Silicone Band Versus Prilocaine Spray for Lifelong Premature Ejaculation

NCT07820865 | Completed

• 1 other identifier: VS-PE-SILICONE-2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ejaculation

Keywords

Lifelong Premature Ejaculation; Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Month 1, and Month 2

Study Arms (2)

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.

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.

Drug: Prilocaine 10% Spray

Interventions

Frenular Silicone Band DEVICE

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.

Frenular Silicone Band Plus Behavioral Therapy

Prilocaine 10% Spray DRUG

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.

Prilocaine Spray Plus Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Department of Urology

Istanbul, Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Prilocaine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD VEYSEL SEZGİN

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

TU (1)