Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intravaginal latency time at week 12
研究概览
简要总结
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.
Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:
- Group 1: Tens + placebo drug therapy
- Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
- Group 3: Tens therapy + standard treatment (paroxetine mg)
The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
- •Age equal to or greater than 18 years.
- •PEDT score greater than
- •Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
- •Sexual activity at least once a week.
- •Minimum chronicity of PE of 6 months.
- •Voluntary participation in the study.
- •Signature of informed consent prior to participation in the study.
排除标准
- •IIEF-EF score greater than
- •Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
- •History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
- •History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive compulsive disorder, post-traumatic stress, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
- •Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
- •Treatment for PD in the last 3 months.
- •Treatment for epileptic syndromes or Parkinson's disease.
- •Use of pacemaker or cardiac defibrillator.
- •Skin lesions in the electrode placement area.
- •Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
- •Couple in a state of pregnancy.
研究组 & 干预措施
Control
Standard treatment (paroxetine 20 mg) + sham therapy
干预措施: Paroxetine (Drug)
TENS Therapy
Tens therapy + placebo drug therapy
干预措施: Transcutaneous posterior tibial nerve stimulation (Other)
Combination therapy
Tens therapy + standard treatment (paroxetine 20 mg)
干预措施: Transcutaneous posterior tibial nerve stimulation (Other)
Combination therapy
Tens therapy + standard treatment (paroxetine 20 mg)
干预措施: Paroxetine (Drug)
结局指标
主要结局
Intravaginal latency time at week 12
时间窗: Week 12
Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.
次要结局
- Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score(weeks 12 and 24)
- Clinical improvement(weeks 12 and 24)