PSA Changes After TURPNCT05533047
Serum Prostatic Specific Antigen Changes After Bipolar and Monopolar TURP
A study testing TURP in people with PSA Changes After TURP, run by Assiut University.
Trial summary
To use PSA levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection . Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- PSA Changes After TURP
- What is being tested?
- TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2023
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients agreeing to participate, clinically fit, age from 50 to 80 years with LUTS related to benign prostate enlargement with no neurological disorder
Who cannot join
- Prostate cancer
- Previous urethral or prostate surgery
- Neurogenic bladder
- Urethral stricture
- Patient unfit for surgery
Trial locations and contacts
No sites are listed yet.
Andrew H Wahba Gerges, Resident doctor contact
About this study
Official title: Serum Prostatic Specific Antigen (PSA) Changes After Bipolar and Monopolar Transurethral Resection of the Benign Prostatic Hyperplasia, a Randomized Controlled Study.
To use PSA levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection .
Read the detailed description
PSA is a protein produced from the prostate epithelium and secreted in semen in huge amounts , small amount find its way to the circulation ,its function is to allow mobility of the sperms by interacting with the Semenogelin . clinical BPH can be defined as prostate adenoma/adenomata, causing a varying degree of BOO, which may eventually cause harm to the patients ,Treatment of this condition varies from conservative, medical and surgical depending on factors related to the patient and the surgeon preference . The early reports of minimally invasive treatment of the prostate dated back to 1937, since then and remarkable development is noticed . TURP is the golden treatment in the BPH . Studies compare between the methods according the blood transfusion , operation time retention after catheter removal , urethral complications , TUR syndrome and hospital-stay which show that bipolar is better. To our knowledge after few studies compare between the techniques according PSA also these studies show weakness in their statistically analysis with no difference between the methods .investigators aim is to study the effect of the operations on PSA levels as an indicator of the quality of resection.
- Conditions
- PSA Changes After TURP
- Being tested
- TURP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
Bipolar and monopolar transurethral resection of the benign prostatic hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| Bipolar TURP | Active comparator | Patients thats will undergo bipolar TURP Receives: Procedure: TURP |
| Monopolar TURP | Active comparator | Patients thats will undergo monopolar TURP Receives: Procedure: TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum PSA changes after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia
To use PSA levels changes after both techniques (bipolar and monopolar transurethral resection of the benign prostatic hyperplasia)as an indicator of the quality of resection
Measured: within one month after intervention
Secondary outcomes (1)
International Prostate Symptom Score
International Prostate Symptom Score after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia
Measured: within one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PSA Changes After TURPStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hamam Wahba Gerges, Assiut University
- Investigators
- Mohamed A Elgamal, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533047
- Sponsor's protocol ID
- PSA Changes after TURP
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geavlete B, Georgescu D, Multescu R, Stanescu F, Jecu M, Geavlete P. Bipolar plasma vaporization vs monopolar and bipolar TURP-A prospective, randomized, long-term comparison. Urology. 2011 Oct;78(4):930-5. doi: 10.1016/j.urology.2011.03.072. Epub 2011 Jul 29.
PubMed 21802121Pahwa M, Pahwa M, Pahwa AR, Girotra M, Chawla A, Sharma A. Changes in S-PSA after transurethral resection of prostate and its correlation to postoperative outcome. Int Urol Nephrol. 2013 Aug;45(4):943-9. doi: 10.1007/s11255-013-0474-3. Epub 2013 May 24.
PubMed 23703547
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Prostatic Specific Antigen (PSA) Changes After Bipolar and Monopolar Transurethral Resection of the Benign Prostatic Hyperplasia, a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05533047
- Acronym / sponsor ID
- PSA Changes after TURP
- Conditions
- PSA Changes After TURP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
To use PSA levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection .
Detailed description
PSA is a protein produced from the prostate epithelium and secreted in semen in huge amounts , small amount find its way to the circulation ,its function is to allow mobility of the sperms by interacting with the Semenogelin . clinical BPH can be defined as prostate adenoma/adenomata, causing a varying degree of BOO, which may eventually cause harm to the patients ,Treatment of this condition varies from conservative, medical and surgical depending on factors related to the patient and the surgeon preference . The early reports of minimally invasive treatment of the prostate dated back to 1937, since then and remarkable development is noticed . TURP is the golden treatment in the BPH . Studies compare between the methods according the blood transfusion , operation time retention after catheter removal , urethral complications , TUR syndrome and hospital-stay which show that bipolar is better. To our knowledge after few studies compare between the techniques according PSA also these studies show weakness in their statistically analysis with no difference between the methods .investigators aim is to study the effect of the operations on PSA levels as an indicator of the quality of resection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar TURP | Active comparator | Procedure: TURPPatients thats will undergo bipolar TURP |
| Monopolar TURP | Active comparator | Procedure: TURPPatients thats will undergo monopolar TURP |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients agreeing to participate, clinically fit, age from 50 to 80 years with LUTS related to benign prostate enlargement with no neurological disorder
Key exclusion criteria (5 listed)
- Prostate cancer
- Previous urethral or prostate surgery
- Neurogenic bladder
- Urethral stricture
- Patient unfit for surgery
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 |
|---|---|---|
| TURPBipolar and monopolar transurethral resection of the benign prostatic hyperplasia | Procedure or surgery | Bipolar TURP, Monopolar TURP |
Primary outcome
serum PSA changes after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia
Time frame: within one month after intervention
To use PSA levels changes after both techniques (bipolar and monopolar transurethral resection of the benign prostatic hyperplasia)as an indicator of the quality of resection
1 secondary outcome
International Prostate Symptom Score
Time frame: within one month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Results publication: PubMed 21802121Geavlete B, Georgescu D, Multescu R, Stanescu F, Jecu M, Geavlete P. Bipolar plasma vaporization vs monopolar and bipolar TURP-A prospective, randomized, long-term comparison. Urology. 2011 Oct;78(4):930-5. doi: 10.1016/j.urology.2011.03.072. Epub 2011 Jul 29.
- Results publication: PubMed 23703547Pahwa M, Pahwa M, Pahwa AR, Girotra M, Chawla A, Sharma A. Changes in S-PSA after transurethral resection of prostate and its correlation to postoperative outcome. Int Urol Nephrol. 2013 Aug;45(4):943-9. doi: 10.1007/s11255-013-0474-3. Epub 2013 May 24.
- Individual participant dataSharing planned: Undecided
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.
Andrew H Wahba Gerges, Resident doctor contact
Mohamed A Elgamal, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing TURP in people with PSA Changes After TURP, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew H Wahba Gerges, Resident doctor (+201015349430 ext. 01287793663, androwhamam1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum PSA changes after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia (time frame: within one month after intervention). 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 NCT05533047, which also lists 2 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 8 Sep 2022.