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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Patient Satisfaction; Rectal Surgery
• Intervention / Treatment: Procedure: rectal surgery

• Study Type: Observational
• Enrollment (Actual): 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction regarding pre-operative information about the possible side-effects of surgery was assessed with a phone call 1 month after surgery. The quality of the information and the importance given to the possible side-effects of surgery, such as ED, were measured according to the patients' perspective on a 1 to 5 Likert-type ascending scale and a "yes or no" type of response.	3 years
Sexual dysfunction and quality of life	Quality of life was measured by the Quality of Life Enjoyment and Satisfaction (LES) Questionnaire Short Form (Q-LES-Q-SF), a 16-item derivative from the Q-LES-Q, a 93-item questionnaire. Patients' satisfaction was evaluated by a 5-point Likert-type ascending scale. The first 14 questions were scored from 14 to 70 points in total, while the last two items addressing medication and overall quality of life were represented by two independent scores of 5 points. Q-LES-Q-SF scores were measured at baseline during the first clinical visit as well as 1 month, 6 months, and 12 months after the surgery.	3 years

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Nathalie McFadden, M.D, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: USherbrooke2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No