Bladder Cancer Requiring CystectomySTENT-OPTNCT06595446
A Feasibility Randomized Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
A study testing Early Stent removal and Late Stent removal in people with Bladder Cancer Requiring Cystectomy and Ileal Conduit, run by Western University, Canada at 1 site in Canada.
Trial summary
Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Requiring Cystectomy, Ileal Conduit, Urinary Diversion
- What is being tested?
- Early Stent removal and Late Stent removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or older) undergoing radical cystectomy and ileal conduit formation for bladder cancer
- Able to give informed written consent to participate.
Who cannot join
- Treatment without curative intent (cT4b, salvage or palliative cystectomies);
- Patients undergoing alternative forms of urinary diversion (e.g. continent cutaneous urinary diversion or orthotopic neobladder formation)
- Patients previously received abdominal/pelvic radiotherapy
- Patients with concomitant upper urinary tract cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital
London, Ontario
Kaydee Connors, BsC, 519-685-8500 ext. 56366
About this study
Official title: A Feasibility Randomized Controlled Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%.
Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs.
Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).
- Being tested
- Early Stent removal, Late Stent removal
- Keywords
- Bladder cancer, Radical cystectomy, Stent dwell time, Complications, Ileal conduit
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Stent removalProcedure or surgery
Ureteral JJ stents removed 5-7 days after radical cystectomy and ileal conduit formation
Late Stent removalProcedure or surgery
Ureteral JJ stents removed 4-6 weeks after radical cystectomy and ileal conduit formation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Early Stent removal Receives: Procedure: Early Stent removal |
| Arm B | Active comparator | Late Stent removal Receives: Procedure: Late Stent removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates
Measured: within 30 days:
Feasibility Outcomes
- Recruitment Metrics:
- Recruitment Rates: Number of participants recruited versus the number of eligible patients.
- Screen Failures: Number of patients screened but found ineligible.
- Non-Consenting Rates: Number of eligible patients who decline participation.
- Protocol Adherence:
- Randomization Process Success: Rate of successful randomizations without errors.
- Protocol Violations / Deviations: Incidents where clinical needs required deviation from the protocol.
- Completion Rate: Proportion of participants who complete the study according to the protocol.
Measured: 1 year
Secondary outcomes (3)
Complication rates
Measured: within 90 days
Readmission rates
Measured: within 90 days
Complication rates
The secondary outcomes will also include composite Uretero-enteric anastomosis (UEA) complications after radical cystectomy and ileal conduit formation.
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start12 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder Cancer Requiring CystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Power, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595446
- Sponsor's protocol ID
- 125609
- Acronym
- STENT-OPT
- Status last verified
- Apr 2025
- First submitted
- 10 Sep 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17.
PubMed 32303901Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18.
PubMed 34416355Bhindi B, Kool R, Kulkarni GS, Siemens DR, Aprikian AG, Breau RH, Brimo F, Fairey A, French C, Hanna N, Izawa JI, Lacombe L, McPherson V, Rendon RA, Shayegan B, So AI, Zlotta AR, Black PC, Kassouf W. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text. Can Urol Assoc J. 2021 Aug;15(8):E424-E460. doi: 10.5489/cuaj.7367. No abstract available.
PubMed 33938798
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Controlled Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
- ClinicalTrials.gov ID
- NCT06595446
- Acronym / sponsor ID
- STENT-OPT / 125609
- Keywords
- Bladder cancer, Radical cystectomy, Stent dwell time, Complications, Ileal conduit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%.
Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs.
Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: Early Stent removalEarly Stent removal |
| Arm B | Active comparator | Procedure: Late Stent removalLate Stent removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years or older) undergoing radical cystectomy and ileal conduit formation for bladder cancer
- Able to give informed written consent to participate.
Key exclusion criteria (4 listed)
- Treatment without curative intent (cT4b, salvage or palliative cystectomies);
- Patients undergoing alternative forms of urinary diversion (e.g. continent cutaneous urinary diversion or orthotopic neobladder formation)
- Patients previously received abdominal/pelvic radiotherapy
- Patients with concomitant upper urinary tract cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Stent removalUreteral JJ stents removed 5-7 days after radical cystectomy and ileal conduit formation | Procedure or surgery | Arm A |
| Late Stent removalUreteral JJ stents removed 4-6 weeks after radical cystectomy and ileal conduit formation | Procedure or surgery | Arm B |
Primary outcome
Complication rates
Time frame: within 30 days:
Feasibility Outcomes
Time frame: 1 year
1. Recruitment Metrics: * Recruitment Rates: Number of participants recruited versus the number of eligible patients. * Screen Failures: Number of patients screened but found ineligible. * Non-Consenting Rates: Number of eligible patients who decline participation. 2. Protocol Adherence: * Randomization Process Success: Rate of successful randomizations without errors. * Protocol Violations / Deviations: Incidents where clinical needs required deviation from the protocol. * Completion Rate: Proportion of participants who complete the study according to the protocol.
3 secondary outcomes
Complication rates
Time frame: within 90 days
Readmission rates
Time frame: within 90 days
Complication rates
Time frame: within 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 32303901Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17.
- Background: PubMed 34416355Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18.
- Background: PubMed 33938798Bhindi B, Kool R, Kulkarni GS, Siemens DR, Aprikian AG, Breau RH, Brimo F, Fairey A, French C, Hanna N, Izawa JI, Lacombe L, McPherson V, Rendon RA, Shayegan B, So AI, Zlotta AR, Black PC, Kassouf W. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text. Can Urol Assoc J. 2021 Aug;15(8):E424-E460. doi: 10.5489/cuaj.7367. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Stent removal and Late Stent removal in people with Bladder Cancer Requiring Cystectomy and Ileal Conduit, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaydee Connors, BSc (519-685-8500 ext. 56366, kaydee.connors@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rates (time frame: within 30 days:). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595446, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.