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

Sponsor
Université de Sherbrooke (Other)
Overall Status
Completed
CT.gov ID
NCT05010486
Collaborator
(none)
16
45

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: rectal surgery

Study Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Prevalence of sexual dysfunction after rectal surgery [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 Outcome Measures

  1. Patient satisfaction [3 years]

    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.

  2. Sexual dysfunction and quality of life [3 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Université de Sherbrooke

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT05010486
Other Study ID Numbers:
  • USherbrooke2
First Posted:
Aug 18, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 18, 2021