Post-TURP Infectious ComplicationsNCT06168708
The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications.
A study testing Transurethral resection of the prostate (TURP), Gentamicin and normal saline in people with Post-TURP Infectious Complications, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Post-TURP Infectious Complications
- What is being tested?
- Transurethral resection of the prostate (TURP), Gentamicin and normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2023to 7 Jul 2024
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with enlarged prostate presenting with LUTS or urine retention
Who cannot join
- Unfit patients
- Renal impairment
- active UTI
- urethral strictures
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urolgy Departement, Faculty of Medicine, Tanta University
Tanta, Outside U.S./Canada, 6620010
Ahmed G. Zoeir, Ph D, +201008634198 ext. +2, drahmedzoeir27@gmail.com
About this study
Official title: The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.
The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.
the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).
Read the detailed description
220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, \& Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.
- Conditions
- Post-TURP Infectious Complications
- Being tested
- Transurethral resection of the prostate (TURP), Gentamicin, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of the prostate (TURP)Procedure or surgery
TURP with addition of gentamicin on irrigation fluid to reduce infectious complications
GentamicinDrug
gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation)
normal salineDrug
normal saline (2 ml) on the irrigation solution (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Garamicin group | Active comparator | the participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) Receives: Procedure: Transurethral resection of the prostate (TURP); Drug: Gentamicin |
| control group | Placebo comparator | the participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo). Receives: Procedure: Transurethral resection of the prostate (TURP); Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
infectious complications
Post-TURP pyuria and bacteruria
Measured: 1 week and 1 month after removal of urethral catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start7 Dec 2023 (estimated)
- Primary completion7 Jun 2024 (estimated)
- Study completion7 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-TURP Infectious ComplicationsStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zoeir, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168708
- Sponsor's protocol ID
- 35121/12/21
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Addition of Gentamicin on Irrigation Fluid in Prevention of Post-Transurethral Resection of the Prostate Infectious Complications: A Prospective Randomized Double Blinded Placebo Controlled Pilot Trial.
- ClinicalTrials.gov ID
- NCT06168708
- Acronym / sponsor ID
- 35121/12/21
- Conditions
- Post-TURP Infectious Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 7 Dec 2023 (estimated)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 7 Jul 2024 (estimated)
- First posted
- 13 Dec 2023 (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.
The aim of this clinical study is to evaluate the safety and efficacy of addition of gentamicin on irrigation fluid during trans-urethral resection of the prostate (TURP) and its role in reduction of post-TURP infectious complications.
the participants will be randomly divided into two groups: Group A (gentamicin group) and group B (Placebo).
Detailed description
220 patients scheduled for TURP for the management of urinary retention or LUTS will be included and divided into two groups; "Group A" includes 110 patients who will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) and "Group B" includes 110 patients who will undergo TURP with addition of normal saline (2 ml) as a placebo on the irrigation solution. Determination of Gentamicin in human serum using HPLC/UV after Chemical Derivatization will be done using the method of Barends et al (Barends, Brouwers, \& Hulshoff, 1987). Both groups will be compared as regards the demographic data, post-operative pyuria and bacteruria (1 week after removal of urethral catheter), fever, and/or sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garamicin group | Active comparator | Procedure: Transurethral resection of the prostate (TURP), Drug: Gentamicinthe participants in this arm will undergo TURP with addition of one ampoule of gentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) |
| control group | Placebo comparator | Procedure: Transurethral resection of the prostate (TURP), Drug: normal salinethe participants in this arm will undergo TURP with addition of normal saline (2 ml) on the irrigation solution (placebo). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with enlarged prostate presenting with LUTS or urine retention
Key exclusion criteria (4 listed)
- Unfit patients
- Renal impairment
- active UTI
- urethral strictures
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 |
|---|---|---|
| Transurethral resection of the prostate (TURP)TURP with addition of gentamicin on irrigation fluid to reduce infectious complications | Procedure or surgery | Garamicin group, control group |
| Gentamicingentamicin 80 mg (2ml) /3L of irrigation solution (the first 9 Liters during resection and the first 6 Liters during post-operative irrigation) | Drug | Garamicin group |
| normal salinenormal saline (2 ml) on the irrigation solution (placebo) | Drug | control group |
Primary outcome
infectious complications
Time frame: 1 week and 1 month after removal of urethral catheter
Post-TURP pyuria and bacteruria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral resection of the prostate (TURP), Gentamicin and normal saline in people with Post-TURP Infectious Complications, run by Tanta 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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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?
Contact Ahmed G. Zoeir, Ph D (+201008634198 ext. +2, drahmedzoeir27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infectious complications (time frame: 1 week and 1 month after removal of urethral catheter). 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 13 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.