Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature

Not Applicable

Completed

• Conditions: Glans Penis; Lifelong Premature; Selective Serotonin Reuptake Inhibitor; Hyaluronic Acid
• Interventions: Drug: Selective serotonin re-uptake inhibitor; Drug: Hyaluronic acid

• Registration Number: NCT06451406
• Lead Sponsor: New Valley University

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.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selective serotonin re-uptake inhibitor	Selective serotonin re-uptake inhibitor	Patients received selective serotonin re-uptake inhibitor (SSRI) as medical treatment for treatment of premature ejaculate.
Hyaluronic acid	Hyaluronic acid	Patients received hyaluronic acid gel injection in the glans penis.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

New Valley University; 🇪🇬 New Valley, Egypt