joea73
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A very good question !!.
American Urological Association (AUA) guidelines recommend the surveillance after treatment as follows.
If the initial diagnosis was high risk non muscle invasive bladder cancers, i.e. T1HG or CIS, which I think was your case.
• Cystoscopy at 3 months
• Subsequent cystoscopy every 3–4 months for 2 years
• Then every 6 months until 5 years
• Life-long annual cystoscopies thereafterEuropean Association of Urology (EAU) guidelines have similar recommendation with life-long annual cystoscopies.
National Comprehensive Cancer Network (NCCN) guidelines say 10 year annual cystoscopies, then shared decision on surveillance.
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BCG can often cause changes to cells of the lining of bladder. According to a study, within 100 days after BCG treatment, sensitivity ( there is a tumor when cytology says positive) was 62% vs 82% when cytology was done after 100 days of BCG treatment, meaning that false positive rate increases by over 20% when cytology was done within 100 days after BCG treatment.
In another study, translucent nuclei and prominent nucleoli, vacuolization of cytoplasm, and eosinophilic cytoplasmic inclusions were frequently observed in urothelial cells as well as an increase in granulocytes, especially within 3 months after BCG instillation therapy.
It is possible that the cytopathologist was not told that you had BCG treatment, otherwise the report could be more specific rather than just several clusters of atypical urothelial cells.
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FDA approved to review resubmitted biologic license application (BLA) of ImmunityBio’s N-803 in combination BCG, for the treatment of certain patients with BCG-unresponsive non muscle invasive bladder cancers.
FDA set a new target action date of April 23, 2024, for the application, so hopefully the new treatment for BCG unresponsive will become available in the first half of 2024.
It is a good news for BCG Unresponsive. I was very disappointed when FDA rejected the approval back in May not because of its effectiveness but rather because the contracted 3rd party manufacturer did not meet the requirement for Good Manufacturing Process. There is a class action from investors claiming that ImmunityBio failed to disclose the problem with the contracted manufacturer. So, I was concerned that ImmunityBio might choose bankruptcy and N-803 would not become accessible to patients with BCG Unresponsive. But ImmunityBio was able to secure financing of $400M by debt and equity last month, so I think the company will stay viable. The FDA has set a user fee goal date (PDUFA date) of April 23, 2024, the FDA must complete by April 23, 2024 the review of ImmunityBio’s Biological License Agreement(BLA) of N-803. So, we can expect that N-803 will be available by April 23, 2024 granted that FDA approves the new BLA by ImmunityBio. FDA charges $4M for the review if clinical data are involved and $2M if clinical data are not involved.
Incidentally, what ImmunityBio applied to FDA is the combination of N-803 and BCG for BC Unresponsive CIS with or without papillary tumors. N-803 is Natural Killer cells (NK-cells) activator based upon IL-15 (immune signaling molecule). N-803 alone probably did not have enough effectiveness . Till recently BCG+Interferon alpha 2b were used for BCG Unresponsive. BCG and Interferon alpha 2b were instilled in bladder so it was easier transition for patients to switch from BCG to BCG+Interferon alpha 2b. Merck dropped interferon alpha 2b business so this has become unavailable. I was not happy with MERCK”s sudden withdrawal from Interferon alpha 2b business because MERCK was the only manufacture for it. Merck instead is now conducting global clinical trial for BCG + immunotherapy drug Pembrolizumab (keytruda) for BCG unresponsive,butPembrolizumab is systemic treatment with systemic side effects. On the other hand, N-803 and BCG are instilled to bladder just like BCG+Interferon alha 2b, so it must be easy transition for patients who has been treated with BCG.This is an example how IL-15 activates idling NK-cells and kill ovarian cancers.
https://www.youtube.com/watch?v=H3joxXidb3MInterstingly,Patrick Soon-Shiong P who is the Company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer in well known figure in medical world as the first surgen to perform pancreatic transplant, entrepreneur to start up several pharmaceutical companies and billionaire who had owned San Diago Tribune till recently and the owner and exectuive chairman of Los Angels Times, and a minority owner of Los Angels Lakers. He is also an investor and owns investing company Nant Capital. Nant Capital is the one who bought $200M worth shares from ImmunityBio. Though the stock price of ImmunityBIo is just above $2 per share, it was over $30 back in eary 2021. It was when ImmunityBio was developing vaccine for Covid-19, which did not materialize as Moderna and Pfizer became dominant suppliers for mRNA based covid-19 vaccine. Patrick Soon-Shiong is well versed with pharmaceutical industry with probably every personal connection in the field including FDA, so in this sense,, I feel more confident that N-803 will become available.
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Good points.
I see the tendency is to overtreat than undertreat cancers, but I think it makes a sense as long as overtreat become hazards.
Dr. Michael O’Donnell of University of Iowa has done many studies for intravesical chemotherapies. So, there must have been a reason why he used 6 weekly induction + monthly maintenance up to 2 years when he decided to try GEM/DOC treatment. Once a certain treatment protocol is established with a good efficacy with acceptable side effects, i see the treatment protocol usually does not change. But, how each patient reacts to the treatment is different so the protocol is adjusted by pausing the treatment or dose reduction to deal with individual cases.
Incidentally, the recent result of retrospective study in regards to side effects between GEM/DOC vs BCG says the early termination of the treatment due to side effects is 2.9% with GEM/DOC and 9.2% with BCG indicates less toxicity of GEM/DOC vs BCG.
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I am NOT qualified to answer to your question from personal experience as I have not been treated with BCG. But I have seen some posting similar situation that though mycobacterium tuberculosis was not confirmed but the patient went on 9 months with multiple antibiotics treatment specific for tuberculosis treatment. Tuberculosis caused by intravesical BCG is so rate that only 1 case is reported in a year in the State of California. In the US with population of 330 million, 7,102 cases of tuberculosis were reported to Center of Disease Control (CDC), of which 121 cases were Bovine tuberculosis which is caused by Mycobacterium bovis, (M. bovis)). BCG is attenuated M.bovis. Majority of 121 people who contracted Bovis tuberculosis are from Mexico and other countries of the south of border. The reason why they developed Bovine tuberculosis is because they eat unpasteurized cheese and drink unpasteurized milk. Some live in Michigan. Deer’s they hunt and eat could have caused people get infected with M. bovis or sometimes butcher get infected from the cut. MERCK manufactures about 800K vials of BCG for bladder cancers each year, so I estimate that 300-500 vials of BCG are prescribe in the US each year. So, it must be extremely rare that BCG treatment causes Bovis tuberculosis.
Dr. Lamm who is considered as a guru of treating NMIBC with BCG published in 1986 on BCG toxicity and its treatment. If patients suffer severe or prolonged symptoms, treatment wit 300mg isoniazid daily, which I believe is one of antibiotics you are taking, and , diphenhydramine (antihistamine) and acetaminophen (pain reliever) or ibuprofen is (anti-inflammatory drug recommended. But it sounds like he did not put the patient with other antibiotics for tuberculosis. Most of the patients with high fever in his experience were not hospitalized but if patients with a simple uncomplicated febrile response to BCG cannot be distinguished from those who will suffer systemic BCG infection or anaphylaxis. Therefore, we recommend that such patients be hospitalized and treated with antituberculous antibiotics ‘
Dr. Michael O’Donnell of University of Iowa, another GURU for NMIBC authored the article on Infectious complications of intravesical BCG immunotherapy.
Localized persistent cystitis (manifested as severe urgency, frequency, and dysuria) even after discontinuing BCG suggest development of BCG cystitis. This is an uncommon condition that presents with systemic symptoms and sterile pyuria (eg abnormal urinalysis with negative bacterial cultures). Symptoms may continue for weeks to months despite antimycobacterial therapy, suggesting a hypersensitivity component. Cystoscopically, the bladder appears red, beefy, and irritated, typically with acute and granulomatous inflammation. In cases of severe BCG cystitis, systemic steroids (in the form of a three to six-week [rapid to slow] prednisone taper) can provide rapid and durable relief from unremitting cystitis symptom. Given risk for potentiating BCG spread, the patient should be maintained on antimycobacterial therapy while on steroids.
https://www.medilib.ir/uptodate/show/2973#rid22
Since CT did not find anything like tuberculosis in your chest, it will be difficult diagnose if you developed M.bovis tuberculosis or not. So, I guess they are doing the treatment for tuberculosis as precautional manner.
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I saw a presentation by Dr. Ashish Kamat of MD ANDERSONS explaining that the reason why BCG is administered thee weeks for maintenance is because the immune response peaks at at 3rd dose, and start declining if the 4h dose is given. They tested the amount of interleukin-2 in urine which regulates CD8 T-cell. CD-T-cells kill BCG infected bladder cancer cells. Declining of interleukin-2 indicates that T-cells are being exhausted. Note that for the same reason, 6 weeks administration of BCG are considered optimum. There are so called memory T-cells. Though most T-cells initially invoked by BCG die 2-3 days after they are invoked by BCG, some percentage of T-cells continue to live. Technically speaking though I do not know how long Memory T-cells live off hand, Memory T-cells give durability of BCG treatment. A case in point, BCG treatment gives about 55% complete response for CIS by initial 6 weeks treatment, but the complete response rate increases to 85% at 9 months without maintenance treatment. This is due to Memory T-cells.
Chemotherapy uses body’s ability to lead cell to Apoptosis (Self Death) when a cell division cycle. fails. Gemcitabine interferes the process of DNA replication in early part of cell division cycle and Docetaxel interferes building of microtubules just before the cell divides into two daughter cells. In both cases, it invokes apoptosis, killing cancer cell. Actually kills normal cells too but normal cell do not go into cell division cycle often whereas cancer cells are constantly dividing. So, chemotherapy kills many cancer cells but a few healthy cells. Chemotherapy does not offer durability as BCG does not rely on immune systems as BCG treatment does.
I do not know when and how they came up with 6 weeks initial treatment for intravesical chemotherapy. Intravesical chemotherapy was first used in 1903 and various chemo agent were tried. I see 1995 publication of a study tested Epirubicin for CIS and T1HG. Patients were given intravesical Epirubicin for weekly for 10 weeks without maintenance. In the current AUA guidelines, a six week course of intravesical chemotherapy or immunotherapy is recommended. Also, it says that in an intermediate patient who completely responded to an induction course of intravesical chemotherapy, a clinician may utilize maintenance therapy. It does not say how often at what interval.
Dr. Michael O’Donnell of Univ of Iowa is know as a early guru for NMIBC along with Dr. Lamm of Univ of Arizona. Dr. Michael O’donnell is considered as a guru for intravesical chemotherapy, and devised six new intravesical chemotherapy treatment. Dr. O’Donnell began studying of intravesical chemotherapy combinations over two decades. So, probably we can take the treatment protocol 6 weeks + monthly maintenance as the result of his years of study and clinical experiences which gave the most efficacy with acceptable toxicity.
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I have never seen such description. It does not look like pathology report as it does not say grade or stage of the tumor samples.
According to internet, a neoplasm is an abnormal growth of tissue that can be benign (noncancerous) or malignant (cancerous), so malignant neoplasm of bladder seems to mean bladder cancer. Unspecified means the location or type of the tumor was not specified.
“Malignant neoplasm of bladder, unspecified” is the description of code C67.9 which is billable code. ICD-10-CM is international classification of disease. The US developed a clinical modification (ICD-10CM) for medial diagnoses based upon WHO’s ICD-10 and CMS developed a new Procedure Coding System. See blow the coding system and its description. The urologist who examined your bladder should know the location of the tumor. So, I do not know why the location of the tumor was unspecified. Also, I do not know who prepared the report and gave it to you. See the link below.
2023 ICD-10-CM Diagnosis Code C67.9
Malignant neoplasm of bladder, unspecified.C67 Malignant neoplasm of bladder
C67.0 Malignant neoplasm of trigone of bladder
C67.1 Malignant neoplasm of dome of bladder
C67.2 Malignant neoplasm of lateral wall of bladder
C67. 3 Malignant neoplasm of anterior wall of bladder
C67. 4 Malignant neoplasm of posterior wall of bladder
C67.5 Malignant neoplasm of bladder neck
C67.6 Malignant neoplasm of ureteric orifice
C67.7 Malignant neoplasm of urachus
C67.8 Malignant neoplasm of overlapping sites of bladder
C67.9 Malignant neoplasm of bladder, unspecifiedhttps://www.icd10data.com/ICD10CM/Codes/C00-D49/C64-C68/C67-/C67.9
You need to click the square next to the US flag to see -
Moderna mRNA based cancer vaccine for Non Muscle Invasive Bladder Cancers (NMIBC) Phase 2 seems to have progressed well and GlobaLData which is data and analytic provider posted an article on August 30, stating Moderna mRNA-4359 + Keytruda combination for NMIBC has a 72% phase transition success rate (PTSR) indicating bench mark for progressing to Phase 3. Below shows the history of FDA approving phase transitions for oncology drugs between 2011-2020.
Phase 1 to 2 1628 Phase POS 48.8%
Phase 2 to 3 1732 Phase POS 24.6%
Phase 3 to NDA/BLA 496 Phase POS 47.7%
NDA/BLA to Approval 324 Phase POS 92.0%Phase transition success rate (PTSR) is only 24.6% for oncology related treatment. So, 72% PTSR indicates Moderna-4359 + Keytruda combination must have had very good result for NMIB. It is not certain whether and when Moderna and Merck want to start Phase 3 clinical trial for Moderna-4359 mRNA based vaccine with combination of Keytruda PD-1 check point inhibitor immunotherapy but had they decided to go ahead with Phase 3, it is highly likely FDA will approve Phase 3 to be started.
Note that I do not now how data and analytic provider gained the result of Phase 2 study, I am very curious what kind of antigens Moderna had chosen for NIMBC. Also, we want to know the detail result of Phase 2.
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Cancer vaccines utilizing mRNA vaccine technology have such potential that ARPA-H, a newly established White House-originated program, has made it the focus of its first ever grant, announced August 23, 2023. The total grant is $25 million over three years, to be split among teams at Emory University, Yale School of Medicine, and the Georgia Tech teams at the three institutions are working together to strive to harness the natural immune system for development of personalized therapeutic vaccines against cancer and emerging infections, along the lines of how the mRNA vaccine targets SARS-CoV-2.
The multi-institutional team will be studying how to advance technology from the burgeoning mRNA vaccine field to program dendritic cells to produce therapeutic immune reactions, with personalized cancer vaccines as the ultimate goal.
The teams are working together to use mRNA—the essential element of vaccines that were developed to prevent COVID-19 infection—to program the dendritic cells to process antigenic proteins, thereby triggering selective immunological responses. “The mRNA teaches these dendritic cells how to ignite the desired systemic immune reaction,” says Edelson, former chair of Yale Dermatology and a past director of Yale Cancer Center. “Without understating the challenges ahead, the possibilities are immense.”
It is interesting the team will focus on dendritic cells. Dendritic cells that take pieces of protein from antigens from cancer cells and deliver it to our immune system, and our immune system produce bunch of T-cells which will attack the cancer cell. Moderna and BioNTeck solutions so far are clinical application on what our body immune system already naturally responds to neoantigens which our body produces from mRNAs which those companies synthesized.
Dr. Philip Santangelo of Georgia Tech and Emory Univ. leads the project. His main research has been RNA and mRNA. He seems to be able to use mRNA as tinker toy to do various tasks.
https://bme.gatech.edu/bme/news/researchers-successfully-use-mrna-activate-genes
Dr. Richard Edelson (MD) of Yale, professor of Dermatology, who was director of immunology at Columbia Univ leads the Yale group, who received $6.5M. Dr. Edelson says “Our work will hopefully forge closer collaboration between physicians and the natural immune system itself,” says Edelson. While Ralph Steinman of Rockefeller University received the 2011 Nobel Prize in Physiology for his discovery of dendritic cells, efforts to translate that breakthrough into treatments for cancer and serious infections have been stymied by two key scientific roadblocks: need to understand how the body naturally produces dendritic cells that function well in patients, and learning how to efficiently program these pivotal cells to produce desirable therapeutic responses. Now that those two roadblocks have been scientifically overcome, exciting opportunities to develop potent dendritic cell vaccines may be on the near-term horizon. ”
In his lab, his team has been striving to figure out how to turn the immune system back on so that it will reject the cancer just as it would a transplanted organ. “It’s potentially the ultimate cancer therapy,” he says. -
There are always exceptions, but it is known that low grade will not change to high grade. Cancer rise because of malfunction/mutation of genes. Sometimes low grade and high grade are different cancers because low grade and high grade tumors have different profile at gene mutations. 60% of low grade tumors have mutation in genes (FGFR) from which Fibroblast Growth Factor Receptor (FGFR) protein is produced. When a cell which makes up the lining of bladder gets old, our body sends a signal to replace it with new cells. Only when FGFR receives the signal, FGFR initiates metabolic process to produce new cells. When FGFR gene is mutated, sometimes FGFR protein initiates metabolic process of producing new cells even without receiving the signal from our body. In this way, cancer cell continue to multiply without stop, growing the size of the cancer tissue. But low grade cancer will not break through the basement or basal layer of the lining of bladder into connective tissue and to muscle tissue.
High grade tumor tend to show mutations of different genes, especially TP53. P53 protein which is produced based on TP53 gene template plays very important role in suppressing the creation of tumor. P53 protein involves in initiating apoptosis ( self death) of cells of which DNA was damaged and cannot be repaired. When P53 protein does not function properly because TP53 gene mutation, our body will allow DNA damaged with gene mutation cell to live and reproduce. High grade tumor if not treated can progress to connective tissue and muscle tissue. As muscle tissue have many blood vessels and lymphatic vessels. bladder cancer cells can get into a blood vessel and lymphatic vessel and circulate in the body and land to other organs and grow as metastasis.
There are a few generally accepted reasons of high recurrence of non muscle bladder cancers. One is that fragments from the original tumor implant to the lining of bladder during the initial TURBT. The guidelines recommend that when urologist thinks it is low grade in cystoscopy, intravesical chemotherapy is administered within 24 hours. Statistically, this procedure has reduced about 10% of recurrence. Another reason is that toxicity which was excreted from kidneys, which could have contributed in the rising of cancer was also affecting other parts of the lining of the bladder.
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Hi JigStep,
Very interesting !!!
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I was surprised to hear you were told BCG was in shortage. The BCG shortage was caused by Merck’s old single production line in Durham, NC could not produce enough BCG to the demand. Because BCG is live bacteria, production volume is not always predictable.
I have thought BCG shortage was subsided as several European countries switched BCG from Merck Onco-Tice BCG to BCG -Medac by Medac in Germany. I have not seen any official announcement from Merck or in media about BCG shortage recently. So, it is likely be short term. Merck uses her distributors of Merck vaccine products for BCG distribution. So, whoever in charge of securing BCG for you can find about particular status of BCG supply can contact Merck’s distributor if they want to. Below is what Merck’s website says.
Any hospitals/hospital pharmacies/medical practices that have questions regarding a specific allocation should contact their wholesaler or distributor. Health care providers with questions may contact the Merck National Service Center at 1-800-672-6372.
best
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Phase I clinical trial of mRNA based cancer vaccine for pancreas cancer
The result of Phase I clinical trial of mRNA based cancer vaccine for pancreas cancer was published on May 10, 2023 in Nature.
PDAC (Pancreas Duct Adeno Carcinoma) is the the third leading cause of cancer death in the US. The survival rate of 12% has remained stagnant for 60 years. Surgery is the only curative treatment, yet 90% of patients have disease recurrence at median 7-9 months. Multiagent chemotherapy delay recurrence but the 5 years overall survival is only 8-10%. PDAC us insensitive to immunotherapy with less than 5% response rate. However, recent observations have shown that most PDACs in fact harbor more neoantigens. This has shown a possibility that vaccine against those neoantigens may work for PDAC. Subsequently, MSK ( Memorial Sloan Kettering Cancer Center) initiated Phase 1 clinical trial, which was funded by NIH( National Institute of Health) and it result was published in Nature.
The project was led by Dr. Balachandran of MSK with collaboration with Genentech, a member of the Roche Group, and BioNTech. BioNTech provided mRNA technology, which was used for Pfizer mRNA based Covid-19 vaccine, and Genentech provided PD-L1 checkpoint inhibitor immunotherapy drug Tecentriq(R) (Atezolizumab). MSK used its own IMPACT (Integrated Profiling of Actionable Cancer Targets) to identify specific gene mutation from patients pancreas cancer tissue.
The clinical trial
After surgery to remove PDAC, the team sent tumor samples from 19 people to partners at BioNTech. BioNTech performed gene sequencing on the tumors to find proteins that might trigger an immune response. They then used that information to create a personalized mRNA vaccine for each patient. Each vaccine targeted up to 20 neoantigens. Customized vaccines were successfully created for 18 of the 19 study participants. The process, from surgery to delivery of the first dose of the vaccine, took an average of about nine weeks. All patients received immunotherapy drug Tecentriq before vaccination. Tecentriq prevents cancer cells from suppressing the immune system. The vaccine was then given in nine doses over several months. After the first eight doses, study participants also started standard chemotherapy drugs for PDAC, followed by a ninth booster dose.
Sixteen volunteers stayed healthy enough to receive at least some of the vaccine doses. In half these patients, the vaccines activated powerful immune cells, called T cells, that could recognize the pancreatic cancer specific to the patient. To track the T cells made after vaccination, the research team developed a novel computational strategy with the lab of Dr. Benjamin Greenbaum at MSKCC. Their analysis showed that T cells that recognized the neoantigens were not found in the blood before vaccination. Among the eight patients with strong immune responses, half had T cells target more than one vaccine neoantigen.
By a year and a half after treatment, the cancer had not returned in any of the people who had a strong T cell response to the vaccine (50%). In contrast, among those whose immune systems didn’t respond to the vaccine, the cancer recurred within an average of just over a year (50%). In one patient with a strong response, T cells produced by the vaccine even appeared to eliminate a small tumor that had spread to the liver. These results suggest that the T cells activated by the vaccines kept the pancreatic cancers in check.
They do not not know 50% of patients responded well to the vaccine but 50% did not.It took only 9 weeks from the surgery, taking patients’ tissue sample of pancreas cancer, MSK to identify cancer related gene mutation, BioNTech to produce mRNA based vaccine for about 20 patient specific neoantigens, and till first injection of the vaccine.
A larger clinical trial at global level is in the plan according to the article. Below are the link to related article and studies.
https://www.nih.gov/news-events/nih-research-matters/mrna-vaccine-treat-pancreatic-cancer
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Hi Jnani,
Thanks for posting new treatment for cancers. I had no idea what EBC-46 till you had posted. It is quite interesting drug which can kill cancers. The link you provided was the work Stanford PhD student did, which was to successfully synthesize EBC-46, technical term Tigilanol tailgate which is extract from seed of blushwood plant, which is grown only in rain forest of Northern Australia. EBC-46 was developed by QBiotics in Australia. EBC-46 is sold under Stelfonta, which was approved by FDA in 2021 for the treatment of mast call cancers to treat dogs with cutaneous (skin) non-metastatic mast cell cancers anywhere in the body or subcutaneous (underskin) non-metastatic mast cell cancers below elbow or below ankle of dog. Stelfonta is injected directly to tumor. Mast cell cancer is the most common skin cancer among dogs. The first line treatment is to remove the tumor by surgery with 3 cm margin. So, the surgery will leave large open wound and looking after open wound is challenging for dog owner. Stelfonta (EBC-46) is intratumoral treatment and usually it will not require anesthesia. After the injection, tumor starts breaking down. Once tumor dies, it has self healing process. Incidentally, BCG which is used to treat bladder cancer was tried first to treat malignant melanoma in human by injecting directly to tumor as early as late 1960s. BCG invoked immune responses and killed the tumor. Stelfonta (EBC-46) works different. It targets a protein called Protein KInase C (PKC) that, when inhibited, prevents tumor cells from making proteins that help them live. EBC-46 may be a novel drug, but its target PKC is not new. PKC has been targeted by several compounds. One such compound was tried for relapsed or refractory malignancies, But the Phase I clinical trial was halted due to severe side effects. Note that EBC-46 was given intravenously.
For human, QBiotics, the sole manufacturer of Stelfonta (EBC-46) sponsored Phase I clinical trial in Australia for solid tumor (Melanoma,etc.). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921293/
It seems the result from Phase I was good enough for Phase II trial. We need wait and see if someone tries for bladder cancers.
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There are two patients support groups for Indiana pouch which I am aware of.
Sandy hosts monthly Zoom meetings for patients with Indiana pouch.
weichersandy@gmail.comNeobladder and Indiana pouch patients support group in British Columbia, Canada
I believe it is held bi-monthly. Fiona – ostomy nurse is hosting Zoom based
support group.bcurinarycontinentdiversions@gmail.com
Discussion board
Below is the link to discussion board of UOAA (United Ostomy Discussion Board)
https://www.uoaa.org/forum/search.php?keywords=indiana+pouch&sid=c42b11b819164ae271946bdc8a7d2cbcA catheter manufacturer site says as follows on incontinency after Indiana pouch surgery.
Incontinence: urine leakage occurs more frequently during the first few months as the pouch is still learning to hold urine. But it can also occur if the ileocecal valve is not totally continent, or if the pouch goes too long without catheterization.