Sexual DysfunctionNCT05010486
Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
An observational study of Sexual Dysfunction and Rectal Surgery, run by Université de Sherbrooke.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Rectal Surgery, Patient Satisfaction
- What is being tested?
- rectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male patients between 18 and 65 years who will have a rectal surgery at the Centre Hospitalier Universitaire de Sherbrooke
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
- Being tested
- rectal surgery
- Medical subject headings
- Sexual Dysfunction, Physiological, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startAug 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie McFadden, M.D, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010486
- Sponsor's protocol ID
- USherbrooke2
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions
- ClinicalTrials.gov ID
- NCT05010486
- Acronym / sponsor ID
- USherbrooke2
- Conditions
- Sexual Dysfunction, Rectal Surgery, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients between 18 and 65 years who will have a rectal surgery at the Centre Hospitalier Universitaire de Sherbrooke
Key inclusion criteria (9 listed)
- Male between 18 and 65 years old
- Will undergo one of the following surgeries in the 12 months after the initial visit:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectal surgery | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Patient satisfaction
Time frame: 3 years
Sexual dysfunction and quality of life
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie McFadden, M.D principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and Rectal Surgery, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sexual dysfunction after rectal surgery (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.