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

NCT06777199 | Completed

• 1 other identifier: MD-273-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation

Keywords

lifelong premature ejaculation; Microscopic Selective Dorsal Neurectomy; intraglanular Hyaluronic acid; pulsed radiofrequency ablation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Improvement in patient and partner sexual satisfaction

  1 month and 3 months

• Presence of voluntary control of ejaculation

  1 month and 3 months

Study Arms (3)

Microscopic Selective Dorsal Neurectomy Group

EXPERIMENTAL

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)

Pulsed Radiofrequency Nerve Ablation Group

EXPERIMENTAL

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

Intraglanular Hyaluronic Acid Injection Group

EXPERIMENTAL

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

Interventions

Microscopic Selective Dorsal Neurectomy (SDN) PROCEDURE

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.

Microscopic Selective Dorsal Neurectomy Group

Pulsed Radiofrequency (PRF) Nerve Ablation PROCEDURE

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.

Pulsed Radiofrequency Nerve Ablation Group

Intraglanular Hyaluronic Acid (HA) Injection PROCEDURE

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.

Intraglanular Hyaluronic Acid Injection Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ahmed Hamdy Ahmed: lead

Study Sites (1)

Cairo University Faculty of Medicine

Giza, El Manial, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Prolactin-Releasing Hormone; Injections

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urology Assistant Lecturer

Model Details: This study uses a parallel-group design with three independent intervention arms. Thirty male patients with lifelong premature ejaculation (PE) were randomly assigned into one of the following treatment groups: Group A: Selective dorsal neurectomy performed under spinal anesthesia. Group B: Pulsed radiofrequency nerve ablation under local anesthesia. Group C: Intraglanular hyaluronic acid injection under local anesthesia. Participants remain in their respective groups throughout the study, and outcomes, including intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), and Premature Ejaculation Diagnostic Tool (PEDT) scores, are evaluated at 1 month and 3 months post-intervention.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 15, 2025
• Study Start: July 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)