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

NCT06123156 | Recruiting Phase 3

• 2 other identifiers: 2019/0398/HP2020-002682-34
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 14

Brief Summary

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

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• the patient's response

  A patient is defined as a responder by a score of at least 22 for the erectile function domain of the International Index of Erectile Function (IIEF), comprising the six IIEF questions relating to erection (Q1-Q5 and Q15).

  12 months postoperatively

Secondary Outcomes (9)

• IIEF erectile function domain score

  Day 0, Month 1, Month 3, Month 6, Month 9, Month12

• International Index of Erectile Function (IIEF) global score

  Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

• Quality of life score

  Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

• LARS score

  Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

• Fecal Continence Score

  Day 0, Month 1, Month 3, Month 6, Month 9, Month 12

Study Arms (2)

Arm I (Sildénafil)

ACTIVE COMPARATOR

Sildénafil during 10 months (50mg daily), start 30 days after surgery

Drug: Sildenafil

Arm II (Placebo)

PLACEBO COMPARATOR

Patients receive placebo during 10 month (1 platelet per day)

Other: Placebo

Interventions

Sildenafil DRUG

Sildénafil during 10 months (50mg daily), start 30 days after surgery

Also known as: Arm I

Arm I (Sildénafil)

Placebo OTHER

1 platelet during 10 months (daily), start 30 days after surgery

Also known as: Arm II

Arm II (Placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 18 to 70
• Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22).
• Nerve-conserving surgery
• Sexually active patient without treatment for erectile function prior to surgery
• Presence of a regular sexual partner (male or female)
• Adult having read and understood the information letter and signed the consent form
• Membership of a social security scheme

You may not qualify if:

• T4 tumor or tumor requiring extended surgery
• Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22.
• History of prostate cancer
• Sleep disorders, patients taking sedatives/hypnotics
• Contraindication to SILDENAFIL EG 50 mg, film-coated tablet
• Contraindication to placebo
• Patients already treated with PDE5 inhibitors
• Patients suffering from SARS COV 2\*
• Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.
• Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent.
• Person participating in another drug trial.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (14)

Chu Amiens

Amiens, 80054, France

RECRUITING

Hopital Beauvais

Beauvais, 60000, France

RECRUITING

Chu Besancon

Besançon, 25030, France

RECRUITING

Aphp Bicetre

Bicêtre, 94275, France

RECRUITING

Chu Bordeaux

Bordeaux, 33000, France

RECRUITING

Institut Bordeaux Colorectal

Bordeaux, 33000, France

RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Chu Lille

Lille, 59000, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Institut Du Cancer Montpellier

Montpellier, 34000, France

RECRUITING

Aphp St Antoine

Paris, 75012, France

RECRUITING

Aphp Hegp

Paris, 75908, France

RECRUITING

Chu Rouen

Rouen, 76031, France

RECRUITING

Chu Tours

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Valérie Bridoux

CONTACT

0232881347; valerie.bridoux@chu-rouen.fr

Julie Rondeaux, PhD

CONTACT

0232885427; julie.rondeaux@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: September 25, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)