Neoplasms

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Urinary Bladder Diseases

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Micronutrients

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Silicon

BCG Vaccine

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of self lubricated silicon tiemann 10 fr urinary catheter.

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of straight tipped latex foley 14 fr urinary catheter

The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.

Bladder cancer is the 9th most common diagnosed cancer according to 2021 statistics (4). It can be divided into muscle invasive (MIBC) and non muscle invasive bladder cancer (NMIBC) , based on the biopsy result after transurethral resection of the bladder tumor.In this research we will abide ourselves to the non muscle invasive bladder cancer.After the transurethral resection of bladder cancer, further management of this disease includes the intravesical instillation of chemotherapy or immunotherapeutic drugs.

The most commonly used drugs in our clinic is epirubicin and Bacillus Calmette Guerrin (BCG) for intravesical instillations.This research will focus on the use of intravesical instillations of BCG .Intravesical instillations of BCG are performed in patients with pTa/High Grade (HG), pT1/Low Grade(LG), pT1/HG and Carcinoma in Situ(CIS) tumors , while epirubicin is used in tumors pTa/LG.

The most common complications after intravesical instillation of BCG are either systemic (mycotic aneyrysms , tuberculosis, hepatitis, arthritis , spondylitis or ev enencephalitis) or are related to the urogenital system (cystitis, prostatitis which can be either tuberculous or bacterial, balanitis or tuberculous epididymitis) (3). The most common complications of the urinary system after the intravesical BCG instillation can appear as a combination of the lower urinary tract symptoms (LUTS) , macroscopic hematuria and fever (4).

There are researches that prove the superiority of silicon catheters for long term catheterization in terms of reduced urethral inflammation and consequently reduced LUTS (1,2). However, there is also an article that claims that latex urinary catheters that are coated with noble metals cause minimal LUTS compared with silicone catheters when used for short term catheterization (3). Nevertheless, there is not a comparative antegrade study for the use of different type of catheters for the intravesical instillation of BCG that proves the superiority of one catheter type over the other.

Purpose of this study The purpose of this study is the comparison of the symptoms arising from the use of two different types of urinary catheters (latex or silicon tiemann) during the intravesical instillation of BCG and the possible display of superiority of one of those catheter types.

Material and Methods This study is an antegrade comparative cohort study. In this are included patients of all age and genders. The patients were diagnosed with non muscle invasive bladder cancer after the transurethral resection of the bladder tumor and are undergoing intravesical BCG instillations after they get their biopsy results.They undergo either 6 weekly intravesical instillations in de novo diagnosed cancer or in 3 weekly instillations during the follow-up based on our clinic's protocol. The intravesical therapy begins 2-4 weeks after the surgery , since the patients has a negative urine culture. Another important condition is that the patient does not have macroscopic hematuria ,does not have fever or does not bleed during the catheter insertion.

The intravesical instillation is performed in the outpatient department of the 2nd University Urology Clinic in Sismanogleio Hospital ,Athens, Greece by three urologist J.M. ,T.B. and S.K.. Those three physicians use aseptic and non traumatic technique during the intravesical instillations (IVIs). For the IVIs either self lubricated silicon tiemann 10 fr urinary catheter or straight tipped latex foley 14 fr urinary catheter was used. The catheterization was done with the use of 2% xylocaine jelly in the urethra.The catheter was advanced slowly while the intravesical instillation was done slowly in a rate so that it was completed in 20-30 s.This technique was used by all the physicians.

The preparation and dilution of the drug used for the IVIs was done by the same trained nurses, under the same conditions for each case and is instilled as soon as it is ready.Before every insillation the physician asks the patient if he has symptoms since the previous instillation such as macroscopic hematuria, fever or LUTS. In case that one of those symptoms exists then the instillation is not performed.In case of hematuria ,instillation is postponed until this symptom disappears.In case of persisting LUTS until the the next instillation the patient receives antibiotic regimen based on urinary culture and continues with the instillation when the culture is negative. In case of fever above 38 celsius the patient undergoes an empiric antibiotic regimen with quinolones. If fever persists over 48 hours then the patient is reffered to an internist with subspecialisation in infectious medicine to exlude the possibility of systemic or urogenital tuberculous complication. The intravesical instillation regimen continues when the patient has no longer fever.

Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer

Complications in both groups- hematuria, fever, LUTS , systemic symptoms

National and Kapodistrian University of Athens

Doctor of Medicine

Anti-Infective Agents

Antineoplastic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Mitomycins

Mitomycin

Enzyme Inhibitors

Alkylating Agents

Group A: 20 mg MMC mixed with 60cc TC-3 hydrogel. (n=8)

• Group B: 40 mg MMC mixed with 60cc TC-3 hydrogel (n=8)

• Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)

TC-3 hydrogel

This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy.

The investigators believe that this study is of importance on several aspects:

1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
2. If proved effective, this mode of treatment might save the need for TURBT performance and serve as a new mode of tumor ablation.
3. Even if proved partially effective, this mode of treatment will diminish tumors size and/or number, thus enable a more limited TURBT procedure.
4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT. This might improve the patient's prognostic outcome.
5. If this experimental treatment will prove to have a better ablative effect in comparison to the standard of care known in the art, this could be translated to a better prophylactic effect of tumor recurrence.
6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence prevention will enable us to reduce adverse effects of higher drug dosage.

Non-muscle-Invasive Bladder cancer is mainly treated by tumor resection (Trans Urethral Resection - TUR), followed by series of intravesical instillations of prophylactic chemotherapeutic drugs such as Mitomycin C (MMC) or BCG. Unfortunately, this treatment approach is limited due to rapid dilution of the chemotherapeutic drug by the incoming urine and clearance by urination.

TheraCoat's core technology is based on a reverse thermal biodegradable gel (TC-3 Gel) (low viscosity at cold temperature (5°C) and gel appearance at body temperature)for drug retention in the urinary bladder.

Prior to instillation, the TC-3 Gel, in its liquid state, is mixed with MMC and instilled into the bladder by a standard catheter. Once inside the bladder, the gel solidifies and forms a drug reservoir. Upon contact with urine, the gel dissolves, release the drug slowly and is finally cleared out from the bladder.

Intravesical MMC instillation using TheraCoat's gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to MMC.

Treatment Protocol - Immediately following baseline cystoscopy and tumor diagnosis and patient undergoes 6 weekly instillations followed by 2-4 weeks healing period.

1st Follow-Up Visit (Pre-Scheduled TURBT Visit): The patient will undergo a second cystoscopy to compare to baseline status. The patient will be followed-up for a period of 1 year as follows: 3,6,9,12 months.

A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)

Comparison of the cystoscopic and pathological effect of pre-TURBT instillations between the 3 different dosages of MMC mixed with TC-3 Hydro-gel groups on bladder lesion(s).

Comparison of one year tumor recurrence rate between the 3 treatment groups

Demonstration that blood levels of MMC following Pre-TURBT TC-3 gel-MMC instillation are below the toxic level (400ng/ml) known in the art for IV MMC administration

Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients.

Demonstration of Pre-TURBT TC-3 gel-MMC instillation safety and adverse event rate.Adverse events will be defined as any adverse change in health or side effect that occurs in the clinical trial participant while the patient is receiving the treatment or until the completion of the post-treatment follow-up cystoscopy.

UroGen Pharma Ltd.

Carcinoma in Situ

Apaziquone

Apaziquone (EOquinTM) 4 mg/40 mL was administered by intravesical instillation once a week for 6 consecutive weeks.

In addition, patients with CIS were to receive further maintenance therapy of 3 weekly apaziquone (EOquinTM) instillations at 3, 6, and 12 months from the date of histological diagnosis.

Alfred Witjes, MD, Prof.

Kees Hendricksen, MD

A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial bladder tumors, and the response and duration of response in patients with carcinoma in situ of the bladder.

Endpoints: Time to recurrence, duration of response and safety

Number of Patients: 53 patients

Study Design: Non-randomized, open-label study.

Key Inclusion Criteria: High-risk patients according to EAU criteria defined as

* pT1 and/or Grade 2b-3, or multiple and highly recurrent
* histologically confirmed carcinoma in situ (CIS)

Key Exclusion Criteria:

pTa Grade 1 or pT1 Grade 1 tumors, existing urinary tract infection or recurrent severe bacterial cystitis; those who cannot tolerate intravesical administration or intravesical surgical manipulation due to the presence of concomitant serious illness; no prior intravesical chemotherapy or immunotherapy in the last three months; no prior EOquin treatment (intravenous or intravesical) in last 12 months.

Study Treatment:

All patients will receive intravesical instillation of EOquin™ 4-mg/40 mL instillate once a week for six consecutive weeks

Patient with carcinoma in situ (CIS) will receive further maintenance therapy with 3 consecutive weekly EOquin instillations at the following time points: 3, 6, 12, 18, and 24 months from the date of TUR. At 3-month follow up visit patients will undergo cystoscopic bladder biopsy and urine cytology. If bladder biopsy is negative at 3-month visit, the follow up during the remaining visits will be by cystoscopy and urine cytology only, which will be done prior to the start of maintenance therapy. In case of positive cytology presence of CIS has to be confirmed histologically with biopsies.

At 6 months follow-up, if biopsies are positive for CIS, no further maintenance therapy will be given; patient will be taken off-study.

Duration of Patient Participation:

Intravesical instillation of EOquin™ will be given once a week for six consecutive weeks. All patients will have follow-up evaluations carried out at 3, 6, 9, 12, 15 and 18 months from the TUR date or until progressive disease is observed. In case of recurrence, patients will go off the study and further treatment will be at the investigator's discretion.

Off Study:

Patients will be taken off the study:

* Upon first recurrence and or progression
* Persistent CIS at 6 months follow up
* Recurrent CIS after biopsy proven complete response

Phase II Trial of EOquin in High-risk Superficial Bladder Cancer

Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer

Spectrum Pharmaceuticals, Inc

Rare Diseases

Recurrence

Carcinoma, Transitional Cell

Disease Attributes

Transitional Cell Carcinoma

Pirarubicin

A single instillation of pirarubicin (THP) plus one year long-term intravesical instillation after nephroureterectomy was performed. The ﬁrst instillation was initiated within 72-168 hours after surgery, followed by four times weekly and 11 times monthly (16 times in total in one year time) . Every time, THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

A single intravesical instillation of THP after nephroureterectomy was performed. This instillation was initiated within 72-168 hours after surgery . THP 30 mg in 30 mL of normal saline was delivered into the bladder through a catheter and was retained for 30 minutes.

pirarubicin(THP)

jiwei huang

jiwei huang, M.D

jin zhang

Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.

Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma

Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma

Bladder recurrence is judged on visual appearance, and histopathologic proof of recurrence was required.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer	NCT05675176	Non-muscle-inva...	BCG	-	National and Kapodistrian University of Athens
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)	NCT01799499	Non Muscle Inva...	TC-3 hydrogel TC-3 hydrogel TC-3 hydrogel	21 Years -	UroGen Pharma Ltd.
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer	NCT00141531	Bladder Neoplas...	Apaziquone	18 Years -	Spectrum Pharmaceuticals, Inc
Single Versus Long-term Intravesical Instillation Chemotherapy for Recurrence After Nephroureterectomy for Upper Tract Urothelial Carcinoma	NCT03030157	Intravesical In...	pirarubicin(THP...	18 Years -	RenJi Hospital

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