Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change in intravaginal latency time
研究概览
简要总结
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
- Group 1: Tens therapy + dapoxetine placebo on demand.
- Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
- •Age between 18 and 62 years.
- •PEDT score greater than
- •Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
- •Sexual activity at least once a week.
- •Minimum chronicity of PD of 6 months.
- •Voluntary participation in the study.
- •Signing of the informed consent prior to participation in the study.
排除标准
- •IIEF-EF score less than
- •Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
- •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 disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
- •Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
- •Treatment for PE in the last 3 months.
- •Treatment for epileptic syndromes or Parkinson's disease.
- •Use of pacemaker or cardiac defibrillator.
- •Skin lesions in the area where the electrodes are placed.
- •Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
- •Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.
研究组 & 干预措施
Group 1: Tens therapy + dapoxetine placebo on demand.
There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
- The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode is attached to the calcaneus.
Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
干预措施: Tens therapy (Device)
Group 1: Tens therapy + dapoxetine placebo on demand.
There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
- The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode is attached to the calcaneus.
Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
干预措施: Dapoxetine placebo (Drug)
Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
干预措施: Standard treatment (dapoxetine 30 mg as needed) (Drug)
Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
干预措施: Placebo therapy (Device)
Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance.
In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
干预措施: Tens therapy (Device)
Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance.
In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
干预措施: Standard treatment (dapoxetine 30 mg as needed) (Drug)
结局指标
主要结局
Change in intravaginal latency time
时间窗: 12 weeks
Average change in intravaginal latency time, measured with a stopwatch by the couple.
次要结局
- Adverse events(24 weeks)
- Change in the diagnosis of premature ejaculation(At weeks 12 and 24 (greater than 12 to less than 12).)
- Clinical improvement in premature ejaculation(At weeks 12 (end of therapy) and 24 (three months of follow-up).)
- Change in intravaginal latency time(24 weeks)
- PEP (Premature Ejaculation Profile) questionnaire score(At weeks 12 and 24)
- Global Impression of Change Scale(Weeks 12 and 24.)