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Enrolling by invitation NCT06914791

Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman

No phase Interventional Pelvic Floor Disorder

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
The protocol lists: Kegel arm, De Gasquet arm.
Who it may be relevant to
Registry conditions: Pelvic Floor Disorder. Basic parameters: 18 years — 50 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
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman: an Interventional Pilto Study Comparing Kegel and De Gasquet Approach

Overview

In this study at least 24 sportswoman (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress.

Detailed description

In this study at least 24 sportswoman (18-50 years old) with pelvic floow symptos (18-50 years old) will be recruited a randomized in two groups which will be differently treated for the following 8 weeks. They should havo no children, other relevant systemic disorders and assume no drugs. They should practice sports by at least one year.

one group will be treated with Kegel approach and the other one with De Gasquet apporach. before and after the treatment they will fill in a battery of falidated questionnaire in order to evaluate the improvement at pelvic floor level, quality of life and psychological distress. In partiqular they fill in:

* Pelvic Floor Distress Inventory (PFDI-20) * Incontinence Severity Index (ISI) * Quality of life questionnaire (SF-36) * King's Health Questionnaire (KHQ) * Intestinal related symptoms questionnaire (ICIQ-B) * Depression Anxiety Stress Scale (DASS-21)

Interventions

  • Procedure Kegel arm
    in this group participants will be followed up for 8 weeks with kegel exercises
  • Procedure De Gasquet arm
    in this group participants will be followed up for 8 weeks with de gasquet exercises

Primary outcome measures

  • Pelvic Floor Distress Inventory (PFDI-20) [Time frame: 8 weeks]
Secondary outcome measures (5)
  • Incontinence Severity Index (ISI) [Time frame: 8 weeks]
  • Quality of life questionnaire (SF-36) [Time frame: 8 weeks]
  • King's Health Questionnaire (KHQ) [Time frame: 8 weeks]
  • Intestinal related symptoms questionnaire (ICIQ-B) [Time frame: 8 weeks]
  • Depression Anxiety Stress Scale (DASS-21) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • practicing sports by at least one year

Exclusion criteria

  • no systemic disorders
  • no drugs assumption
  • no children

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • UNITER Onlus Foundation — Fara in Sabina

Publications

  • Campbell KG, Batt ME, Drummond A. Prevalence of pelvic floor dysfunction in recreational athletes: a cross-sectional survey. Int Urogynecol J. 2023 Oct;34(10):2429-2437. doi: 10.1007/s00192-023-05548-8. Epub 2023 May 10. PMID 37162534
  • Brandt F, Solomayer EF, Sklavounos P. Correlation between the Incontinence Severity Index (ISI) and the quality of life dimensions of the King's Health Questionnaire (KHQ) in German-speaking urinary incontinent women. J Gynecol Obstet Hum Reprod. 2022 Feb;51(2):102288. doi: 10.1016/j.jogoh.2021.102288. Epub 2021 Dec 10. PMID 34902634
  • Bø K. Exercise and Pelvic Floor Dysfunction in Female Elite Athletes. Handbook of Sports Medicine and Science: The Female Athlete. 2015
  • Blazek D, Stastny P, Maszczyk A, Krawczyk M, Matykiewicz P, Petr M. Systematic review of intra-abdominal and intrathoracic pressures initiated by the Valsalva manoeuvre during high-intensity resistance exercises. Biol Sport. 2019 Dec;36(4):373-386. doi: 10.5114/biolsport.2019.88759. Epub 2019 Oct 17. PMID 31938009
  • Barba M, Cola A, Melocchi T, Braga A, Castronovo F, Manodoro S, Pennacchio M, Munno GM, Ruffolo AF, Degliuomini RS, Salvatore S, Torella M, Frigerio M. Italian validation of the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Int Urogynecol J. 2023 Oct;34(10):2459-2465. doi: 10.1007/s00192-023-05572-8. Epub 2023 May 17. PMID 37195425
  • Alves JO, Luz STD, Brandao S, Da Luz CM, Jorge RN, Da Roza T. Urinary Incontinence in Physically Active Young Women: Prevalence and Related Factors. Int J Sports Med. 2017 Nov;38(12):937-941. doi: 10.1055/s-0043-115736. Epub 2017 Sep 26. PMID 28950397
  • Almeida MB, Barra AA, Saltiel F, Silva-Filho AL, Fonseca AM, Figueiredo EM. Urinary incontinence and other pelvic floor dysfunctions in female athletes in Brazil: A cross-sectional study. Scand J Med Sci Sports. 2016 Sep;26(9):1109-16. doi: 10.1111/sms.12546. Epub 2015 Sep 15. PMID 26369504
  • Abd El-Aty E.M., Hassan M.E.-G. Effect of Kegel Exercise Training Program On Improving Quality Of Life Among Women With Urinary Incontinence. Egypt. J. Health Care. 2021

Identifiers

NCT: NCT06914791 · PelvicRehab1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗