Managing Impact-related Leakage During Exercise Using Intravaginal Support
ConditionStress Urinary Incontinence (SUI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Ottawa
About this trial
The goal of this study is to evaluate the effectiveness of using a regular menstrual tampon or a Uresta pessary to reduce urine leakage associated with running-induced stress urinary incontinence (RI-SUI) in females aged 18 and older. Secondly, the study aims to assess whether either intervention mitigates transient changes in pelvic morphology that occur following a single running bout. Lastly, we aim to evaluate whether participants continue using either intervention during running over the 4-week period following their in-lab participation. The hypotheses are:
Hypothesis 1: Among females with RI-SUI, both a tampon and pessary used during a single running bout will reduce urinary leakage symptoms, with greater symptom reduction observed when using the pessary.
Hypothesis 2: Participants will report high satisfaction and perceived symptom improvement with both the tampon and pessary, with higher satisfaction and greater improvement reported for the pessary.
Hypothesis 3: Both the tampon and pessary will reduce pelvic floor strain incurred by the end of the run, as evidenced by less bladder neck descent, levator plate lengthening, and levator hiatus area increasing relative to that observed when no tampon or pessary is used.
Hypothesis 4: A greater proportion of participants will report continued use of the pessary compared to the tampon over the 4-week post-lab period, with higher frequency of use and fewer reported discontinuations.
We will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support.
Participants will complete a baseline questionnaire to collect demographic information and assess incontinence severity. They will then attend three laboratory visits within a 10-day period. At each visit, bladder volume will be standardized to between 100 and 200mL, then the participant will undergo three-dimensional (3D) transperineal ultrasound imaging conducted in a standing position. Following imaging, participants will complete a treadmill protocol consisting of 25-minutes running at a moderately difficult pace (rated at 13 - 14 on the Borg Perceiver Rate of Exertion scale), followed by 5 minutes of running at a higher intensity pace. During the run, participants will be asked at 5 minute intervals whether they experienced any urine leakage and to report their perceived amount of leakage. The ultrasound image protocol will be repeated immediately after the run.
Participants will be allowed to keep the pessary and will be contacted 4-weeks after the final visit to evaluate whether or not they continued use of a tampon or the pessary, and, if so, we will ask them to report their satisfaction with the intervention(s) they used.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years of age
Participate in any exercise or sport modality involving running or brisk walking
Experiences urine leakage during running or brisk walking
Speak and read English or French
Disqualifiers
No urine leakage in the first laboratory assessment (baseline / no intervention)
Currently pregnant or have been pregnant in the previous 6 months
Had or have had cardiac, pulmonary, metabolic and/or neurological conditions
History of incontinence surgery
Trial design
Design model
Crossover
Treatments tested in this trial
Uresta bladder support device
DeviceThe Uresta bladder support device is an intravaginal device indicated for adult women over 18 years of age who experience stress urinary incontinence, including urine leakage during exercise and non-exercise activities such as coughing and laughing. The device is FDA-cleared and licensed by Health Canada. Participants receive the entire kit that includes the three most common sizes which fit 90% of women. Two additional sizes are available in the lab if needed. Participants will be instructed to self-insert the Uresta prior to running, following the manufacturer instructions with researcher guidance as needed. The device aims to provide mechanical support to the urethra and bladder neck to prevent urine leakage during activities that provoke leakage.
Sportex regular tampon
DeviceParticipants will use a regular absorbency Sportex tampon as a conservative intravaginal support to potentially reduce stress urinary incontinence (SUI) symptoms during running. Participants will be instructed to insert the tampon prior to running into the mid-to-upper vaginal canal while standing or sitting.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Tampon Visit: run with tamponActive comparator 1 intervention
Group B: Pessary Visit: run with pessaryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urine leakage severity
Self-reported urine leakage is evaluated as presence (yes/no) and amount (drops, squirts, gush) every 5 minutes during a 38-minute treadmill run. Leakage severity index is calculated as the proportion of 5-minute blocks with leakage times the median leakage amount per block.
Time frame
At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.Secondary outcomes
1
Participant's perception of improvement
Participants report perception of improvement with each device on a scale of 0% (not improved) to 100% (very much improved).
Time frame
At Visit 2 and Visit 3 only, which will occur within 10 days of Baseline (Visit 1).2
Change in levator plate length observed after an acute running bout
Levator plate length will be assessed before and after running under each condition. The primary outcome is the change in levator plate length, calculated as the difference between pre- and post-run measurements. Levator plate length is measured using 2D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the straight-line distance between the anorectal junction and the pubic symphysis.
Time frame
At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.3
Change in bladder neck height observed after an acute running bout
Bladder neck height will be assessed before and after running under each condition. The primary outcome is the change in bladder neck height, calculated as the difference between per- and post-run measurements. Bladder neck height is measured using 2D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the perpendicular distance from the pubic symphyseal line to the bladder neck.
Time frame
At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.4
Change in levator hiatus area observed after an acute running bout
Levator hiatus area will be assessed before and after running under each condition. The primary outcome is the change in levator hiatus area, calculated as the difference between pre- and post-run measurements. Levator hiatus area is measured using 3D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the hypoechoic region visualized in the transverse plane.
Time frame
At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.Sponsors and contacts
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Source ClinicalTrials.gov