Premature EjaculationNCT07879105
Dorsal Penile Nerve Cryoneurolysis for Lifelong PE
A study testing Percutaneous Dorsal Penile Nerve Cryoneurolysis, Sertraline (Oral Antidepressant) and Tadalafil 5 mg in people with Premature Ejaculation, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Percutaneous Dorsal Penile Nerve Cryoneurolysis, Sertraline (Oral Antidepressant) and Tadalafil 5 mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2026to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University Faculty of Medicine Hospital
Istanbul, Küçükçekmece, 34295
About this study
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
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:
Read more
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.
Read the 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.
- Conditions
- Premature Ejaculation
- Being tested
- Percutaneous Dorsal Penile Nerve Cryoneurolysis, Sertraline (Oral Antidepressant), Tadalafil 5 mg, Behavioral Education for Ejaculatory Control
- Keywords
- Lifelong Premature Ejaculation, Dorsal Penile Nerve, Cryoneurolysis, Intravaginal Ejaculatory Latency Time, Premature Ejaculation Diagnostic Tool, Premature Ejaculation Profile, Randomized Controlled Trial
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Dorsal Penile Nerve CryoneurolysisProcedure or surgery
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)Drug
Sertraline 50 mg was taken orally once daily for 3 months.
Tadalafil 5 mgDrug
Tadalafil 5 mg was taken orally once daily for 3 months.
Behavioral Education for Ejaculatory ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis Plus Combined Therapy | Experimental | 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. Receives: Procedure: Percutaneous Dorsal Penile Nerve Cryoneurolysis; Drug: Sertraline (Oral Antidepressant); Drug: Tadalafil 5 mg; Behavioral: Behavioral Education for Ejaculatory Control |
| Combined Therapy Alone | Active comparator | 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. Receives: Drug: Sertraline (Oral Antidepressant); Drug: Tadalafil 5 mg; Behavioral: Behavioral Education for Ejaculatory Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the cryoneurolysis procedure through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start4 Feb 2026
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barış Nuhoğlu, MD, Principal investigator, Biruni University Faculty of Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879105
- Sponsor's protocol ID
- BiruniUCryoneurolysisStudy
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
PubMed 10637462Patrick DL, Giuliano F, Ho KF, Gagnon DD, McNulty P, Rothman M. The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice. BJU Int. 2009 Feb;103(3):358-64. doi: 10.1111/j.1464-410X.2008.08041.x. Epub 2008 Sep 12.
PubMed 18793300Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
PubMed 17275165Culha MG, Erkoc M, Baran C, Ozcan L. Clinical efficacy and safety of selective dorsal neurectomy/cryoablation for treatment of premature ejaculation: systematic review and meta-analysis. J Sex Med. 2025 Aug 4;22(8):1383-1389. doi: 10.1093/jsxmed/qdaf140.
PubMed 40488424Liu Q, Li S, Zhang Y, Cheng Y, Fan J, Jiang L, Li S, Tang Y, Zeng H, Wang J, Zhu Z. Anatomic Basis and Clinical Effect of Selective Dorsal Neurectomy for Patients with Lifelong Premature Ejaculation: A Randomized Controlled Trial. J Sex Med. 2019 Apr;16(4):522-530. doi: 10.1016/j.jsxm.2019.01.319.
PubMed 30935469David Prologo J, Snyder LL, Cherullo E, Passalacqua M, Pirasteh A, Corn D. Percutaneous CT-guided cryoablation of the dorsal penile nerve for treatment of symptomatic premature ejaculation. J Vasc Interv Radiol. 2013 Feb;24(2):214-9. doi: 10.1016/j.jvir.2012.09.015. Epub 2012 Nov 22.
PubMed 23182939Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28.
PubMed 25356302Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. J Sex Med. 2014 Jun;11(6):1423-41. doi: 10.1111/jsm.12524. Epub 2014 May 22.
PubMed 24848805
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07879105
- Acronym / sponsor ID
- BiruniUCryoneurolysisStudy
- Conditions
- Premature Ejaculation
- Keywords
- Lifelong Premature Ejaculation, Dorsal Penile Nerve, Cryoneurolysis, Intravaginal Ejaculatory Latency Time, Premature Ejaculation Diagnostic Tool, Premature Ejaculation Profile, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis Plus Combined Therapy | Experimental | Procedure: Percutaneous Dorsal Penile Nerve Cryoneurolysis, Drug: Sertraline (Oral Antidepressant), Drug: Tadalafil 5 mg, Behavioral: Behavioral Education for Ejaculatory ControlParticipants 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. |
| Combined Therapy Alone | Active comparator | Drug: Sertraline (Oral Antidepressant), Drug: Tadalafil 5 mg, Behavioral: Behavioral Education for Ejaculatory ControlParticipants 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Dorsal Penile Nerve CryoneurolysisA 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. | Procedure or surgery | Cryoneurolysis Plus Combined Therapy |
| Sertraline (Oral Antidepressant)Sertraline 50 mg was taken orally once daily for 3 months. | Drug | Combined Therapy Alone, Cryoneurolysis Plus Combined Therapy |
| Tadalafil 5 mgTadalafil 5 mg was taken orally once daily for 3 months. | Drug | Combined Therapy Alone, Cryoneurolysis Plus Combined Therapy |
| Behavioral Education for Ejaculatory ControlParticipants 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. | Behavioural | Combined Therapy Alone, Cryoneurolysis Plus Combined Therapy |
Primary outcome
Change in Intravaginal Ejaculatory Latency Time From Baseline to 3 Months
Time frame: 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.
6 secondary outcomes
Change in Premature Ejaculation Diagnostic Tool Score From Baseline to 3 Months
Time frame: Baseline to 3 months
Change in Premature Ejaculation Profile 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
Time frame: Baseline to 3 months
Patient Satisfaction at 3 Months
Time frame: 3 months
Partner Satisfaction at 3 Months
Time frame: 3 months
Number of Participants With Procedure-Related Adverse Events
Time frame: From the cryoneurolysis procedure through 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 10637462Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
- Background: PubMed 18793300Patrick DL, Giuliano F, Ho KF, Gagnon DD, McNulty P, Rothman M. The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice. BJU Int. 2009 Feb;103(3):358-64. doi: 10.1111/j.1464-410X.2008.08041.x. Epub 2008 Sep 12.
- Background: PubMed 17275165Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
- Background: PubMed 40488424Culha MG, Erkoc M, Baran C, Ozcan L. Clinical efficacy and safety of selective dorsal neurectomy/cryoablation for treatment of premature ejaculation: systematic review and meta-analysis. J Sex Med. 2025 Aug 4;22(8):1383-1389. doi: 10.1093/jsxmed/qdaf140.
- Background: PubMed 30935469Liu Q, Li S, Zhang Y, Cheng Y, Fan J, Jiang L, Li S, Tang Y, Zeng H, Wang J, Zhu Z. Anatomic Basis and Clinical Effect of Selective Dorsal Neurectomy for Patients with Lifelong Premature Ejaculation: A Randomized Controlled Trial. J Sex Med. 2019 Apr;16(4):522-530. doi: 10.1016/j.jsxm.2019.01.319.
- Background: PubMed 23182939David Prologo J, Snyder LL, Cherullo E, Passalacqua M, Pirasteh A, Corn D. Percutaneous CT-guided cryoablation of the dorsal penile nerve for treatment of symptomatic premature ejaculation. J Vasc Interv Radiol. 2013 Feb;24(2):214-9. doi: 10.1016/j.jvir.2012.09.015. Epub 2012 Nov 22.
- Background: PubMed 25356302Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28.
- Background: PubMed 24848805Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. J Sex Med. 2014 Jun;11(6):1423-41. doi: 10.1111/jsm.12524. Epub 2014 May 22.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barış Nuhoğlu, MD principal investigator
Biruni University Faculty of Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Dorsal Penile Nerve Cryoneurolysis, Sertraline (Oral Antidepressant) and Tadalafil 5 mg in people with Premature Ejaculation, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intravaginal Ejaculatory Latency Time From Baseline to 3 Months (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879105, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.