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Dorsal Penile Nerve Cryoneurolysis for Lifelong PE
Sponsor: Biruni University
Summary
The goal of this clinical trial was to learn whether adding dorsal penile nerve cryoneurolysis to medication and behavioral therapy helps men with lifelong premature ejaculation. Cryoneurolysis is a treatment that uses cold to temporarily reduce nerve signals. The study also looked at the safety of this treatment. The main questions were: Does adding cryoneurolysis make the time from vaginal penetration to ejaculation longer after 3 months? Does adding cryoneurolysis improve premature ejaculation symptoms and satisfaction without worsening erectile function? What side effects occur after cryoneurolysis? Researchers compared cryoneurolysis plus medication and behavioral therapy with the same medication and behavioral therapy without cryoneurolysis. Participants: Took sertraline and tadalafil once daily for 3 months. Received education about behavioral techniques for better ejaculation control. Were randomly assigned either to receive one cryoneurolysis procedure or to receive no cryoneurolysis procedure. Used a stopwatch to record the time from vaginal penetration to ejaculation and completed questionnaires during follow-up.
Official title: Percutaneous Dorsal Penile Nerve Cryoneurolysis as an Adjunct to Combined Pharmacological and Behavioural Therapy for Lifelong Premature Ejaculation: A Single-Centre Randomized Controlled Study
Key Details
Gender
MALE
Age Range
25 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2026-02-04
Completion Date
2026-05-25
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Percutaneous Dorsal Penile Nerve Cryoneurolysis
A single percutaneous dorsal penile nerve cryoneurolysis procedure was performed under sterile conditions using a CRYO-S® Painless cryoanalgesia system with a 21-gauge, 0.8-mm cryoprobe. Four dorsal treatment targets were accessed through one dorsal coronal puncture site. Each target received two 2-minute freezing cycles at approximately -78°C, separated by a 15-second thaw period.
Sertraline (Oral Antidepressant)
Sertraline 50 mg was taken orally once daily for 3 months.
Tadalafil 5 mg
Tadalafil 5 mg was taken orally once daily for 3 months.
Behavioral Education for Ejaculatory Control
Participants received one individual educational session addressing premature ejaculation and ejaculatory control. The session included recognition of rising arousal and pre-ejaculatory sensations, the stop-start technique, and the squeeze technique as an alternative. Participants were instructed to practice these strategies at home and during sexual activity.
Locations (1)
Biruni University Faculty of Medicine Hospital
Istanbul, Küçükçekmece, Turkey (Türkiye)