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Interest of early erectile rehabilitation with Sildenafil after proctectomy for rectal cancer : Randomized controlled trial (RECTIL)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515431-30-00
Acronym
2019/0398/HP
Enrollment
188
Registered
2024-09-03
Start date
2025-08-14
Completion date
Unknown
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men treated with proctectomy for rectal cancer

Brief summary

Patient response at 12 months post-operatively. A patient is defined as a responder by a score of at least 22 on the erectile function domain of the International Index of Erectile Function (IIEF), which includes the six questions of the IIEF related to erection (Q1-Q5 and Q15)

Detailed description

IIEF erectile function domain score combining the six IIEF questions related to erection (Q1-Q5 and Q15) measured at surgery, D0, M3, M6 and M9 postoperative, International Index of Erectile Function global score measured at surgery, D0, M3, M6, M9 and M12 postoperative, Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at surgery, D0, M3, M6, M9 and M12 postoperative, LARS score measured at surgery, D0, M3, M6, M9 and M12 postoperative, Fecal Continence Score (Wexner score) measured at surgery, D0, M3, M6, M9 and M12 postoperative, The number of patients presenting spontaneous erections under treatment at M3, M6, M9 postoperative and without treatment at D0, and M12 postoperative., The number of patients with or without regular psychological followup. A patient is defined as having regular follow-up if he visits a psychologist and/or psychiatrist once or twice a month, Number of unused tablets during the study. The patient will be considered as non-compliant if tablet intake over the entire 10 months of treatment is < 80%., The number of AEs and SAEs in each group at D0, M3, M6, M9 and M12 postoperative

Interventions

DRUGSILDENAFIL EG 50 mg
DRUGcomprimé pelliculé
DRUGPlacebo de Sildenafil EG 50mg

Sponsors

Centre Hospitalier Universitaire Rouen
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Patient response at 12 months post-operatively. A patient is defined as a responder by a score of at least 22 on the erectile function domain of the International Index of Erectile Function (IIEF), which includes the six questions of the IIEF related to erection (Q1-Q5 and Q15)

Secondary

MeasureTime frame
IIEF erectile function domain score combining the six IIEF questions related to erection (Q1-Q5 and Q15) measured at surgery, D0, M3, M6 and M9 postoperative, International Index of Erectile Function global score measured at surgery, D0, M3, M6, M9 and M12 postoperative, Quality of life score (EORTC QLQ - C30 and QLQ - CR29) measured at surgery, D0, M3, M6, M9 and M12 postoperative, LARS score measured at surgery, D0, M3, M6, M9 and M12 postoperative, Fecal Continence Score (Wexner score) measured at surgery, D0, M3, M6, M9 and M12 postoperative, The number of patients presenting spontaneous erections under treatment at M3, M6, M9 postoperative and without treatment at D0, and M12 postoperative., The number of patients with or without regular psychological followup. A patient is defined as having regular follow-up if he visits a psychologist and/or psychiatrist once or twice a month, Number of unused tablets during the study. The patient will be considered as non-compliant if tablet in

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026