BPH With Urinary ObstructionNCT06101576
Readmission Following Prostatic Surgery
An observational study of BPH With Urinary Obstruction, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to estimate readmission rate and reasons for readmission after all modalities of endoscopic transurethral surgeries for treatment of BOO secondary to BPH in the last 20 years. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH With Urinary Obstruction
- What is being tested?
- TUIP, TURP and Prostate Vaporization
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2005to 1 Feb 2025
- Phase
- Observational
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: They will be the subdivided into four groups: Group I: Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam. Group II: Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current. Group III: Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). Group IV: Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.
Who may be able to join
- Men who underwent transurethral prostatic surgery for BPH causing BOO at Urology and Nephrology Center, Mansoura University, Egypt from Jun. 2005 to Dec. 2024.
Who cannot join
- Patients who underwent TUR tunnelling for prostatic adenocarcinoma.
- LUTS secondary to neuropathic bladder.
- Incidentally diagnosed prostate cancer after surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, 35516
Ahmed R EL-Nahas, MD, 00201221136899, ar_el_nahas@yahoo.com
Amr W Yehia, MD, +201027383536, amrwaei33@yahoo.com
About this study
Official title: Readmission Following Endourological Prostatic Surgery for Benign Prostatic Obstruction: Review of 20 Years of Experience
This study will be conducted to estimate readmission rate and reasons for readmission after all modalities of endoscopic transurethral surgeries for treatment of BOO secondary to BPH in the last 20 years.
Read the detailed description
Computerized patient information system (PIS) of Urology and Nephrology Center (UNC) and database of prostate unit of UNC will be reviewed for all preoperative, intraoperative and post discharge data. All follow up visits will be traced for outcome measurement. Patients with no hospital follow up visit will be contacted by phone and interrogated about their LUTS control state, ongoing medication and history of secondary procedures.
- Conditions
- BPH With Urinary Obstruction
- Being tested
- TUIP, TURP, Prostate Vaporization, AEEP
- Keywords
- BPH, TURP, Laser prostatectomy, BNC, Holmium Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUIPProcedure or surgery
Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam.
TURPProcedure or surgery
Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current.
Prostate VaporizationProcedure or surgery
Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate).
AEEPProcedure or surgery
Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.
| Study group | Role | What they receive |
|---|---|---|
| Transurethral incision of the prostate (TUIP) | Patients who underwent TUIP using electrocautery or Laser. Receives: Procedure: TUIP | |
| Transurethral resection of the prostate (TURP) | Patients who underwent TURP using monopolar or bipolar electrocautery. Receives: Procedure: TURP | |
| Prostate Vaporization | Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). Receives: Procedure: Prostate Vaporization | |
| Anatomical endoscopic enucleation of the prostate (AEEP) | Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current. Receives: Procedure: AEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for post discharge hospital readmission.
The need for post discharge hospital readmission after surgery.
Measured: 90 days
Secondary outcomes (3)
Differences of readmission rates
Difference of readmission rates for different modalities of transuretheral prostatic surgery.
Measured: 90 days
Change in the causes of readmission over time.
Change in the causes of readmission over time.
Measured: 20 years
Causes and predictors of readmission.
Causes and predictors of readmission.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2005
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Urinary ObstructionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed R EL-Nahas, MD, Principal investigator, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101576
- Sponsor's protocol ID
- 2436
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readmission Following Endourological Prostatic Surgery for Benign Prostatic Obstruction: Review of 20 Years of Experience
- ClinicalTrials.gov ID
- NCT06101576
- Acronym / sponsor ID
- 2436
- Conditions
- BPH With Urinary Obstruction
- Keywords
- BPH, TURP, Laser prostatectomy, BNC, Holmium Laser
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 26 Oct 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.
This study will be conducted to estimate readmission rate and reasons for readmission after all modalities of endoscopic transurethral surgeries for treatment of BOO secondary to BPH in the last 20 years.
Detailed description
Computerized patient information system (PIS) of Urology and Nephrology Center (UNC) and database of prostate unit of UNC will be reviewed for all preoperative, intraoperative and post discharge data. All follow up visits will be traced for outcome measurement. Patients with no hospital follow up visit will be contacted by phone and interrogated about their LUTS control state, ongoing medication and history of secondary procedures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transurethral incision of the prostate (TUIP) | – | Procedure: TUIPPatients who underwent TUIP using electrocautery or Laser. |
| Transurethral resection of the prostate (TURP) | – | Procedure: TURPPatients who underwent TURP using monopolar or bipolar electrocautery. |
| Prostate Vaporization | – | Procedure: Prostate VaporizationPatient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). |
| Anatomical endoscopic enucleation of the prostate (AEEP) | – | Procedure: AEEPPatient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- They will be the subdivided into four groups: Group I: Patient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam. Group II: Patient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current. Group III: Patient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). Group IV: Patient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current.
Key inclusion criteria (1 listed)
- Men who underwent transurethral prostatic surgery for BPH causing BOO at Urology and Nephrology Center, Mansoura University, Egypt from Jun. 2005 to Dec. 2024.
Key exclusion criteria (3 listed)
- Patients who underwent TUR tunnelling for prostatic adenocarcinoma.
- LUTS secondary to neuropathic bladder.
- Incidentally diagnosed prostate cancer after 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 |
|---|---|---|
| TUIPPatient who underwent transurethral incision of the prostate (TUIP) using electrical current or laser beam. | Procedure or surgery | Transurethral incision of the prostate (TUIP) |
| TURPPatient who underwent transurethral resection of the prostate (TURP) using momopolar or bipolar current. | Procedure or surgery | Transurethral resection of the prostate (TURP) |
| Prostate VaporizationPatient who underwent vaporization of the prostate using plasma or laser energy (GreenLight PVP and Thulium vaporization of the prostate). | Procedure or surgery | Prostate Vaporization |
| AEEPPatient who underwent anatomical endoscopic enucleation of the prostate (AEEP) using Holmium, Thulium or GreenLight laser or bipolar current. | Procedure or surgery | Anatomical endoscopic enucleation of the prostate (AEEP) |
Primary outcome
The need for post discharge hospital readmission.
Time frame: 90 days
The need for post discharge hospital readmission after surgery.
3 secondary outcomes
Differences of readmission rates
Time frame: 90 days
Change in the causes of readmission over time.
Time frame: 20 years
Causes and predictors of readmission.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Ahmed R EL-Nahas, MD principal investigator
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH With Urinary Obstruction, run by Mansoura 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 3 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 26 Oct 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. 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 R EL-Nahas, MD (+201221136899, ar_el_nahas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The need for post discharge hospital readmission. (time frame: 90 days). 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 26 Oct 2023.