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Silicone Band Versus Prilocaine Spray for Lifelong Premature Ejaculation

2026年9月10日 更新者：SEZGIN、Başakşehir Çam & Sakura City Hospital

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）、34200
        • Başakşehir Çam and Sakura City Hospital, Department of Urology

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Frenular Silicone Band Plus Behavioral Therapy
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.
设备：Frenular Silicone Band
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.
有源比较器：Prilocaine Spray Plus Behavioral Therapy
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.
药品：Prilocaine 10% Spray
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
大体时间：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.
Baseline, Month 1, and Month 2
Change From Baseline in Patient-Estimated Intravaginal Ejaculatory Latency Time (IELT)
大体时间：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.
Baseline, Month 1, and Month 2

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Başakşehir Çam & Sakura City Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月15日

初级完成 (实际的)

2025年12月15日

研究完成 (实际的)

2026年1月15日

研究注册日期

首次提交

2026年9月10日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • VS-PE-SILICONE-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享访问标准

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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