Rigi10™ Malleable Penile Prosthesis
Also Known As
Intravesical administration, intravesical instillation, intravesical treatment, intravesical chemotherapy (when chemotherapeutic agents are used), intravesical immunotherapy (when immunotherapeutic agents are used), intravesical BCG therapy (specific to Bacillus Calmette-Guérin treatment)
Definition
Intravesical therapy is a specialized treatment approach in which medication is administered directly into the bladder through a catheter inserted via the urethra, rather than being given systemically through oral or intravenous routes.1 This localized delivery method allows therapeutic agents to come into direct contact with the bladder lining while minimizing systemic exposure and associated side effects.2 The primary goal of intravesical therapy is to eradicate existing or residual tumors through direct cytoablation or immunostimulation.3 During the procedure, the medication is instilled as a liquid and retained in the bladder for a specified period, typically 1-2 hours, before being expelled through urination.4 This treatment modality is predominantly used for non-muscle invasive bladder cancer (NMIBC) and carcinoma in situ (CIS), where it serves as an adjuvant therapy following transurethral resection of bladder tumor (TURBT) to reduce recurrence and progression rates.1,3
Clinical Context
Intravesical therapy is primarily utilized in the management of non-muscle invasive bladder cancer (NMIBC), which includes stage 0 (carcinoma in situ) and stage I bladder cancers that have not penetrated the muscle layer of the bladder wall.1 This treatment modality is most commonly employed in the following clinical scenarios:
As an adjuvant therapy following transurethral resection of bladder tumor (TURBT), intravesical therapy significantly reduces the risk of tumor recurrence, which affects up to 70% of patients with NMIBC within five years of initial treatment.3 A single dose of intravesical chemotherapy is often administered within 24 hours of TURBT, followed by a maintenance schedule based on the patient’s risk stratification.1
For intermediate and high-risk NMIBC, intravesical therapy typically follows a schedule of weekly treatments for approximately 6 weeks (induction phase), followed by less frequent maintenance treatments extending from 1 year for intermediate-risk to up to 3 years for high-risk cancers.1,2 This regimen has been shown to reduce recurrence rates by 14-17% compared to TURBT alone.3
Intravesical therapy is particularly valuable for treating carcinoma in situ (CIS), a flat, high-grade cancer that is difficult to completely remove with surgery alone.2 The direct application of medication to the bladder lining allows for targeted treatment of these superficial but aggressive lesions.
Two main categories of intravesical therapeutic agents are employed:
Immunotherapy agents stimulate the body’s immune system to target and destroy cancer cells. Bacillus Calmette-Guérin (BCG) remains the gold standard first-line immunotherapeutic agent for high-risk NMIBC and CIS, demonstrating superior efficacy in preventing recurrence compared to several chemotherapeutic agents.3 For BCG-unresponsive disease, newer FDA-approved options include Nadofaragene firadenovec (Adstiladrin), a gene therapy that introduces interferon alpha-2b to activate immune cells, and Nogapendekin alfa inbakicept (Anktiva), which enhances immune response by activating interleukin-15.2,3
Chemotherapy agents directly kill rapidly dividing cancer cells. Commonly used intravesical chemotherapeutics include Mitomycin C, Gemcitabine, Docetaxel, Valrubicin, Epirubicin, and Thiotepa.1,2 These agents are particularly valuable for patients who are ineligible for or unresponsive to BCG therapy.
Patient selection for intravesical therapy is based on risk stratification, with factors including tumor grade, stage, size, multiplicity, and previous recurrence history determining the appropriate agent and treatment schedule.4 The treatment is delivered through a catheter inserted into the bladder via the urethra, with the medication retained for a specified period before being expelled through urination.4
Side effects are generally localized to the bladder and include irritative voiding symptoms, mild hematuria, and bladder spasms.2 Systemic side effects are minimal due to the limited absorption across the urothelium, which is one of the primary advantages of this treatment approach.1,2