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Completed
NCT07820865
Silicone Band Versus Prilocaine Spray for Lifelong Premature Ejaculation
Conditions: Premature Ejaculation
Sex: Male
Ages: 18 Years – 35 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 32
Sponsor: Başakşehir Çam & Sakura City Hospital
Location: Başakşehir Çam and Sakura City Hospital, Department of Urology Istanbul Istanbul
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07820865). StuddyBuddy aggregates publicly available trial information.