Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-27 @ 5:51 AM
Study NCT ID:
NCT07103161
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Impact-related Leakage During Exercise Using Intravaginal Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052576', 'term': 'Menstrual Hygiene Products'}], 'ancestors': [{'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is an assessor blind randomized crossover study design in which all participants complete a baseline visit and are then repeat the protocol at two subsequent visits, one with the tampon and one with the pessary, with the order randomized.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine leakage severity', 'timeFrame': 'At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Participant's perception of improvement", 'timeFrame': 'At Visit 2 and Visit 3 only, which will occur within 10 days of Baseline (Visit 1).', 'description': 'Participants report perception of improvement with each device on a scale of 0% (not improved) to 100% (very much improved).'}, {'measure': 'Change in levator plate length observed after an acute running bout', 'timeFrame': 'At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.', 'description': '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.'}, {'measure': 'Change in bladder neck height observed after an acute running bout', 'timeFrame': 'At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.', 'description': '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.'}, {'measure': 'Change in levator hiatus area observed after an acute running bout', 'timeFrame': 'At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.', 'description': '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.'}, {'measure': 'Use of tampon or pessary throughout the 4-week post-lab period', 'timeFrame': 'At 4-week follow-up (4 weeks after Visit 3, approximately Day 38 post-Baseline).', 'description': 'Participants complete an online questionnaire that evaluates their use of either the tampon or pessary intervention during running over a 4-week period after completing the in-lab component of the study. They are asked whether they used the tampon or pessary while running (Yes/No) and to rate the frequency of usage on a scale of 0 (not used) to 100 (used during every run). If they did not use the pessary/tampon at all or if they stopped using the pessary/tampon during the 4-week period, they are asked to share the number of runs they ran with the device and their reasons for stopping its usage.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress urinary incontinence', 'conservative treatment', 'pelvic floor strain', 'pessary', 'bladder support device', 'urinary symptoms', 'tampon', 'urine leakage', 'urine leakage with exercise', 'urine leakage with running'], 'conditions': ['Stress Urinary Incontinence (SUI)']}, 'referencesModule': {'references': [{'pmid': '18793993', 'type': 'BACKGROUND', 'citation': 'Raizada V, Mittal RK. Pelvic floor anatomy and applied physiology. Gastroenterol Clin North Am. 2008 Sep;37(3):493-509, vii. doi: 10.1016/j.gtc.2008.06.003.'}, {'pmid': '39043585', 'type': 'BACKGROUND', 'citation': 'Petter Rodrigues M, Berube ME, Charette M, McLean L. Conservative interventions for female exercise-induced urinary incontinence: a systematic review. BJU Int. 2024 Dec;134(6):906-917. doi: 10.1111/bju.16474. Epub 2024 Jul 23.'}, {'pmid': '27438055', 'type': 'BACKGROUND', 'citation': 'Lovatsis D, Best C, Diamond P. Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.'}, {'pmid': '28675537', 'type': 'BACKGROUND', 'citation': 'Leitner M, Moser H, Eichelberger P, Kuhn A, Baeyens JP, Radlinger L. Evaluation of pelvic floor kinematics in continent and incontinent women during running: An exploratory study. Neurourol Urodyn. 2018 Feb;37(2):609-618. doi: 10.1002/nau.23340. Epub 2017 Jul 4.'}, {'pmid': '17466709', 'type': 'BACKGROUND', 'citation': 'Farrell SA, Baydock S, Amir B, Fanning C. Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8. doi: 10.1016/j.ajog.2006.11.038.'}, {'pmid': '33416968', 'type': 'BACKGROUND', 'citation': 'Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.'}, {'pmid': '33971737', 'type': 'BACKGROUND', 'citation': "Dakic JG, Hay-Smith J, Cook J, Lin KY, Calo M, Frawley H. Effect of Pelvic Floor Symptoms on Women's Participation in Exercise: A Mixed-Methods Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2021 Jul;51(7):345-361. doi: 10.2519/jospt.2021.10200. Epub 2021 May 10."}, {'pmid': '37991566', 'type': 'BACKGROUND', 'citation': 'Berube ME, McLean L. The acute effects of running on pelvic floor morphology and function in runners with and without running-induced stress urinary incontinence. Int Urogynecol J. 2024 Jan;35(1):127-138. doi: 10.1007/s00192-023-05674-3. Epub 2023 Nov 22.'}, {'pmid': '12681869', 'type': 'BACKGROUND', 'citation': 'Waetjen LE, Subak LL, Shen H, Lin F, Wang TH, Vittinghoff E, Brown JS. Stress urinary incontinence surgery in the United States. Obstet Gynecol. 2003 Apr;101(4):671-6. doi: 10.1016/s0029-7844(02)03124-1.'}, {'pmid': '33380887', 'type': 'BACKGROUND', 'citation': 'Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15.'}, {'pmid': '24575741', 'type': 'BACKGROUND', 'citation': 'Shaw JM, Hamad NM, Coleman TJ, Egger MJ, Hsu Y, Hitchcock R, Nygaard IE. Intra-abdominal pressures during activity in women using an intra-vaginal pressure transducer. J Sports Sci. 2014;32(12):1176-85. doi: 10.1080/02640414.2014.889845. Epub 2014 Feb 28.'}, {'pmid': '33747266', 'type': 'BACKGROUND', 'citation': 'Rzymski P, Burzynski B, Knapik M, Kociszewski J, Wilczak M. How to balance the treatment of stress urinary incontinence among female athletes? Arch Med Sci. 2020 Oct 21;17(2):314-322. doi: 10.5114/aoms.2020.100139. eCollection 2021.'}, {'pmid': '16055580', 'type': 'BACKGROUND', 'citation': 'Nygaard 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.'}, {'pmid': '34505171', 'type': 'BACKGROUND', 'citation': 'Nekkanti S, Wu JM, Hundley AF, Hudson C, Pandya LK, Dieter AA. A randomized trial comparing continence pessary to continence device (Poise Impressa(R)) for stress incontinence. Int Urogynecol J. 2022 Apr;33(4):861-868. doi: 10.1007/s00192-021-04967-9. Epub 2021 Sep 9.'}, {'pmid': '26630349', 'type': 'BACKGROUND', 'citation': 'Imamura M, Williams K, Wells M, McGrother C. Lifestyle interventions for the treatment of urinary incontinence in adults. Cochrane Database Syst Rev. 2015 Dec 2;2015(12):CD003505. doi: 10.1002/14651858.CD003505.pub5.'}, {'pmid': '23687004', 'type': 'BACKGROUND', 'citation': 'Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.'}, {'pmid': '32453209', 'type': 'BACKGROUND', 'citation': 'Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.'}, {'pmid': '31456864', 'type': 'BACKGROUND', 'citation': 'Chisholm L, Delpe S, Priest T, Reynolds WS. Physical Activity and Stress Incontinence in Women. Curr Bladder Dysfunct Rep. 2019 Sep;14(3):174-179. doi: 10.1007/s11884-019-00519-6. Epub 2019 Jul 1.'}, {'pmid': '11905931', 'type': 'BACKGROUND', 'citation': 'Brown WJ, Miller YD. Too wet to exercise? Leaking urine as a barrier to physical activity in women. J Sci Med Sport. 2001 Dec;4(4):373-8. doi: 10.1016/s1440-2440(01)80046-3.'}, {'pmid': '28685262', 'type': 'BACKGROUND', 'citation': "Brennand E, Ruiz-Mirazo E, Tang S, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Urinary leakage during exercise: problematic activities, adaptive behaviors, and interest in treatment for physically active Canadian women. Int Urogynecol J. 2018 Apr;29(4):497-503. doi: 10.1007/s00192-017-3409-1. Epub 2017 Jul 6."}, {'pmid': '15233598', 'type': 'BACKGROUND', 'citation': 'Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.'}, {'pmid': '29713205', 'type': 'BACKGROUND', 'citation': 'Al-Shaikh G, Syed S, Osman S, Bogis A, Al-Badr A. Pessary use in stress urinary incontinence: a review of advantages, complications, patient satisfaction, and quality of life. Int J Womens Health. 2018 Apr 17;10:195-201. doi: 10.2147/IJWH.S152616. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nHypothesis 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.\n\nHypothesis 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.\n\nHypothesis 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.\n\nHypothesis 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.\n\nWe will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support.\n\nParticipants 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.\n\nParticipants 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.', 'detailedDescription': 'More than 30% of females experience urinary incontinence (UI) during exercise. For many women, urine leakage during exercise can become a barrier to staying active, leading them to modify their exercise routine or avoid triggering activities altogether. Beyond the physical inconvenience, urinary incontinence can affect self-esteem, social participation, and mental health. Helping women stay active without embarrassment or fear of leakage has both physical and psychological benefits.\n\nThe pelvic floor muscles (PFMs) and associated connective tissues play a critical role in continence control. These structures support the pelvic organs and help maintain their positioning such that the urethra is optimally compressed during increases in intra-abdominal pressure. Dysfunction of the PFMs and connective tissues will cause the bladder to descend during weight-bearing activities, and the urethra, no longer in its optimal position, may remain open - resulting in urine leakage. This form of UI, known as stress urinary incontinence (SUI), is commonly experienced as urine leakage during tasks such as coughing, laughing, and physical activity. High-impact movements like running, jumping, and inclined walking are known to increase the loads experienced by the pelvic floor, making SUI especially common during these types of activities.\n\nIntravaginal products such as tampons and pessaries (reusable medical devices placed in the vagina) are recommended to help manage UI during everyday activities such as coughing and sneezing. However, their effectiveness during physical activities - such as running or brisk walking - remains unclear. This study aims to determine whether a standard menstrual tampon and/or a bladder support (Uresta) pessary can reduce urine leakage during running and/or brisk walking in active females. A secondary objective is to assess whether these devices mitigate the descent of the bladder that we have observed in females after running or brisk walking. Lastly, we aim to assess continued device use over a 4-week period following all laboratory visits.\n\nBy evaluating the effectiveness of accessible, non-invasive devices, this research may offer immediate, low-barrier strategies to help active women self-manage urinary incontinence - empowering them to maintain their physical activity routines and support their long-term health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years of age\n* Participate in any exercise or sport modality involving running or brisk walking\n* Experiences urine leakage during running or brisk walking\n* Speak and read English or French\n\nExclusion Criteria:\n\n* No urine leakage in the first laboratory assessment (baseline / no intervention)\n* Currently pregnant or have been pregnant in the previous 6 months\n* Had or have had cardiac, pulmonary, metabolic and/or neurological conditions\n* History of incontinence surgery\n* Hysterectomy\n* Symptoms consistent with urgency incontinence only\n* Experience pain with tampon use or during gynecologic examinations'}, 'identificationModule': {'nctId': 'NCT07103161', 'acronym': 'MILES', 'briefTitle': 'Managing Impact-related Leakage During Exercise Using Intravaginal Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Ottawa'}, 'officialTitle': 'Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?', 'orgStudyIdInfo': {'id': 'H-06-22-8153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tampon Visit: run with tampon', 'interventionNames': ['Device: Sportex regular tampon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pessary Visit: run with pessary', 'interventionNames': ['Device: Uresta bladder support device']}], 'interventions': [{'name': 'Uresta bladder support device', 'type': 'DEVICE', 'otherNames': ['Uresta pessary'], 'description': 'The 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.', 'armGroupLabels': ['Pessary Visit: run with pessary']}, {'name': 'Sportex regular tampon', 'type': 'DEVICE', 'otherNames': ['Menstrual tampon'], 'description': 'Participants 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.', 'armGroupLabels': ['Tampon Visit: run with tampon']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1N 6N5', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Grace Collins, BSc.', 'role': 'CONTACT', 'email': 'gcollins@uottawa.ca', 'phone': '613-562-5800', 'phoneExt': '4102'}, {'name': 'Anne-Marie Lake, MSc.', 'role': 'CONTACT', 'email': 'alake@uottawa.ca', 'phone': '613-562-5800', 'phoneExt': '4102'}, {'name': 'Linda McLean, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Grace Collins, BSc.', 'role': 'CONTACT', 'email': 'gcollins@uottawa.ca', 'phone': '613-562-5800', 'phoneExt': '4102'}, {'name': 'Anne-Marie Lake, MSc.', 'role': 'CONTACT', 'email': 'alake@uottawa.ca', 'phone': '613-562-5800', 'phoneExt': '4102'}], 'overallOfficials': [{'name': 'Linda McLean, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Information will be available beginning 1 month after publication with no end date.', 'ipdSharing': 'YES', 'description': 'Data will be shared to investigators who contact the researchers and request access.', 'accessCriteria': 'No data sharing agreement necessary. Data will be made available to researchers wishing to perform secondary analyses or include the data in systematic reviews or meta-analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ottawa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Dr. Linda McLean', 'investigatorAffiliation': 'University of Ottawa'}}}}