Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 17, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2031

Conditions
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Interventions
DRUG

Mitomycin C (MMC)

When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (mitomycin) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery)

DRUG

Normal Saline (Placebo)

When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (Normal Saline) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery)

Trial Locations (3)

430000

RECRUITING

The central Hospital of wuhan, Wuhan

430030

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

Unknown

RECRUITING

Xiangyang Central Hospital, Xiangyang

All Listed Sponsors
lead

Shaogang Wang

OTHER