Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
ConditionUrinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Ottawa
About this trial
More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence (UI) is a substantial barrier to exercise. As many as one in three females with UI report that they limit their physical activity due to incontinence: 11.6% by not exercising at all, 11.3% by exercising less and 12.4% by changing the type of exercise they perform. It is imperative to look for alternatives to manage this condition, as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life.
While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged 18 years and over who run at least twice a week for a minimum of 10K/week (minimum speed of 6 km/h to ensure high impact), who have done so for at least 6 months (to ensure adequate duration of exposure), and who commit to continue the same amount during the study period
Who regularly (≥ 1 per week) experience urine leakage while running.
Disqualifiers
Any risk factors related to exercise;
Pain or musculoskeletal injury at the time of the screening;
History of urogenital surgery;
Symptoms of the female athlete triad;
Trial design
Design model
Parallel
Treatments tested in this trial
Pessary Intervention
DeviceParticipants will receive a 3-size fitting kit and will fit the appropriate size based on manufacturer instruction. Once the size is verified, the participants will be asked to use the pessary while running over a 10-week period.
Tampon Intervention
DeviceParticipants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Pessary InterventionExperimental treatment 1 intervention
Group B: Tampon InterventionExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred
At baseline, participants will be asked to complete a bladder diary, recording leakage experiences during each running session over a two-week period, while running without any intervention. This tracking will be repeated for another two-week period starting in the eighth week of running with the intervention (weeks 10-12 of the protocol). Participants will receive daily reminders to fill it out.
Time frame
at baseline, and during intervention week 10-122
Patient's global impression of improvement
Participants will be asked to rate their overall impression of symptom improvement over the 10-week intervention on a 7 step scale (7= very much worse, to 1= very much better). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their overall impression again at 16, 24 and 36 weeks.
Time frame
Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks3
Patient's global satisfaction with treatment
The participants will be asked how satisfied they were with their progress during the 10-weeks, on a scale from 0 to 100% (0 = not at all satisfied, 100 = completely satisfied). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their satisfaction again at 16, 24 and 36 weeks.
Time frame
Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks4
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
The ICIQ-FLUTS is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life in research and clinical practice, with validity, reliability and responsiveness established with rigour in several data sets. It has a total of 12 questions; four questions on filling symptoms, three on voiding symptoms and five questions on urinary incontinence symptoms. The overall score ranges from 0-48, where all subscales scores are added. Higher scores indicate greater impact of individual symptoms for the patient. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.
Time frame
Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeksSecondary outcomes
1
Intervention questionnaire
A custom questionnaire with 20 questions was developed to collect information regarding participant's experience running with the intervention (tampon or pessary). The questions addresses the frequency of intervention use, ease of insertion and removal, comfort level while using the device, unintended effects (bleeding, vaginal discharge, pain), overall satisfaction, and the extent of urine leakage with the dispositive. Each question is rated on a scale form 0 to 100, with higher scores indicating a greater experience with the intervention. Participants randomized to the intervention groups will be asked to complete the questionnaire related to their assigned intervention after 12-weeks. Additionally, a follow-up will be conducted upon completing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks later.
Time frame
Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks2
Adherence to each intervention
Adherence to the interventions will be logged through weekly e-mail and/or text contact, followed up with telephone contact if there is no response to the e-mail/text.
Time frame
Once a week during the 12 weeks of the study3
Unintended effects
Adverse events (bleeding, vaginal discharge, pain, etc.) will be assessed through weekly e-mail/text contact, followed up with telephone contact if there is no response to the e-mail/text.
Time frame
Once a week during the 12 weeks of the study4
Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score
The Brisk walking and Running Lower Urinary Tract Symptoms Questionnaire evaluates the symptoms and management strategies associated with urinary urgency and urinary incontinence that occurs during brisk walking, jogging, and running. Participants will be asked to complete it at baseline and post intervention (after 12-weeks). Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks. The questionnaire has 4 domains: (1) about urgency symptoms, (2) about urgency urinary incontinence (UUI), (3) about stress urinary incontinence (SUI) and (4) about symptoms management. Scores are all 0-100 and higher scores mean a worse outcome with regards to the impact of lower urinary tract symptoms. The total score is still out of 100 (Urgency + UUI + SUI + Management / 4).
Time frame
Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeksSponsors and contacts
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Source ClinicalTrials.gov