Clinical trial NCT06914791: Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman
Official title: Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman: an Interventional Pilto Study Comparing Kegel and De Gasquet Approach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pelvic Floor Disorder
Keywords: pelvic floor rehabilitation
Lead sponsor: Uniter Onlus
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: Inclusion Criteria:

* practicing sports by at least one year

Exclusion Criteria:

* no systemic disorders
* no drugs assumption
* no children

Primary outcomes:
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 8 weeks
Secondary outcomes:
measure: Incontinence Severity Index (ISI)
timeFrame: 8 weeks
measure: Quality of life questionnaire (SF-36)
timeFrame: 8 weeks
measure: King's Health Questionnaire (KHQ)
timeFrame: 8 weeks
measure: Intestinal related symptoms questionnaire (ICIQ-B)
timeFrame: 8 weeks
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fara in Sabina
country: Italy
facility: UNITER Onlus Foundation
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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