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Completed

NCT Number: NCT06451406

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New Valley University

New Valley, New Valley Governorate, 72511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective serotonin re-uptake inhibitor

Drug

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

Hyaluronic acid

Drug

Patients received injection of glans penis with hyaluronic acid

Primary outcomes

  1. Intravaginal ejaculation latency time (IELT)

    Time frame: 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 outcomes

  1. International index of erectile function-5 (IIEF-5)

    Time frame: 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.

  2. Index of premature ejaculation (IPE)

    Time frame: 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.

  3. Patient satisfaction

    Time frame: 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.

  4. Incidence of side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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