A Comparative Study to Assess the Role of Selective Dorsal Neurectomy Versus Pulsed Radiofrequency Neuromodulation Versus Intraglanular Hyaluronic Acid Injection for Patients With Lifelong Premature Ejaculation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prolongation of intravaginal ejaculatory latency time (IELT)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and safety of three treatment methods for lifelong premature ejaculation (PE) in adult males. The main questions this study aims to answer are:
Does selective dorsal neurectomy, pulsed radiofrequency nerve ablation, or hyaluronic acid injection prolong intravaginal ejaculatory latency time (IELT)? What are the differences in patient satisfaction and safety among the three treatments?
In this study:
Participants will be randomized into three groups (10 patients each). Group 1 will undergo selective dorsal neurectomy under local or spinal anesthesia.
Group 2 will receive pulsed radiofrequency nerve ablation sessions. Group 3 will have hyaluronic acid injections into the glans penis under local anesthesia.
Researchers will measure treatment outcomes using:
Stopwatch measurements of IELT. Patient-reported questionnaires (IPE, PEP). International Index of Erectile Function-5 (IIEF-5) to confirm no erectile dysfunction.
详细描述
This randomized clinical trial aims to assess the efficacy and safety of three treatment modalities for lifelong premature ejaculation (PE) in adult males. Premature ejaculation is a common male sexual dysfunction that significantly impacts quality of life, affecting relationships and psychological well-being. The study will compare three therapeutic approaches: selective dorsal neurectomy, pulsed radiofrequency nerve ablation, and intraglanular hyaluronic acid injection.
Study Population:
Male patients aged 18 years and older. Participants must have lifelong PE that has not responded to or cannot be continued with medical treatment.
Patients with erectile dysfunction, severe comorbidities, or recent use of SSRIs or topical anesthetics will be excluded.
Intervention Groups:
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
- Single (Participant)
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
- •all male patients ≥ 18 years old who are having regular sexual life and suffering from lifelong premature ejaculation, not responding to medical treatment or not willing to continue on medical treatment
排除标准
- •Patients suffering from ED
- •Patients suffering of several debilitating co-morbidities (uncontrolled DM, on corticosteroids or receiving immunosuppression therapy)
- •Patients suffering of neurological disorders
- •Patients receiving any kind of SSRIs or topical anesthetics within 3 months to treat LPE
- •Patients suffering from any other form of PE (i.e. acquired, subjective, variable PE)
研究组 & 干预措施
Microscopic Selective Dorsal Neurectomy Group
Participants in this group will undergo microscopic selective dorsal neurectomy (SDN). The procedure involves partial transection of the dorsal penile nerves under spinal or local anesthesia to reduce sensitivity of the glans penis. Post-procedure, outcomes will be assessed at 1 and 3 months using stopwatch-measured intravaginal ejaculatory latency time (IELT) and validated questionnaires (AIPE, PEDT, and PEP).
干预措施: Microscopic Selective Dorsal Neurectomy (SDN) (Procedure)
Pulsed Radiofrequency Nerve Ablation Group
Participants in this group will receive pulsed radiofrequency (PRF) neuromodulation targeting the dorsal penile nerves. The procedure involves delivering low-energy radiofrequency pulses through an RF cannula inserted into the flaccid penile skin. The goal is to reduce glans sensitivity and improve IELT. Outcomes will be evaluated at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP).
干预措施: Pulsed Radiofrequency (PRF) Nerve Ablation (Procedure)
Intraglanular Hyaluronic Acid Injection Group
Participants in this group will receive intraglanular hyaluronic acid (HA) injections. The circumference of the glans penis will be divided into multiple sections, and HA gel will be injected under local anesthesia to reduce glans sensitivity. Outcomes will be assessed at 1 and 3 months using stopwatch-measured IELT and validated questionnaires (AIPE, PEDT, and PEP).
干预措施: Intraglanular Hyaluronic Acid (HA) Injection (Procedure)
结局指标
主要结局
Prolongation of intravaginal ejaculatory latency time (IELT)
时间窗: 1 month and 3 months
Improvement in patient-reported outcomes using the Index of Premature Ejaculation (IPE) questionnaire
时间窗: 1 month and 3 months
The IPE questionnaires scoring is normally classified to measure severity as follows: • IPE scoring (the lower the score, the higher the PE severity): Severe PE: 7-13 Moderate PE: 14-19 Mild to Moderate PE: 20-25 Mild PE: 26-30 No PE: 31-35
Improvement in patient-reported outcomes using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire
时间窗: 1 month and 3 months
The PEDT questionnaire scoring is normally classified to measure severity as follows: • PEDT scoring (the lower the score, the lower the PE probability): Highly PE: ≥11 Borderline PE: 9-10 No PE: ≤ 8
次要结局
- Presence of voluntary control of ejaculation(1 month and 3 months)
- Improvement in patient and partner sexual satisfaction(1 month and 3 months)
研究者
Ahmed Hamdy Ahmed
Urology Assistant Lecturer
Cairo University