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.

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Key information

Conditions

Sexual Dysfunction Behavior Genital Diseases Health Behavior Patient Satisfaction Rectal Surgery Sexual Dysfunction, Physiological Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rectal surgery

Procedure

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

Time frame: 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.
Sexual dysfunction and quality of life

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Aug 18, 2021
Registry last updated: Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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