Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman

NCT ID: NCT06914791

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-08-15

Brief Summary

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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

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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)

Conditions

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Pelvic Floor Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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kegel arm

Group Type ACTIVE_COMPARATOR

Kegel arm

Intervention Type PROCEDURE

in this group participants will be followed up for 8 weeks with kegel exercises

De Gasquet arm

Group Type EXPERIMENTAL

De Gasquet arm

Intervention Type PROCEDURE

in this group participants will be followed up for 8 weeks with de gasquet exercises

Interventions

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Kegel arm

in this group participants will be followed up for 8 weeks with kegel exercises

Intervention Type PROCEDURE

De Gasquet arm

in this group participants will be followed up for 8 weeks with de gasquet exercises

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* practicing sports by at least one year

Exclusion Criteria

* no systemic disorders
* no drugs assumption
* no children
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alessandro Micarelli

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Micarelli

Scientific Director - Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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UNITER Onlus Foundation

Fara in Sabina, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 37162534 (View on PubMed)

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.

Reference Type RESULT
PMID: 34902634 (View on PubMed)

Bø K. Exercise and Pelvic Floor Dysfunction in Female Elite Athletes. Handbook of Sports Medicine and Science: The Female Athlete. 2015

Reference Type RESULT

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.

Reference Type RESULT
PMID: 31938009 (View on PubMed)

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.

Reference Type RESULT
PMID: 37195425 (View on PubMed)

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.

Reference Type RESULT
PMID: 28950397 (View on PubMed)

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.

Reference Type RESULT
PMID: 26369504 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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PelvicRehab1

Identifier Type: -

Identifier Source: org_study_id

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