The most extensive randomized, single-blind, placebo-controlled study ever conducted on premature ejaculation shows the effectiveness of Steady Freddy Delay Spray with impressive results of significant improvement in sexual satisfaction.
Clinical trial study shows effectiveness of Steady Freddy Delay Spray on premature ejaculation.

Study Description

Brief Summary

Premature Ejaculation (PE) is reported to be the most common sexual dysfunction in men, which is defined as the inability to control or delay ejaculation.

Steady Freddy is a lidocaine-based ejaculation-delaying spray. 

This article examines the results of a randomized, single-blind, placebo-controlled clinical trial of Steady Freddy ejaculation-delaying spray. 

The study explores the direct impact on intravaginal ejaculatory latency time (IELT) control and overall quality of sexual experience (QSE) by using Steady Freddy Delay Spray.

Here's a video that we made that highlights the two most important takeaways from this clinical trial study.

Detailed Description

Premature Ejaculation (PE) is reported to be the most common sexual dysfunction in men, affecting between 30-50% of the male population.

According to the International Society for Sexual Medicine, premature ejaculation is defined as a male sexual dysfunction in which ejaculation always or almost always occurs before or within about 1 minute of sexual penetration. The inability to delay ejaculation during sexual activity may have negative personal consequences such as distress, frustration, and/or the avoidance of sexual intimacy.

Four subtypes describe premature ejaculation symptoms: lifelong, acquired, variable, and subjective PE.

Lifelong and acquired PE present as a persistent ejaculatory problem with an intravaginal ejaculatory latency time (IELT) of less than 1 minute for lifelong and less than 3 minutes for acquired. Conversely, either variable and subjective PE are inconsistent and present short, normal, or prolonged IELT.

PE assessment relies on questionnaires that have been developed and published.

Based on the nature of this condition, treatment options for PE may include a range of psychological, behavioral, surgical, and pharmaceutical therapies. Among these, topical anesthetic agents pose the lowest risk for patients and are characterized by minimal side effects and can be used on demand.

Steady Freddy is an over-the-counter lidocaine-based topical spray that is applied directly to the penile skin before sexual interaction for the purpose of delaying ejaculation and improving the quality of sexual experience (QSE). Spray usage reduced frustration and anxiety; 58% of users reported feeling content, while 79% of placebo users reported feeling frustrated and anxious.

To date, no other studies have evaluated the effectiveness of Steady Freddy nor tested the effectiveness of 9.6% lidocaine topical spray formulation with 45% ethanol on PE or QSE.

ALSO READ: Premature Ejaculation: A Man's Ultimate Guide

Study Design

Aim of the Study

  • To evaluate the Steady Freddy lidocaine-based spray on improving the duration of the intravaginal ejaculatory latency time (IELT), less formally described as the time between penetration and ejaculation during sexual activity.
  • This study also aims to objectively measure the impact of Steady Freddy lidocaine-based pump spray on the quality of sexual experience (QSE) of men who have self-reported suffering from PE or who ejaculate sooner than they desire.
Clinical trial study shows that Steady Freddy delay spray helps men last longer during sex.
Source: Shariev A, Savdie R, Hart K. The Effects of Steady Freddy, a Lidocaine-Based Pump Spray for the Treatment of Premature Ejaculation (PE). Am J Mens Health. 2022

Data

The study recruited 150 male participants who met all eligibility criteria. In order to participate, the subjects must be between the ages of 18-45 years, are currently involved in a sexual relationship, and have no medical history that may be associated with sexual performance or ejaculation.

The eligible participants were randomized to either the treatment group (taking 9.6% lidocaine dissolved in 45% ethanol) or the placebo group (taking 45% ethanol dissolved in water). Since this was a single-blinded trial, the participants were not aware of which group they were assigned to.

Item Placebo Treatment
Sample Size 75 75
PEDT 15.0 ± 0.5 14.9 ± 0.5
IELT (<1 minute) 59% 61%
Satisfied with sexual 2% 2%
Frustrated with intercourse duration 83% 80%

Table 1. Baseline Values of Participants in Both the Placebo and Treatment Group. Values Were Self-Reported and Recorded Via Online Participant Questionnaire Before the Usage of the Allocated Treatments. Error Is Represented as Standard Error of the Mean (SEM).

Participants received their product sample and were instructed to use it every time they engaged in sex (defined as oral, anal, or vaginal), then report their sexual behavior and relationship context every 4 weeks using an electronic survey.

 Flow Diagram of the Progress Through the Phases of a Placebo Controlled Parallel Randomized Trial of Two Treatment Group
Flow Diagram of the Progress Through the Phases of a Placebo Controlled Parallel Randomized Trial of Two Treatment Groups (i.e., Enrolment, Intervention Allocation, Follow-Up, and Data Analysis)

Outcome Measures

At the beginning of the study, participants completed a premature ejaculation diagnostic tool (PEDT) assessment, which demonstrated strong validity and reliability in assessing PE.

They answered five questions on a 5-point scale reflecting their perceived difficulty delaying ejaculation, ejaculating before desired, ejaculation with very little stimulation, frustration with ejaculating before desired, and perception of whether time to ejaculation affected the sexual fulfillment of their partner. A score of 11 or higher was associated with the diagnosis of PE, a score of 9 and 10 were considered as probable PE, and a score of 8 or lower indicated no PE.

In addition to the PEDT, participants also provided data once every 4 weeks regarding the product's impact on their sexual experience. This included questions about IELT during penetration, the importance of ejaculatory control, the extent of impact on satisfaction, and confidence.

ALSO READ: A Guide to How to Use Steady Freddy Delay Spray

Statistical Analyses

Participants who only used the product without completing the survey were removed from the trial because the researchers could not accurately estimate the product effect. After these participants were removed, statistical analysis was performed using GraphPad Prism software to compare the product’s effect before and after usage via a series of random effect mixed models.

Since data was collected from the same men over the course of 12 weeks, researchers were able to compare the placebo group to the treatment group at all time points using two-way analysis of variance (ANOVA) to determine statistical significance.

Study Results Results

Written and verbal consent was obtained from 150 male participants, with 75 assigned to each group. As seen below in Table 2, the PEDT score at baseline indicated that both groups had a clinical diagnosis of PE in accordance with the PEDT scoring scale.

Prior to product usage, IELT was <1 minute for 90 (60%) of the participants, who also expressed being almost or almost always distressed or concerned about ejaculating sooner.

Electronic Report Results

After only 4 weeks, the participants in the treatment group using Steady Freddy Delay Spray displayed a significant increase in their IELT with 43 (61%) participants lasting longer than 2 minutes and 20 (28%) lasting between 1.5 and 2 minutes.

Compared to baseline, the product usage displayed an astounding 59% increase in participants lasting >2 minutes. This can be seen below in Figure 1.

Intravaginal Ejaculatory Latency Time (IELT) in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. IELT Was Self-Reported and Recorded Via Online Participant Questionnaire
Figure 1: Intravaginal Ejaculatory Latency Time (IELT) in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. IELT Was Self-Reported and Recorded Via Online Participant Questionnaire

Similarly, Steady Freddy Delay Spray was also shown to help significantly boost self-reported sexual satisfaction in 37 (53%) participants. No changes were observed for the placebo group as a vast majority of participants expressed being ‘very dissatisfied’ with their overall sexual satisfaction.

These results were consistent throughout the entire trial and can be seen in more detail below in Figure 2.

Overall Sexual Satisfaction in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. IELT Was Self-Reported and Recorded Via Online Participant Questionnaire. Note:  IELT (Intravaginal Ejaculatory Latency Time).
Figure 2: Overall Sexual Satisfaction in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. IELT Was Self-Reported and Recorded Via Online Participant Questionnaire. Note: IELT (Intravaginal Ejaculatory Latency Time).

As seen in Figures 3 and 4, 39 (56%) participants allocated to the treatment group expressed greater sexual satisfaction with their partners immediately following sexual intercourse while another 23 (33%) indicated they were very satisfied overall.

Participants largely felt the use of the product positively affected their sexual experience, with 42 (61%) reporting that sexual intercourse was more than half the time or always satisfactory while a total of 49 (71%) participants expressed being more satisfied with the duration of intercourse.

On the other hand, 42 (63%) participants in the placebo group reported being very dissatisfied, 53 (78%) reported sexual intercourse as not being satisfactory, and 55 (81%) reported being dissatisfied with the duration of intercourse.

Satisfaction in Sexual Intercourse in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire
Figure 3: Satisfaction in Sexual Intercourse in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire
Frustration in Duration of Sexual Intercourse in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire
Figure 4: Frustration in Duration of Sexual Intercourse in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire

In Figure 5, we can see that the usage of Steady Freddy Delay Spray resulted in 48 (68%) participants claiming to be satisfied with their control over ejaculation. Conversely, 53 (79%) participants in the placebo group reported being dissatisfied or very dissatisfied.

Satisfaction of Ejaculation Control in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire
Figure 5: Satisfaction of Ejaculation Control in Both Placebo and Treatment Groups Post 4 Weeks of Treatment. Results Were Self-Reported and Recorded Via Participant Patient Questionnaire

A comparison was made between the Steady Freddy treatment and placebo. The results showed that using the treatment had a significant positive impact on QSE. This finding was displayed through a decrease in PEDT scores from an average of 15.3 ± 4.3 to 14.2 ± 4.5.

Additionally, Steady Freddy Delay Spray was also shown to decrease feelings of frustration and anxiety as 41 (58%) participants claimed they were content, while 53 (79%) participants in the placebo group claimed to be very frustrated and anxious.

Lastly, ejaculatory control and anxiety related to ejaculation improved with the use of Steady Freddy Delay Spray, as 46 (65%) participants claimed they were never distressed while 46 (68%) placebo participants claimed to be more distressed.

Study Limitations

This study has some limitations.

First, all medical history was self-reported, so future studies should consider verifying medical history independently.

Second, the study had a modest sample size (150 participants) over the course of a long timeframe (12 weeks) within a single-blinded placebo-controlled environment. As such, a randomized double-blind, placebo controlled, cross-over trial would provide more reliable evidence of the effects demonstrated in this study.

ALSO READ: Sex Positions to Help Men Last Longer

Conclusion

Steady Freddy is a lidocaine-based pump spray used as a topical agent to delay ejaculation. After only 4 weeks, the results displayed a significant improvement in sexual satisfaction (53%) and quality of sexual experience, as well as an increase in penetration time (61% lasting longer than 2 minutes). Consistent improvements were shown over the 12 week period.

Compared to baseline, 90% of men who lasted only 30 seconds increased their intravaginal time by over 2 minutes when given Steady Freddy Delay Spray!

Additional study findings include: 92% of spray users were satisfied with their sex life after 12 weeks vs. 10% placebo group. 5x increase in people satisfied with duration before ejaculation using the spray. Spray users 3x more likely to report high confidence than non-users before sex.

To read the original posting of the study, follow the study source below.

Study authors: Shariev A, Savdie R, Hart K.

Study source: The Effects of Steady Freddy, a Lidocaine-Based Pump Spray for the Treatment of Premature Ejaculation (PE). Am J Mens Health. 2022;16(6):15579883221145245. doi:10.1177/15579883221145245

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Medical Disclaimer: This article is for informational purposes only and is not intended to give medical advice or substitute for the medical advice of a physician.

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