Premature Ejaculation
Conditions
Keywords
Lifelong Premature Ejaculation, Dorsal Penile Nerve, Cryoneurolysis, Intravaginal Ejaculatory Latency Time, Premature Ejaculation Diagnostic Tool, Premature Ejaculation Profile, Randomized Controlled Trial
Brief 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.
Detailed description
This prospective, single-centre, parallel-group randomized controlled study was conducted at Biruni University Faculty of Medicine Hospital, Istanbul, Türkiye. Men with lifelong premature ejaculation were assigned in a 1:1 ratio to one of two treatment groups. Participants in the experimental group received a single session of percutaneous dorsal penile nerve cryoneurolysis in addition to combined pharmacological and behavioural therapy. Participants in the comparator group received the same combined pharmacological and behavioural therapy without cryoneurolysis. Combined pharmacological treatment consisted of sertraline 50 mg and tadalafil 5 mg orally once daily for 3 months. Both groups also received an individual behavioural education session addressing ejaculatory control and behavioural techniques, including the stop-start technique and, as an alternative, the squeeze technique. Percutaneous dorsal penile nerve cryoneurolysis was performed under sterile conditions using a CRYO-S® Painless cryoanalgesia system (METRUM CRYOFLEX S.A., Poland) with a 21-G, 0.8-mm cryoprobe. Four dorsal treatment targets were accessed through a single dorsal coronal puncture site. Each target received two 2-minute freezing cycles at approximately -78°C, separated by a 15-second thaw period. The primary endpoint was the change in stopwatch-measured intravaginal ejaculatory latency time from baseline to 3 months. Secondary and supportive assessments included PEDT, PEP, IIEF-5, patient and partner satisfaction, and adverse events. A total of 117 participants were randomized. The protocol-evaluable 3-month efficacy population consisted of 107 participants, including 53 in the cryoneurolysis plus combined therapy group and 54 in the combined therapy alone group.
Interventions
PROCEDUREPercutaneous 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 50 mg was taken orally once daily for 3 months.
DRUGTadalafil 5 mg
Tadalafil 5 mg was taken orally once daily for 3 months.
BEHAVIORALBehavioral 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.
Sponsors
Biruni University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants were randomized in a 1:1 ratio to two parallel treatment groups. One group received a single percutaneous dorsal penile nerve cryoneurolysis procedure in addition to combined pharmacological and behavioral therapy, while the comparator group received the same combined pharmacological and behavioral therapy without cryoneurolysis.
Eligibility
Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male participants aged 25 to 60 years. * Lifelong premature ejaculation beginning with the earliest sexual experiences. * Stable sexual partner for at least 6 months. * Sufficient sexual activity to allow stopwatch recording of intravaginal ejaculatory latency time. * Median stopwatch-measured intravaginal ejaculatory latency time of -60 seconds or less during the 4-week baseline period.
Exclusion criteria
* Active genitourinary infection, prostatitis, or penile dermatologic disease. * Clinically important erectile dysfunction or other sexual dysfunction. * Previous dorsal penile nerve surgery or ablation. * Neurologic disease or neuropathy affecting penile sensation. * Contraindication to, or clinically relevant interaction with, the study medications. * Unstable psychiatric disorder or substance-use disorder. * Uncontrolled bleeding risk or anticoagulation that could not be interrupted. * Recent treatment directed at premature ejaculation without an adequate washout period. * Inability to complete the assigned treatment or scheduled follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intravaginal Ejaculatory Latency Time From Baseline to 3 Months | Baseline to 3 months | Intravaginal ejaculatory latency time (IELT) was recorded by participants using a stopwatch and measured from vaginal penetration to intravaginal ejaculation. The primary outcome was the change in IELT from baseline to the 3-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Premature Ejaculation Diagnostic Tool Score From Baseline to 3 Months | Baseline to 3 months | Premature ejaculation symptoms were assessed using the Premature Ejaculation Diagnostic Tool (PEDT). The PEDT consists of 5 items and has a total score ranging from 0 to 20, with higher scores indicating more severe premature ejaculation symptoms. The outcome was the change in PEDT total score from baseline to the 3-month follow-up. |
| Change in Premature Ejaculation Profile Index From Baseline to 3 Months | Baseline to 3 months | The Premature Ejaculation Profile (PEP) consists of 4 items assessing ejaculatory control, intercourse satisfaction, personal distress, and interpersonal difficulty. Each item was coded from 0 to 4, and the 4 items were averaged to produce a PEP index ranging from 0 to 4. Higher scores indicate a more favorable premature ejaculation-related profile. The outcome was the change in PEP index from baseline to 3 months. |
| Change in Five-Item International Index of Erectile Function Score From Baseline to 3 Months | Baseline to 3 months | Erectile function was assessed using the five-item International Index of Erectile Function (IIEF-5). The total score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome was the change in IIEF-5 total score from baseline to the 3-month follow-up. |
| Patient Satisfaction at 3 Months | 3 months | Participant satisfaction with treatment was assessed at the 3-month follow-up using a 5-point ordinal scale ranging from 1 to 5, with higher scores indicating greater treatment satisfaction. |
| Partner Satisfaction at 3 Months | 3 months | Partner satisfaction with treatment was assessed at the 3-month follow-up using a 5-point ordinal scale ranging from 1 to 5, with higher scores indicating greater treatment satisfaction. |
| Number of Participants With Procedure-Related Adverse Events | From the cryoneurolysis procedure through 3 months | Procedure-related adverse events were assessed through systematic questioning for numbness or hypoesthesia, paresthesia, dysesthesia, neuropathic or glans pain, hematoma, infection, skin injury, erectile dysfunction, delayed ejaculation, anejaculation, and treatment dissatisfaction. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORBarış Nuhoğlu, MD
Biruni University Faculty of Medicine Hospital
Outcome results
None listed