Urologists at Cleveland Clinic and the University of Virginia are partnering on a prospective clinical trial designed to better understand urogynecologic complications following female cystectomy. With these data, they hope to improve patient counseling and tease out possible modifiable factors.
While men are three times more likely than women to receive a bladder cancer diagnosis, women make up a sizeable portion—approximately 17,500—of annual cases. Radical cystectomy in women involves removal of the bladder in addition to pelvic organs, such as ovaries, fallopian tubes, uterus, and the anterior vaginal wall.
There is increasing evidence in the literature that bladder cancer rarely affects these organs, but removing them can worsen quality of life by causing sexual dysfunction and pelvic organ prolapse.
Jacqueline Zillioux, MD, urology fellow at Cleveland Clinic is leading the study along with Sandip Vasavada, MD, Urologic Director, Center for Female Urology and Reconstructive Pelvic Surgery at Cleveland Clinic. Dr. Zillioux says, “We know that, in general, cystectomy in women can disrupt pelvic floor support and innervation, as well as hormonal and sexual function, but there are no good prospective data to help us fully understand pelvic floor complications following the procedure.”
The authors say that most studies have examined post-cystectomy function and disorders in male patients, but they’re hopeful that this study, and others like it, will contribute to the growing momentum into female-specific quality-of-life outcomes following bladder cancer treatment.
“Traditionally, female-centered research examining the sexual function and pelvic floor health would fall exclusively in the domain of the female pelvic medicine and reconstruction specialty,” she says. “But this study is a true collaboration between our urologic oncology and female urology teams.”
This is important because previous literature has existed largely within the subspecialty: oncology or female urology. Cleveland Clinic is well-suited for a study like this, she says. The Department of Urology has a robust female pelvic medicine and reconstructive surgery program. In 2021, the service completed nearly 1,250 surgical cases. It’s also a high-volume center for female cystectomy.
The study authors say this collaborative approach is important and, ultimately, provides a better service to the patient. Byron Lee, MD, PhD, urologic oncologist and co-investigator, explains, “About half of women who undergo radical cystectomy are sexually active, but not many receive preoperative counseling on how sex changes after cystectomy. The most common problems after cystectomy are pain with sexual activity, decreased desire for sex, and vaginal dryness.”
He continues, “We hope this study will answer key quality-of-life questions for women undergoing radical cystectomy that will ultimately improve preoperative counseling, better characterize rates of postoperative sexual dysfunction and pelvic organ prolapse, and support novel approaches to mitigate the risk of negative functional impact after surgery.”
A female pelvic reconstructive surgeon conducts a pelvic exam on the patient prior to the cystectomy to establish baseline measurements, including vaginal length and prolapse evaluation. Patients also fill out a preoperative questionnaire about their pelvic floor symptoms and sexual function. After surgery, at various intervals, the team repeats the exam and will again administer the questionnaire.
After the first year, the team will continue collecting the data annually for up to five years.
Radical cystectomy is a complex surgery, and there are significant considerations when it comes to counseling patients about postoperative outcomes and managing their cancer care. Investigators hope this study adds a new layer to the patient-provider conversation.
“We absolutely cannot overlook the negative effect these complications can have on sexual and pelvic floor health,” says Dr. Zillioux. “At the very least, we should be consistently counseling our patients and managing expectations — and hopefully one day we can identify modifiable factors to minimize risks altogether.”