A Frenular Silicone Band for Lifelong Premature Ejaculation: A Randomized Controlled Pilot Trial of Preliminary Efficacy, Tolerability, and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Secondary (acquired) premature ejaculation.
- •Erectile dysfunction, defined as a five-item International Index of Erectile Function (IIEF-5) score below
- •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.
研究组 & 干预措施
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.
干预措施: Frenular Silicone Band (Device)
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.
干预措施: Prilocaine 10% Spray (Drug)
结局指标
主要结局
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
SEZGIN
MD VEYSEL SEZGİN
Başakşehir Çam & Sakura City Hospital