Catheter ComplicationsNCT06345261
Diphenhydramine in Catheter Related Bladder Discomfort
A study testing DiphenhydrAMINE 50 Mg/mL Injectable Solution and Saline in people with Catheter Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action . Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Catheter Complications
- What is being tested?
- DiphenhydrAMINE 50 Mg/mL Injectable Solution and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 May 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r
Who cannot join
- overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time > 6 h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Diphenhydramine in Prevention of Catheter Related Bladder Discomfort
Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .
- Conditions
- Catheter Complications
- Being tested
- DiphenhydrAMINE 50 Mg/mL Injectable Solution, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydrAMINE 50 Mg/mL Injectable SolutionDrug
injection of Diphenhydramine 50 Mg/mL
SalineDrug
injection of saline
| Study group | Role | What they receive |
|---|---|---|
| Diphenhydramine group | Active comparator | Not described Receives: Drug: DiphenhydrAMINE 50 Mg/mL Injectable Solution |
| control group | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of catheter related bladder discomfort postoperative
- none, did not complain of any CRBD even upon asking.
- mild, revealed only on questioning.
- moderate, reported without questioning but not accompanied by any behavioral response.
- severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even attempting to pull out the urinary catheter
Measured: UP TO 6 HOURE
Secondary outcomes (1)
visual analog scale (VAS)
0 (no pain) to 10 (the worst imaginable pain)
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Amr s wahdan, MD, Principal investigator, Cairo university , Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345261
- Sponsor's protocol ID
- 2024-872
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diphenhydramine in Prevention of Catheter Related Bladder Discomfort
- ClinicalTrials.gov ID
- NCT06345261
- Acronym / sponsor ID
- 2024-872
- Conditions
- Catheter Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Apr 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.
Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diphenhydramine group | Active comparator | Drug: DiphenhydrAMINE 50 Mg/mL Injectable Solution |
| control group | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r
Key exclusion criteria (1 listed)
- overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time > 6 h
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 |
|---|---|---|
| DiphenhydrAMINE 50 Mg/mL Injectable Solutioninjection of Diphenhydramine 50 Mg/mL | Drug | Diphenhydramine group |
| Salineinjection of saline | Drug | control group |
Primary outcome
incidence of catheter related bladder discomfort postoperative
Time frame: UP TO 6 HOURE
* none, did not complain of any CRBD even upon asking. * mild, revealed only on questioning. * moderate, reported without questioning but not accompanied by any behavioral response. * severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even attempting to pull out the urinary catheter
1 secondary outcome
visual analog scale (VAS)
Time frame: up to 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided. still working
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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.
Amr s wahdan, MD principal investigator
Cairo university , Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiphenhydrAMINE 50 Mg/mL Injectable Solution and Saline in people with Catheter Complications, run by Cairo 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 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
incidence of catheter related bladder discomfort postoperative (time frame: UP TO 6 HOURE). 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 3 Apr 2024.