Rectal Cancer Stage IMETEORRNCT01843218
Erectile Rating During the Treatment of Rectal Cancers Localized
A study testing Evaluation of erectile dysfunction in people with Rectal Cancer Stage I, run by Institut Bergonié at 1 site in France.
Trial summary
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Rectal Cancer Stage I
- What is being tested?
- Evaluation of erectile dysfunction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient.
- Age greater than 18 years.
- Neoplastic rectal stage ≤ T3.
- Patient sexually active before diagnosis.
- Laparoscopic surgery.
- Medico-surgical institute Bergonié.
- Patient information and consent for participation in the study.
Who cannot join
- Patients already treated for erectile dysfunction.
- Absence of sexual activity before diagnosis.
- Presence of secondary lesions at diagnosis (M +).
- Classified T4 tumor preoperatively.
- Surgery by laparotomy.
- History of pelvic cancer surgery prostate or bladder.
Show all 10Show fewer
- History of pelvic radiotherapy (outside of the current process).
- History of prostate or bladder neoplasia known.
- Other neoplastic known.
- Patient for psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patient deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Aim : Objectively assess the presence of erectile dysfunction induced by medical and surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the RIGISCAN® PLUS system coupled with polysomnographic recording.
Read the detailed description
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. After surgical treatment alone, sexual dysfunction can be observed in 40 to 90% of patients, depending on the studies and the technique used. It is the result of direct vascular and nerve damage caused during surgery. It occurs immediately after surgery. It can sometimes recover over time, up to 18 months after the operation. Pelvic radiotherapy also has side effects on sexual function. The damage is caused by alterations in microvascularization or direct nerve damage.
It develops more gradually, over a period of several weeks or months. After treatment combining radiotherapy and surgery, the risk of sexual dysfunction is significant and can affect up to 90% of patients.
In an attempt to improve these results, surgical techniques have gradually evolved towards complete resection of the mesorectum with nerve preservation. Studies published on this subject show an improvement in functional outcomes, without any deterioration in oncological outcomes. This has now become the standard surgical technique.
In the specific case of the management of neoplastic disease, it is common to observe a reactive anxiety-depression syndrome in patients. This mood disorder affects libido and sexuality. A lack of sexual activity in the postoperative period is therefore not necessarily related to iatrogenic vascular-nerve damage. In order to improve patients' quality of life, it is useful to know how to objectively diagnose post-operative erectile dysfunction. This diagnosis should make it possible to distinguish between disorders related to vascular-nervous damage and those that are part of a post-operative anxiety-depression syndrome.
An accurate diagnosis of sexual dysfunction can lead to specific treatment:
intracavernosal injections of prostaglandins are the standard treatment, but phosphodiesterase 5 inhibitors can also be used. For these reasons, it is necessary to develop a method for evaluating objective erectile dysfunction after resection.
The Rigiscan Plus device is a commercially available measurement tool that has received CE certification.
It can be used to assess several parameters of erection: rigidity, intensity, and duration. This measuring device has been validated for the assessment of erectile dysfunction, and normal values have been established in healthy subjects.
Combining these two tests makes it possible to assess the presence or absence of erections during REM sleep and to objectively diagnose erectile dysfunction:
in the presence of decreased libido, nocturnal erections are preserved, whereas they are impaired following vascular-nervous damage. Recording nocturnal erections is useful for assessing erectile dysfunction after rectal surgery in two ways. Preoperatively, it provides objective confirmation that the patient has spontaneous erections of good quality. Postoperatively, recording allows confirmation that the autonomic nervous system required for erection has been preserved. It is an objective examination that is independent of the patient's libido, which is often impaired by the treatment of a neoplastic disease.
- Conditions
- Rectal Cancer Stage I
- Being tested
- Evaluation of erectile dysfunction
- Keywords
- Localized rectal cancer in a male patient
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of erectile dysfunctionOther
Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)
| Study group | Role | What they receive |
|---|---|---|
| Patients with localized rectal cancer | Other | Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) Receives: Other: Evaluation of erectile dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)
Measured: 3 months after surgery
Secondary outcomes (1)
Quality of Nocturnal Erections
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.
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJan 2009
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rectal Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EVRARD Serge, PU-PH, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843218
- Sponsor's protocol ID
- IB2008-07
- Acronym
- METEORR
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2012
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study
- ClinicalTrials.gov ID
- NCT01843218
- Acronym / sponsor ID
- METEORR / IB2008-07
- Conditions
- Rectal Cancer Stage I
- Keywords
- Localized rectal cancer in a male patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. Aim : Objectively assess the presence of erectile dysfunction induced by medical and surgical treatment of rectal cancer three months after surgery. These objective data will be obtained using the RIGISCAN® PLUS system coupled with polysomnographic recording.
Detailed description
Sexual dysfunction is a common side effect of medical and surgical treatments for rectal cancer. It can manifest as ejaculation disorders or erectile dysfunction. Due to the modesty of both patients and doctors, these disorders are poorly understood and probably underestimated at present. After surgical treatment alone, sexual dysfunction can be observed in 40 to 90% of patients, depending on the studies and the technique used. It is the result of direct vascular and nerve damage caused during surgery. It occurs immediately after surgery. It can sometimes recover over time, up to 18 months after the operation. Pelvic radiotherapy also has side effects on sexual function. The damage is caused by alterations in microvascularization or direct nerve damage.
It develops more gradually, over a period of several weeks or months. After treatment combining radiotherapy and surgery, the risk of sexual dysfunction is significant and can affect up to 90% of patients.
In an attempt to improve these results, surgical techniques have gradually evolved towards complete resection of the mesorectum with nerve preservation. Studies published on this subject show an improvement in functional outcomes, without any deterioration in oncological outcomes. This has now become the standard surgical technique.
In the specific case of the management of neoplastic disease, it is common to observe a reactive anxiety-depression syndrome in patients. This mood disorder affects libido and sexuality. A lack of sexual activity in the postoperative period is therefore not necessarily related to iatrogenic vascular-nerve damage. In order to improve patients' quality of life, it is useful to know how to objectively diagnose post-operative erectile dysfunction. This diagnosis should make it possible to distinguish between disorders related to vascular-nervous damage and those that are part of a post-operative anxiety-depression syndrome.
An accurate diagnosis of sexual dysfunction can lead to specific treatment:
intracavernosal injections of prostaglandins are the standard treatment, but phosphodiesterase 5 inhibitors can also be used. For these reasons, it is necessary to develop a method for evaluating objective erectile dysfunction after resection.
The Rigiscan Plus device is a commercially available measurement tool that has received CE certification.
It can be used to assess several parameters of erection: rigidity, intensity, and duration. This measuring device has been validated for the assessment of erectile dysfunction, and normal values have been established in healthy subjects.
Combining these two tests makes it possible to assess the presence or absence of erections during REM sleep and to objectively diagnose erectile dysfunction:
in the presence of decreased libido, nocturnal erections are preserved, whereas they are impaired following vascular-nervous damage. Recording nocturnal erections is useful for assessing erectile dysfunction after rectal surgery in two ways. Preoperatively, it provides objective confirmation that the patient has spontaneous erections of good quality. Postoperatively, recording allows confirmation that the autonomic nervous system required for erection has been preserved. It is an objective examination that is independent of the patient's libido, which is often impaired by the treatment of a neoplastic disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with localized rectal cancer | Other | Other: Evaluation of erectile dysfunctionAssessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patient.
- Age greater than 18 years.
- Neoplastic rectal stage ≤ T3.
- Patient sexually active before diagnosis.
- Laparoscopic surgery.
Key exclusion criteria (10 listed)
- Patients already treated for erectile dysfunction.
- Absence of sexual activity before diagnosis.
- Presence of secondary lesions at diagnosis (M +).
- Classified T4 tumor preoperatively.
- Surgery by laparotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of erectile dysfunctionAssessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography) | Other | Patients with localized rectal cancer |
Primary outcome
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer
Time frame: 3 months after surgery
Erectile dysfunction is defined by the absence of normal nocturnal erections according to R/P recording (RIGISCAN® PLUS / polysomnography)
1 secondary outcome
Quality of Nocturnal Erections
Time frame: 3 years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EVRARD Serge, PU-PH study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of erectile dysfunction in people with Rectal Cancer Stage I, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Erectile Dysfunction Induced by Medical and Surgical Treatment of Rectal Cancer (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.