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临床试验/NCT06451406
NCT06451406已完成不适用

Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature: A Randomized Controlled Trial

New Valley University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Intravaginal ejaculation latency time (IELT)

研究概览

简要总结

The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.

详细描述

Over the past 30 years, the common knowledge of Premature ejaculation (PE) has advanced strikingly. PE is a very common and upsetting sexual male dysfunction. It is disturbing for both partners affecting their sexual experience, reducing their quality of life up to sexual abstinence, causing lack of self-confidence and even depression. It has a prevalence of a variable range, yet it is thought that one third of all males might complain of PE at a certain point throughout their lives and the incidence is rising.

Many treatment modalities have been currently used for PE varying from behavioral therapy to medical treatment and finally surgical therapy. Methods of behavioral therapy are: Squeeze technique and Start/stop technique. Pharmacological therapies include: nonselective and selective SSRIs, topical therapy with anesthetics, PDE5 inhibitors, opioid agonists and others. As for surgical modalities for PE there are several techniques including: glans augmentation, frenectomy, dorsal selective neurectomy, pulsed radiofrequency neuromodulation, removal of foreskin remnants and varicocelectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Age ≥ 18 years old.
  • Suffering from lifelong premature ejaculation not responding to the behavioral therapy.

排除标准

  • Erectile dysfunction.
  • Prostatitis.
  • Acquired premature ejaculation.
  • Addiction.
  • Psychiatric disorders (e.g., schizophrenia, bipolar disorder, and other psychoses).
  • Historical use of ejaculatory medication within the previous three months.

研究组 & 干预措施

Selective serotonin re-uptake inhibitor

Active Comparator

Patients received selective serotonin re-uptake inhibitor (SSRI) as medical treatment for treatment of premature ejaculate.

干预措施: Selective serotonin re-uptake inhibitor (Drug)

Hyaluronic acid

Experimental

Patients received hyaluronic acid gel injection in the glans penis.

干预措施: Hyaluronic acid (Drug)

结局指标

主要结局

Intravaginal ejaculation latency time (IELT)

时间窗: 6 months following treatment

Intravaginal ejaculation latency time (IELT) is time from initiating sexual activity to ejaculation and used for diagnosis of Long-term premature ejaculation. It was assessed at the 1st, 3rd, and 6th months following treatment.

次要结局

  • Incidence of side effects(6 months following treatment)
  • Index of premature ejaculation (IPE)(6 months following treatment)
  • Patient satisfaction(6 months following treatment)
  • International index of erectile function-5 (IIEF-5)(6 months following treatment)

研究者

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

Waheed Fawzy Abdelrasol

Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt

New Valley University

研究点 (1)

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