Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05914519 |
| Other study ID # |
Soh-Med-23-06-02MD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
June 2023 |
| Source |
Sohag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
