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

NCT06451406 | Completed

• 1 other identifier: 20240130002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Selective Serotonin Reuptake Inhibitor; Hyaluronic Acid; Glans Penis; Lifelong Premature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• International index of erectile function-5 (IIEF-5)

  6 months following treatment

• Index of premature ejaculation (IPE)

  6 months following treatment

• Patient satisfaction

  6 months following treatment

• Incidence of side effects

  6 months following treatment

Study Arms (2)

Selective serotonin re-uptake inhibitor

ACTIVE COMPARATOR

Patients received selective serotonin re-uptake inhibitor (SSRI) as medical treatment for treatment of premature ejaculate.

Drug: Selective serotonin re-uptake inhibitor

Hyaluronic acid

EXPERIMENTAL

Patients received hyaluronic acid gel injection in the glans penis.

Drug: Hyaluronic acid

Interventions

Selective serotonin re-uptake inhibitor DRUG

Patients received selective serotonin re-uptake inhibitor as medical treatment for treatment of premature ejaculate.

Selective serotonin re-uptake inhibitor

Hyaluronic acid DRUG

Patients received injection of glans penis with hyaluronic acid

Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males suffering from lifelong premature ejaculation not responding to the behavioral therapy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Males.
• Suffering from lifelong premature ejaculation not responding to the behavioral therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

Location

MeSH Terms

Interventions

Selective Serotonin Reuptake Inhibitors; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)