Clinicians explore real-world use of mitomycin for intravesical solution for bladder preservation

A group of urologists convened in Indianapolis, Indiana, to discuss evolving approaches to recurrent low-grade and intermediate-risk non–muscle invasive bladder cancer (NMIBC). Moderated by Eugene B. Cone, MD, of Urology of Indiana, an affiliate of U.S. Urology,discussion explored how changing evidence, patient expectations, and new intravesical options—including mitomycin for intravesical solution (Zusduri)—are shaping treatment strategies aimed at reducing surgical burden and improving patient quality of life.

This summary was generated by artificial intelligence and edited by humans for clarity.

Refining risk and adapting management

The conversation began with a review of risk stratification frameworks from the American Urological Association and the National Comprehensive Cancer Network. Panelists reaffirmed that low-risk disease typically includes solitary, <3-cm, low-grade Ta lesions, whereas intermediate-risk encompasses recurrent, multifocal, or larger low-grade tumors. These patients face low rates of progression but high rates of recurrence, placing them in what 1 participant called “a chronic care cycle” of repeat resections and surveillance.

The group agreed that the intermediate-risk space is where decision-making is most nuanced. The continuing BCG shortage has reinforced reliance on chemotherapy-based alternatives—most commonly gemcitabine or gemcitabine-docetaxel combinations—as induction or maintenance therapy. The panel emphasized tailoring intensity to patient factors such as comorbidity, anesthesia tolerance, and lifestyle constraints. “At this stage,” one participant noted, “you’re not just managing tumors—you’re managing people’s lives and how much treatment they can bear.”

Case 1: Early recurrence after TURBT

The first case involved a 63-year-old man with a low-grade Ta tumor who underwent complete TURBT and a 6-week course of intravesical gemcitabine. Within months, he developed small recurrent papillary lesions.

Some urologists favored repeat resection to confirm grade and stage, whereas others preferred office-based fulguration or chemoablation for clearly low-grade recurrences. “We shouldn’t take every patient back to the OR if the disease biology and history are well established,” one participant said. “In selected patients, chemoablation can be an effective and less invasive option.”

Intravesical therapy and perioperative practice

Panelists described differences in how they incorporate immediate postoperative chemotherapy. Many administer single-dose intravesical gemcitabine immediately following TURBT if bladder integrity is confirmed. Others employ short courses of continuous bladder irrigation with sterile water to minimize tumor seeding when chemotherapy is unavailable.

The group emphasized practical details—confirming no perforation, ensuring adequate visualization, and maintaining consistent technique—as key determinants of success, regardless of the specific agent used.

Mitomycin for intravesical solution introduces a new chemoablation model

Discussion then turned to chemoablation and the clinical experience with mitomycin for intravesical solution, a reverse-thermal hydrogel formulation of mitomycin C designed for prolonged bladder dwell time. The group reviewed findings from the phase 3 ENVISION trial (NCT05243550), which led to FDA approval of mitomycin for intravesical solution in 2025 for adults with low-grade, intermediate-risk NMIBC.

Panelists highlighted that ENVISION enrolled 240 patients—most with multifocal, recurrent low-grade Ta disease—who received 6 once-weekly instillations. The complete response rate at 3 months was roughly 79%, with 12-month durability exceeding 75% among initial responders. Adverse events were primarily grade 1 to 2 urinary symptoms, including dysuria, urgency, and frequency; grade ≥3 events occurred in about 14% of patients.

Clinicians noted that mitomycin for intravesical solution’s sustained release allows for a single, flat-dose instillation (75 mg mitomycin in 56 mL gel) that liquefies at body temperature and remains in the bladder for 5 to 24 hours before being voided. The drug’s on-label use as a non-surgical primary therapy or alternative to repeat resection was described as “a paradigm shift” for selected patients.

Selecting candidates for chemoablation

The panel agreed that mitomycin for intravesical solution and other chemoablative approaches are best suited for patients with multifocal low-grade disease, multiple prior TURBTs, or significant anesthesia risk. For these individuals, office-based instillation offers a way to break the “TURBT treadmill.”

“After the third or fourth recurrence, patients start to ask if there’s any other option,” one urologist said. “[Mitomycin for intravesical solution] gives us a reasonable, evidence-based answer.”

Participants emphasized the importance of setting realistic expectations: Chemoablation does not eliminate recurrence risk but may lengthen disease-free intervals and reduce surgical frequency.

Case 2: The patient exhausted by repeated procedures

The second case focused on a 68-year-old woman with multiple prior resections who was reluctant to undergo another OR-based procedure after developing recurrent multifocal low-grade lesions.

Most panelists viewed this as a strong indication for mitomycin for intravesical solution. They discussed workflow logistics—nurse administration, brief catheter dwell, and same-day discharge—as well as institutional barriers such as cost approval and medication access. In some systems, chemotherapy instillations require dual verification by 2 providers, which can strain clinical schedules. Still, most agreed that outpatient delivery of mitomycin for intravesical solution was feasible once protocols were established.

“I think of this as a new layer of bladder-sparing therapy,” one participant said. “It’s not replacing TURBT entirely, but it can delay or reduce the need for it in the right patients.”

Follow-up and defining recurrence intervals

After chemoablation or TURBT, most urologists maintain cystoscopic surveillance every 3 to 6 months. Early recurrence (within 12 months) was viewed as an indicator to reassess therapy, whereas recurrence beyond a year often justified continued conservative management.

Participants noted that long-term follow-up data for mitomycin for intravesical solution remain limited beyond 18 to 24 months, although initial durability signals are encouraging. “We want to see if the response curve holds beyond the first year,” one clinician said. “That will tell us how best to integrate it into sequencing.”

Evolving access and real-world integration

The group also addressed practical adoption issues. Insurance coverage and cost remain early challenges, particularly for independent or community-based practices. Several urologists described ongoing efforts to secure institutional buy-in and integrate mitomycin for intravesical solution into outpatient infusion protocols.

Most participants saw value in developing regional referral pathways or shared-care models to ensure consistent use across settings. “Bladder cancer care is becoming too complex for every practice to do everything,” one physician observed. “We’ll need collaboration and clear communication between community urologists and tertiary centers.”

Patient communication and adherence

Panelists emphasized that patient understanding and reassurance are essential for chemoablation success. The term chemotherapy can cause anxiety, so clinicians often explain that mitomycin for intravesical solution is a localized bladder treatment, not systemic chemotherapy. Patients are generally receptive once they learn it can reduce surgery frequency and recovery time.

Smoking cessation counseling remains a cornerstone of NMIBC management. “No therapy can overcome continued smoking,” one participant reminded. “That’s the most modifiable risk factor we have.”

The art and science of NMIBC management

The discussion concluded with reflections on how new technologies are reshaping practice. Panelists characterized NMIBC management as a balance between evidence, experience, and empathy. “There’s nuance in every case,” one said. “It’s not about rigid algorithms—it’s about judgment.”

The group viewed chemoablation with mitomycin for intravesical solution as an important addition to the therapeutic landscape, expanding the urologist’s ability to individualize care. Although TURBT remains the cornerstone of management, office-based chemoablation provides a viable alternative for select patients seeking to avoid repeated anesthesia and operative recovery.

“After decades with few innovations in this space,” one participant concluded, “we finally have new tools that align with what patients have been asking for—less invasive, evidence-based options that still preserve oncologic control.”