Last updated: September 18, 2023
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting
Phase
2
Condition
Bladder Cancer
Urothelial Cancer
Pressure Ulcers
Treatment
Pseudomonas aeruginosa
Clinical Study ID
NCT05975151
bks02
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- Age ≥18 years old, both male and female;
- Diagnosed as Intermediate or high risk non-muscle invasive bladder cancer, withprevious recurrent pathological diagnosis report and cystoscopy available.Intermediate risk was defined as the presence of one or two of the following: multipletumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBCwithin 1 year after diagnosis). High risk was defined as meeting any one of thefollowing: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large (> 3cm) TaG1G2/ low-risk tumor (simultaneous);
- Not receiving BCG or other immune drug infusion chemotherapy at the same time
- Informed consent and signed informed consent form by patients and their families;
- Clear consciousness and able to answer questions independently, Patients were asked tocomplete the questionnaire by themselves;
- No history of neurological diseases, severe hematological diseases, and dysfunction ofheart, lung, liver, or kidney were observed.
Exclusion
Exclusion criteria:
- Patients with other genitourinary system tumors or other organ tumors;
- Patients with muscle invasive bladder urothelial carcinoma (≥T2);
- Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy);
- Pregnant or lactating women, women of childbearing age who did not use effectivecontraception, and those who planned to become pregnant during the trial (includingthe partner of male subjects);
- Known or suspected intraoperative bladder perforation;
- Gross hematuria was present before enrollment, and the surgical wound was suspected tobe unhealed or damaged urinary mucosa;
- Patients with cystitis, or previous treatment with other intravesical agents, whosebladder irritation significantly affected the evaluation of the study;
- Patients who had participated in a clinical trial with other drugs within 3 monthsbefore enrollment;
- Patients with known opioid or alcohol dependence;
- Patients with any condition considered by the investigators to increase the risk ofthe subject or interfere with the conduct of the trial;
Study Design
Total Participants: 63
Treatment Group(s): 1
Primary Treatment: Pseudomonas aeruginosa
Phase: 2
Study Start date:
October 01, 2023
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
Qilu hospital
Jinan, Shandong 276600
ChinaActive - Recruiting
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