NCT06777199

A Comparative Study of Selective Dorsal Neurectomy, Pulsed Radiofrequency Neuromodulation, and Intragranular Hyaluronic Acid Injection for Premature Ejaculation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ahmed Hamdy Ahmed · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: Selective Dorsal Neurectomy (SDN): Performed under spinal or local anesthesia. Involves microsurgical dissection of the dorsal penile nerves to reduce glans sensitivity. Pulsed Radiofrequency Nerve Ablation (PRF): Involves neuromodulation of the dorsal penile nerves using pulsed radiofrequency energy. The goal is to reduce glans sensation while preserving nerve function. Hyaluronic Acid Injection: Hyaluronic acid is injected into the glans penis using the multiple puncture technique under local anesthesia to reduce sensitivity. Outcome Measures: Primary Outcomes: Prolongation of intravaginal ejaculatory latency time (IELT) using stopwatch measurements. Improvement in patient-reported outcomes via validated questionnaires (IPE, PEP). Secondary Outcomes: Improvement in patient and partner sexual satisfaction. Presence of voluntary control of ejaculation. Reduction in stress and psychological distress. Study Design: A total of 30 patients will be randomized into three equal groups (10 patients per group). The follow-up period includes evaluations at 1 month and 3 months post-intervention. Diagnostic tools include IELT stopwatch measures, penile duplex ultrasound, and questionnaires. Statistical Analysis: Data will be analyzed using SPSS software. Descriptive statistics (mean, standard deviation) and comparative tests (paired t-tests, Chi-square tests) will determine the significance of results. This study aims to provide evidence-based guidance on the optimal treatment strategy for lifelong premature ejaculation, focusing on efficacy, safety, and patient satisfaction.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
PROCEDURE	Microscopic Selective Dorsal Neurectomy (SDN)	Selective dorsal neurectomy (SDN) involves microsurgical dissection and partial transection of the dorsal penile nerves to reduce glans sensitivity. The procedure is performed under spinal anesthesia or local anesthesia with 1% lidocaine. A midline or dorsal sub-coronal incision is made 1 cm proximal to the coronal sulcus. The skin is retracted, exposing the Dartos fascia and Buck's fascia to reach the neurovascular bundle (two dorsal penile nerves lateral to two dorsal penile arteries). Every other nerve on either side of the corpora cavernosa is transected to damage approximately 50% of the nerve supply to the glans. Suturing is done using 7-0 or 8-0 prolene sutures, and the incision is closed. Patients are evaluated at 1 month and 3 months post-procedure for IELT, AIPE, and PEDT scores to determine success.
PROCEDURE	Pulsed Radiofrequency (PRF) Nerve Ablation	Pulsed radiofrequency (PRF) nerve ablation aims to reduce sensitivity of the dorsal penile nerves using low-energy radiofrequency pulses. Under sterile conditions, a 22-gauge RF cannula (5-cm-long, 10-mm active tip) is inserted into the flaccid penile skin at the 1-o'clock position for the right dorsal penile nerve. Sensory stimulation testing is performed at 50 Hz to identify the point of maximum glans sensitivity. Pulsed radiofrequency is applied at an energy output of 45 V for 180 seconds at 42°C (using the NeuroTherm generator). The procedure is repeated at the 11-o'clock position for the left dorsal penile nerve, ensuring both sides are treated. The goal is to ablate sensation over as large an area of the glans as possible without causing permanent nerve damage. Post-procedure, patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores.
PROCEDURE	Intraglanular Hyaluronic Acid (HA) Injection	Intraglanular hyaluronic acid (HA) injection involves administering HA gel into the glans penis to reduce its sensitivity. The circumference of the glans penis is divided into three circles (1 cm apart, starting from the base), and each circle is further divided into quarter circles. Topical anesthetic cream (Emla®, lidocaine 25 mg + prilocaine 25 mg) is applied for 30 minutes to numb the glans. Using two prefilled syringes of HA gel (Hyabell Ultra® 24 mg/ml with 0.3% lidocaine), 12 injections are administered into the deep dermis of the glans using a 27-G needle. Each injection site receives 0.25 ml of HA gel following the multiple puncture technique. Patients are evaluated at 1 and 3 months for IELT, AIPE, and PEDT scores to assess efficacy.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2025-01-15
• Last updated: 2025-01-22

Locations

1 site across 1 country: Egypt