Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions

NCT05010486 | Completed DMC

• 1 other identifier: USherbrooke2
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sexual dysfunction after rectal surgery varies widely in the literature. Prevalence of sexual dysfunction before surgery and desire of patient to treat this condition is also not well established. Objectives of this prospective cohort study were to determine prevalence of sexual dysfunction with a questionnaire before and after surgery. Patient's satisfaction and quality of life were also collected regarding preoperative information given.

Conditions

Sexual Dysfunction; Rectal Surgery; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Prevalence of sexual dysfunction after rectal surgery

  Prevalence of sexual dysfunction will be determined with a validated questionnaire on erectile dysfunction (ED). The International Index of Erectile Dysfunction-5 (IIEF-5) focuses on ED; therefore, it only includes the first 5 questions of the IIEF-15. Each item is scored on a 5-point Likert-type ascending scale with a total score between 1 and 25, where a score of 22 and above corresponds to normal erectile function.

  3 years

Secondary Outcomes (2)

• Patient satisfaction

  3 years

• Sexual dysfunction and quality of life

  3 years

Interventions

rectal surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients between 18 and 65 years who will have a rectal surgery at the Centre Hospitalier Universitaire de Sherbrooke

You may qualify if:

• Male between 18 and 65 years old
• Will undergo one of the following surgeries in the 12 months after the initial visit:
• Low anterior resection
• Abdominoperineal resection with end colostomy
• Total proctocolectomy with ileostomy
• Total proctocolectomy with ileoanal reservoir
• Proctectomy
• Having had a sexual intercourse in the 4 weeks prior to the initial visit
• Having the desire to maintain sexual activities in the post-operative period

You may not qualify if:

• Tadalafil allergy/hypersensitivity
• Having received treatment for erectile dysfunction or medical treatment in the 4 weeks prior to the initial visit
• Active consumption of nitrate derivatives (NO)
• History of non-arteritic ischemic optic neuropathy
• Severe renal or hepatic insufficiency
• Stroke in the last 6 months
• Myocardial infarction in the last 3 months
• Unstable angina pectoris or angina pectoris during sexual relations
• Cardiac insufficiency Class ≥ 2 in the last 6 months
• Uncontrolled arrhythmia, hypotension or hypertension

Sponsors & Collaborators

• Université de Sherbrooke: lead

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Patient Satisfaction

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nathalie McFadden, M.D

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 18, 2021

Record last verified: 2021-08