Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman (DiRehFloor)

April 2, 2025 updated by: Alessandro Micarelli

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Fara in Sabina, Italy, 02032
        • UNITER Onlus Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • practicing sports by at least one year

Exclusion Criteria:

  • no systemic disorders
  • no drugs assumption
  • no children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: kegel arm
Procedure: Kegel arm
in this group participants will be followed up for 8 weeks with kegel exercises
Experimental: De Gasquet arm
Procedure: De Gasquet arm
in this group participants will be followed up for 8 weeks with de gasquet exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
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
8 weeks
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
8 weeks
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
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alessandro Micarelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PelvicRehab1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it is not possible for the law of our contry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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