NCT06914791

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

March 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

March 22, 2025

Last Update Submit

April 2, 2025

Conditions

Keywords

pelvic floor rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Pelvic Floor Distress Inventory (PFDI-20)

    Pelvic Floor Distress Inventory evalueates the pelvic floor distress with values ranging from 0 to 300 indicating respectively better and worse score

    8 weeks

Secondary Outcomes (5)

  • Incontinence Severity Index (ISI)

    8 weeks

  • Quality of life questionnaire (SF-36)

    8 weeks

  • King's Health Questionnaire (KHQ)

    8 weeks

  • Intestinal related symptoms questionnaire (ICIQ-B)

    8 weeks

  • Depression Anxiety Stress Scale (DASS-21)

    8 weeks

Study Arms (2)

kegel arm

ACTIVE COMPARATOR
Procedure: Kegel arm

De Gasquet arm

EXPERIMENTAL
Procedure: De Gasquet arm

Interventions

Kegel armPROCEDURE

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

kegel arm

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

De Gasquet arm

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • practicing sports by at least one year

You may not qualify if:

  • no systemic disorders
  • no drugs assumption
  • no children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNITER Onlus Foundation

Fara in Sabina, 02032, Italy

Location

Related Publications (8)

  • 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.

  • 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.

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

    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.

  • 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.

  • 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.

  • 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.

  • 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

    RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientific Director - Principal Investigator

Study Record Dates

First Submitted

March 22, 2025

First Posted

April 6, 2025

Study Start

April 1, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

it is not possible for the law of our contry

Locations