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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06451406
Other study ID # 20240130002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date June 1, 2023

Study information

Verified date June 2024
Source New Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Selective serotonin re-uptake inhibitor
Patients received selective serotonin re-uptake inhibitor as medical treatment for treatment of premature ejaculate.
Hyaluronic acid
Patients received injection of glans penis with hyaluronic acid

Locations

Country Name City State
Egypt New Valley University New Valley

Sponsors (1)

Lead Sponsor Collaborator
New Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intravaginal ejaculation latency time (IELT) 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. 6 months following treatment
Secondary International index of erectile function-5 (IIEF-5) 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. 6 months following treatment
Secondary Index of premature ejaculation (IPE) 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. 6 months following treatment
Secondary Patient satisfaction 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.
6 months following treatment
Secondary Incidence of side effects Side effects such as nausea, dizziness, headache, dry mouth, pain at site of injection, ecchymosis, and bullae formation at site of injection were recorded. 6 months following treatment
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