Trial Outcomes & Findings for Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate (NCT NCT05914519)
NCT ID: NCT05914519
Last Updated: 2026-01-06
Results Overview
The number of patients who can ejaculate after TURP
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
6 months
Results posted on
2026-01-06
Participant Flow
In this study, 103 patients were assessed for eligibility; 8 patients did not meet the criteria and 5 patients refused to participate in the study. The remaining patients were randomly allocated into two equal groups (45 patients in each). All allocated patients were followed-up and analyzed statistically.
Participant milestones
| Measure |
Group 1
Ejaculatory Preserving Transurethral resection of prostate: Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging
|
Group 2
Standard Transurethral Resection of prostate: Transurethral resection of prostate including whole adenoma till the capsule.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
43
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=45 Participants
Ejaculatory Preserving Transurethral resection of prostate: Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging
|
Group 2
n=45 Participants
Standard Transurethral Resection of prostate: Transurethral resection of prostate including whole adenoma till the capsule.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.76 years
STANDARD_DEVIATION 8.16 • n=45 Participants
|
65.58 years
STANDARD_DEVIATION 7.98 • n=45 Participants
|
64.17 years
STANDARD_DEVIATION 8.07 • n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
45 Participants
n=45 Participants
|
45 Participants
n=45 Participants
|
90 Participants
n=90 Participants
|
|
Maximum Flow Rate (Qmax)
|
4.92 ml/sec
STANDARD_DEVIATION 1.73 • n=45 Participants
|
4.5 ml/sec
STANDARD_DEVIATION 1.88 • n=45 Participants
|
4.71 ml/sec
STANDARD_DEVIATION 1.805 • n=90 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=45 Participants
|
45 Participants
n=45 Participants
|
90 Participants
n=90 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe number of patients who can ejaculate after TURP
Outcome measures
| Measure |
Group 1
n=43 Participants
ejaculatory preserving TURP
|
Group 2
n=41 Participants
classic TURP
|
|---|---|---|
|
Preservation of Ejaculation
|
34 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe maximum flow of urine measured by Uroflowmetry
Outcome measures
| Measure |
Group 1
n=43 Participants
ejaculatory preserving TURP
|
Group 2
n=41 Participants
classic TURP
|
|---|---|---|
|
Maximum Flow Rate (Qmax)
|
18.78 ml/sec
Standard Deviation 5.16
|
19.71 ml/sec
Standard Deviation 6.22
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=45 participants at risk
Ejaculatory Preserving Transurethral resection of prostate: Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging
|
Group 2
n=45 participants at risk
Standard Transurethral Resection of prostate: Transurethral resection of prostate including whole adenoma till the capsule.
|
|---|---|---|
|
Renal and urinary disorders
intraperitoneal bladder perforation
|
0.00%
0/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
2.2%
1/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
Other adverse events
| Measure |
Group 1
n=45 participants at risk
Ejaculatory Preserving Transurethral resection of prostate: Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging
|
Group 2
n=45 participants at risk
Standard Transurethral Resection of prostate: Transurethral resection of prostate including whole adenoma till the capsule.
|
|---|---|---|
|
Renal and urinary disorders
Minor Capsular perforation
|
2.2%
1/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Renal and urinary disorders
sever irritative LUTS
|
8.9%
4/45 • Number of events 9 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
15.6%
7/45 • Number of events 9 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Blood and lymphatic system disorders
Blood transfusion
|
2.2%
1/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Renal and urinary disorders
Clot retention
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
8.9%
4/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Renal and urinary disorders
Stress incontinence
|
2.2%
1/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Renal and urinary disorders
Bladder neck contracture
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
8.9%
4/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
|
Renal and urinary disorders
Stricture bulbar urethra
|
2.2%
1/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
4.4%
2/45 • 6 months
TURP is an elective surgery that the patient is prepared with full lab and surgical fitness in preoperative assessment furthermore, TURP has a high safety profile that all adverse events rarely lead to mortality
|
Additional Information
Ahmed Sabri mahmoud
faculty of medicine sohag university
Phone: 201061691091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place