Glans Penis, Hyaluronic Acid, Lifelong Premature, Selective Serotonin Reuptake Inhibitor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Patients received selective serotonin re-uptake inhibitor as medical treatment for treatment of premature ejaculate.
DRUGHyaluronic acid
Patients received injection of glans penis with hyaluronic acid
Sponsors
New Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old. * Males. * Suffering from lifelong premature ejaculation not responding to the behavioral therapy.
Exclusion criteria
* Erectile dysfunction. * Prostatitis. * Acquired premature ejaculation. * Addiction. * Psychiatric disorders (e.g., schizophrenia, bipolar disorder, and other psychoses). * Historical use of ejaculatory medication within the previous three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intravaginal ejaculation latency time (IELT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International index of erectile function-5 (IIEF-5) | 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. |
| Index of premature ejaculation (IPE) | 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. |
| Patient satisfaction | 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. |
| Incidence of side effects | 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. |
Countries
Egypt
Outcome results
None listed