Pelvic Floor DisorderDiRehFloorNCT06914791
Differential Rehabilitative Treatment for Pelvic Floor in Sportswoman
A study testing Kegel arm and De Gasquet arm in people with Pelvic Floor Disorder, run by Alessandro Micarelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorder
- What is being tested?
- Kegel arm and De Gasquet arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 15 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- practicing sports by at least one year
Who cannot join
- no systemic disorders
- no drugs assumption
- no children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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)
- Conditions
- Pelvic Floor Disorder
- Being tested
- Kegel arm, De Gasquet arm
- Keywords
- pelvic floor rehabilitation
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel armProcedure or surgery
in this group participants will be followed up for 8 weeks with kegel exercises
De Gasquet armProcedure or surgery
in this group participants will be followed up for 8 weeks with de gasquet exercises
| Study group | Role | What they receive |
|---|---|---|
| kegel arm | Active comparator | Not described Receives: Procedure: Kegel arm |
| De Gasquet arm | Experimental | Not described Receives: Procedure: De Gasquet arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (5)
Incontinence Severity Index (ISI)
the Incontinence Severity Index evaluates the incontinence with values ranging from 0 to 12 indicating respectively better and worse score
Measured: 8 weeks
Quality of life questionnaire (SF-36)
the Quality of life questionnaire evaluates the quality of life with values ranging from 0 % to 100 % indicating respectively better and worse limitations
Measured: 8 weeks
King's Health Questionnaire (KHQ)
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
Measured: 8 weeks
Intestinal related symptoms questionnaire (ICIQ-B)
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
Measured: 8 weeks
Depression Anxiety Stress Scale (DASS-21)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessandro Micarelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alessandro Micarelli, Uniter Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914791
- Sponsor's protocol ID
- PelvicRehab1
- Acronym
- DiRehFloor
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is not possible for the law of our contry
Publications
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.
PubMed 37162534Brandt 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.
PubMed 34902634Bø K. Exercise and Pelvic Floor Dysfunction in Female Elite Athletes. Handbook of Sports Medicine and Science: The Female Athlete. 2015
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.
PubMed 31938009Barba 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.
PubMed 37195425Alves 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.
PubMed 28950397Almeida 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.
PubMed 26369504Abd 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