Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- aspermia (A)
研究概览
简要总结
Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.
详细描述
Every year in France, more than 60 000 people are operated for benign prostatic hyperplasia (BPH). This surgery is accompanied by a change or even a loss of ejaculations externalized what constitutes the main constraint for patients. Empirically, the investigators talk to the patient "retrograde ejaculation" to explain a possible loss of ejaculation. Yet the underlying mechanism of this modification or loss of ejaculation remains completely unknown. No study could not determine whether the predominant mechanism was a real retrograde ejaculation or aspermia. Moreover, technical changes are sometimes tempted to preserve antegrade ejaculation but no scientific rationale can not validate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man, at least 18 years, which is scheduled for a BPH surgery
- •Sexually active
- •Measurement of Residual postvoid less than 6 months
- •Patients accepting the constraints of the study
- •Signed Consent
- •Affiliate or beneficiary of social security system.
排除标准
- •Patients unable to understand the study or to give consent
- •Patients with known infertility
- •Patients previously operated prostate
- •Patients previously treated with a natural prostate treatment (radiotherapy, microwave, radio frequency, ultrasound)
- •Patients with known urethral stenosis before surgery
- •Patient with impaired preoperative in ejaculation
- •Patient under guardianship or under judicial protection
- •Patient subject to psychiatric care
研究组 & 干预措施
Search retrograde ejaculation
Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.
干预措施: Search retrograde ejaculation (Procedure)
结局指标
主要结局
aspermia (A)
时间窗: Baseline and 9 months
Aspermia is determined by the ratio of the difference of total spz between before surgery and after surgery on the number of spz before surgery
retrograde ejaculation (R)
时间窗: Baseline and 9 months
retrograde ejaculation is determined by the difference in percentage of retrograde ejaculation between postoperative and preoperative
Sperm count
时间窗: Baseline and 9 months
Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.
Evaluation of the coefficient C
时间窗: 9 months
A and R will be subtracted to obtain the coefficient C
次要结局
- Preoperative prostate volume(9 months)
- Evaluation of the coefficient C depending on changing sexual symptoms relating to the change of sexuality questionary (IIEF15) before and after surgery(Baseline and 9 months)
- Changing in urinary output before and after surgery(Baseline and 9 months)
- Evaluation of urinary symptoms questionary (IPSS) before and after surgery(Baseline and 9 months)
- Type of surgery(9 months)
- Degree of resection evaluated by pre/postoperative prostate volume ratio, ratio of prostatic specific antigen (PSA) preoperative / postoperative and measurement of the resected weight (or the number of joules used in case of laser vaporization).(Baseline and 9 months)