An interventional study of Frenular Silicone Band and lidocaine-prilocaine spray in Premature Ejaculation, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Başakşehir Çam & Sakura City Hospital · Not applicable, Interventional, and Treatment
Among 14 studies in Premature Ejaculation with a site in Turkey — 3 open to participants now, 3 under way, none of them phase 3. Premature Ejaculation · Turkey.
Among the 14 studies in Premature Ejaculation with a site in Turkey, this one is the 10th largest by enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2025, is one of 8 with no phase, and was the 14th registered.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
Browse Premature Ejaculation studies →3 of the 14 studies in Premature Ejaculation with a site in Turkey are open now. Recruiting first, the newest first:
Uskudar University · Sites in Turkey
Başakşehir Çam & Sakura City Hospital · Sites in Turkey
Medipol University · Sites in Turkey
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 9 Premature Ejaculation studies recruiting now, 2 (22%) set no upper age limit and 6 (67%) stop at 75 or younger; 0 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 35 Years · male · healthy volunteers too.
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14 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2025.
This study's enrollment of 32 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Median enrollment 67 across the 10 interventional studies, 102 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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2 of 14 have an industry lead sponsor. The 10 most frequent:
Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Başakşehir Çam & Sakura City Hospital has 2 studies filed under Premature Ejaculation — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Premature Ejaculation with a site in Turkey, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Frenular Silicone Band
Participants used topical lidocaine-prilocaine 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.
Drug: lidocaine-prilocaine spray
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.
lidocaine-prilocaine 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.
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.
Time frame: 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.
Time frame: Baseline, Month 1, and Month 2
Plan to share: 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.
Access criteria: Researchers may request access by contacting the corresponding author at [veyselsezgin1@gmail.com](mailto:veyselsezgin1@gmail.com) and submitting a proposal describing the research question, requested data, and planned analyses. Requests will be assessed for scientific relevance and consistency with participant consent and institutional requirements. Approved researchers will receive only the de-identified data needed for the agreed purpose, subject to a data use agreement prohibiting participant re-identification and unauthorized redistribution.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Dec 2025, 3 months.
Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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