Postoperative Return to Sexual Activity

NCT05342090 | Completed

• 1 other identifier: 21-0749
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Function Disturbances; Pelvic Organ Prolapse; Stress Urinary Incontinence; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sexual Function

  2-6 months postoperative

• Postoperative Pain

  2-6 months postoperative

• Time to Return to Sexual Function

  2-6 months postoperative

Study Arms (2)

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.

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.

Interventions

Structured Counselling Tool OTHER

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

Standardized Counselling Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• University of Wisconsin, Madison: collaborator
• Albany Medical College: collaborator
• Penn State University: collaborator
• Columbia University: collaborator
• University of Chicago: collaborator
• University of Florida: collaborator
• WellSpan Health: collaborator
• University of New Mexico: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

Alberta Health Services, University of Calgary

Calgary, Alberta, T3L 0C9, Canada

Location

Related Publications (8)

• 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.

  PMID: 9988790 BACKGROUND

• 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.

  PMID: 9083302 BACKGROUND

• 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.

  PMID: 20966694 BACKGROUND

• 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.

  PMID: 31187179 BACKGROUND

• 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.

  PMID: 33030874 BACKGROUND

• 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.

  PMID: 18060968 BACKGROUND

• Kim-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.

  PMID: 40934518 DERIVED

• Caldwell 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.

  PMID: 40505118 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Mental Disorders; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Shunaha Kim-Fine, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 22, 2022
• Study Start: April 5, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)