Patients administration intravesical. Medical search. Frequent questions

This is a Phase 1 study designed to test the tolerability and feasibility of intravesical therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant chemotherapy. (bcan.org)
Study VYR-MV1-102 is a Phase 1 study designed to determine the tolerability, feasibility and preliminary efficacy of attenuated MV-NIS virus after neoadjuvant intravesical administration prior to RC in patients with UC who are ineligible for current neoadjuvant chemotherapy. (bcan.org)
In a patient with suspected or known low- or intermediate-risk bladder cancer, a clinician should consider administration of a single postoperative instillation of intravesical chemotherapy (eg, gemcitabine, mitomycin C) within 24 hours of a transurethral resection for bladder tumor (TURBT). (medscape.com)
Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. (nih.gov)
Between December 2006 and December 2014, 53 patients with NMIBC who underwent TUR were randomly assigned to receive BHPC (BHPC group, 28 patients) or intravesical chemotherapy alone (chemotherapy group, 25 patients) at the Intracelom Hyperthermic Perfusion Therapy Center of Guangzhou Medical University Cancer Hospital (Guangzhou, China). (spandidos-publications.com)
BHPC was performed by combining perfusion-based hyperthermia with chemotherapeutic agent mitomycin C (MMC) in the bladder, and the chemotherapy group of patients received bladder MMC perfusion. (spandidos-publications.com)
Although, the recurrence rate of NMIBC is significantly decreased by TUR in combination with intravesical chemotherapy, the rate of cancer progression is not diminished ( 7 - 12 ). (spandidos-publications.com)
Alternative treatments for these patients include chemotherapy or a procedure called "complete cystectomy. (biopharmadive.com)
One chemotherapy agent, called Valstar (valrubicin), is approved for this patient group. (biopharmadive.com)
Systemic ACT-treated mice were given T cells intravenously after lymphodepleting chemotherapy and followed by interleukin (IL)-2 administration. (bmj.com)
Intravesical ACT treated mice were given T cells directly into the bladder, without chemotherapy or IL-2. (bmj.com)
Intravesical chemotherapy should be used as the first-line option for patients with intermediate-risk NMIBC. (auanet.org)
Patients with recurrent/multifocal low-grade Ta lesions who require intravesical therapy should receive intravesical chemotherapy such as mitomycin, gemcitabine, epirubicin, or docetaxel instead of BCG. (auanet.org)
If BCG would be administered as second-line therapy for patients with intermediate-risk NMIBC, an alternative intravesical chemotherapy should be used rather than BCG in the setting of this BCG shortage. (auanet.org)
Cisplatin-based chemotherapy has been the best option for decades, but only 50% of patients benefit in the form of objective responses, and just 13-25% experience a complete response [ 1 ]. (iospress.com)
Further intravesical chemotherapy and repeat TURB. (urology-textbook.com)
Intravesical chemotherapy can be used both as a single, immediate postoperative instillation, and as adjuvant chemotherapy. (uk.com)
Meta-analysis of randomised controlled trials has shown that instillation of intravesical chemotherapy immediately following TURBT prolongs the recurrence free interval by 38% compared to both no treatment and placebo [5]. (uk.com)
Although there has been no consensus on the optimal duration of adjuvant intravesical chemotherapy, it is not recommended beyond one year [3]. (uk.com)
Electromotive drug administration is based on the enhancement of intravesical chemotherapy transport with a current gradient between the drug and bladder wall. (healthybladderclub.com)
Hemorrhagic cystitis (HC) may be a complication of infection (particularly in immunocompromised patients), chemotherapy, or radiation to the pelvic area. (uic.edu)
False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, and recent BCG therapy or intravesical chemotherapy. (cysview.com)

Delay administration at least two weeks after transurethral resection and/or fulguration. (drugs.com)
We determined if a third of the dose of intravesical bacillus Calmette-Guerin (BCG) has the same efficacy than a standard dose for decreasing the risk of recurrence and progression after transurethral resection in patients with superficial high risk (stages T1G3 and carcinoma in situ) bladder cancer. (nih.gov)
2 3 Per clinical guidelines, intermediate-risk and high-risk NMIBC are initially treated locally with transurethral resection (TURBT) followed by therapeutic or adjuvant intravesical BCG. (bmj.com)
These standardized feasibility questionnaires highlighted that all 8 patients preferred at-home to in-office treatment, and 5 of 6 patients recommended UGN-102 home instillation instead of transurethral resection of bladder tumors (TURBT). (yahoo.com)
Intravesical treatments after transurethral resection (TUR) are the mainstay of treatment for non-muscle invasive urothelial cancer (NMIUC), and Bacillus Calmette-Guerin (BCG) immunotherapy is the standard, most commonly used intravesical treatment. (blogspot.com)
Seventy percent of new cases will be non-muscle invasive bladder cancer (NMIBC) at diagnosis and therefore will be managed in a bladder sparing manner with transurethral resection (TURBT), with or without intravesical therapy . (uk.com)

Currently, intravesical administration of BCG is delayed four to six weeks after TURBT to reduce the likelihood of systemic BCG absorption and BCG sepsis. (bcan.org)
MV-NIS has been proven safe at a dose of 1x1011 TCID50 intravenously in patients lacking MV immunity (Russell 2014), which allays concern for systemic toxicity after intravesical administration even if post-TURBT administration results in systemic MV-NIS absorption. (bcan.org)
Final results from a pivotal clinical trial show that the investigational agent N-803 combined with bacillus Calmette-Guérin (BCG) is safe and more effective than other intravesical and systemic options for high-risk nonmuscle-invasive bladder cancer (NMIBC) that is unresponsive to BCG alone, according to an oral presentation at the 2022 ASCO Annual Meeting. (renalandurologynews.com)
Delivery through a catheter, called intravesical administration, limits systemic exposure to both the viral vectors and to inteferon, said Neal Shore, m edical director for the Carolina Urologic Research Center and an investigator in the trial. (biopharmadive.com)
Significant symptomatic relief has been achieved in the majority of patients so treated, and no systemic or local toxicity has been noted. (dmso.org)
To date little, if any, local or systemic toxicity has been noted in the human after the administration of DMSO. (dmso.org)
3D-printing offers the possibility of freely tailoring drug delivery systems to manufacture indwelling devices that may administer drugs locally over an extended time and avoiding frequently repeated administrations while minimizing systemic side-effects. (desktopmetal.com)
Administration of EO9 in an acidic vehicle could be employed to reduce possible systemic toxicity as any drug absorbed into the blood stream would become relatively inactive due to an increase in pH. (brad.ac.uk)
Systemic absorption following administration of Cysview is expected to be minimal. (cysview.com)
Systemic embolization may occur in patients with cardiac shunts. (lumason.com)
However, it also points out the weaknesses of immunotherapy, as not all tumors respond to therapy and the co-administration of different immunomodulators may be severely limited due to their systemic toxicity. (mdpi.com)

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin (see WARNINGS and ADVERSE REACTIONS sections). (nih.gov)
Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. (nih.gov)
In humans, mitomycin is rapidly cleared from the serum after intravenous administration. (nih.gov)
Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. (nih.gov)
The adjuvant intravesical therapy is possible with mitomycin C or BCG, depending on the risk profile according to the table simple risk stratification . (urology-textbook.com)
Early single-shot intravesical instillation of mitomycin C after TURB reduces the recurrence rate by 40% (Sylvester et al. (urology-textbook.com)
2004). Dosage: 40 mg intravesical mitomycin C, exposure time 1-2 hours (no irrigation or gravity drainage). (urology-textbook.com)
Multiple, large, and recurrent tumours (those that have come back) may benefit from adjuvant treatment with intravesical Mitomycin or Epirubicin. (ivo.es)

ADSTILADRIN was approved by the U.S. Food & Drug Administration (FDA) in December 2022 for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. (ferringusa.com)
Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. (drugs.com)
Bacille Calmette-Guérin (BCG) plus N-803 yielded promising responses and an encouraging safety profile in patients with BCG-unresponsive, non-muscle invasive bladder cancer carcinoma in situ. (onclive.com)
Bacille Calmette-Guérin (BCG) plus N-803 (ALT-803) yielded promising responses and an encouraging safety profile in patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), according to updated data from cohort A of the phase 2/3 QUILT-3.032 trial (NCT03022825) that were presented during the 2021 American Urological Association Annual Meeting. (onclive.com)
NCT03022825 ), which included 161 patients with BCG-unresponsive high-risk NMIBC divided into 2 cohorts: 84 patients with carcinoma in situ (CIS) and 77 with papillary disease. (renalandurologynews.com)
Our results suggest that a 3-fold decreased dose of intravesical BCG is as effective as the standard dose against progression in patients with high risk stages T1G3 and Tis superficial bladder carcinoma but with significantly less toxicity. (nih.gov)
The registration study for Valstar demonstrated a twenty percent complete response rate three months following six weekly intravesical (transurethral administration into the bladder) instillations of the novel anthracycline in patients with BCG-refractory carcinoma in situ of the bladder. (shu.edu)
Initial management with TURBT can eradicate stage Ta or T1 transitional cell carcinoma (TCC) but risk of recurrence is high in these patients with a 50-70% risk of recurrence within five years and risk of progression to muscle invasive disease can be up to 50% [2]. (uk.com)
The milestone payment is contingent on certain manufacturing goals that are expected to be achieved in 2025 for the FDA-approved intravesical gene therapy that Ferring will make available next month through an early experience program for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. (ferring.in)
I. To estimate complete response at 25 weeks after registration for those with a carcinoma in situ (CIS) component and to evaluate event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS) treated with atezolizumab. (clinicaltrialsgps.com)
Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. (cysview.com)
We are highly encouraged by preliminary results from the dose-escalation component of ADVANCED-1 and look forward to deepening our understanding of TARA-002's potential in the ongoing expansion trial, which is currently enrolling NMIBC patients with carcinoma in situ (CIS)," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. (tipranks.com)
ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977 and NCT05085990) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). (protaratx.com)

The IVO works with a strict intravesical adjuvant protocol that, in addition to standard treatments, also includes innovative instillation systems such as hyperthermia and electromotive drug administration (EMDA), which improve the administration of these drugs. (ivo.es)

The current standard treatment for BC follows a routine weekly Bacillus Calmette-Guérin (BCG) immunotherapy-based therapy protocol which is applied to all patients alike. (bvsalud.org)
The immunotherapy that uses Bacillus of Calmette and Guerin (BCG) effectively treats bladder cancer by stimulating the immune response of patients. (bvsalud.org)
A prospective, single-center, non-randomized Phase II study was carried out in order to evaluate the efficacy in terms of response and progression rate and safety of the EMDA®-MMC treatment in 26 (21 male, 5 female) consecutive patients with HGNMIBC unresponsive after at least one cycle of intravesical immunotherapy with BCG. (auanet.org)
High-grade tumours are treated with intravesical immunotherapy (BCG) to reduce the risk of recurrence and progression. (ivo.es)

In an intermediate- or high-risk patient with persistent or recurrent disease or positive cytology following intravesical therapy, consider performing prostatic urethral biopsy and an upper tract evaluation prior to administering additional intravesical therapy (conditional recommendation, evidence strength, grade C). (medscape.com)

In elderly patients, first efforts should be directed to use non‐drug therapies, such as behavioural therapy. (intechopen.com)
To overcome these limitations and increase patients' quality of life, intravesical therapies are continuously being explored. (desktopmetal.com)
When and if BCG fails, patients are left with the difficult choice of proceeding to radical surgery or, often unproven, additional intravesical therapies. (blogspot.com)
What is the effectiveness of surgical and non-surgical therapies in the treatment of ischemic priapism in patients with sickle cell disease? (elsevierpure.com)
Bladder cancer: where are we with intravesical therapies? (uk.com)

In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. (protaratx.com)

Valrubicin intravesical solution contains polyoxyl castor oil, which has been known to cause leaching of di(2-ethylhexyl) phthalate (DEHP) a hepatotoxic plasticizer, from polyvinyl chloride (PVC) bags and intravenous tubing. (drugs.com)
Further efforts will focus on the prospects for intravenous administration of this or similar constructs for targeted fluorescence, contrast or drug delivery. (urotoday.com)
All patients were first investigated by careful history, complete physical examination, routine urine analysis with culture and cytology studies, intravenous urography and renal function studies, routine hemogram, and SMA-12 profiles. (dmso.org)
The indolequinone EO9 demonstrated good preclinical activity but failed to show clinical efficacy against a range of tumours following intravenous drug administration. (brad.ac.uk)
LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is contraindicated in patients with known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG). (lumason.com)

Eighty-five percent of our patients avoided a cystectomy," according to lead study author Karim Chamie, MD, associate professor of urology at the University of California, Los Angeles. (onclive.com)
Eighty-five percent of patients have not progressed to radical cystectomy through a data analysis as of this time point, as well. (onclive.com)
Patients treated with the combination treatment had high rates of complete response (CR), cystectomy avoidance, and cancer-specific survival. (renalandurologynews.com)
Cystectomy was avoided in 94% of the patients. (renalandurologynews.com)
Deferred cystectomy for progression was performed in 7 patients (8.4%) treated with the standard dose and in 7 (9.5%) of those treated with the decreased dose. (nih.gov)
After 3 years of follow-up, 16 patients (56.5%) preserved their native bladder, 10 patients (43.5%) underwent radical cystectomy, in 26.1% of cases (6 patients) for recurrent HGNMIBC and in 17.4% of cases (4 patients) for progression to muscle-invasive disease. (auanet.org)
Alternatives to cystectomy should be considered in patients with a high surgical risk. (urology-textbook.com)
Therefore, combination therapy with both BCG and IFN-α may have a salvage role in patients with single course BCG failure or late relapse, while those who recur quickly after initial BCG treatment may be destined to failure and better served by radical cystectomy. (blogspot.com)
To estimate progression-free survival, cystectomy-free survival, bladder cancer-specific survival, overall survival in all patients. (clinicaltrialsgps.com)

Embryo-Fetal Toxicity: Valrubicin intravesical solution can cause fetal harm. (drugs.com)
While the current study was performed on ex-vivo specimens, preliminary data on toxicity of the molecule are encouraging and a natural next step will be immediate preoperative intravesical instillation for patients undergoing transurethral bladder tumor resections to aid in tumor identification and perhaps even allow for real time tumor staging. (urotoday.com)
These trials generally seek to find drugs that are more effective than the current best therapeutic option for patients, or that have similar efficacy but a better toxicity profile. (ivo.es)

Nearly 300,000 patients are diagnosed with urothelial cancer (UC) of the bladder each year in the United States. (blogspot.com)
Erickson ;Emerson and Perezmarrero A;Perez-Marrero, Emerson, and Feltis One of the theories on which intravesical treatment is based, claims that the glycosaminoglycan layer, which protects the urothelial cells is damaged. (nv-holders.hu)
Our ambition is for Adstiladrin to become the new standard of care and the backbone therapy for these patients and to drive research in other urothelial cancers. (ferring.in)
The difference between low- and high-grade urothelial cancer has consequences for risk classification and patient treatment. (medtigo.com)

Parsippany, NJ - September 12, 2023 - Ferring Pharmaceuticals today announced the first patient in the United States with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) was dosed with the commercially available intravesical gene therapy ADSTILADRIN ® (nadofaragene firadenovec-vncg) as part of the ADSTILADRIN Early Experience Program announced earlier this year . (ferringusa.com)
It is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy. (ferringusa.com)
Making this novel and efficacious intravesical gene therapy commercially available for patients underscores our commitment to changing the trajectory of NMIBC. (ferringusa.com)
The Early Experience Program is designed to ensure every patient who starts on therapy will continue to receive future doses of ADSTILADRIN for the duration of their treatment. (ferringusa.com)
BCG therapy also reduces the risk of recurrence, and ongoing maintenance therapy with BCG reduces the risk of progression in patients with high-grade non-muscle invasive bladder cancer (NMIBC). (medscape.com)
BCG therapy is done by intravesical instillation (drug administration into the urinary bladder via a catheter) and has been used since 1970 on cancer patients. (wikipedia.org)
For initial induction therapy, patients received 50 mg BCG plus 400 µg N-803 intravesically weekly once a week for 6 weeks. (renalandurologynews.com)
A gene therapy for bladder cancer that recently received $400 million in support from the private equity company Blackstone Group helped more than half of treated patients with resistant disease achieve remission. (biopharmadive.com)
For patients with high-risk NMIBC, high-grade T1 and CIS patients receiving induction therapy, they should be prioritized for use of full-strength BCG. (auanet.org)
If supply exists for maintenance therapy for patients with NMIBC, limit BCG dose to one year. (auanet.org)
The benefits of BCG therapy must carefully be weighed against the possibility of an ectopic BCG infection in patients with pre-existing arterial aneurysms or prosthetic devices of any kind. (medscape.co.uk)
However, because of its simplicity and ease of administration, intravesical DMSO therapy is recommended in all noninfectious or non-neoplastic inflammatory conditions presenting initially with severe symptoms, or that have failed to respond to conventional therapy. (dmso.org)
Patients with various intractable irritable bladder conditions were considered candidates for DMSO therapy. (dmso.org)
The EMDA®-MMC is a safe and effective tool in the long term conservative treatment of the high-risk NMIBC unresponsive to BCG, as second line "sparing bladder" therapy in selected patients. (auanet.org)
Intravesical maintenance therapy. (urology-textbook.com)
If a R0 resection is achieved, continue with intravesical therapy and close follow-up with repeat biopsies. (urology-textbook.com)
Intravesical therapy can safely reduce the risk of recurrence and progression of superficial bladder carcinomas. (urology-textbook.com)
IFN-α may play a role in patients who have failed an initial course of intravesical BCG therapy. (blogspot.com)
In mice, bladder cancers responded to intravesical treatments of IL-12 and BCG, the levels of urinary IFN-α were noted to be significantly increased after therapy, and immune reaction dampened when IL-12 was neutralized. (blogspot.com)
Despite advances in all areas of medicine, the use of intravesical therapy is inconsistent worldwide and advances have been adopted slowly. (uk.com)
Use of intravesical therapy is guided by risk of progression and recurrence of individual tumours. (uk.com)
IBR is commonly used for treatment of B-cell malignancies and for targeted therapy in patients with chronic lymphocytic leukemia [14]. (ampksignal.com)
This major investment by Royalty Pharma, the largest buyer of biopharmaceutical royalties and a leading funder of innovation, is yet another demonstration of the value and confidence in our gene therapy Adstiladrin to address significant unmet medical needs for patients. (ferring.in)
[i] Adstiladrin is a non-replicating adenovirus vector-based gene therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC. (ferring.in)
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. (protaratx.com)
No blood tests are specific for bladder cancer, but a general evaluation is necessary prior to initiating therapy with intravesical bacillus Calmette-Guérin (BCG) vaccine. (medscape.com)

If premalignant lesions could be identified in a reliable and actionable fashion this might offer the opportunity of preventing disease progression and subsequent patient morbidity. (urotoday.com)

The earliest research of this type of bacteria was highlighted in 1813 when scientists began observing that patients that had gas gangrene, an infection caused by the bacteria Clostridium, were able to have tumor regressions. (wikipedia.org)
Those were enrolled were heavily pretreated patients with a median of 5.0 transurethral resections of a bladder tumor, and a median of 12.0 prior BCG instillations. (onclive.com)
In the present study our group showed the utility of intravesical instillation of the ICG pHLIP ® (ICG is a FDA approved near infrared fluorescent dye and pHLIP ® is a pH (Low) Insertion Peptide, which targets tumor acidity) construct for bladder tumor identification and staging. (urotoday.com)
Numerous clinical trials have shown that combining MMC administration with hypothermia can improve tumor ablation and prevent recurrence post-TUR. (spandidos-publications.com)
Tumor progressed in 20 patients (24.7%) with the standard dose and in 19 (26%) with the decreased dose. (nih.gov)
Subgroup analysis by patient age, tumor status, number, size and T stage (T1G3 vs Tis) did not differ significantly. (nih.gov)
Intravesical delivery of TIL expanded from MB49 tumors was also able to decrease tumor growth in mice with MB49 orthotopic tumors. (bmj.com)
Blocking CXCR3 on OT-I T cells prior to intravesical delivery decreased T cell infiltration into the tumor and prevented the control of tumor growth. (bmj.com)
The aim of resection is the complete removal of the tumor manifestation, for this purpose the tumor is either resected in fractions (standard method) or dissected en bloc with tumor base from the bladder wall. (urology-textbook.com)
Indications: high-grade tumor cells in urine cytology, in all patients with a history of multifocal or high-grade tumors. (urology-textbook.com)
The large inter-individual variability is mainly attributed to genetic differences between individuals, tumor sensitivity to treatment, patient compliance and drug-drug interaction. (ampksignal.com)
The clinical data indicate that TARA-002, a novel intravesical monotherapy, was generally well tolerated and showed anti-tumor activity in high-grade NMIBC patients. (tipranks.com)
Of those three patients with CIS, one heavily pre-treated BCG-unresponsive patient achieved a complete response (CR) at the 20KE dose, and tumor regression was observed in the other two patients. (tipranks.com)

Patients with small, unilocular, noninvasive, and well-differentiated bladder carcinomas (Ta low-grade) are adequately treated with a single resection and can be followed with cystoscopies. (urology-textbook.com)
En-bloc resection is done with a monopolar hook, the resection loop, or the laser technique. (urology-textbook.com)

Earlier this month, Ferring made doses of ADSTILADRIN commercially available through an Early Experience Program to urologists at the clinical trial sites that participated in the Phase 3 study 1 and a mix of community clinics with the highest number of eligible high-risk patients with NMIBC. (ferringusa.com)
QUILT-3.032 enrolled 81 patients with histologically confirmed BCG-unresponsive NMIBC, with persistent or recurrent CIS within 12 months of receiving adequate BGC treatment. (onclive.com)
In a phase 1b trial, administration of intravesical N-803 plus BCG in BCG-naïve patients with NMIBC induced CR without recurrences for the study duration of 24 months, according to investigators. (renalandurologynews.com)
On May 23, ImmunityBio Inc, which is developing N-803, announced that it submitted a Biologics License Application to the US Food and Drug Administration for N-803 for use with BCG as a treatment for BCG-unresponsive NMIBC CIS with or without Ta or T1 disease. (renalandurologynews.com)
Among patients with bladder cancer, ~75% are diagnosed with non-muscle invasive bladder cancer (NMIBC) which has a much more favorable prognosis than muscle-invasive bladder cancer ( 1 , 2 ). (spandidos-publications.com)
However, NMIBC recurs in ~70% of patients post-TUR, and requires lifelong treatment ( 3 - 6 ). (spandidos-publications.com)
The study enrolled patients with recurrent LG-IR-NMIBC who agreed to receive UGN‑102 at home. (yahoo.com)
The AUA recommends several management approaches to maintain high quality care for patients with Non-Muscle-Invasive Bladder Cancer (NMIBC). (auanet.org)
Intravesical BCG is the first-line treatment in high grade non muscle invasive bladder cancer (HG-NMIBC). (auanet.org)
Although BCG remains the first-line standard of care for people living with high-grade NMIBC, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease. (ferring.in)
After several decades of little progress in the field, Adstiladrin brings a major innovation to patients with high-risk NMIBC who no longer respond to current first-line treatment and have few other good options. (ferring.in)
These promising results suggest TARA-002 may provide meaningful benefit to patients with NMIBC, who currently have limited treatment options," said Neal Shore, M.D., Medical Director, Carolina Urologic Research Center, Chief Medical Officer, GenesisCare US, and study investigator. (tipranks.com)
We plan to initiate larger clinical trials in NMIBC patients with CIS who are Bacillus Calmette-Guérin (BCG)-naïve and BCG-unresponsive in the second half of this year. (tipranks.com)
Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. (protaratx.com)

Investigators will use a novel adaptive trial design that varies the time between TURBT, virus administration and RC. (bcan.org)
Given this clinical safety precedent, Investigators propose initial patients be treated within one week of RC to maximize the time between TURBT and MV-NIS administration. (bcan.org)
Subsequent patients will be treated earlier before RC (up to 29 days prior), thereby reducing the interval between TURBT and virus administration to maximize the treatment duration before RC. (bcan.org)
A separate study arm evaluated a post-TURBT single IMI/IVT administration of NanoDoce for safety over a 45-day period in 17 patients with muscle invasive bladder cancer. (crititech.com)

Out of a group of 103 patients with superficial tumors in the bladder wall, just over half were in complete remission at three months, 41% at six months, and 24% at one year. (biopharmadive.com)

Patients were followed for AEs and treatment response was evaluated by visual observation, for cause biopsy, and urine cytology 3 months after treatment initiation. (yahoo.com)

The clinical trial enrolled 157 patients with bladder cancer that has not spread to muscle walls and has stopped responding to treatment with Bacillus Calmette-Guérin vaccine. (biopharmadive.com)

The ABLE-41 US RWE Study is a real-world observational study of ADSTILADRIN focused on patient treatment outcomes and early use experiences in U.S. routine care settings. (ferringusa.com)
Studies have consistently shown that BCG treatment can eradicate this cancer in 70% of patients with CIS who meet these criteria. (medscape.com)
The logical second‐line treatment is the intravesical injection of botulinum toxin A, considering its temporary effectiveness and the possibility of retention. (intechopen.com)
For these patients, bladder removal often follows, which results in among the highest lifetime treatment costs and negative impact to quality of life of any cancer. (crititech.com)
The vast majority of patients enrolled in the pivotal N-803 clinical trial who received the drug in combination with BCG had a complete response to the treatment, investigators reported. (renalandurologynews.com)
The vast majority of the patients enrolled in the clinical trial and received N-803 with BCG had a complete response to the treatment, and more than half of the patients who responded maintained that response for 2 years. (renalandurologynews.com)
Furthermore, in an era of rising healthcare costs for both patients and institutions, early detection and prevention may represent significant savings in treatment and follow up surveillance costs. (urotoday.com)
In this study, UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% of patients achieving a complete response, defined as no detectable disease 3 months after starting treatment. (yahoo.com)
Many bladder cancer patients are elderly and suffer from comorbidities that make frequent office visits for treatment a real burden,' said study investigator David Morris, M.D., F.A.C.S., Urologist at Urology Associates PC, Nashville, TN. (yahoo.com)
Moving healthcare out of the clinical setting and into a patient's home would represent a new treatment paradigm for bladder cancer, which may reduce clinic and hospital costs while increasing patient comfort and convenience. (yahoo.com)
Six patients completed treatment (6 doses), and 2 patients discontinued the study (5 doses and 4 doses, respectively) due to adverse events (AEs) unrelated to treatment. (yahoo.com)
All 8 patients were evaluable for treatment response, and 6 of 8 (75%) achieved a complete response 3 months after starting treatment. (yahoo.com)
Treatment-related AEs were mild to moderate in severity (most common: dysuria and fatigue in 2 patients), and 3 patients with significant comorbidities had a serious AE, all of which were unrelated to treatment with UGN-102. (yahoo.com)
The clinical outcomes associated with BCG treatment vary significantly among patients due to the biological and clinical complexity of the interaction between the immune system, treatments, and cancer cells. (bvsalud.org)
Intravesical dimethyl sulfoxide (DMSO) has been used in the treatment of 213 patients with various inflammatory conditions involving the lower genitourinary tract, including intractable interstitial cystitis , radiation cystitis, chronic prostatitis, and chronic female trigonitis. (dmso.org)
Some patients failed to respond entirely, and others relapsed after DMSO treatment periods of several months, ultimately coming to augmentation cystoplasty or urinary diversion. (dmso.org)
The medication was instilled slowly to avoid spasm, and belladonna and opiate suppositories were inserted just prior to treatment in particularly sensitive patients. (dmso.org)
The treatment protocol varied somewhat in male patients with chronic prostatitis. (dmso.org)
Inform patients that there is a risk of irreversible myocardial damage associated with treatment with ELLENCE. (pfizermedicalinformation.com)
Inform patients that there is an increased risk of treatment-related leukemia from ELLENCE [see Warnings and Precautions (5.2) ]. (pfizermedicalinformation.com)
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ELLENCE. (pfizermedicalinformation.com)
The aim of this study was to explore a role of EMDA®-MMC as first line salvage treatment in patients suffering from HGNMIBC unresponsive to BCG. (auanet.org)
The European Organization for Research and Treatment of Cancer (EORTC) Genito-Urinary Cancer Group (GUCG) has developed a scoring system and risk tables based on patients diagnosed with stage Ta or T1 tumours. (uk.com)
There are four types of treatment for patients with bladder cancer. (healthybladderclub.com)
GIF is classified as a signal transduction inhibitor [12] and its combination with metformin is used for treatment of bladder cancer via intravesical administration [13]. (ampksignal.com)
Next to oral treatment with tricyclic antidepressants or pentosan polysulphate, intravesical treatment can be used as well. (nv-holders.hu)
Bladder hydrodistension under anesthesia, tricyclic antidepressants, antihistaminics and intravesical DMSO instillations are the only treatment for which some evidence exists in the literature. (nv-holders.hu)
After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 24 weeks for 3 years. (clinicaltrialsgps.com)
15 BK virus-related HC is difficult to treat in these patients and, to date, the approach to treatment remains to be optimized. (uic.edu)
Background: The human resources for health crisis in rural Eswatini led to a novel community-based multidrug-resistant tuberculosis (MDR-TB) treatment strategy based on task-shifting, that is delegation of directly observed treatment (DOT) and administration of MDR-TB injections, traditionally restricted to professional nurses, to lay community treatment supporters (CTSs). (bvsalud.org)

In comparison to other FDA-approved treatments for this patient population, N-803 plus BCG significantly improved outcomes. (onclive.com)
In patients with cancer, MDSC are associated with adverse oncologic outcomes and therapeutic resistance. (iospress.com)

Patients underwent an EMDA®-MMC induction cycle (40 mg of MMC diluted in 100 ml of PPI retained in the bladder for 30 minutes with 20 mA pulsed electric current) of 6 weekly instillations and then a monthly maintenance cycle for a total of 6 treatments. (auanet.org)
A study of 40 patients failing one or more courses of BCG showed a disease-free rate of 53% at 24 months when they went on to receive 6-8 weekly instillations of low-dose BCG plus IFN-α [5]. (blogspot.com)

Valrubicin intravesical solution is recommended at a dose of 800 mg administered intravesically once a week for six weeks. (drugs.com)
Disease recurred in 32 patients (39%) treated with the standard dose and in 33 (45%) treated with the decreased dose. (nih.gov)
Four patients (6.1%) with Tis had local extension into the prostatic urethra and ducts, including 3 (8.3%) treated with the standard dose and 1 (3.4%) treated with the decreased dose. (nih.gov)
If not available, these patients and other high-risk patients may be given a reduced 1/2 to 1/3 dose, if feasible. (auanet.org)
A multicenter trial including 467 patients with previous BCG failure demonstrated a disease-free rate of 45% after being treated with reduced-dose BCG and IFN-α [6]. (blogspot.com)
Patient enrollment is ongoing in the open-label expansion trial (ADVANCED-1EXP), which is evaluating intravesical TARA-002 at the 40KE dose in 12 CIS patients, including BCG-naïve, BCG-unresponsive, and BCG-inadequately treated patients. (tipranks.com)

A total of nine patients were enrolled in the study, including three patients with CIS who reached the three-month efficacy assessment. (tipranks.com)

A small catheter was used to administer the drug in most cases, although particularly sensitive patients were treated by direct instillation with an Asepto syringe. (dmso.org)
Ultrasonography of the urinary tract: 1mL via intravesical bolus inj through the urinary catheter. (empr.com)

Grade 3 TRAEs occurred in just 2 patients and included urinary tract infection and arthralgia. (onclive.com)
LUMASON is the first and only FDA-approved CEUS agent indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux. (lumason.com)
The effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. (lumason.com)
A standard imaging test has been an X-ray examination with intravesical administration of an iodine contrast agent for assessment of the excretory urinary tract. (bracco.com)

Although many clinical trials are taking place, as of right now only a few confirmed treatments are being administered to patients. (wikipedia.org)
Treatments were repeated as often as necessary to control symptoms, ranging from weekly intervals in patients with severe symptoms up to periods of three to six months in patients with symptomatic relief. (dmso.org)
This group of patients did not receive any prior intravesical treatments, and there was no significant difference in recurrence-free survival at two years, although the IFN group did exhibit a higher incidence of constitutional symptoms and fever [4]. (blogspot.com)
Repeat treatments are costly and cause morbidity to patients so it is vital we use the most effective treatments available to mitigate this. (uk.com)
Patient reported outcome parameters are more frequently used to assess treatments in overactive bladder disease and in painful bladder research. (nv-holders.hu)

The side-effects of interferon include flu-like symptoms in patients who inject it for other conditions like multiple sclerosis. (biopharmadive.com)

For those who are ineligible for cisplatin-based regimens or experience progression of disease, in 2016-2017 the United States Food and Drug Administration approved five monoclonal antibodies that achieve immune checkpoint blockade by targeting the programmed cell death protein-1/programmed death-ligand 1 (PD-1/PD-L1) pathway. (iospress.com)

Evaluation of neutrophil-to-lymphocyte ratio prior to prostate biopsy to predict biopsy histology: Results of 1836 patients. (bahceci.com)

These highlights do not include all the information needed to use VALRUBICIN INTRAVESICAL SOLUTION safely and effectively. (drugs.com)
See full prescribing information for VALRUBICIN INTRAVESICAL SOLUTION. (drugs.com)
Warm valrubicin intravesical solution slowly to room temperature, but do not heat. (drugs.com)
Use caution when handling and preparing the solution of valrubicin intravesical solution. (drugs.com)
Evaluate the status of the bladder before the intravesical instillation of valrubicin intravesical solution. (drugs.com)
Handle and dispose of valrubicin intravesical solution in a manner consistent with other cytotoxic drugs. (drugs.com)
Valrubicin intravesical solution should be prepared and stored in glass, polypropylene, or polyolefin containers and tubing. (drugs.com)
Valrubicin intravesical solution is a clear red solution. (drugs.com)

Additional data showed that among patients who achieved an initial complete response at 3 months, there was a 64% (95% CI, 47.3%-77.3%) probability of maintaining that response at 12 months, and a 61% (95% CI, 43.2%-74.5%) probability of maintaining it at 18 months. (onclive.com)

Forty-50% of these patients experience recurrent disease. (auanet.org)

In a small cohort, intravesical IL-2 administered after incomplete TUR of low grade T1 papillary UC demonstrated regression of the "marker lesion" in 8 of 10 patients [13]. (blogspot.com)

There is some evidence to support improved recurrence free survival in intermediate risk patients [3], particularly those with multiple tumours at presentation. (uk.com)

Inform patients that ELLENCE can cause severe injection site reactions. (pfizermedicalinformation.com)
Advise patients to contact a healthcare provider if injection site pain occurs after receiving ELLENCE [see Warnings and Precautions (5.3) ]. (pfizermedicalinformation.com)
L'agrégation plaquettaire induite par le collagène dans des échantillons de plasma riche en plaquettes de 14 lapins sains a été mesurée par turbidimétrie en utilisant un agrégomètre, avant et une heure après une injection intra- veineuse d'alun. (who.int)

Advise patients to contact a healthcare provider should they develop any severe symptoms [see Adverse Reactions (6.1) ]. (pfizermedicalinformation.com)
Inform patients of the expected adverse effects of ELLENCE, including diarrhea, stomatitis, and alopecia [see Adverse Reactions (6.1) ]. (pfizermedicalinformation.com)
Advise patients that their urine may appear red for 1 to 2 days after administration of ELLENCE and that they should not be alarmed [see Adverse Reactions (6.2) ]. (pfizermedicalinformation.com)

Felix d'Herelle first coined the term "bacteriophage" ( 4 ), literally meaning "bacterium eater," and began using phages to treat bacterial infections in human patients ( Fig. 1 ). (asm.org)
A simple instillation protocol is bacterial prostatitis diagnostic criteria, meaning that the patient can move immediately after the instillation of the product. (nv-holders.hu)
C. Constantinides, T. Manousakas, P. Nikolopoulos, A. Stanitsas, K. Haritopoulos, A. Giannopoulos: Prevention of recurrent bacterial cystitis by intravesical administration of hyaluronic acid: a pilot study. (dunant.gr)

Use of Artificial Intelligence in Radiology: Impact on Pediatric Patients, a White Paper From the ACR Pediatric AI Workgroup. (stanford.edu)
Safety and effectiveness have not been established in pediatric patients. (cysview.com)
Safety of intravesical use of LUMASON was based on the evaluation of published literature involving the use of LUMASON in over 6000 pediatric patients. (lumason.com)

To identify markers that predict response to atezolizumab in the CIS population and that are associated with event-free survival (EFS) in patients with Ta/T1/CIS BCG-unresponsive non-muscle invasive bladder cancer. (clinicaltrialsgps.com)

The management of these patients requires a multidisciplinary approach involving urology, medical oncology, radiology and, occasionally, radiation oncology, palliative medicine and home care. (ivo.es)
Ultrasound scanning is patient-friendly and doesn't expose the patient to radiation, unlike X-ray imaging. (bracco.com)

This intravesical administration is quite favorable, and quite familiar amongst those who normally treat patients with BCG-unresponsive bladder cancer. (onclive.com)

Patients, nurses and investigators completed home instillation feasibility questionnaires. (yahoo.com)

The first patient dosed with ADSTILADRIN marks an incredible milestone for Ferring, the bladder cancer community and the patients we aim to serve," said Shetal Vyas, Vice President, General Manager, Uro-Oncology at Ferring Pharmaceuticals. (ferringusa.com)

Aside from the remission rates, Shore said nadofaragene firadenovec would differentiate itself from Keytruda in practice because its intravesical delivery means it could be administered by community-based urologists at outpatient clinics. (biopharmadive.com)

These reactions may occur in patients with no history of prior exposure to sulfur hexafluoride lipid-containing microspheres. (lumason.com)

However, this technique is not always appropriate, especially for patients who are at high risk for anesthesia, a multi-operated abdomen, or in recurrent prolapse. (intechopen.com)

Adequately treated Stage I or II cancer from which the patient is currently incomplete remission or other cancer from which the patient has been disease-free for 2 years. (bcan.org)
In a group of 48 patients whose cancer had spread to the connective tissue outside the bladder, 73% had no recurrence of serious disease at three months, which fell to 44% at 12 months. (biopharmadive.com)
BCG should not be used for patients with low-risk disease. (auanet.org)
However, patients with recurrence within one year did poorly, with a disease-free rate of 34-43% at two years. (blogspot.com)
The Service's team of professionals accompanies cancer patients throughout the whole disease process. (ivo.es)
Role of neutrophil-to-lymphocyte ratio in prediction of Gleason score upgrading and disease upstaging in low-risk prostate cancer patients eligible for active surveillance. (bahceci.com)

Anatomy12

Organisms7

Diseases21

Chemicals and Drugs17

Analytical, Diagnostic and Therapeutic Techniques and Equipment19

Psychiatry and Psychology1

Phenomena and Processes8

Anthropology, Education, Sociology and Social Phenomena1

Health Care2

Chemotherapy22

Transurethral resection6

Systemic11

Mitomycin8

Carcinoma13

Adjuvant1

Immunotherapy4

Additional intravesical therapy1

Therapies5

Weekly intravesical1

Intravenous5

Cystectomy9

Toxicity3

Urothelial4

Therapy26

Lesions1

Tumor13

Resection2

NMIBC14

TURBT4

Tumors1

Cytology1

Bacillus1

Treatment30

Outcomes2

Instillations2

Dose6

Efficacy1

Catheter2

Urinary tract4

Treatments5

Interferon1

Progression1

Histology1

Valrubicin8

Initial1

Recurrent disease1

Cohort1

Recurrence-free survival1

Injection3

Adverse3

Bacterial3

Pediatric Patients3

Invasive bladder cancer1

Radiation2

Favorable1

Feasibility1

Ferring1

Nadofaragene1

Exposure1

Anesthesia1

Disease6