Bladder (Urothelial, Transitional Cell) CancerPhase 2/3NCT07279792
Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection
A Phase 2/3 study testing Continuous Bladder Irrigation with distilled water, Continuous Bladder Irrigation with normal saline and Continuous Bladder Irrigation with hypertonic saline in people with Bladder (Urothelial, Transitional Cell) Cancer and Nonmuscle Invasive Bladder Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer, Nonmuscle Invasive Bladder Cancer, Irrigation
- What is being tested?
- Continuous Bladder Irrigation with distilled water, Continuous Bladder Irrigation with normal saline and Continuous Bladder Irrigation with hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Sep 2025
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of non-muscle invasive urinary bladder urothelial carcinoma amenable for complete resection
Who cannot join
- Patients with post-operative complications that need prolonged irrigation.
- Patient who underwent incomplete resection during TURBT.
- When large bladder perforation was suspected during TURBT.
- Patients with chronic kidney disease.
- Muscle invasive disease
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Short term (6 months) recurrence and progression free survival are mainly evaluated.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Nonmuscle Invasive Bladder Cancer, Irrigation, Hypertonic Saline, Normal Saline, Distilled Water
- Being tested
- Continuous Bladder Irrigation with distilled water, Continuous Bladder Irrigation with normal saline, Continuous Bladder Irrigation with hypertonic saline
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Bladder Irrigation with distilled waterDrug
Continuous Bladder Irrigation with distilled water post non muscle invasive bladder cancer urethral resection by endoscopy
Continuous Bladder Irrigation with normal salineDrug
Continuous Bladder Irrigation with normal saline post non muscle invasive bladder cancer urethral resection by endoscopy
Continuous Bladder Irrigation with hypertonic salineDrug
Continuous Bladder Irrigation with hypertonic saline post non muscle invasive bladder cancer urethral resection by endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Continuous Bladder Irrigation with distilled water | Active comparator | Not described Receives: Drug: Continuous Bladder Irrigation with distilled water |
| Continuous Bladder Irrigation with normal saline | Active comparator | Not described Receives: Drug: Continuous Bladder Irrigation with normal saline |
| Continuous Bladder Irrigation with hypertonic saline | Active comparator | Not described Receives: Drug: Continuous Bladder Irrigation with hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Recurrence
Measured: 6 months
Risk of progression of bladder cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Oct 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279792
- Sponsor's protocol ID
- FMASU MS 685/2024
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection
- ClinicalTrials.gov ID
- NCT07279792
- Acronym / sponsor ID
- FMASU MS 685/2024
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Nonmuscle Invasive Bladder Cancer, Irrigation, Hypertonic Saline, Normal Saline, Distilled Water
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 12 Dec 2025 (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.
This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Short term (6 months) recurrence and progression free survival are mainly evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Bladder Irrigation with distilled water | Active comparator | Drug: Continuous Bladder Irrigation with distilled water |
| Continuous Bladder Irrigation with normal saline | Active comparator | Drug: Continuous Bladder Irrigation with normal saline |
| Continuous Bladder Irrigation with hypertonic saline | Active comparator | Drug: Continuous Bladder Irrigation with hypertonic saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of non-muscle invasive urinary bladder urothelial carcinoma amenable for complete resection
Key exclusion criteria (5 listed)
- Patients with post-operative complications that need prolonged irrigation.
- Patient who underwent incomplete resection during TURBT.
- When large bladder perforation was suspected during TURBT.
- Patients with chronic kidney disease.
- Muscle invasive disease
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 |
|---|---|---|
| Continuous Bladder Irrigation with distilled waterContinuous Bladder Irrigation with distilled water post non muscle invasive bladder cancer urethral resection by endoscopy | Drug | Continuous Bladder Irrigation with distilled water |
| Continuous Bladder Irrigation with normal salineContinuous Bladder Irrigation with normal saline post non muscle invasive bladder cancer urethral resection by endoscopy | Drug | Continuous Bladder Irrigation with normal saline |
| Continuous Bladder Irrigation with hypertonic salineContinuous Bladder Irrigation with hypertonic saline post non muscle invasive bladder cancer urethral resection by endoscopy | Drug | Continuous Bladder Irrigation with hypertonic saline |
Primary outcome
Risk of Recurrence
Time frame: 6 months
Risk of progression of bladder cancer
Time frame: 6 months
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 29 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Bladder (Urothelial, Transitional Cell) Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
Bladder Cancer, Urothelial Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Continuous Bladder Irrigation with distilled water, Continuous Bladder Irrigation with normal saline and Continuous Bladder Irrigation with hypertonic saline in people with Bladder (Urothelial, Transitional Cell) Cancer and Nonmuscle Invasive Bladder Cancer, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 5 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 29 Dec 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Risk of Recurrence (time frame: 6 months). 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?
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 29 Dec 2025.