Making cystoscopy accessible in gynecology

Gynecologists have used the cystoscope for decades to examine the urethra and bladder, despite urology’s traditional claim that the procedure falls under its purview.

The lines between urology and gynecology have blurred, and cystoscopy has become an even more important and natural part of gynecology’s realm.

Dr. Neeraj Kohli

During the past 2 decades, gynecologists have become even more involved both in evaluating problems such as overactive bladder symptoms, recurrent urinary tract infection, and bladder/pelvic pain, and in performing pelvic reconstruction procedures.

The American College of Obstetricians and Gynecologists has recommended adoption of cystoscopy by ob.gyns. for diagnostic purposes and some operative indications – most importantly for ruling out cystotomy and intravesical or intraurethral suture or mesh placement, and for verifying ureteral patency. ACOG’s 2007 committee opinion on the role of cystourethroscopy in the generalist obstetrican-gyncecologist practice was reaffirmed in 2015 (Obstet Gynecol. 2007 Jul;110[1]:221-24.).

Yet, to a large extent, cystoscopy has been a good fit in principle, rather than in practice. Training in residency programs has been limited, and traditional cystoscopy can be cumbersome and time consuming. It also is costly, requiring equipment – including a light source and camera – and service contracts that may make it too expensive for many gynecologists to set up and maintain in their offices.

Cystoscopy has therefore often required referral to urologists, resulting in additional appointments, patient inconvenience, and increased costs to the health care system. The learning curve for traditional cystoscopy has been relatively steep, and delays in diagnosis and management as a result of referrals are not uncommon.

^{Courtesy Emmy Medical}

A standard three-way Foley catheter used in OR cases today (top) is shown, along with a standard cystoscope employed today for cystoscopy (bottom).

Moreover, cystoscopes were never designed to be safe and comfortable for women. Men and women have different anatomy, yet there always has been a one-size-fits-all device. The flexible cystoscope commonly used by urologists was designed for the unique length and anatomy of the male urethra.

A new catheter-based system specifically for female cystoscopy and simple diagnostic visualization of the female bladder and ureters is now available. The system – called CystoSure (Emmy Medical) – comprises a single-use silicone access catheter (18 French today, 16 French in development) and a reusable 2.7 mm, 70-degree rigid-rod lens optic.

The CystoSure catheter is of shorter length than the traditional catheter is, and it adds a fourth self-sealing port; this fourth port allows it to function both as a three-way urinary catheter and as an access sheath for female cystoscopy. When the scope is not inserted, the port remains sealed. The catheter design allows for multiple passes of the Cystosure scope without additional trauma, infection risk, or discomfort.

Additionally, the distal tip of the catheter is open with a flat pancake-shaped balloon that ensures that the scope is consistently placed and fixed at the trigonal ridge. Since the scope tip cannot advance beyond the lower bladder segment, bladder perforation and trauma risk are negligible.

Comprehensive evaluation of the entire bladder lumen including the trigone and ureters is performed with a simple 360-degree rotation of the scope, with minimal manipulation, compared with the traditional in-and-out technique used to circumferentially view sections of the bladder surface.

^{Courtesy Emmy Medical}

A pancake-shaped balloon keeps the Cystosure scope tip low in the bladder to ensure easy and safe visualization of the ureteral openings.

Full evaluation of the bladder and ureters takes less than 1 minute, and the urethra can be visualized, if desired, by decompressing the distal balloon and removing the entire unit.

The new cystoscopy procedure involves no assembly and is safer, simpler and more consistent than traditional cystoscopy – factors that we hope will make it easier to perform more often in the office for evaluation of bladder conditions (with or without simple cystometrogram testing), as well as during laparoscopic surgery, hysterectomy, incontinence/prolapse surgery, and other urologic procedures to ensure that the bladder and ureters are uninjured and to verify bilateral ureteral flow.

From May 2015 through the mid-summer, we completed and reviewed 55 cases of cystoscopy with Cystosure at several Harvard hospitals, including Brigham and Women’s Faulkner Hospital, Boston, the majority of them in the operating room during sling procedures and other laparoscopic surgeries. We achieved complete bladder and ureter visualization in all cases – including a small number of procedures done in the office setting – with no complications and an extremely short learning curve. For most physicians, it was possible to learn how to perform comprehensive cystoscopy with Cystosure in just one case.