Assessment of the therapeutic effect of intravesical Gemcitabine in patients with bladder cancer.
Phase 3
Recruiting
- Conditions
- Bladder Cancer.Malignant neoplasm of bladder, unspecifiedC67.9
- Registration Number
- IRCT20200402046915N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
All the patients with bladder cancer who are not candidates for chemotherapy or bladder removal surgery.
Patients with no history of TURT surgery.
Patients have no history of intravesical injections.
Patients respond to the initial pathology under the moderate risk group with no muscle involvement.
Exclusion Criteria
Patients with ruptured bladder during TURT surgery.
Patients with immunodeficiency.
Patients who are pregnant.
Patients who are unable to perform TURT due to urethral stricture or urethral obstruction.
Patients with a history of intravesical injections.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of bladder cancer. Timepoint: First, a cystoscopy will be performed one month after the last injection into the bladder. Then, in the first year, it will be evaluated by cystoscopy every 3 months, and then every 6 months by cystoscopy. Method of measurement: Direct observation inside the bladder through cystoscopy.
- Secondary Outcome Measures
Name Time Method