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

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Procedure: Microscopic Selective Dorsal Neurectomy (SDN); Procedure: Pulsed Radiofrequency (PRF) Nerve Ablation; Procedure: Intraglanular Hyaluronic Acid (HA) Injection

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Giza, El Manial, Egypt
      • Cairo University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
Experimental: 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).	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.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 month and 3 months
Improvement in patient-reported outcomes using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire	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	1 month and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient and partner sexual satisfaction	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.	1 month and 3 months
Presence of voluntary control of ejaculation		1 month and 3 months

Collaborators and Investigators

• Sponsor: Ahmed Hamdy Ahmed

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pulsed radiofrequency ablation; lifelong premature ejaculation; Microscopic Selective Dorsal Neurectomy; intraglanular Hyaluronic acid
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Ejaculatory Dysfunction; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Premature Birth; Premature Ejaculation; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MD-273-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No