Trial Outcomes & Findings for Erectile Rating During the Treatment of Rectal Cancers Localized (NCT NCT01843218)

Results Overview

Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

3 months after surgery

Results posted on

2025-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Localized Rectal Cancer Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
Overall Study STARTED	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Localized Rectal Cancer Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Localized Rectal Cancer n=7 Participants Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
Age, Continuous	61 years n=7 Participants
Sex: Female, Male Female	0 Participants n=7 Participants
Sex: Female, Male Male	7 Participants n=7 Participants
Region of Enrollment France	7 participants n=7 Participants

PRIMARY outcome

Timeframe: 3 months after surgery

Population: Participants with R/P recording (RIGISCAN® PLUS / polysomnography) performed

Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)

Outcome measures

Outcome measures
Measure	Patients With Localized Rectal Cancer n=7 Participants Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer	0 Participants

SECONDARY outcome

Timeframe: 3 years after surgery

Population: Participants with available R/P recording (RIGISCAN® PLUS / polysomnography).

Erections are assessed according to R/P recording (RIGISCAN® PLUS / polysomnography). Erectile function will be described and categorized into 4 distinct stages: * Stage 1: Normal erections. Rigidity measured at the tip of the penis is ≥ 60% for at least 10 minutes. * Stage 2: Intermediate erections. Rigidity measured at the tip of the penis is between 40 and 60% for at least 5 minutes. * Stage 3: Failing erections. Erectile episodes are noted but their intensity is less than 40% OR their duration is less than 5 minutes. * Stage 4: Absence of erections. No erectile episodes are recorded.

Outcome measures

Outcome measures
Measure	Patients With Localized Rectal Cancer n=6 Participants Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Evaluation of erectile dysfunction: Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
Quality of Nocturnal Erections Normal erections	3 Participants
Quality of Nocturnal Erections Intermediate erections	2 Participants
Quality of Nocturnal Erections Failing erections	1 Participants
Quality of Nocturnal Erections Absence of erections	0 Participants

Adverse Events

Patients With Localized Rectal Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place