Sexual Functions and Problems in the Adult Clinical Trial
Official title:
Evaluation of the Effects of Monopolar Transurethral Resection Versus Bipolar Transurethral Resection and Holmium Laser Enucleation of the Prostate on Urinary and Sexual Function; a Prospective Comparative Study.
The impact of of different surgical treatment modalities of benign prostatic hyperplasia in
men on their sexual function is not well studied.
The investigators will investigate prospectively the effect of conventional monopolar
transurethral resection of the prostate (TURP), bipolar TURP and Holmium laser enucleation
on urinary and sexual functions.
Benign prostatic hyperplasia (BPH), one of the most common diseases of aging men, can be
associated with bothersome lower urinary tract symptoms (LUTS) that affect quality of life.
The prevalence of histopathologic BPH is age dependent, with initial development usually
after 40 years of age. Similar to that of histologic evidence, the prevalence of bothersome
symptoms also increases with age. Approximately half of all men who have a histologic
diagnosis have moderate to severe LUTS.
The other common disorder associated with BPH is sexual dysfunction based purely on age.
Sexual dysfunction encompasses not only erectile dysfunction (ED), but also ejaculation
abnormalities, difficulty in reaching orgasm, decreased libido and overall dissatisfaction.
Many studies suggest that the presence of LUTS is a risk factor for sexual dysfunction.
Increasing life expectancy has been associated with improvements in the health and quality
of life of the elderly, and many studies examined the sexuality of these groups of subjects
and reported that their interest in sex persist.
By reviewing the literature, the effect of different modalities for treating BPH, including
medical, open surgical, endourological procedures, on urinary function has been extensively
discussed and to a less extent on sexual function. A significant problem which arises when
discussing the sexual function with patients and partners, and when reviewing the
literature, is to know which aspect of male sexual function is being referred to.
Transurethral resection of the prostate (TURP) is still considered the gold standard in
treating BPH. However, most authors accept that there will be some impairment of sexual
function secondary to this procedure. The exact magnitude of this problem has been difficult
to assess by reviewing the published literature. Most of the large series reported ED rates
of 10 to 15%. (11&12) The etiology of ED secondary to TURP is poorly understood. Most likely
it is secondary to electrical trauma to the cavernous nerves close to the prostate apex at 5
and 7 o`clock positions. Furthermore, thrombosis of the cavernosal arteries may result from
mechanical trauma or from thermal damage.
Post TURP ejaculatory dysfunction was reported and documented to be in the form of
retrograde ejaculation in between 25-99 %. The mechanism for that was destruction of the
bladder neck mechanism which is responsible for sympathetic mediated occlusion of the
bladder neck during ejaculation ending in forward expulsion of the ejaculate.
Since introduction of TURP as an effective tool for treatment of BPH, many endo-urologic
techniques were tried to overcome the limitations and drawbacks of this gold standard
procedure mainly caused by perioperative bleeding requiring transfusion or re-intervention,
irrigation fluid absorption (TUR syndrome) and need for hospital stay.
Currently holmium laser enucleation of the prostate (HoLEP) seems to be an attractive
alternative to standard TURP. The efficacy and safety of HoLEP have been demonstrated even
in cases of large prostates that otherwise would usually require open prostatectomy. In
several comparative randomized studies, HoLEP was found to be superior to TURP in term of
catheter time, hospital stay, weight of removed tissue, blood loss but with longer operative
time.
However, its impact on male sexual function has not been well established. The successful
outcome of relief of LUTs is postulated to favor improving the overall sexual function.
However, other factors including laser heating effect, is hypothesized to contribute to
postoperative erectile dysfunction.
The safety of bipolar TURP is enhanced by the use of normal saline eliminating the incidence
of the metabolite toxicities and dilutional hyponatremia and the physics of electrical
current return theoretically reduce the thermal tissue damage at the site of surgery or at a
distant site by faulty patient grounding ( patient return electrode pad ). Urologists have
observed better intra-operative visibility during bipolar resection, which may also enhance
resident education. The deep coagulation effect of bipolar resection is thought to
contribute in the postoperative sexual dysfunction. However, sexual function after bipolar
TURP is still not well established in the literature.
To the best of the investigators' knowledge there is no any prospective study in the
literature comparing these three widely available procedures monopolar TURP, bipolar TURP
and HoLEP in term of their urinary, erectile and ejaculatory outcome.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01407445 -
Effects of Tribulus Terrestris on Sexual Function in Post-menopausal Women
|
Phase 4 |