Skip to main content
Clinical Trials/NCT05010486
NCT05010486
Completed
Not Applicable

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

Université de Sherbrooke0 sites16 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexual Dysfunction
Sponsor
Université de Sherbrooke
Enrollment
16
Primary Endpoint
Prevalence of sexual dysfunction after rectal surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
May 2019
Last Updated
4 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of sexual dysfunction after rectal surgery

Time Frame: 3 years

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.

Secondary Outcomes

  • Patient satisfaction(3 years)
  • Sexual dysfunction and quality of life(3 years)

Similar Trials