NCT07119476

Brief Summary

The primary goal of this research is to collect data on hip strength for active females and assess if there is a relationship between hip strength and pelvic floor dysfunction (PFD). The participants will fill out a REDCap questionnaire that includes informed consent, demographics, injury history, history of PFD and/or hip pain, characteristics of physical activity and/or sport(s), knowledge of pelvic floor musculature, and questions regarding the correlation between PFD and performance. Additionally, Patient Reported Outcomes Measurement Information System (PROMIS) surveys assessing anxiety and depression will be included. After completing the questionnaires, a one time hip strength assessment will be performed in four directions on each hip and the evaluator will be blinded to their results. Foster et al researched hip and pelvic floor strength in a different patient population (Urgency and Frequency prominent lower urinary tract symptoms) in 2021 with 18-60 year olds and did not have a classification for level of physical activity. This research group found that there was a reduction in hip external rotation and abduction strength compared to case controls. To this point, there has not been any research assessing the relationship between hip strength and relaxing versus nonrelaxing pelvic floor dysfunction and controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 11, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 30, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

pelvic healthactive femalepelvic floor dysfunction

Outcome Measures

Primary Outcomes (3)

  • Inline Tension Dynamometer: Hip Strength Assessment

    The hip strength assessment will be performed in person and will include four strength assessments (hip abduction, hip adduction, hip external rotation and hip internal rotation) for each lower extremity.

    Baseline (one time assessment)

  • International Consensus on Incontinence Questionnaire (ICIQ-FLUTS Long Form)

    a questionnaire that evaluates female lower urinary tract symptoms and quality of life in clinical practice and research. This questionnaire has been found to be valid, reliable, and responsive. The time required to complete this questionnaire is 4-5 minutes. This scale is 0-48 where all subscale scores are added and higher scores indicate greater impact of individual symptoms for the patient.

    Baseline (one time assessment)

  • Patient Reported Outcome Measure Information System (PROMIS)

    PROMIS Anxiety- CAT that focuses on fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of anxiety. A score of 50 represents the average and a standard deviation (SD) of 10. PROMIS Depression- CAT that focuses on negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The scale is between 8 and 40 raw score and is converted into a t score metric and a higher score indicates greater levels of depression. A score of 50 represents the average and a standard deviation (SD) of 10.

    Baseline (one time assessment)

Study Arms (1)

Active Females

Active Females Ages 18-45

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

18-45 year old females who are active as described by the WHO.

You may qualify if:

  • Age range 18-45 years
  • Female gender
  • Patients can either have no pelvic floor symptoms, current pelvic floor dysfunction (relaxing or nonrelaxing), or current musculoskeletal pain.
  • Participants must be physically active as defined by the World Health Organization (WHO) as performing 150-300 minutes of moderate-intensity aerobic physical activity or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week.

You may not qualify if:

  • Pregnancy
  • Gynecological or Obstetric Surgery within 6 months
  • Active infection (including Sexually Transmitted Infection, Pelvic, Urinary Tract Infection (UTI), Yeast)
  • Cancer
  • Inflammatory Disease
  • Connective Tissue Disease
  • Or have been instructed by a Healthcare provider to not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Fox University Medical Sciences Building

Newberg, Oregon, 97132, United States

Location

Related Publications (9)

  • Beisecker L, Harrison P, Josephson M, DeFreese JD. Depression, anxiety and stress among female student-athletes: a systematic review and meta-analysis. Br J Sports Med. 2024 Mar 8;58(5):278-285. doi: 10.1136/bjsports-2023-107328.

    PMID: 38233087BACKGROUND
  • Vrijens D, Berghmans B, Nieman F, van Os J, van Koeveringe G, Leue C. Prevalence of anxiety and depressive symptoms and their association with pelvic floor dysfunctions-A cross sectional cohort study at a Pelvic Care Centre. Neurourol Urodyn. 2017 Sep;36(7):1816-1823. doi: 10.1002/nau.23186. Epub 2017 Feb 21.

    PMID: 28220586BACKGROUND
  • Sheikhhoseini R, Arab AM. Dry Needling in myofascial tracks in Non-Relaxing Pelvic Floor Dysfunction: A case study. J Bodyw Mov Ther. 2018 Apr;22(2):337-340. doi: 10.1016/j.jbmt.2017.09.016. Epub 2017 Sep 25.

    PMID: 29861229BACKGROUND
  • Louis-Charles K, Biggie K, Wolfinbarger A, Wilcox B, Kienstra CM. Pelvic Floor Dysfunction in the Female Athlete. Curr Sports Med Rep. 2019 Feb;18(2):49-52. doi: 10.1249/JSR.0000000000000563.

    PMID: 30730341BACKGROUND
  • Faubion SS, Shuster LT, Bharucha AE. Recognition and management of nonrelaxing pelvic floor dysfunction. Mayo Clin Proc. 2012 Feb;87(2):187-93. doi: 10.1016/j.mayocp.2011.09.004.

    PMID: 22305030BACKGROUND
  • Almousa 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.

    PMID: 29169586BACKGROUND
  • 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
  • Sorrigueta-Hernandez A, Padilla-Fernandez BY, Marquez-Sanchez MT, Flores-Fraile MC, Flores-Fraile J, Moreno-Pascual C, Lorenzo-Gomez A, Garcia-Cenador MB, Lorenzo-Gomez MF. Benefits of Physiotherapy on Urinary Incontinence in High-Performance Female Athletes. Meta-Analysis. J Clin Med. 2020 Oct 10;9(10):3240. doi: 10.3390/jcm9103240.

    PMID: 33050442BACKGROUND
  • Foster SN, Spitznagle TM, Tuttle LJ, Sutcliffe S, Steger-May K, Lowder JL, Meister MR, Ghetti C, Wang J, Mueller MJ, Harris-Hayes M. Hip and Pelvic Floor Muscle Strength in Women with and without Urgency and Frequency Predominant Lower Urinary Tract Symptoms. J Womens Health Phys Therap. 2021 Jul-Sep;45(3):126-134. doi: 10.1097/jwh.0000000000000209.

    PMID: 34366727BACKGROUND

MeSH Terms

Conditions

Pelvic Floor DisordersPelvic Pain

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 13, 2025

Study Start

November 11, 2024

Primary Completion

February 24, 2025

Study Completion

February 24, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations