NCT07183800

Brief Summary

The goal of this clinical trial is to evaluate whether a short bout of high-intensity trampoline jumping induces urinary leakage or measurable changes in pelvic floor morphology in active females aged 18-40 who do not report symptoms of urinary incontinence. The main questions it aims to answer are: Hypothesis 1: Does a single 10-minute trampoline protocol result in acute changes in pelvic floor structure, including bladder neck position, levator plate length, and/or posterior urethrovesical angle (PUVA)? Hypothesis 2: Do participants report any urinary leakage during the jumping protocol, despite being asymptomatic at baseline? Hypothesis 3: Do pelvic morphology changes recover within 30 minutes post-jumping, or do alterations persist? Researchers will perform within-subject comparisons at multiple time points (pre-jump, immediately post-jump, and 30 minutes post-jump) using transperineal ultrasound imaging to assess structural changes. Participants will:

  • Attend one laboratory visit
  • Complete baseline pelvic health questionnaires (ICIQ-UI Short Form and PFD Sentinel).
  • Undergo 2D transperineal ultrasound imaging in the standing position at rest, immediately post-jumping, and 30 minutes post-jumping.
  • Perform a 10-minute high-intensity jumping protocol on a mini-trampoline, while heart rate and perceived exertion are monitored.
  • Verbally report any urine leakage during jumping using standardized descriptors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

October 3, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

September 12, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

stress urinary incontinencepelvic floorpelvic floor morphologyhigh impact exerciseurine leakageurinary symptomslevator platefemale athletesbladder neckposterior urethro-vesical anglePUVAjumptrampolinehigh impacthigh intensityhealthy femaleincontinenceleakageurinary leakage

Outcome Measures

Primary Outcomes (1)

  • Assessing whether a short-duration trampoline protocol induces urinary leakage in active females.

    Urinary leakage is assessed via self-report during a 10-minute high-intensity trampoline jumping protocol. Every 2 minutes, participants are verbally prompted to report whether they experienced leakage, and to classify it using standardized descriptors ("drops," "squirt," or "gush"). Leakage severity is indexed based on the timing of first report, frequency of episodes, and qualitative volume descriptors. Descriptive statistics will be used to report the proportion of participants who leak, frequency of leakage, and severity profiles.

    Urinary leakage is assessed during the 10-minute jumping protocol on the single lab visit.

Secondary Outcomes (3)

  • Assessing whether a short-duration trampoline protocol induces acute changes in bladder neck morphology in active females.

    Bladder neck morphology outcomes are assessed across a single session spanning approximately 45-60 minutes (baseline through 30 minutes post-exercise).

  • Assessing whether a short-duration trampoline protocol induces acute changes in levator plate length in active females.

    Levator plate length outcomes are assessed across a single session spanning approximately 45-60 minutes (baseline through 30 minutes post-exercise).

  • Assessing whether a short-duration trampoline protocol induces acute changes in the posterior urethrovesicle angle (PUVA) in active females.

    Posterior urethrovesicle angle (PUVA) outcomes are assessed across a single session spanning approximately 45-60 minutes (baseline through 30 minutes post-exercise).

Study Arms (1)

healthy young active females

18-40yo active females with no self-reported urinary incontinence

Other: Water

Interventions

WaterOTHER

Participants will undergo a standardized 10-minute high-intensity trampoline jumping protocol designed to elicit mechanical loading on the pelvic floor. Prior to the jumping session, bladder volume will be assessed via transabdominal ultrasound. If a participant's bladder contains less than 100 mL of urine, they will be asked to drink water and wait until a target range of 100-200 mL is reached to ensure consistent pre-jump bladder filling across participants. This approach minimizes variability in bladder volume, which could influence pelvic floor measurements.

healthy young active females

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the Ottawa region through local gyms, university facilities, and social media platforms. The study population includes recreationally active females aged 18-40 who engage in activities such as running or brisk walking and are willing to attend a single in-person session at the University of Ottawa's Motor Function Measurement Laboratory.

You may qualify if:

  • Aged 18-40
  • Engage in regular physical activity or sport
  • Do not experience frequent urinary leakage (no more than once per month during exercise, coughing, or sneezing)
  • Can complete a 10-minute jumping protocol

You may not qualify if:

  • Currently pregnant or have been pregnant in the past 6 months
  • Have cardiac, pulmonary, metabolic, and/or neurological conditions
  • Have a lower body injury that limits your ability to jump
  • Have had a hysterectomy and/or incontinence surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa - Lees Campus

Ottawa, Ontario, K1S 5S9, Canada

RECRUITING

Related Publications (22)

  • Nygaard I, DeLancey JO, Arnsdorf L, Murphy E. Exercise and incontinence. Obstet Gynecol. 1990 May;75(5):848-51.

    PMID: 2325968BACKGROUND
  • Zhao B, Wen L, Liu D, Huang S. Urethral configuration and mobility during urine leaking described using real-time transperineal ultrasonography. Ultrasonography. 2022 Jan;41(1):171-176. doi: 10.14366/usg.21058. Epub 2021 Jun 15.

    PMID: 34399041BACKGROUND
  • Zhang Y, Weaver RG, Armstrong B, Burkart S, Zhang S, Beets MW. Validity of Wrist-Worn photoplethysmography devices to measure heart rate: A systematic review and meta-analysis. J Sports Sci. 2020 Sep;38(17):2021-2034. doi: 10.1080/02640414.2020.1767348. Epub 2020 Jun 19.

    PMID: 32552580BACKGROUND
  • Youssef A, Montaguti E, Sanlorenzo O, Cariello L, Salsi G, Morganelli G, Azzarone C, Pilu G, Rizzo N. Reliability of new three-dimensional ultrasound technique for pelvic hiatal area measurement. Ultrasound Obstet Gynecol. 2016 May;47(5):629-35. doi: 10.1002/uog.14933. Epub 2016 Mar 29.

    PMID: 26105710BACKGROUND
  • Weinstein MM, Jung SA, Pretorius DH, Nager CW, den Boer DJ, Mittal RK. The reliability of puborectalis muscle measurements with 3-dimensional ultrasound imaging. Am J Obstet Gynecol. 2007 Jul;197(1):68.e1-6. doi: 10.1016/j.ajog.2007.02.041.

    PMID: 17618762BACKGROUND
  • Teixeira RV, Colla C, Sbruzzi G, Mallmann A, Paiva LL. Prevalence of urinary incontinence in female athletes: a systematic review with meta-analysis. Int Urogynecol J. 2018 Dec;29(12):1717-1725. doi: 10.1007/s00192-018-3651-1. Epub 2018 Apr 13.

    PMID: 29654349BACKGROUND
  • 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: 33380887BACKGROUND
  • Schnider P, Birner P, Gendo A, Ratheiser K, Auff E. Bladder volume determination: portable 3-D versus stationary 2-D ultrasound device. Arch Phys Med Rehabil. 2000 Jan;81(1):18-21. doi: 10.1016/s0003-9993(00)90215-6.

    PMID: 10638870BACKGROUND
  • Scherr J, Wolfarth B, Christle JW, Pressler A, Wagenpfeil S, Halle M. Associations between Borg's rating of perceived exertion and physiological measures of exercise intensity. Eur J Appl Physiol. 2013 Jan;113(1):147-55. doi: 10.1007/s00421-012-2421-x. Epub 2012 May 22.

    PMID: 22615009BACKGROUND
  • Schallom M, Prentice D, Sona C, Vyers K, Arroyo C, Wessman B, Ablordeppey E. Accuracy of Measuring Bladder Volumes With Ultrasound and Bladder Scanning. Am J Crit Care. 2020 Nov 1;29(6):458-467. doi: 10.4037/ajcc2020741.

    PMID: 33130866BACKGROUND
  • Pires T, Pires P, Moreira H, Viana R. Prevalence of Urinary Incontinence in High-Impact Sport Athletes: A Systematic Review and Meta-Analysis. J Hum Kinet. 2020 Jul 21;73:279-288. doi: 10.2478/hukin-2020-0008. eCollection 2020 Jul.

    PMID: 32774559BACKGROUND
  • de Mattos Lourenco TR, Matsuoka PK, Baracat EC, Haddad JM. Urinary incontinence in female athletes: a systematic review. Int Urogynecol J. 2018 Dec;29(12):1757-1763. doi: 10.1007/s00192-018-3629-z. Epub 2018 Mar 19.

    PMID: 29552736BACKGROUND
  • Hajebrahimi S, Nourizadeh D, Hamedani R, Pezeshki MZ. Validity and reliability of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and its correlation with urodynamic findings. Urol J. 2012 Fall;9(4):685-90.

    PMID: 23235974BACKGROUND
  • 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: 23687004BACKGROUND
  • Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284.

    PMID: 28709155BACKGROUND
  • Giagio S, Salvioli S, Innocenti T, Gava G, Vecchiato M, Pillastrini P, Turolla A. PFD-SENTINEL: Development of a screening tool for pelvic floor dysfunction in female athletes through an international Delphi consensus. Br J Sports Med. 2023 Jul;57(14):899-905. doi: 10.1136/bjsports-2022-105985. Epub 2022 Dec 14.

    PMID: 36517214BACKGROUND
  • Giagio S. Bridging gaps, shaping futures: pelvic floor health for athletes (PhD Academy Award). Br J Sports Med. 2024 Jun 20;58(13):751-752. doi: 10.1136/bjsports-2024-108359. No abstract available.

    PMID: 38724072BACKGROUND
  • Dietz HP, Rojas RG, Shek KL. Postprocessing of pelvic floor ultrasound data: how repeatable is it? Aust N Z J Obstet Gynaecol. 2014 Dec;54(6):553-7. doi: 10.1111/ajo.12250. Epub 2014 Oct 22.

    PMID: 25338743BACKGROUND
  • Chan H. Noninvasive bladder volume measurement. J Neurosci Nurs. 1993 Oct;25(5):309-12. doi: 10.1097/01376517-199310000-00007.

    PMID: 8270812BACKGROUND
  • 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: 11905931BACKGROUND
  • Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.

    PMID: 15233598BACKGROUND
  • Yoshida S, Orimoto N, Tsukihara H, Noma T, Hakozaki A, Sasaki E. TAC-302 promotes neurite outgrowth of isolated peripheral neurons and prevents bladder denervation related bladder dysfunctions following bladder outlet obstruction in rats. Neurourol Urodyn. 2018 Feb;37(2):681-689. doi: 10.1002/nau.23375. Epub 2017 Jul 26.

    PMID: 28745805BACKGROUND

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, Stress

Interventions

Water

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 19, 2025

Study Start

July 16, 2025

Primary Completion

December 31, 2025

Study Completion

April 30, 2026

Last Updated

October 3, 2025

Record last verified: 2025-07

Locations