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NCT Number: NCT06442020

Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.

The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location status: Recruiting

About this study

Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged ≤75 yrs;
  • Low-risk PCa (PSA <10 ng/mL and GS <7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
  • preoperative IIEF-5 score ≥ 17;
  • First PSA (45d after surgery) <0.2
  • compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
  • patients able to provide a written informed consent for the trial.

Exclusion criteria

  • anaesthesiologic contraindications to robotic surgery;
  • patients submitted to pelvic radiotherapy or androgen deprivation;
  • patients reporting major postoperative complications (CD≥3);
  • cardiovascular contraindications to PDE5i medical treatment.

Treatment and study plan

Tadalafil (PDE5i)

Procedure

Tadalafil at a dose of 5mg/day

Primary outcomes

  1. Impact of LiESWT

    Time frame: 3 years

    To evaluate the impact that the use of low intensity extracorporeal shock waves LiESWT in combination with the early administration of phosphodiesterase 5 inhibitors has on the patient in the process of penile rehabilitation in erectile dysfunction following post-assisted radical prostatectomy robot

Secondary outcomes

  1. Assess how many patients reach orgasm

    Time frame: 3 years

    Compare the rate of patients achieving orgasm. The International Index of Erectile Function short form (IIEF-5) questionnaire is the recognized tool for assessing erectile function both before surgery and during follow-up.

  2. Questionnaires of Quality of life

    Time frame: 3 years

    Compare health-related quality of life outcomes through a validated self-administered questionnaire preoperatively and at postoperative follow-up assessment.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Jun 4, 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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