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Recruiting NCT07727460

The Reliability of Pelvic Floor Measures From Ultrasound Images Acquired at Rest and During Weightlifting Tasks.

— Observational Urinary Incontinence , Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Urinary Incontinence , Stress. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Reliability of Pelvic Floor Morphometry Measured From Ultrasound Images Acquired at Rest and During Weightlifting Tasks.

Overview

We will evaluate the inter-and intra-rater reliability of pelvic floor morphometry obtained from transperineal ultrasound images collected at rest and during standardized weight lifting tasks.

Detailed description

The aim is to evaluate the inter-rater and intra-rater reliability of pelvic floor morphometry at rest and during dynamic, externally loaded barbell resistance training tasks using 2-dimensional (2D) transperineal ultrasound (TPUS) imaging in individuals with female pelvic anatomy. Establishing measurement reliability under these conditions is a necessary methodological prerequisite for future research in which we plan to investigate pelvic floor behaviour during resistance training and its potential relationship to exercise-induced urinary incontinence.

After a standard bladder filling protocol, TPUS imaging will be performed by two trained assessors using 2D ultrasound. Images and cine loops will be acquired under four standardized conditions: supine; standing; three loaded barbell back squats at 40%, 60%, and 80% of the participant's one-repetition maximum (1RM); and three loaded barbell deadlifts at 40%, 60%, and 80% of 1RM. Images and cine loops will be processed offline to measure levator plate length, levator plate angle, bladder neck height and anorectal junction height. The inter and intra-rater reliability of image acquisition and analysis will be determined for each measure under each condition.

Primary outcome measures

  • Bladder Neck Height [Time frame: Day 1]
  • Levator Plate Length [Time frame: Day 1]
  • Ano-rectal Junction Height [Time frame: Day 1]
  • Levator Plate Angle [Time frame: Day 1]
  • Bladder Neck Funnelling [Time frame: single visit]
Secondary outcome measures (4)
  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Time frame: At enrolment]
  • Australian Pelvic Floor Questionnaire (APFQ) [Time frame: At enrolment]
  • Five-part questionnaire on hypermobility (5PQ) [Time frame: At enrolment]
  • Beighton Score [Time frame: At enrolment]

Eligibility criteria

Inclusion criteria

  • Individuals with female or vulvo-vaginal anatomy
  • Age 18 years or older
  • No history of urogenital surgery
  • Not currently pregnant or less than 12 months postpartum, if applicable
  • Be able to safely perform a barbell back squat and deadlift exercises with a submaximal load of 80% of their body weight
  • Able to communicate in English to sufficiently understand study procedures and provide informed consent

Exclusion criteria

  • Presence of significant medical conditions that could affect safety, including cardiac, pulmonary, metabolic or neurological conditions
  • Currently pregnant or less than 12 months postpartum
  • Current pelvic, hip, or low back injury that limits lifting or impairs safe performance of squats or deadlifts with a barbell
  • Unable to safely lift 80% of their body weight
  • Known pelvic organ prolapse > stage 2

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 2 centers
  • Eclipse Physiotherapy and Sport Injury Clinic — Langley
  • beSTRONG Training — North Vancouver

Publications

  • Forner LB, Cyr MP, Beckman EM, Hodges PW, Smith MD. The Immediate Impact of Heavy Weightlifting on Pelvic Floor Morphometry in Vaginally Parous Women: A Repeated Measures Study. Int Urogynecol J. 2026 Jun 20. doi: 10.1007/s00192-026-06772-8. Online ahead of print. PMID 42322404
  • Chen Y, Peng L, Liu M, Shen H, Luo D. Diagnostic value of transperineal ultrasound in patients with stress urinary incontinence (SUI): a systematic review and meta-analysis. World J Urol. 2023 Mar;41(3):687-693. doi: 10.1007/s00345-022-04264-0. Epub 2023 Jan 4. PMID 36598556
  • Braekken IH, Majida M, Ellstrom-Engh M, Dietz HP, Umek W, Bo K. Test-retest and intra-observer repeatability of two-, three- and four-dimensional perineal ultrasound of pelvic floor muscle anatomy and function. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):227-35. doi: 10.1007/s00192-007-0408-7. Epub 2007 Jun 29. PMID 17599234
  • Czyrnyj CS, Labrosse MR, Graham RB, McLean L. UROKIN: A Software to Enhance Our Understanding of Urogenital Motion. Ann Biomed Eng. 2018 May;46(5):726-735. doi: 10.1007/s10439-018-1989-7. Epub 2018 Feb 7. PMID 29417352
  • Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. doi: 10.1002/uog.939. PMID 14971006
  • 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 25338743
  • Almousa S, Bandin Van Loon A. The prevalence of urinary incontinence in nulliparous female sportswomen: A systematic review. J Sports Sci. 2019 Jul;37(14):1663-1672. doi: 10.1080/02640414.2019.1585312. Epub 2019 Mar 1. PMID 30822258
  • 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 29654349

Identifiers

NCT: NCT07727460 · H-02-26-12513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗