Hypothesis / aims of study
Physical activities such as running, jogging and brisk walking can trigger urinary incontinence (UI), but our ability to assess the relationship between the nature and duration of activity and the experience of UI is limited. Recommended UI symptoms questionnaires include a limited number of items that address physical activity, but do not assess the characteristics of the aggravating activity. Customized questionnaires have been used in individual studies to gain a more detailed understanding of the relationship between UI and physical activity [e.g., 1]. However, these questionnaires are often poorly described and lack reporting of their measurement properties. The lack of a reference standard for reporting UI symptoms associated with running, jogging or brisk walking makes comparisons among studies difficult and limits our ability to assess the effectiveness of interventions designed specifically to address UI experienced by females during physical activities.
The primary aim of this study was to develop a new questionnaire, the “Running and Related Activities Urinary Incontinence Symptoms Questionnaire” (RARA-UISQ) and to establish its content validity through consultation with an expert panel.
Study design, materials and methods
This study received ethical approval from the local institutional research ethics board with informed consent to participate being obtained from each panelist. A draft questionnaire was developed through focus-group consultation with three local physiotherapy clinicians who treat UI, two local patients who experience UI during exercise and four academic researchers who study UI. Next, a Delphi process was used to refine the questionnaire and to establish its content validity. Health care practitioners located in Canada and the United States, including medical doctors who had completed surgical fellowship training in urogynaecology as well as physiotherapists working in women’s health and with experience managing UI in female patients. In addition, females who experience UI during running, jogging and/or brisk walking were invited to participate in the remote expert panel consultation.
Panel members were presented with the draft questionnaire and responded by either agreeing or disagreeing with each included construct and with each individual question, providing explanatory comments for each response. All comments were anonymized and shared with the other panel members in the next round. Consultation rounds continued until consensus was achieved for each construct and question, where consensus was defined as >66% agreement amongst panelists.
Results
The panel was comprised of four urogynaecologic surgeons, three physiotherapists and three females who regularly experience UI during running, jogging or brisk walking. The initial questionnaire consisted of six sections with 22 questions. Two rounds of consultation were required to reach consensus. The final version of the questionnaire has five sections, including: Screening (to determine if an individual experiences UI and/or a sense of urgency with running, jogging and/or brisk walking), Exercise Characteristics, Urgency Urinary Incontinence Symptoms, Stress Urinary Incontinence Symptoms and Management Strategies, resulting in a total of 45 questions across these categories.
Interpretation of results
Overall, the expert panel provided feedback that focused the scope of the RARA-UISQ as a research tool, while increasing the amount of detail that is provided by research participants. The screening, exercise characteristics and urgency UI sections underwent the largest changes, with the number of questions in each section more than doubling. In the case of the urgency UI section, changes were made to account for individuals who experience urinary urgency while running, without associated leakage. The initial questionnaire included a section to screen for co-morbidities but this was removed following feedback from the expert panel. Instead, use of previously validated questionnaires for co-morbid pelvic symptoms (e.g., ICIQ modules for urinary, vaginal and bowel symptoms) will be recommended for use alongside the RARA-UISQ.
The knowledge and experience of the panelists (urogynaecologic surgeons, physiotherapists, or individuals with UI) influenced responses. Urogynecologic surgeons more frequently commented that questions around the characteristics of the physical activity (e.g., frequency, distance travelled, total number of hours) were not relevant, while physiotherapists and panelists with UI agreed that these were important factors to report, as severity of leakage may be associated with volume or intensity of activity.
The most contentious aspect of the questionnaire was the separation of symptoms by UI subtype (i.e., stress vs urgency). Some panelists interpreted the separation of symptoms in this way as an attempt to diagnose questionnaire respondents as having stress, urgency or mixed UI. Indeed, the RARA-UISQ is a patient reported outcome that focuses on symptoms of UI associated with running, jogging and brisk walking with an intended use of evaluating the efficacy of interventions for UI experienced predominantly during physical exercise. It is not intended to be used for diagnosis. The consensus was to retain this separation for symptom reporting.