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

Ahmed Hamdy Ahmed

Status: Completed

Conditions: Premature Ejaculation

Treatments: Procedure: Intraglanular Hyaluronic Acid (HA) Injection; Procedure: Microscopic Selective Dorsal Neurectomy (SDN); Procedure: Pulsed Radiofrequency (PRF) Nerve Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06777199

MD-273-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Microscopic Selective Dorsal Neurectomy Group

Experimental group

Description:

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).

Treatment:

Procedure: Microscopic Selective Dorsal Neurectomy (SDN)

Pulsed Radiofrequency Nerve Ablation Group

Experimental group

Description:

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).

Treatment:

Procedure: Pulsed Radiofrequency (PRF) Nerve Ablation

Intraglanular Hyaluronic Acid Injection Group

Experimental group

Description:

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).

Treatment:

Procedure: Intraglanular Hyaluronic Acid (HA) Injection