Premature ejaculation
Conditions
Interventions
Group 1:Regular penis-root masturbatory training combines with Dapoxetine 30 mg on demand
Group 2:Dapoxetine 30 mg on demand
Sponsors
Affiliated Panyu Central Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-40 years old, male; (2) Premature ejaculation (PE) patients: Defined according to the 2014 International Society for Sexual Medicine (ISSM) criteria for PE, i.e., ejaculation always or nearly always occurs within 1 minute of vaginal penetration (lifelong PE) or a clinically significant reduction in ejaculation latency to 3 minutes or less (acquired PE), starting from the first sexual experience; inability to delay ejaculation during all or nearly all vaginal penetrations; accompanied by negative personal consequences such as distress, frustration, avoidance of sexual intimacy, and/or psychological burden; (3) Sexually active patients with a stable, monogamous heterosexual relationship for at least 6 months, maintaining regular sexual activity (at least twice weekly), and capable of sustaining this relationship throughout the study period; (4) Premature Ejaculation Diagnostic Tool (PEDT) score >= 9; (5) No prior or current treatment for PE, or discontinuation of any PE-related therapies for at least 3 months; (6) Signed informed consent form and willingness to participate in monthly follow-ups (via WeChat, telephone, or outpatient visits) and adhere to medical guidance.
Exclusion criteria
Exclusion criteria: (1) ?Variable premature ejaculation or ?subjective premature ejaculation: ?Variable PE: Refers to irregular occurrences of short ejaculation latency accompanied by a subjective perception of reduced ejaculatory control. This subtype is not considered a sexual dysfunction but rather a normal variation in sexual function. ?Subjective PE: Characterized by one or more of the following features: persistent or non-persistent subjective perception of short intravaginal ejaculation latency time (IELT); obsessive belief in short ejaculation latency or poor ability to delay ejaculation; actual IELT within or above the normal range; lack or reduction of ejaculatory control (ability to delay ejaculation at the moment of imminent ejaculation). This obsessive belief cannot be attributed to other psychiatric disorders. (2) ?Homosexual, bisexual, or paraphilic patients; (3) ?Use of selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), phosphodiesterase-5 inhibitors (PDE5-Is), or other medications that may interfere with dapoxetine; (4) ?Comorbid erectile dysfunction, defined by a self-reported International Index of Erectile Function (IIEF-5) score < 22; (5) ?PE patients currently using medications for endocrine, metabolic, chronic systemic, or psychiatric disorders, or those with comorbid chronic systemic diseases such as hypertension or diabetes; (6) ?Hormonal abnormalities, hyperthyroidism, hypothyroidism, Peyronie’s disease, prostatitis, urethritis, or urinary tract infections; (7) ?Comorbid depression, anxiety disorders, manic episodes, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, schizophrenia, or other psychiatric conditions; (8) ?Alcohol abuse or substance use disorder; (9) ?History of dorsal penile nerve neurectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravaginal Ejaculatory Latency Time (IELT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Premature Ejaculation Diagnostic Tool (Total Score);The Clinical Global Impression Scale (CGII);Possible adverse reactions following penile root behavioral training or pharmacotherapy.; | — |
Countries
China
Contacts
Public ContactYang Ruilin
Affiliated Panyu Central Hospital of Guangzhou Medical University
Outcome results
None listed