Clinical trial NCT06777199: A Comparative Study of Selective Dorsal Neurectomy, Pulsed Radiofrequency Neuromodulation, and Intragranular Hyaluronic Acid Injection for Premature Ejaculation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Keywords: lifelong premature ejaculation
Microscopic Selective Dorsal Neurectomy
intraglanular Hyaluronic acid
pulsed radiofrequency ablation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prolongation of intravaginal ejaculatory latency time (IELT)
timeFrame: 1 month and 3 months
measure: Improvement in patient-reported outcomes using the Index of Premature Ejaculation (IPE) questionnaire
timeFrame: 1 month and 3 months
measure: Improvement in patient-reported outcomes using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire
timeFrame: 1 month and 3 months
Secondary outcomes:
measure: Improvement in patient and partner sexual satisfaction
timeFrame: 1 month and 3 months
measure: Presence of voluntary control of ejaculation
timeFrame: 1 month and 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University Faculty of Medicine
state: El Manial
Study officials:
References: