Postoperative Return to Sexual Activity

Study Overview
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Brief Summary
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To determine if standardized counselling regarding first sexual encounter after pelvic reconstructive surgery for pelvic organ prolapse and / or urinary incontinence improves postoperative preparedness to return to sexual activity and sexual function.

Detailed Description
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The investigators will conduct a randomized controlled trial comparing standardized counselling to routine counseling regarding return to sexual activity using a previously developed structured counselling instrument. Adult women (age ≥18 years) who are undergoing reconstructive surgery for pelvic organ prolapse and / or urinary incontinence who report that they are currently sexually active (as defined by their own assessment of the meaning of this question) will be eligible to participate and recruited during their preoperative visit. The recruitment will take place across 10 sites in Canada and the Unites States. The hypothesis is that use of a newly developed standardized counselling intervention regarding resumption of sexual activity will result in improved preparedness to return to sexual function compared to routine care. The primary outcome will be preparedness at 2-6 months postoperatively. Preparedness for return to sexual activity will be measured by modifying the Patient Preparedness Questionnaire, Question #11: Overall, I feel prepared for my upcoming surgery to make it relevant to sexual activity following surgery. The investigators will consider women prepared if they answer strongly agree on a 6-point Likert scale from strongly agree to strongly disagree to the modified statement: Overall, I feel prepared for resuming sexual activity after my surgery. In addition to the primary outcome, the investigators will compare the secondary outcomes of sexual function, time to return to sexual activity, and postoperative pain with sexual activity. Sexual function will be measured by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) score. Pain with sexual activity will be assessed by response to question 11 on PISQ-IR: How often do you feel pain during sexual intercourse? Women who have already consented for surgery for pelvic organ prolapse surgery will be approached to offer participation in the study at the pre-operative visit. After enrollment in the study, women will complete demographic information, undergo a pelvic organ prolapse quantification examination, and complete the PISQ IR and the Pelvic Floor Distress Inventory - 20 (PFDI-20). Women will then be randomized to either usual or scripted counseling for resumption of sexual activity. The randomization assignment will occur as close to the intervention as possible, i.e. the night before, or the morning of, scheduled 6-8 week postoperative appointment. The randomization schema will be generated using an online randomization table with alternating blocks of 4 and 6. If randomized to the treatment group, patients will be counselled using the structured counselling instrument, and given a bulleted list of the counseling instrument to take home with them. After the visit, women will complete the PFDI-20 and Preparedness question in telephone-administered, paper or online questionnaire format. The study team will contact each participant by telephone or electronically at 1 month intervals starting at 2 months after surgery, to ascertain whether they had returned to sexual activity. If the postoperative visit occurred at 8 weeks, the first contact will occur at 3 months. If the patient has returned to sexual activity, again defined by the patient's own interpretation of the question about return to sexual activity, then women will be asked to complete the PISQ-IR and Preparedness question by telephone-administered, mailed paper, or online questionnaire format. No further followup will be required after return to sexual activity. If women are not yet returned to sexual activity, they will be contacted at 1 month intervals, to a maximum interval of 6 months after surgery, to determine return to sexual activity and timing of administration of the PISQ-IR and Preparedness question. If a woman has not yet returned to sexual activity by 6 months, we will administer the PISQ-IR and Preparedness question by telephone-administered, mailed paper, or online questionnaire format.

Official Title
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Randomized Controlled Trial of Standardized Counselling on Postoperative Return to Sexual Activity After Pelvic Reconstructive Surgery

Conditions
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Sexual Function Disturbances, Pelvic Organ Prolapse, Stress Urinary Incontinence, Surgery

Intervention / Treatment
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* Other: Structured Counselling Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women (age ≥ 18 years) consented for pelvic reconstructive surgery for pelvic organ prolapse and / or urinary incontinence currently sexually active as defined by self-report able to speak and read English Exclusion Criteria: Not currently sexually active as defined by self-report vulvar dermatologic pathology (Lichen sclerosus, lichen planus) chronic pelvic pain unable to consent or complete outcomes due to mental incapacity, prisoners or incarcerated women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standardized Counselling Tool<br>If randomized to the treatment group, patients will be counselled using the structured counselling tool, and given a bulleted list of the counseling instrument to take home with them. | Other: Structured Counselling Tool<br>* Participants will be administered a Structured Counselling Tool that addresses the following themes: outside influences, conflicting emotions, uncertainty, sexual changes and stability, normalization, self-image<br>|
| No Intervention: Control<br>Routine postoperative counselling and care will be administered with no specific standardized counselling for return to sexual activity after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparedness to return to sexual activity | Preparedness for return to sexual activity will be measured by modifying the Patient Preparedness Questionnaire, Question #11: Overall, I feel prepared for my upcoming surgery to make it relevant to sexual activity following surgery. We will consider women prepared if they answer strongly agree on a 6-point Likert scale. The scale ranges from strongly agree to strongly disagree to the modified statement: Overall, I feel prepared for resuming sexual activity after my surgery. | 2-6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Function | Sexual function will be measured by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) score. Higher scores indicate better sexual function. Scores can range from 0 to 125. Pain with sexual activity will be assessed by response to question 11 on PISQ-IR: How often do you feel pain during sexual intercourse? Possible responses to this question are: Never, Rarely, Sometimes, Usually, Always | 2-6 months postoperative | 
| Postoperative Pain | Postoperative pain will be evaluated with responses to the question: Have you experienced pain in your pelvis in the last week (7 days)? Responses of yes and no will be recorded | 2-6 months postoperative | 
| Time to Return to Sexual Function | Time to Return to Sexual Function will be determined by responses to self-report of date of return to sexual activity after surgery. The duration of time between surgery and return to sexual activity will be calculated. | 2-6 months postoperative |