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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

April 1, 2023

Study Completion Date

May 1, 2023

Conditions
Premature Ejaculation
Interventions
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."

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."

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."

Trial Locations (1)

Unknown

Cairo University Faculty of Medicine, Giza

All Listed Sponsors
lead

Ahmed Hamdy Ahmed

OTHER