Sexual Function DisturbancesPoRSNCT05342090
Postoperative Return to Sexual Activity
A study testing Structured Counselling Tool in people with Sexual Function Disturbances and Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Function Disturbances, Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Structured Counselling Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2022to 29 Feb 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services, University of Calgary
Calgary, Alberta, T3L 0C9
About this study
Official title: Randomized Controlled Trial of Standardized Counselling on Postoperative Return to Sexual Activity After Pelvic Reconstructive Surgery
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.
Read the 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.
- Being tested
- Structured Counselling Tool
- Medical subject headings
- Sexual Dysfunctions, Psychological, Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Counselling ToolOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standardized Counselling Tool | Active comparator | 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. Receives: Other: Structured Counselling Tool |
| Control | No intervention | Routine postoperative counselling and care will be administered with no specific standardized counselling for return to sexual activity after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 2-6 months postoperative
Secondary outcomes (3)
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"
Measured: 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
Measured: 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.
Measured: 2-6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start5 Apr 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sexual Function DisturbancesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, Albany Medical College, Penn State University, Columbia University, University of Chicago, University of Florida, WellSpan Health, University of New Mexico, Weill Medical College of Cornell University, University of Texas at Austin
- Responsible party
- Principal investigator, Shunaha Kim-Fine, University of Calgary
- Investigators
- Shunaha Kim-Fine, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342090
- Sponsor's protocol ID
- 21-0749
- Acronym
- PoRS
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiers will be shared among co-investigators or other researchers. This is because the information is stored in Redcap and site PIs and their research staff will only have access to IPDs in their own institution but not across outside institutions.
Publications
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.
PubMed 9988790Olsen 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.
PubMed 9083302Smith 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.
PubMed 20966694Dunivan 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.
PubMed 31187179Antosh 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.
PubMed 33030874Kenton 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.
PubMed 18060968Kim-Fine S, Caldwell L, Long J, Meriwether KV, Iyer S, Heisler CA, Hudson P, Husk K, Lozo S, Demtchouk V, Huang B, Antosh DD, Rogers RG; Society of Gynecologic Surgeons Consortium of Research in Pelvic Surgery. Intervention Counseling for Return to Sex After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2025 Nov 1;146(5):701-709. doi: 10.1097/AOG.0000000000006064. Epub 2025 Sep 11.
PubMed 40934518Caldwell L, Kim-Fine S, Antosh DD, Husk K, Meriwether KV, Long JB, Heisler CA, Hudson PL, Lozo S, Iyer S, Weber LeBrun EE, Rogers RG. Standardized Counseling Tool for Returning to Sexual Activity After Pelvic Reconstructive Surgery. Obstet Gynecol. 2025 Nov 1;146(5):e80-e84. doi: 10.1097/AOG.0000000000005938. Epub 2025 Jun 13.
PubMed 40505118
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Standardized Counselling on Postoperative Return to Sexual Activity After Pelvic Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT05342090
- Acronym / sponsor ID
- PoRS / 21-0749
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, Albany Medical College, Penn State University, Columbia University, University of Chicago, University of Florida, WellSpan Health, University of New Mexico, Weill Medical College of Cornell University, University of Texas at Austin
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Apr 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Counselling Tool | Active comparator | Other: Structured Counselling ToolIf 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. |
| Control | No intervention | –Routine postoperative counselling and care will be administered with no specific standardized counselling for return to sexual activity after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Structured Counselling ToolParticipants will be administered a Structured Counselling Tool that addresses the following themes: outside influences, conflicting emotions, uncertainty, sexual changes and stability, normalization, self-image | Other | Standardized Counselling Tool |
Primary outcome
Preparedness to return to sexual activity
Time frame: 2-6 months postoperative
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".
3 secondary outcomes
Sexual Function
Time frame: 2-6 months postoperative
Postoperative Pain
Time frame: 2-6 months postoperative
Time to Return to Sexual Function
Time frame: 2-6 months postoperative
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 2 Apr 2025.
- Background: PubMed 9988790Samuelsson 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.
- Background: PubMed 9083302Olsen 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.
- Background: PubMed 20966694Smith 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.
- Background: PubMed 31187179Dunivan 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.
- Background: PubMed 33030874Antosh 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.
- Background: PubMed 18060968Kenton 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.
- Derived from this study: PubMed 40934518Kim-Fine S, Caldwell L, Long J, Meriwether KV, Iyer S, Heisler CA, Hudson P, Husk K, Lozo S, Demtchouk V, Huang B, Antosh DD, Rogers RG; Society of Gynecologic Surgeons Consortium of Research in Pelvic Surgery. Intervention Counseling for Return to Sex After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2025 Nov 1;146(5):701-709. doi: 10.1097/AOG.0000000000006064. Epub 2025 Sep 11.
- Derived from this study: PubMed 40505118Caldwell L, Kim-Fine S, Antosh DD, Husk K, Meriwether KV, Long JB, Heisler CA, Hudson PL, Lozo S, Iyer S, Weber LeBrun EE, Rogers RG. Standardized Counseling Tool for Returning to Sexual Activity After Pelvic Reconstructive Surgery. Obstet Gynecol. 2025 Nov 1;146(5):e80-e84. doi: 10.1097/AOG.0000000000005938. Epub 2025 Jun 13.
- Individual participant dataSharing planned: No. No identifiers will be shared among co-investigators or other researchers. This is because the information is stored in Redcap and site PIs and their research staff will only have access to IPDs in their own institution but not across outside institutions.
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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.
Shunaha Kim-Fine, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Counselling Tool in people with Sexual Function Disturbances and Pelvic Organ Prolapse, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 4 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Preparedness to return to sexual activity (time frame: 2-6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342090, which also lists 8 linked publications.
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 2 Apr 2025.