Clinical trial NCT05342090: Postoperative Return to Sexual Activity
Official title: Randomized Controlled Trial of Standardized Counselling on Postoperative Return to Sexual Activity After Pelvic Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Function Disturbances
Pelvic Organ Prolapse
Stress Urinary Incontinence
Surgery
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: Albany Medical College
name: Penn State University
name: Columbia University
name: University of Chicago
name: University of Florida
name: WellSpan Health
name: University of New Mexico
name: Weill Medical College of Cornell University
name: University of Texas at Austin
First posted: 2022-04-22
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Preparedness to return to sexual activity
timeFrame: 2-6 months postoperative
Secondary outcomes:
measure: Sexual Function
timeFrame: 2-6 months postoperative
measure: Postoperative Pain
timeFrame: 2-6 months postoperative
measure: Time to Return to Sexual Function
timeFrame: 2-6 months postoperative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Shunaha Kim-Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samuelsson EC, Victor FT, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 1):299-305. doi: 10.1016/s0002-9378(99)70203-6.
citation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
citation: Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
citation: Dunivan GC, McGuire BL, Rishel Brakey HA, Komesu YM, Rogers RG, Sussman AL. A longitudinal qualitative evaluation of patient perspectives of adverse events after pelvic reconstructive surgery. Int Urogynecol J. 2019 Dec;30(12):2023-2028. doi: 10.1007/s00192-019-03998-7. Epub 2019 Jun 11.
citation: Antosh DD, Kim-Fine S, Meriwether KV, Kanter G, Dieter AA, Mamik MM, Good M, Singh R, Alas A, Foda MA, Balk EM, Rahn DD, Rogers RG. Changes in Sexual Activity and Function After Pelvic Organ Prolapse Surgery: A Systematic Review. Obstet Gynecol. 2020 Nov;136(5):922-931. doi: 10.1097/AOG.0000000000004125.
citation: Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.