Actively Recruiting

Phase 3
Age: 18Years - 70Years
MALE
NCT06123156

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer

Led by University Hospital, Rouen · Updated on 2026-05-12

188

Participants Needed

14

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.

CONDITIONS

Official Title

Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer

Who Can Participate

Age: 18Years - 70Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 to 70 years
  • Undergoing total mesorectal excision surgery for lower or middle rectal cancer after neoadjuvant radiotherapy
  • Normal erectile function before surgery (IIEF erectile function domain score of at least 22)
  • Surgery includes nerve-conserving techniques
  • Sexually active without prior erectile dysfunction treatment
  • Has a regular sexual partner (male or female)
  • Adult able to understand study information and provide consent
  • Enrolled in a social security scheme
Not Eligible

You will not qualify if you...

  • Tumor classified as T4 or requiring extended surgery
  • Abnormal erectile function before surgery (IIEF erectile function domain score less than 22)
  • History of prostate cancer
  • Sleep disorders or use of sedatives/hypnotics
  • Contraindications to Sildenafil 50 mg or placebo
  • Current treatment with PDE5 inhibitors
  • Infection with SARS-CoV-2
  • Legal restrictions or guardianship preventing consent
  • Psychological or sensory conditions impairing understanding or consent
  • Participation in another drug trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Chu Amiens

Amiens, France, 80054

Actively Recruiting

2

Hopital Beauvais

Beauvais, France, 60000

Actively Recruiting

3

Chu Besancon

Besançon, France, 25030

Actively Recruiting

4

Aphp Bicetre

Bicêtre, France, 94275

Actively Recruiting

5

Chu Bordeaux

Bordeaux, France, 33000

Actively Recruiting

6

Institut Bordeaux Colorectal

Bordeaux, France, 33000

Actively Recruiting

7

Chu Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

8

Chu Lille

Lille, France, 59000

Actively Recruiting

9

Institut Paoli-Calmettes

Marseille, France, 13009

Actively Recruiting

10

Institut Du Cancer Montpellier

Montpellier, France, 34000

Actively Recruiting

11

Aphp St Antoine

Paris, France, 75012

Actively Recruiting

12

Aphp Hegp

Paris, France, 75908

Actively Recruiting

13

Chu Rouen

Rouen, France, 76031

Actively Recruiting

14

Chu Tours

Tours, France, 37000

Actively Recruiting

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Research Team

V

Valérie Bridoux

CONTACT

J

Julie Rondeaux, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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