Premature EjaculationNCT07820865
Silicone Band Versus Prilocaine Spray for Lifelong Premature Ejaculation
A study testing Frenular Silicone Band and Prilocaine 10% Spray in people with Premature Ejaculation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This pilot study compared two approaches for men with lifelong premature ejaculation, a condition in which ejaculation occurs sooner than desired from the first sexual experiences and is difficult to delay. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Frenular Silicone Band and Prilocaine 10% Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Jan 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 18-35 years.
- Lifelong (primary) premature ejaculation with a reported inability to delay ejaculation.
- Premature Ejaculation Diagnostic Tool (PEDT) score of 11 or higher.
- In a stable heterosexual relationship for at least six months.
- Able to engage in vaginal intercourse at least three times per week.
- Willing to comply with the study protocol and provide written informed consent.
Who cannot join
- Secondary (acquired) premature ejaculation.
- Erectile dysfunction, defined as a five-item International Index of Erectile Function (IIEF-5) score below 22.
- Any chronic systemic disease, including diabetes mellitus or hypertension.
- Any psychiatric disorder or current or recent use of psychiatric medications.
- Regular use of medication affecting ejaculatory function.
- Use of any treatment for premature ejaculation at enrollment.
- Known hypersensitivity to prilocaine or silicone-based materials.
- Any penile anatomical abnormality.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, Istanbul, 34200
About this study
Official title: A Frenular Silicone Band for Lifelong Premature Ejaculation: A Randomized Controlled Pilot Trial of Preliminary Efficacy, Tolerability, and Patient Satisfaction
This pilot study compared two approaches for men with lifelong premature ejaculation, a condition in which ejaculation occurs sooner than desired from the first sexual experiences and is difficult to delay. The aim was to explore their effects on ejaculation time, symptoms, treatment satisfaction, and side effects, and whether improvements persisted after treatment stopped.
Thirty-two men aged 18-35 years were assigned by chance to use either a soft silicone band over the frenulum, the sensitive area on the underside of the head of the penis, or a prilocaine spray, a medicine that temporarily reduces sensation. Both treatments were used before or during intercourse as instructed for one month. Both groups also received guidance on techniques to help control ejaculation, including pausing stimulation and relaxation exercises.
After the first month, participants stopped using the band or spray and continued the behavioural techniques alone for another month. Assessments took place at the start of the study and after one and two months. Participants estimated their average time from vaginal penetration to ejaculation and completed a questionnaire about premature ejaculation symptoms. Treatment satisfaction, treatment experience, and side effects were also assessed.
Read the detailed description
This single-centre, randomized, open-label pilot trial compared a frenular silicone band plus behavioural counselling with topical prilocaine 10% spray plus the same counselling in men with lifelong premature ejaculation. The sample size was pragmatic, with 16 participants per group, and the study was intended to provide preliminary estimates to inform further research.
Participants were allocated in a 1:1 ratio using a computer-generated random sequence. Treatment assignments were concealed from the enrolling investigator using envelopes. Participants and treating clinicians were aware of the assigned intervention.
The silicone band was cut from medical-grade silicone adhesive tape intended for wound contact and used outside its stated intended purpose. Its use for premature ejaculation was described in the ethics-approved protocol and participant information sheet. Participants received standardized training in positioning and removing the band.
Both groups received counselling on the stop-start technique, the squeeze technique, and breathing and relaxation exercises. The assigned band or spray was used during the first month and then discontinued. Behavioural techniques continued throughout the two-month follow-up. This design allowed assessment of changes during treatment and whether these changes persisted during the month after withdrawal.
At baseline and each follow-up visit, participants recalled their average intravaginal ejaculatory latency time over the preceding two weeks, rounded to the nearest minute. These values were subjective estimates; no stopwatch, diary, or contemporaneous record was used. Premature Ejaculation Diagnostic Tool scores were collected at the same visits. The Premature Ejaculation Treatment Outcome questionnaire and a five-point treatment satisfaction scale were administered at the end of the first month. Participants were also asked about local reactions, discomfort, band displacement, and other adverse events.
The trial was not prospectively registered. This record is being submitted after study completion.
- Conditions
- Premature Ejaculation
- Being tested
- Frenular Silicone Band, Prilocaine 10% Spray
- Keywords
- Lifelong Premature Ejaculation, Behavioral Therapy
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frenular Silicone BandDevice
A single-use segment measuring 4 cm × 2 cm and 2 mm thick was cut from medical-grade silicone adhesive tape intended for wound contact. Once a full erection was achieved, the participant positioned the band over the ventral frenular region, leaving the remainder of the glans exposed. The band remained in place throughout intercourse and was removed immediately afterward. A fresh segment was used for each encounter during the first month. Participants received standardized application and removal training. The tape was used outside its stated intended purpose.
Prilocaine 10% SprayDrug
Prilocaine 10% spray was applied to the glans penis approximately 5 minutes before each vaginal intercourse encounter during the first month. Participants received standardized instructions on application. The spray was discontinued at the end of the first month.
| Study group | Role | What they receive |
|---|---|---|
| Frenular Silicone Band Plus Behavioral Therapy | Experimental | Participants used a frenular silicone band during each vaginal intercourse encounter for one month and received behavioral counselling. The band was discontinued after the first month, while behavioral techniques continued for a second month. Receives: Device: Frenular Silicone Band |
| Prilocaine Spray Plus Behavioral Therapy | Active comparator | Participants used topical prilocaine 10% spray before each vaginal intercourse encounter for one month and received behavioral counselling. The spray was discontinued after the first month, while behavioral techniques continued for a second month. Receives: Drug: Prilocaine 10% Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Change from baseline in the total PEDT score at the end of Month 1 and Month 2. The PEDT is a five-item questionnaire assessing ejaculatory control, frequency of premature ejaculation, ejaculation with minimal stimulation, distress, and interpersonal difficulty. Each item is scored from 0 to 4, yielding a total score of 0 to 20. Higher scores indicate more severe symptoms; a reduction from baseline indicates improvement. Month 1 assessed response during the assigned intervention plus behavioral therapy, and Month 2 assessed response after intervention withdrawal while behavioral therapy continued.
Measured: Baseline, Month 1, and Month 2
Change From Baseline in Patient-Estimated Intravaginal Ejaculatory Latency Time (IELT)
Change from baseline in patient-estimated IELT, measured in minutes, at the end of Month 1 and Month 2. IELT was defined as the time from vaginal penetration to ejaculation. At each visit, participants recalled their average IELT over the preceding two weeks, rounded to the nearest minute. No stopwatch or intercourse diary was used. Higher values indicate longer ejaculatory latency. Month 1 assessed response to the assigned intervention plus behavioral therapy; Month 2 assessed persistence of response after withdrawal of the assigned intervention, with behavioral therapy continuing alone.
Measured: Baseline, Month 1, and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Sep 2025
- Primary completion15 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- 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
- Model description
- Participants were randomized in a 1:1 ratio to a frenular silicone band or topical prilocaine 10% spray, with 16 participants per group. Both groups received identical behavioural counselling throughout the two-month study. The assigned band or spray was used during the first month and discontinued during the second month, while behavioural techniques continued. Participants remained in their original groups without crossover.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SEZGIN, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820865
- Sponsor's protocol ID
- VS-PE-SILICONE-2025
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. These data will include treatment allocation, baseline characteristics, IELT estimates and PEDT scores at each assessment, PETO scores, treatment satisfaction scores, and recorded adverse events. Direct identifiers will not be shared, and potentially identifying information will be removed or generalized to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Frenular Silicone Band for Lifelong Premature Ejaculation: A Randomized Controlled Pilot Trial of Preliminary Efficacy, Tolerability, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07820865
- Acronym / sponsor ID
- VS-PE-SILICONE-2025
- Conditions
- Premature Ejaculation
- Keywords
- Lifelong Premature Ejaculation, Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 15 Sep 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.
This pilot study compared two approaches for men with lifelong premature ejaculation, a condition in which ejaculation occurs sooner than desired from the first sexual experiences and is difficult to delay. The aim was to explore their effects on ejaculation time, symptoms, treatment satisfaction, and side effects, and whether improvements persisted after treatment stopped.
Thirty-two men aged 18-35 years were assigned by chance to use either a soft silicone band over the frenulum, the sensitive area on the underside of the head of the penis, or a prilocaine spray, a medicine that temporarily reduces sensation. Both treatments were used before or during intercourse as instructed for one month. Both groups also received guidance on techniques to help control ejaculation, including pausing stimulation and relaxation exercises.
After the first month, participants stopped using the band or spray and continued the behavioural techniques alone for another month. Assessments took place at the start of the study and after one and two months. Participants estimated their average time from vaginal penetration to ejaculation and completed a questionnaire about premature ejaculation symptoms. Treatment satisfaction, treatment experience, and side effects were also assessed.
Detailed description
This single-centre, randomized, open-label pilot trial compared a frenular silicone band plus behavioural counselling with topical prilocaine 10% spray plus the same counselling in men with lifelong premature ejaculation. The sample size was pragmatic, with 16 participants per group, and the study was intended to provide preliminary estimates to inform further research.
Participants were allocated in a 1:1 ratio using a computer-generated random sequence. Treatment assignments were concealed from the enrolling investigator using envelopes. Participants and treating clinicians were aware of the assigned intervention.
The silicone band was cut from medical-grade silicone adhesive tape intended for wound contact and used outside its stated intended purpose. Its use for premature ejaculation was described in the ethics-approved protocol and participant information sheet. Participants received standardized training in positioning and removing the band.
Both groups received counselling on the stop-start technique, the squeeze technique, and breathing and relaxation exercises. The assigned band or spray was used during the first month and then discontinued. Behavioural techniques continued throughout the two-month follow-up. This design allowed assessment of changes during treatment and whether these changes persisted during the month after withdrawal.
At baseline and each follow-up visit, participants recalled their average intravaginal ejaculatory latency time over the preceding two weeks, rounded to the nearest minute. These values were subjective estimates; no stopwatch, diary, or contemporaneous record was used. Premature Ejaculation Diagnostic Tool scores were collected at the same visits. The Premature Ejaculation Treatment Outcome questionnaire and a five-point treatment satisfaction scale were administered at the end of the first month. Participants were also asked about local reactions, discomfort, band displacement, and other adverse events.
The trial was not prospectively registered. This record is being submitted after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to a frenular silicone band or topical prilocaine 10% spray, with 16 participants per group. Both groups received identical behavioural counselling throughout the two-month study. The assigned band or spray was used during the first month and discontinued during the second month, while behavioural techniques continued. Participants remained in their original groups without crossover.
| Arm | Type | Receives |
|---|---|---|
| Frenular Silicone Band Plus Behavioral Therapy | Experimental | Device: Frenular Silicone BandParticipants used a frenular silicone band during each vaginal intercourse encounter for one month and received behavioral counselling. The band was discontinued after the first month, while behavioral techniques continued for a second month. |
| Prilocaine Spray Plus Behavioral Therapy | Active comparator | Drug: Prilocaine 10% SprayParticipants used topical prilocaine 10% spray before each vaginal intercourse encounter for one month and received behavioral counselling. The spray was discontinued after the first month, while behavioral techniques continued for a second month. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male participants aged 18-35 years.
- Lifelong (primary) premature ejaculation with a reported inability to delay ejaculation.
- Premature Ejaculation Diagnostic Tool (PEDT) score of 11 or higher.
- In a stable heterosexual relationship for at least six months.
- Able to engage in vaginal intercourse at least three times per week.
Key exclusion criteria (8 listed)
- Secondary (acquired) premature ejaculation.
- Erectile dysfunction, defined as a five-item International Index of Erectile Function (IIEF-5) score below 22.
- Any chronic systemic disease, including diabetes mellitus or hypertension.
- Any psychiatric disorder or current or recent use of psychiatric medications.
- Regular use of medication affecting ejaculatory function.
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 |
|---|---|---|
| Frenular Silicone BandA single-use segment measuring 4 cm × 2 cm and 2 mm thick was cut from medical-grade silicone adhesive tape intended for wound contact. Once a full erection was achieved, the participant positioned the band over the ventral frenular region, leaving the remainder of the glans exposed. The band remained in place throughout intercourse and was removed immediately afterward. A fresh segment was used for each encounter during the first month. Participants received standardized application and removal training. The tape was used outside its stated intended purpose. | Device | Frenular Silicone Band Plus Behavioral Therapy |
| Prilocaine 10% SprayPrilocaine 10% spray was applied to the glans penis approximately 5 minutes before each vaginal intercourse encounter during the first month. Participants received standardized instructions on application. The spray was discontinued at the end of the first month. | Drug | Prilocaine Spray Plus Behavioral Therapy |
Primary outcome
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Time frame: Baseline, Month 1, and Month 2
Change from baseline in the total PEDT score at the end of Month 1 and Month 2. The PEDT is a five-item questionnaire assessing ejaculatory control, frequency of premature ejaculation, ejaculation with minimal stimulation, distress, and interpersonal difficulty. Each item is scored from 0 to 4, yielding a total score of 0 to 20. Higher scores indicate more severe symptoms; a reduction from baseline indicates improvement. Month 1 assessed response during the assigned intervention plus behavioral therapy, and Month 2 assessed response after intervention withdrawal while behavioral therapy continued.
Change From Baseline in Patient-Estimated Intravaginal Ejaculatory Latency Time (IELT)
Time frame: Baseline, Month 1, and Month 2
Change from baseline in patient-estimated IELT, measured in minutes, at the end of Month 1 and Month 2. IELT was defined as the time from vaginal penetration to ejaculation. At each visit, participants recalled their average IELT over the preceding two weeks, rounded to the nearest minute. No stopwatch or intercourse diary was used. Higher values indicate longer ejaculatory latency. Month 1 assessed response to the assigned intervention plus behavioral therapy; Month 2 assessed persistence of response after withdrawal of the assigned intervention, with behavioral therapy continuing alone.
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 15 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. These data will include treatment allocation, baseline characteristics, IELT estimates and PEDT scores at each assessment, PETO scores, treatment satisfaction scores, and recorded adverse events. Direct identifiers will not be shared, and potentially identifying information will be removed or generalized to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frenular Silicone Band and Prilocaine 10% Spray in people with Premature Ejaculation, run by Başakşehir Çam & Sakura City Hospital 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 6 inclusion and 8 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 15 Sep 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 From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score (time frame: Baseline, Month 1, and Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.