The Mindfulness, Incontinence and Sexual Function Treatment Study

NCT02863497 | Terminated

• 1 other identifier: H16-00719
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if there is an impact on sexual distress using mindfulness-based sex therapy (MBST) in addition to standard urogynecologic care, in women with both urinary incontinence (UI) and sexual dysfunction.

Conditions

Urinary Incontinence; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Improvement in Female Sexual Distress

  To determine the difference in score improvement on the Female Sexual Distress Scale (FSDS-R) between MBST intervention vs. control groups at three months post-treatment

  3 months post treatment

Secondary Outcomes (6)

• Patient Demographics

  3 month post treatment

• Patient retention

  The study recruitment on average of 1 year

• Measuring patient follow up post treatment

  3 months post treatment

• Sexual Intercourse resumption as assessed by questionnaire

  3 months post treatment

• To collect feedback about the treatment experience through an informal questionnaire

  3 months post treatment

Study Arms (2)

Mindfulness Intervention

ACTIVE COMPARATOR

For those randomly selected to receive mindfulness-based sex therapy, they will be asked to participate in four sessions of group therapy, over a period of 2 months. Sessions will occur in a conference room at St. Paul's Hospital. Part of the protocol of the Mindfulness - based sex therapy is that they will have a diary to be filled in. This diary will not be collected at the end of the therapy, as it is for the participant to keep. The group facilitators will be collecting session attendance.

Behavioral: Mindfulness-based Sex Therapy

No Intervention

NO INTERVENTION

For those who are not in the intervention group they will simply be asked to fill the initial questionnaire and the 3 month post questionnaire. They will not participate in any other questionnaires.

Interventions

Mindfulness-based Sex Therapy BEHAVIORAL

These group sessions will include education about sexuality, and the practice of mindfulness skills (including paying attention to the present moment, and to body sensations). Each group will include 7-8 women, plus the group facilitators. The group facilitators for the study will include Dr. Laurel Paterson (who has extensive experience in administering Mindfulness-based sex therapy in other populations of women), and occasionally one of the research team members.

Mindfulness Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 19 years and older with both UI and sexual dysfunction, seen at the Centre for Pelvic Floor, and are interested and available to participate in the study.
• UI is defined as one of the items below:
• Stress UI: involuntary loss of urine with increased intra-abdominal pressure (effort, coughing, laughing, sneezing, physical exercise, etc.)
• Symptoms and positive response to question # 17 of Pelvic Floor Distress Inventory (PFDI-20)
• Or Positive cough stress test on exam
• Or positive urodynamics stress UI Urgency UI (also referred to as overactive bladder): involuntary loss of urine with urgency
• Symptoms and positive response to question # 16 of PFDI-20
• Or positive urodynamics overactive bladder
• Mixed UI: combination of stress and urgency UI
• +/- prolapse or other PFDs concomitantly
• Can chose any treatment for their condition that is offered to them, but for analysis purposes, must agree to using only one line of treatment during the course of study (should not change treatment during study)
• Female sexual dysfunctions are categorized by the DSM-5 as sexual interest/arousal disorder, genitopelvic pain/penetration disorder, and female orgasmic disorder. The diagnoses require symptoms to be present for six months or more, for significant distress to be experienced as a result, and for the condition to not be better explained by a mental or medical condition.
• Sexual distress will be diagnosed as score of 11 or higher on the female sexual dysfunction scale

You may not qualify if:

• Non-English speaking
• Pregnancy
• Neurological conditions explaining UI
• Congenital genitourinary defects
• Genital fistulas

Sponsors & Collaborators

• University of British Columbia: lead
• Sexual Medicine Society of North America: collaborator

Study Sites (1)

Centre for Pelvic Floor

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Genital Diseases

Study Officials

• Geoffrey W. Cundiff

  UBC Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

• Maryse Larouche

  Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

• Lori Brotto

  UBC Obstetrics & Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 11, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)