An interventional study of Percutaneous Dorsal Penile Nerve Cryoneurolysis and Sertraline (Oral Antidepressant) in Premature Ejaculation, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 117 is above the median of 95 across 89 interventional studies indexed under Premature Ejaculation.
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Exclusion Criteria:
Participants received a single percutaneous dorsal penile nerve cryoneurolysis procedure in addition to sertraline 50 mg once daily, tadalafil 5 mg once daily, and behavioral education for premature ejaculation. Pharmacological treatment continued for 3 months.
Procedure: Percutaneous Dorsal Penile Nerve Cryoneurolysis · Drug: Sertraline (Oral Antidepressant) · Drug: Tadalafil 5 mg · Behavioral: Behavioral Education for Ejaculatory Control
Participants received sertraline 50 mg once daily, tadalafil 5 mg once daily, and behavioral education for premature ejaculation for 3 months, without dorsal penile nerve cryoneurolysis.
Drug: Sertraline (Oral Antidepressant) · Drug: Tadalafil 5 mg · Behavioral: Behavioral Education for Ejaculatory Control
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.
Tadalafil 5 mg was taken orally once daily for 3 months.
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.
Change in Intravaginal Ejaculatory Latency Time From 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.
Time frame: Baseline to 3 months
Change in Premature Ejaculation Diagnostic Tool Score From 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.
Time frame: Baseline to 3 months
Change in Premature Ejaculation Profile Index From 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.
Time frame: Baseline to 3 months
Change in Five-Item International Index of Erectile Function Score From 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.
Time frame: Baseline to 3 months
Patient Satisfaction at 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.
Time frame: 3 months
Partner Satisfaction at 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.
Time frame: 3 months
Number of Participants With Procedure-Related Adverse Events
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.
Time frame: From the cryoneurolysis procedure through 3 months
Plan to share: No — Individual participant data are not planned to be shared because this study did not include a prespecified plan or mechanism for external sharing of de-identified participant-level data. Study findings will be reported in aggregate form.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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