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Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate

Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914519
Enrollment
90
Registered
2023-06-22
Start date
2023-07-01
Completion date
2025-06-01
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH, Ejaculatory Dysfunction

Brief summary

The purpose of this study is to assess the outcomes and efficacy of ejaculatory preserving TURP in terms of voiding, erectile function, and ejaculation.

Detailed description

The prostatic gland plays a central role in andrology. It is involved both in fertility and in sexuality with a major role in ejaculation and possibly in orgasm. This could explain the association between the andrological symptoms and prostatic disorders. The prevalence of Benign Prostatic Hyperplasia (BPH) is approximately 50% for men in their fifties and reaches up to 80% for men over 80 years of age, representing one of the most common diseases affecting males, with potentially significant impact on their quality of life. It is estimated that around half of men suffering severe or medical treatment unresponsive lower urinary tract symptoms (LUTS) will be offered a surgical procedure to relieve benign prostatic obstruction (BPO). Despite continuing development of new minimally invasive surgical methods, transurethral resection of the prostate (TURP) still remains the gold standard surgical treatment for LUTS due to BPH. Although it is benign, this disease has been shown to have a negative impact on the patient's health-related quality of life (HRQL), marked by obstructive and irritative LUTS. As BPH in most cases is not a life-threatening condition, the main outcomes of its treatment are not only the improvement in LUTS and functional parameters but also quality of life after surgery. Whilst efficacy of the conventional TURP is proven, a common potentially bothersome side effect, the retrograde ejaculation (RE) which occurs in 65-90% of patients undergoing TURP. It has been reported that ablative techniques like TURP and recent laser procedures including holmium, thulium and greenlight cause similar rates of ejaculatory dysfunction, occurring in almost three out of four to five men. For decades, men have been counseled to expect dry orgasm after TURP because of the retrograde flow of semen as a result of bladder neck disruption. Erectile dysfunction and Ejaculatory dysfunction (EjD) can have a substantial deleterious effect on the Quality of life (QoL) of men who have previously maintained regular sexual activity, inducing significantly increased levels of anxiety and depression. More recently, a better understanding of ejaculation physiology has enabled the emergence of modified surgical techniques with the aim of preserving antegrade ejaculation. The key point of standard TURP is resecting the tissues enveloped in the prostatic capsule and the bladder neck, while protecting the urethral tissues below the verumontanum. The bladder neck plays a significant role in reproduction. For men, bladder neck closure facilitates anterograde ejaculation. It actively contracts the bladder neck during ejaculation through a rich noradrenergic innervation by sympathetic nerves. Vernet et al. showed that contraction of the bladder neck was not important for anterograde ejaculation. Using endorectal ultrasound videos performed during masturbation in 30 men, it was possible to visualize the bladder neck, the prostate, and the bulbar urethra during ejaculation. They observed that during ejaculation, the verumontanum underwent a slight caudal shift, momentarily making contact with the opposite urethral wall and sperm emitted from the ejaculatory ducts was directed distally by contractions of the external sphincter coordinated with contractions of the bulbar urethra, thus demonstrating the importance of the muscular tissue around the verumontanum and particularly its proximal part. They described this area as a high-pressure ejaculatory area. The closure of the bladder neck did not seem to play a role in this mechanism. As a result, one can conclude that as long as the tissues around the verumontanum are not injured, ejaculation should still occur even with a well-open bladder neck. Recently, together with a better understanding of the mechanisms of ejaculation, a greater importance has been given to the impact of dry ejaculation on patients' QoL. A balance between symptomatic improvement in LUTS and preservation of sexual function needs to be addressed for men seeking surgical treatment. Modifications based on Supramontanal sparing hypothesis have reported favorable outcomes to as high as 92%. Although preservation of bladder neck structures is often associated with preservation of antegrade ejaculation, the current modern approach is the preservation of the precollicular and para-collicular tissue in the area where the ejaculatory ducts emerge near the verumontanum in the distal apical tissue in laser, aquablation, and bipolar electrosurgical prostatectomy techniques.

Interventions

PROCEDUREEjaculatory Preserving Transurethral resection of prostate

Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging

PROCEDUREStandard Transurethral Resection of prostate

Transurethral resection of prostate including whole adenoma till the capsule.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult patient \> 45 years old. * Drug refractory urinary retention. * Prostate volume range: 20-60 mL. * IPSS \> 19 after the medical therapy failure. * Qmax \< 10 mL/s. * PSA \< 4 ng/mL. * Active and healthy sexual life.

Exclusion criteria

* History of prostate or urethral surgery. * Neurogenic bladder. * UTI. * Urethral stricture disease. * prostate cancer. * Bleeding diathesis. * Capsular or bladder perforation during surgery.

Design outcomes

Primary

MeasureTime frameDescription
Preservation of Ejaculation6 monthsThe number of patients who can ejaculate after TURP

Secondary

MeasureTime frameDescription
Maximum Flow Rate (Qmax)6 monthsThe maximum flow of urine measured by Uroflowmetry

Countries

Egypt

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Group 1
Ejaculatory Preserving Transurethral resection of prostate: Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging
45
Group 2
Standard Transurethral Resection of prostate: Transurethral resection of prostate including whole adenoma till the capsule.
45
Total90

Baseline characteristics

CharacteristicGroup 1Group 2Total
Age, Continuous62.76 years
STANDARD_DEVIATION 8.16
65.58 years
STANDARD_DEVIATION 7.98
64.17 years
STANDARD_DEVIATION 8.07
Maximum Flow Rate (Qmax)4.92 ml/sec
STANDARD_DEVIATION 1.73
4.5 ml/sec
STANDARD_DEVIATION 1.88
4.71 ml/sec
STANDARD_DEVIATION 1.805
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Egypt
45 Participants45 Participants90 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
45 Participants45 Participants90 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 450 / 45
other
Total, other adverse events
12 / 4523 / 45
serious
Total, serious adverse events
0 / 451 / 45

Outcome results

Primary

Preservation of Ejaculation

The number of patients who can ejaculate after TURP

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1Preservation of Ejaculation34 Participants
Group 2Preservation of Ejaculation8 Participants
Secondary

Maximum Flow Rate (Qmax)

The maximum flow of urine measured by Uroflowmetry

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Group 1Maximum Flow Rate (Qmax)18.78 ml/secStandard Deviation 5.16
Group 2Maximum Flow Rate (Qmax)19.71 ml/secStandard Deviation 6.22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026