A prospective and comparative evaluation of a male masturbation device for premature ejaculation-functional outcomes, safety, and satisfaction assessment: a pilot study
Abstract
BACKGROUND
Premature ejaculation (PE) is a common sexual dysfunction that negatively impacts the quality of life and relationships for men.
AIM
To compare the effectiveness, side effects, and satisfaction between a novel cognitive-behavioral therapy based on sphincter control training (SCT) supported by a mechanical masturbation device and dapoxetine, a pharmacological treatment for PE.
METHODS
A crossover study with 20 male patients diagnosed with PE was designed. Participants were randomly assigned to start with an 8-week cognitive-behavioral therapy program supported by a masturbation device or an 8-week treatment with dapoxetine (60 mg). After a 2-week washout time, treatments were crossed. Effectiveness was measured through intravaginal ejaculation latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT) scores, and the International Index of Erectile Function. Satisfaction rates were measured using the Erectile Dysfunction Inventory of Treatment Satisfaction scale and Likert scale. Adverse effects were recorded for both treatments.
OUTCOMES
Changes in IELT, PEDT scores, satisfaction rates, and side effects.
RESULTS
In the randomized phase, SCT + device demonstrated superior outcomes compared to dapoxetine for PEDT scores: 15.2 (SD = 1.7) vs 18.4 (SD = 2.6), P = .01; though IELT improvements were comparable: 111.7 (SD = 56.7) seconds vs 91.8 (SD = 77.8) seconds, P = .20. After crossover, patients switching from dapoxetine to SCT + device achieved significantly…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 20 participants or records.
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