Silicone Band Versus Prilocaine Spray for Lifelong Premature Ejaculation
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Istanbul
-
Istanbul, Istanbul, Turkki (Türkiye), 34200
- Başakşehir Çam and Sakura City Hospital, Department of Urology
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Ejakulaatiohäiriö
- Mielenterveyshäiriöt
- Sukuelinten sairaudet, mies
- Miesten urogenitaaliset sairaudet
- Seksuaalinen toimintahäiriö, fysiologinen
- Seksuaaliset häiriöt, psykologiset
- Ennenaikainen siemensyöksy
- Orgaaniset kemikaalit
- Anilidit
- Amidit
- Aniliiniyhdisteet
- Amiini
- Prilokaiini
Muut tutkimustunnusnumerot
- VS-PE-SILICONE-2025
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon käyttöoikeuskriteerit
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .