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

Not Applicable

Completed

• Conditions: Premature Ejaculation

• Registration Number: NCT06777199
• Lead Sponsor: Ahmed Hamdy Ahmed

Brief 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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01
• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prolongation of intravaginal ejaculatory latency time (IELT)	1 month and 3 months
Improvement in patient-reported outcomes using the Index of Premature Ejaculation (IPE) questionnaire	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	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

Secondary Outcome Measures

Name	Time	Method
Presence of voluntary control of ejaculation	1 month and 3 months
Improvement in patient and partner sexual satisfaction	1 month and 3 months	Sexual Satisfaction Scale (SSS); Minimum Value: 4 (very dissatisfied across all items) Maximum Value: 20 (very satisfied across all items); Scoring: The SSS evaluates sexual satisfaction using four items rated on a 5-point scale: 1 = Very dissatisfied 2 = Dissatisfied 3 = Neutral 4 = Satisfied 5 = Very satisfied; Interpretation: Higher scores indicate greater overall sexual satisfaction for the patient and their partner.; Assessment Method: Patients and their partners independently complete the Sexual Satisfaction Scale (SSS) questionnaire.; The total score is calculated separately for the patient and partner. The average score across both individuals is used for reporting overall satisfaction.

Trial Locations

Locations (1)

Cairo University Faculty of Medicine; 🇪🇬 Giza, El Manial, Egypt