Non Muscle-invasive Bladder CancerNCT02075060
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
A study testing IPOI and IPOP in people with Non Muscle-invasive Bladder Cancer, run by Poitiers University Hospital at 3 sites in France.
Trial summary
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early postoperative administration (IPOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle-invasive Bladder Cancer
- What is being tested?
- IPOI and IPOP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Feb 2014to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age > 18 years,
- Primary or recurrent bladder tumor with endoscopic papillary aspect,
- One or two bladder tumors,
- Cytology before RTUV showing no high-grade cells,
- Patients without tutorship or subordination (ou curatorship),
- Patients under the general social security system or qualifying through a third party,
- Informed consent signed by the patient after clear and fair information.
Who cannot join
- Age < 18 years,
- Allergy to mitomycin C,
- Traumatic stenting,
- Upper tract urothelial cancer,
- Urethral invasion,
- History of muscle invasive bladder cancer,
Show all 12Show fewer
- Extensive tumor (3 cm or more),
- Any contraindication to RTUV,
- Simultaneous participation in another clinical research study,
- Patients not insured by the social security or not qualifying through a third party,
- Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,
- Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Bicêtre Hospital
Le Kremlin-Bicêtre, 94270
Poitiers University Hospital
Poitiers, 86100
Rouen University Hospital
Rouen, 76000
About this study
Official title: Evaluation of Mitomycin C in Immediate Pre-operative Instillation (IPOI) of Endoscopic Resections of Bladder Tumors Compared to Early Post-operative Instillation (IPOP) : Multicentric, Randomized Study
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early postoperative administration (IPOP).
It's a national, multicenter, prospective, randomized, comparative study.
Read the detailed description
Methods. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score
- Conditions
- Non Muscle-invasive Bladder Cancer
- Being tested
- IPOI, IPOP
- Keywords
- low-grade, NMIBC
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPOIProcedure or surgery
It consists to an administration of Mitomycin C before the RTUV.
IPOPProcedure or surgery
It consists to an administration of Mitomycin C after the RTUV.
| Study group | Role | What they receive |
|---|---|---|
| IPOI | Experimental | One arm with pre-operative instillation of mitomycine 1h before RTUV (IPOI) Receives: Procedure: IPOI |
| IPOP | Active comparator | One arm with early post-operative instillation of mitomycine within 24 hours (IPOP) Receives: Procedure: IPOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease recurrence
Time to disease recurrence is defined as the time between resection and the first cystoscopy that detects a recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start17 Feb 2014
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques IRANI, MD, PhD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075060
- Sponsor's protocol ID
- IPOI vs IPOP
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2014
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Breton J, Bernardeau S, Vallee M, Pillot P, Lebacle C, Delpech PO, Charles T, Biscans C, Vallat A, Pfister C, Irani J. [Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial]. Prog Urol. 2021 Feb;31(2):63-70. doi: 10.1016/j.purol.2020.07.245. Epub 2020 Sep 3. French.
PubMed 32891506
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mitomycin C in Immediate Pre-operative Instillation (IPOI) of Endoscopic Resections of Bladder Tumors Compared to Early Post-operative Instillation (IPOP) : Multicentric, Randomized Study
- ClinicalTrials.gov ID
- NCT02075060
- Acronym / sponsor ID
- IPOI vs IPOP
- Conditions
- Non Muscle-invasive Bladder Cancer
- Keywords
- low-grade, NMIBC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2014 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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.
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early postoperative administration (IPOP).
It's a national, multicenter, prospective, randomized, comparative study.
Detailed description
Methods. We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPOI | Experimental | Procedure: IPOIOne arm with pre-operative instillation of mitomycine 1h before RTUV (IPOI) |
| IPOP | Active comparator | Procedure: IPOPOne arm with early post-operative instillation of mitomycine within 24 hours (IPOP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years,
- Primary or recurrent bladder tumor with endoscopic papillary aspect,
- One or two bladder tumors,
- Cytology before RTUV showing no high-grade cells,
- Patients without tutorship or subordination (ou curatorship),
Key exclusion criteria (12 listed)
- Age < 18 years,
- Allergy to mitomycin C,
- Traumatic stenting,
- Upper tract urothelial cancer,
- Urethral invasion,
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 |
|---|---|---|
| IPOIIt consists to an administration of Mitomycin C before the RTUV. | Procedure or surgery | IPOI |
| IPOPIt consists to an administration of Mitomycin C after the RTUV. | Procedure or surgery | IPOP |
Primary outcome
Time to disease recurrence
Time frame: 12 months
Time to disease recurrence is defined as the time between resection and the first cystoscopy that detects a recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 32891506Breton J, Bernardeau S, Vallee M, Pillot P, Lebacle C, Delpech PO, Charles T, Biscans C, Vallat A, Pfister C, Irani J. [Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial]. Prog Urol. 2021 Feb;31(2):63-70. doi: 10.1016/j.purol.2020.07.245. Epub 2020 Sep 3. French.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jacques IRANI, MD, PhD principal investigator
Poitiers University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPOI and IPOP in people with Non Muscle-invasive Bladder Cancer, run by Poitiers University Hospital at 3 sites in France.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease recurrence (time frame: 12 months). 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 NCT02075060, which also lists 1 linked publication.
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 2 Sep 2026.