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

NCT ID: NCT06451406

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selective serotonin re-uptake inhibitor

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

Group Type: ACTIVE_COMPARATOR

Selective serotonin re-uptake inhibitor

Intervention Type: DRUG

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

Hyaluronic acid

Patients received hyaluronic acid gel injection in the glans penis.

Group Type: EXPERIMENTAL

Hyaluronic acid

Intervention Type: DRUG

Patients received injection of glans penis with hyaluronic acid

Interventions

Selective serotonin re-uptake inhibitor

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

Intervention Type: DRUG

Hyaluronic acid

Patients received injection of glans penis with hyaluronic acid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

New Valley University

OTHER

Sponsor Role: lead

Responsible Party

Waheed Fawzy Abdelrasol

Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New Valley University

New Valley, New Valley Governorate, Egypt

Countries

Egypt

Other Identifiers

20240130002

Identifier Type: -

Identifier Source: org_study_id