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

New Valley University

Status: Completed

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

Treatments: Drug: Hyaluronic acid; Drug: Selective serotonin re-uptake inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06451406

20240130002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Selective serotonin re-uptake inhibitor

Active Comparator group

Description:

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

Treatment:

Drug: Selective serotonin re-uptake inhibitor

Hyaluronic acid

Experimental group

Description:

Patients received hyaluronic acid gel injection in the glans penis.

Treatment:

Drug: Hyaluronic acid