess any pre-existing signs of prolapse. Patients also fill out a questionnaire in advance of the surgery to describe their pelvic floor symptoms and sexual function.
At the first postoperative exam, patients are evaluated by a female pelvic reconstruction surgeon as well as a urologic oncologist. Then at regular intervals for up to five years after the surgery, the team repeats the exam and readministers the questionnaire.
The investigators expect this trial will provide many opportunities to improve care. "We hope we can use information about things like risk factors before surgery or specific surgical techniques to eventually find ways to improve patient outcomes," Zillioux says.
Trial Is First to Focus on Outcomes in Women
Sexual health and other outcomes have long been studied in men undergoing radical cystectomy as well as those having other surgeries that affect the pelvic region, including radical prostatectomy for prostate cancer. But until now, similar studies on women have not been done.
Zillioux notes that this subject may have been ignored in the past, because only a small proportion of patients having this surgery are female. Furthermore, she adds, the surgery can bring up topics that are uncomfortable for women to discuss. "But if you don't ask about it, then you don't learn about it," she says.
"I think it helps to have a female doctor recruiting patients, especially one who is so passionate about this topic," she adds.
In addition to establishing metrics and learning more about patient outcomes, Zillioux hopes this trial will raise awareness among doctors who perform these surgeries.