The Mindfulness, Incontinence and Sexual Function Treatment Study

Purpose: To evaluate the feasibility of a large multicenter randomized controlled trial to determine the impact on sexual distress of mindfulness-based sex therapy (MBST) in addition to standard urogynecologic care, in women with both urinary incontinence (UI) and sexual dysfunction.

Hypothesis: The addition of MBST to standard urogynecologic care reduces sexual distress in women with UI and sexual dysfunction.

Background/Justification: Sexual dysfunction is a common finding in women over the age of 40 seeking gynecologic care, with 66% of women reporting at least one complaint, and 26% reporting sexual distress. This can have profound negative consequences on health related quality of life, interpersonal relationships, stress level, and mood. Some studies have also shown that the prevalence of sexual dysfunction increases with age, with as many as 80% of elderly women reporting dysfunction. In parallel, urinary incontinence, the involuntary leakage of urine, is also increasingly prevalent with age, with 30-50% of elderly women being affected. Limited evidence suggests that treatments for urinary incontinence, whether conservative or surgical, can improve sexual function. Specifically, after surgery for stress urinary incontinence, 32% of women show improved sexual function, 55% see no change, and 13% report worsened function. Mindfulness is a type of meditation that brings the individual's awareness to the present moment in a non-judgmental manner. Since the 1970s, mindfulness-based therapies have been used increasingly to treat multiple conditions including chronic pain, anxiety, depression, and many others. Mindfulness-based sex therapy (MBST) has been shown to be effective in managing sexual dysfunctions in women with arousal disorders, vulvar pain, a history of gynecological cancer, and a history of sexual abuse. The International Consultation on Sexual Medicine, at the last meeting in June 2015, has recommended the use of mindfulness-based therapy in women with low sexual desire. Mechanisms through which mindfulness is believed to impact sexual function are numerous. First, mindfulness practice produces changes in brain structure and functioning in areas involved in attention, emotion and self-awareness. It also leads to improvements in mood, and decreases stress and anxiety, all of which are major contributors to sexual dysfunction. Second, mindfulness' emphasis on non-judgment can help foster acceptance of the partner. It can also reduce self-criticism associated with a distorted body image. Additionally, improved attention on sensual stimuli and lessened distractibility can increase arousal.

Research Design:

This will be a pilot randomized study of women with UI referred to the Centre for Pelvic Floor, St. Paul's Hospital, in Vancouver, British Columbia, Canada. Recruitment will begin after obtaining ethics approval for the study. All women referred to the Centre for Pelvic Floor complete an intake questionnaire prior to their first consultation. That questionnaire includes a sexual function assessment. Women with identified sexual dysfunction with distress, on baseline questionnaire, will be invited to participate in the proposed study. Potential participants will be first informed about the study by the physician seeing the patient in consultation. If patients are willing to meet the research team, the research coordinator or a trained medical student will further explain the study, and enroll interested women who meet the inclusion and exclusion criteria, while obtaining informed consent to participate. After having completed baseline assessments, participants will then be randomized to the standard urogynecological care control group, or the standard care plus mindfulness-based sex therapy (MBST) intervention group (60 total participants, 30 in each group). Standard urogynecological care for UI varies based on the type of UI and patient preferences, but can include pelvic floor exercises, pelvic floor physiotherapy, medications for bladder function, pessary fitting (a silicone ring placed in the vagina to reduce symptoms of urinary incontinence, as well as pelvic organ prolapse), and/or surgery.