Erectile Rating During the Treatment of Rectal Cancers Localized

NCT ID: NCT01843218

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-12-31

Brief 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. 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.

Conditions

Rectal Cancer Stage I

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with localized rectal cancer

Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)

Group Type: OTHER

Evaluation of erectile dysfunction

Intervention Type: OTHER

Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)

Interventions

Evaluation of erectile dysfunction

Assessment (at night) of erctile dysfunction using R/P recording (RIGISCAN® PLUS / polysomonography)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male patient.

2. Age greater than 18 years.

3. Neoplastic rectal stage ≤ T3.

4. Patient sexually active before diagnosis.

5. Laparoscopic surgery.

6. Medico-surgical institute Bergonié.

7. Patient information and consent for participation in the study.

Exclusion Criteria

1. Patients already treated for erectile dysfunction.

2. Absence of sexual activity before diagnosis.

3. Presence of secondary lesions at diagnosis (M +).

4. Classified T4 tumor preoperatively.

5. Surgery by laparotomy.

6. History of pelvic cancer surgery prostate or bladder.

7. History of pelvic radiotherapy (outside of the current process).

8. History of prostate or bladder neoplasia known.

9. Other neoplastic known.

10. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EVRARD Serge, PU-PH

Role: STUDY_CHAIR

Institut Bergonié

Locations

Institut Bergonié

Bordeaux, Aquitaine, France

Countries

France

Other Identifiers

IB2008-07

Identifier Type: -

Identifier Source: org_study_id