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临床试验/NCT01810068
NCT01810068已完成4 期

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.

Mansoura University2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
262
试验地点
2
主要终点
Change in sexual function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
  • Failed medical treatment of BPH.
  • International prostate symptom score (IPSS) >
  • Peak urinary flow rate (Qmax) <10 ml/sec.
  • Patients in retention secondary to BPH.
  • Total prostate size not less than 30 gm by TRUS (transrectal ultrasound)

排除标准

  • Patient who have a neurological disorder as neurogenic bladder, cerebrovascular stroke or Parkinson disease.
  • Non BPH causes of LUTS as cystitis.
  • Infravesical causes of LUTS other than BPH as urethral stricture.
  • Presence of active bladder cancer (within the last 2 years).
  • Known cancer prostate patients on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

结局指标

主要结局

Change in sexual function

时间窗: 12 months postoperative

Sexual function questionnaire (change in the score from baseline)

次要结局

  • Change in urinary function(six months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elshal

Lecturer of endourology

Mansoura University

研究点 (2)

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