Urinary IncontinenceNCT05773378
Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?
A study testing Pessary Intervention and Tampon Intervention in people with Urinary Incontinence, run by University of Ottawa at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pessary Intervention and Tampon Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Have a known neurologic disorder (e.g. stroke, multiple sclerosis);
- Pregnancy or partum within the previous year;
Show all 10Show fewer
- For the in-lab assessment:
- Ability to run with a moderately full bladder for 38 minutes on a treadmill
- BMI ≥ 30
- Pelvic organ prolapse ≥ 2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McLean Function Measurement Lab
Ottawa, Ontario, K1S 1S2
Anne-Marie MacDonald, MSc, (613) 562-5800 ext. 4102, mfmlab@uottawa.ca
Linda McLean, PhD, (613) 562-5800 ext. 2544, lmclea2@uottawa.ca
About this study
Official title: Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
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.
Read the detailed description
Urinary incontinence (UI) is a serious public health concern, imposing a significant financial burden. In Canada the direct and indirect health costs associated with UI total over 3.6 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life. Although the primary risk factor for UI is pregnancy and vaginal delivery, it was recently reported that between 20% and 40% of nulliparous females report urine leakage when they engage in physical activity.
Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure. This is accomplished through a complex combination of mechanisms, including smooth and striated urethral sphincter muscle action, urethral venous engorgement and mucous secretions within the urethra, and the proper transfer of loads to the urethra, which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle (PFM) action. The associations among physical activity, pelvic floor morphology and function, and UI are not clear. A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction. Exercise at mild to moderate intensity appears to be protective, decreasing both the odds and the risk of experiencing urinary incontinence. However, females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise, thus chronic and repetitive loading of the pelvic floor may have negative consequences.
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 investigated about interventions specific to running-induced UI.
- Conditions
- Urinary Incontinence
- Being tested
- Pessary Intervention, Tampon Intervention
- Keywords
- exercise-induced urinary incontinence, running-induced urinary incontinence, intravaginal pessary, tampon, pelvic floor
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pessary InterventionDevice
Participants 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 InterventionDevice
Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.
| Study group | Role | What they receive |
|---|---|---|
| Pessary Intervention | Experimental | Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 10-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over.
Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them. Receives: Device: Pessary Intervention |
| Tampon Intervention | Experimental | Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so. Receives: Device: Tampon Intervention |
| Control Group | No intervention | Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, and during intervention week 10-12
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.
Measured: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
Measured: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
Measured: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire that includes three questions about urinary incontinence frequency, severity, and impact on daily life, resulting in a score of 0-21. The fourth question aims to classify the type of urinary incontinence, for this study 'leaks when you are physically active/exercising.' The questionnaire has a Level A validation grade according to ICI standards, as its validity, reliability, and responsiveness have been tested in several data sets. 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.
Measured: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
Secondary outcomes (10)
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.
Measured: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
Measured: Once a week during the 12 weeks of the study
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.
Measured: Once a week during the 12 weeks of the study
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).
Measured: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
Changes in bladder neck height
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in bladder neck height will be assessed using ultrasound imaging at baseline and after 12 weeks. The images will be recorded before and after a 30-minute treadmill running protocol
Measured: Baseline and post intervention (at 12 weeks)
Changes in levator hiatus area
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in levator hiatus area will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill.
Measured: Baseline and post intervention (at 12 weeks)
Changes in levator plate length
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in levator plate lenght will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill.
Measured: Baseline and post intervention ( at 12 weeks)
Changes in pelvic floor muscle strength
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in pelvic floor muscle strength will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill.
Measured: Baseline and post intervention ( at 12 weeks)
Changes in pelvic floor muscle stiffness
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in pelvic floor muscle stiffness will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill.
Measured: Baseline and post intervention ( at 12 weeks)
Pad weight gain
A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. These participants will be provided with a pre-weighed pad to attach to their underwear and wear it while running for 30 minutes on the treadmill. Once they finish running, the pad will be weighted again to record urine leakage. This will be done at the baseline and after 12-weeks.
Measured: Baseline and post intervention ( at 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start14 Apr 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Linda McLean, University of Ottawa
- Investigators
- Linda McLean, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773378
- Sponsor's protocol ID
- H-06-22-8219
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Spreadsheets will be provided by email upon request and based on the planned use of the data.
Publications
Herschorn S, Gajewski J, Schulz J, Corcos J. A population-based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey. BJU Int. 2008 Jan;101(1):52-8. doi: 10.1111/j.1464-410X.2007.07198.x. Epub 2007 Oct 1.
PubMed 17908260Almousa S, Bandin van Loon A. The prevalence of urinary incontinence in nulliparous adolescent and middle-aged women and the associated risk factors: A systematic review. Maturitas. 2018 Jan;107:78-83. doi: 10.1016/j.maturitas.2017.10.003. Epub 2017 Oct 7.
PubMed 29169586Windle G, Hughes D, Linck P, Russell I, Woods B. Is exercise effective in promoting mental well-being in older age? A systematic review. Aging Ment Health. 2010 Aug;14(6):652-69. doi: 10.1080/13607861003713232.
PubMed 20686977Sun F, Norman IJ, While AE. Physical activity in older people: a systematic review. BMC Public Health. 2013 May 6;13:449. doi: 10.1186/1471-2458-13-449.
PubMed 23648225Nygaard I, Girts T, Fultz NH, Kinchen K, Pohl G, Sternfeld B. Is urinary incontinence a barrier to exercise in women? Obstet Gynecol. 2005 Aug;106(2):307-14. doi: 10.1097/01.AOG.0000168455.39156.0f.
PubMed 16055580Smith AR, Hosker GL, Warrell DW. The role of pudendal nerve damage in the aetiology of genuine stress incontinence in women. Br J Obstet Gynaecol. 1989 Jan;96(1):29-32. doi: 10.1111/j.1471-0528.1989.tb01572.x.
PubMed 2923841Ree ML, Nygaard I, Bo K. Muscular fatigue in the pelvic floor muscles after strenuous physical activity. Acta Obstet Gynecol Scand. 2007;86(7):870-6. doi: 10.1080/00016340701417281.
PubMed 17611834Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
PubMed 15233598Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. doi: 10.1196/annals.1389.034. Epub 2007 Apr 7.
PubMed 17416924Dietz HP, Clarke B, Herbison P. Bladder neck mobility and urethral closure pressure as predictors of genuine stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):289-93. doi: 10.1007/s001920200063.
PubMed 12355287Rud T, Andersson KE, Asmussen M, Hunting A, Ulmsten U. Factors maintaining the intraurethral pressure in women. Invest Urol. 1980 Jan;17(4):343-7.
PubMed 7188694DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
PubMed 8203431DeLancey JO, Trowbridge ER, Miller JM, Morgan DM, Guire K, Fenner DE, Weadock WJ, Ashton-Miller JA. Stress urinary incontinence: relative importance of urethral support and urethral closure pressure. J Urol. 2008 Jun;179(6):2286-90; discussion 2290. doi: 10.1016/j.juro.2008.01.098. Epub 2008 Apr 18.
PubMed 18423707Pontbriand-Drolet S, Tang A, Madill SJ, Tannenbaum C, Lemieux MC, Corcos J, Dumoulin C. Differences in pelvic floor morphology between continent, stress urinary incontinent, and mixed urinary incontinent elderly women: An MRI study. Neurourol Urodyn. 2016 Apr;35(4):515-21. doi: 10.1002/nau.22743. Epub 2015 Mar 1.
PubMed 25727524Madill SJ, Harvey MA, McLean L. Women with SUI demonstrate motor control differences during voluntary pelvic floor muscle contractions. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Apr;20(4):447-59. doi: 10.1007/s00192-008-0800-y. Epub 2009 Jan 23.
PubMed 19165411
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?
- ClinicalTrials.gov ID
- NCT05773378
- Acronym / sponsor ID
- H-06-22-8219
- Conditions
- Urinary Incontinence
- Keywords
- exercise-induced urinary incontinence, running-induced urinary incontinence, intravaginal pessary, tampon, pelvic floor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Urinary incontinence (UI) is a serious public health concern, imposing a significant financial burden. In Canada the direct and indirect health costs associated with UI total over 3.6 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life. Although the primary risk factor for UI is pregnancy and vaginal delivery, it was recently reported that between 20% and 40% of nulliparous females report urine leakage when they engage in physical activity.
Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure. This is accomplished through a complex combination of mechanisms, including smooth and striated urethral sphincter muscle action, urethral venous engorgement and mucous secretions within the urethra, and the proper transfer of loads to the urethra, which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle (PFM) action. The associations among physical activity, pelvic floor morphology and function, and UI are not clear. A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction. Exercise at mild to moderate intensity appears to be protective, decreasing both the odds and the risk of experiencing urinary incontinence. However, females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise, thus chronic and repetitive loading of the pelvic floor may have negative consequences.
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 investigated about interventions specific to running-induced UI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pessary Intervention | Experimental | Device: Pessary InterventionParticipants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 10-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over. Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them. |
| Tampon Intervention | Experimental | Device: Tampon InterventionParticipants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so. |
| Control Group | No intervention | –Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
- Have a known neurologic disorder (e.g. stroke, multiple sclerosis);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pessary InterventionParticipants 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. | Device | Pessary Intervention |
| Tampon InterventionParticipants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. | Device | Tampon Intervention |
Primary outcome
Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred
Time frame: at baseline, and during intervention week 10-12
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.
Patient's global impression of improvement
Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
Patient's global satisfaction with treatment
Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
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.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire that includes three questions about urinary incontinence frequency, severity, and impact on daily life, resulting in a score of 0-21. The fourth question aims to classify the type of urinary incontinence, for this study 'leaks when you are physically active/exercising.' The questionnaire has a Level A validation grade according to ICI standards, as its validity, reliability, and responsiveness have been tested in several data sets. 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.
10 secondary outcomes
Intervention questionnaire
Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
Adherence to each intervention
Time frame: Once a week during the 12 weeks of the study
Unintended effects
Time frame: Once a week during the 12 weeks of the study
Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score
Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks
Changes in bladder neck height
Time frame: Baseline and post intervention (at 12 weeks)
Changes in levator hiatus area
Time frame: Baseline and post intervention (at 12 weeks)
Changes in levator plate length
Time frame: Baseline and post intervention ( at 12 weeks)
Changes in pelvic floor muscle strength
Time frame: Baseline and post intervention ( at 12 weeks)
Changes in pelvic floor muscle stiffness
Time frame: Baseline and post intervention ( at 12 weeks)
Pad weight gain
Time frame: Baseline and post intervention ( at 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 17908260Herschorn S, Gajewski J, Schulz J, Corcos J. A population-based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey. BJU Int. 2008 Jan;101(1):52-8. doi: 10.1111/j.1464-410X.2007.07198.x. Epub 2007 Oct 1.
- Background: PubMed 29169586Almousa S, Bandin van Loon A. The prevalence of urinary incontinence in nulliparous adolescent and middle-aged women and the associated risk factors: A systematic review. Maturitas. 2018 Jan;107:78-83. doi: 10.1016/j.maturitas.2017.10.003. Epub 2017 Oct 7.
- Background: PubMed 20686977Windle G, Hughes D, Linck P, Russell I, Woods B. Is exercise effective in promoting mental well-being in older age? A systematic review. Aging Ment Health. 2010 Aug;14(6):652-69. doi: 10.1080/13607861003713232.
- Background: PubMed 23648225Sun F, Norman IJ, While AE. Physical activity in older people: a systematic review. BMC Public Health. 2013 May 6;13:449. doi: 10.1186/1471-2458-13-449.
- Background: PubMed 16055580Nygaard I, Girts T, Fultz NH, Kinchen K, Pohl G, Sternfeld B. Is urinary incontinence a barrier to exercise in women? Obstet Gynecol. 2005 Aug;106(2):307-14. doi: 10.1097/01.AOG.0000168455.39156.0f.
- Background: PubMed 2923841Smith AR, Hosker GL, Warrell DW. The role of pudendal nerve damage in the aetiology of genuine stress incontinence in women. Br J Obstet Gynaecol. 1989 Jan;96(1):29-32. doi: 10.1111/j.1471-0528.1989.tb01572.x.
- Background: PubMed 17611834Ree ML, Nygaard I, Bo K. Muscular fatigue in the pelvic floor muscles after strenuous physical activity. Acta Obstet Gynecol Scand. 2007;86(7):870-6. doi: 10.1080/00016340701417281.
- Background: PubMed 15233598Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
- Background: PubMed 17416924Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. doi: 10.1196/annals.1389.034. Epub 2007 Apr 7.
- Background: PubMed 12355287Dietz HP, Clarke B, Herbison P. Bladder neck mobility and urethral closure pressure as predictors of genuine stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):289-93. doi: 10.1007/s001920200063.
- Background: PubMed 7188694Rud T, Andersson KE, Asmussen M, Hunting A, Ulmsten U. Factors maintaining the intraurethral pressure in women. Invest Urol. 1980 Jan;17(4):343-7.
- Background: PubMed 8203431DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.
- Individual participant dataSharing planned: Yes. Spreadsheets will be provided by email upon request and based on the planned use of the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda McLean principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pessary Intervention and Tampon Intervention in people with Urinary Incontinence, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda McLean (613-562-5800 ext. 4102, lmclea2@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred (time frame: at baseline, and during intervention week 10-12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05773378, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.