New Valley University
New Valley, New Valley Governorate, 72511, Egypt
NCT Number: NCT06451406
The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.
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Notify Me18 year and older
Male
Interventional
Not applicable
New Valley, New Valley Governorate, 72511, Egypt
Over the past 30 years, the common knowledge of Premature ejaculation (PE) has advanced strikingly. PE is a very common and upsetting sexual male dysfunction. It is disturbing for both partners affecting their sexual experience, reducing their quality of life up to sexual abstinence, causing lack of self-confidence and even depression. It has a prevalence of a variable range, yet it is thought that one third of all males might complain of PE at a certain point throughout their lives and the incidence is rising.
Many treatment modalities have been currently used for PE varying from behavioral therapy to medical treatment and finally surgical therapy. Methods of behavioral therapy are: Squeeze technique and Start/stop technique. Pharmacological therapies include: nonselective and selective SSRIs, topical therapy with anesthetics, PDE5 inhibitors, opioid agonists and others. As for surgical modalities for PE there are several techniques including: glans augmentation, frenectomy, dorsal selective neurectomy, pulsed radiofrequency neuromodulation, removal of foreskin remnants and varicocelectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received selective serotonin re-uptake inhibitor as medical treatment for treatment of premature ejaculate.
Patients received injection of glans penis with hyaluronic acid
Time frame: 6 months following treatment
Intravaginal ejaculation latency time (IELT) is time from initiating sexual activity to ejaculation and used for diagnosis of Long-term premature ejaculation. It was assessed at the 1st, 3rd, and 6th months following treatment.
Time frame: 6 months following treatment
International index of erectile function-5 (IIEF-5) was used for diagnosis of Long-term premature ejaculation and classified into five categories: no (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7). It was assessed at the 1st, 3rd, and 6th months following treatment.
Time frame: 6 months following treatment
Index of premature ejaculation (IPE) is a 10 item self-administered questionnaire designed to evaluate sexual satisfaction, control and distress in men with premature ejaculation. It diagnosis premature ejaculation (PE) (≤8), possible PE (9 or 10), and no PE (≥11).It was assessed at the 1st, 3rd, and 6th months following treatment.
Time frame: 6 months following treatment
Degree of patient satisfaction was assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Degree of patient satisfaction was assessed at the 1st, 3rd, and 6th months following treatment.
Time frame: 6 months following treatment
Side effects such as nausea, dizziness, headache, dry mouth, pain at site of injection, ecchymosis, and bullae formation at site of injection were recorded.
New Valley University
Other
Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature: A Randomized Controlled Trial
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