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Enrolling by Invitation

NCT Number: NCT06914791

Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman

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.

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Key information

Conditions

Pelvic Floor Disorder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNITER Onlus Foundation

Fara in Sabina, 02032, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • practicing sports by at least one year

Exclusion criteria

  • no systemic disorders
  • no drugs assumption
  • no children

Treatment and study plan

Kegel arm

Procedure

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

De Gasquet arm

Procedure

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

Primary outcomes

  1. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: 8 weeks

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

Secondary outcomes

  1. Incontinence Severity Index (ISI)

    Time frame: 8 weeks

    the Incontinence Severity Index evaluates the incontinence with values ranging from 0 to 12 indicating respectively better and worse score

  2. Quality of life questionnaire (SF-36)

    Time frame: 8 weeks

    the Quality of life questionnaire evaluates the quality of life with values ranging from 0 % to 100 % indicating respectively better and worse limitations

  3. King's Health Questionnaire (KHQ)

    Time frame: 8 weeks

    the King's Health Questionnaire evaluates the urinary tract consequences on daily life with values ranging from 0 to 100 indicating respectively better and worse limitations

  4. Intestinal related symptoms questionnaire (ICIQ-B)

    Time frame: 8 weeks

    the Intestinal related symptoms questionnaire evaluates the intestinal consequences on daily quality of life with values ranging from 0 to 26 indicating respectively better and worse scores

  5. Depression Anxiety Stress Scale (DASS-21)

    Time frame: 8 weeks

    Depression Anxiety Stress Scale evaluates anxiety, depression and stress with values ranging from 0 to 14 indicating respectively better and worse scores for depression, 0 to 10 indicating respectively better and worse scores for anxiety and 0 to 17 indicating respectively better and worse scores for stress

Sponsors and collaborators

Lead sponsor

Alessandro Micarelli

Other

Registry information

Official study title

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

Acronym: DiRehFloor

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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