- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06599190
Effect Of Abdominal Hypopressive Training On Stress Urinary Incontinence
Effect Of Abdominal Hypopressive Training On Stress Urinary IncontinenceIn Female Athletes
Study Overview
Status
Conditions
Detailed Description
They will be randomly distributed into 2 groups equal in numbers:
Group (A) (Control group) consists of 25 female athletes. They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
Group (B) (Study group) consists of 25 female athletes. They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.
Before data collection, the purpose and procedures will be fully explained to the females. Informed consent will be obtained from each female. Each female will be evaluated following a standard protocol.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Cairo
-
New Cairo, Cairo, Egypt, 470001
- El Zohour Club
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female athletes suffering from SUI.
- They will be diagnosed with SUI using bladder stress test.
- Their ages will range from 14-18 years old.
- Their body mass index (BMI) will range from 18.5-24.9 kg/m2.
- They are single females.
Exclusion Criteria:
The female athlete will be excluded if they had:
- Urinary tract infection.
- Family history of genito-urinary tract cancer.
- Diabetes mellitus.
Study Plan
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: Group (A) (Control group)
consists of 25 female athletes.
They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
|
They will receive nutritional instructions and pelvic floor muscle exercises three sessions/week for 3 months.
|
|
Experimental: Group (B) (Study group)
consists of 25 female athletes.
They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.
|
consists of 25 female athletes.
They will receive the same treatment for the control group and abdominal hypopressive exercises three sessions/week of 30 mins per week for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of urine loss
Time Frame: 24 hours pad test for12 weeks
|
Pad testing will be used to quantify the volume of urine loss by weighing an absorbent pad before and after some type of leakage provocation.
The test will start with weighting clean empty pad in grams.
Then, it will be used until next time and weighted again.
The weight of the used pad will be subtracted from the weight of the empty pad so the net result will determine the amount of leakage.
|
24 hours pad test for12 weeks
|
|
assesment of pelvic floor muscle contraction and tonning
Time Frame: 12 weeks
|
The measurements will be taken in crock-lying position with a full bladder, neutral lumbar spine.
The ultrasound transducer will be inserted transversely directly superior to the symphysis pubis, probe is tilted 60 degrees from vertical (Arab, 2010).
Every female will perform 3 maximal PFM contractions so that displacement of the bladder wall, because of a PFM contraction, could be measured.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of symptoms and health related quality of life
Time Frame: 12 weeks
|
The ICIQ-SF will be used in assessment of each female in both groups.
It is used to measure severity and impact of UI on the quality of life in women.
The ICIQ-SF is formed of six items of which four main items ask for rating of UI symptoms in the past 4 weeks.
A score of zero means no leakage of urine and no affection on quality of life.
(Question 1): quantifies the frequency of urinary leaking, (question 2): evaluates the amount of leaking and (question 3): how much the urinary incontinence interferes with everyday life (Hilton and Robinson, 2011).
The scores for items 3, 4 and 5 are taken for the final ICIQ-SF score.
Items 1 and 2 are demographic and the final item is a self-diagnostic item for the type of UI.
ICIQ- SF (range 0-21) is given four scoring categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Abeer ElDeeb, Professor, PROFESSOR DOCTOR
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
Other Study ID Numbers
- P.T.REC/012/004947
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Female Stress Urinary Incontinence
-
Kafrelsheikh UniversityCompletedFemale Stress Urinary IncontinenceEgypt
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Shin Kong Wu Ho-Su Memorial HospitalCompletedFemale Stress Urinary Incontinence | Stress Urinary Incontinence (SUI)Taiwan
-
Bezmialem Vakif UniversityNot yet recruitingUrinary Incontinence | Stress Urinary Incontinence | Urinary Incontinence,Stress | Mixed Incontinence Due to Prolapse of Female Genital OrganTurkey (Türkiye)
-
University College, LondonRecruitingUrodynamic Stress Incontinence | Stress Incontinence Female | Urodynamic ExamUnited Kingdom
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
University of New MexicoCompletedUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Lahore University of Biological and Applied SciencesActive, not recruitingStress Urinary Incontinence in Women | Stress Urinary Incontinence (SUI)Pakistan
-
MagCathHerlev HospitalRecruiting
-
Hampshire Hospitals NHS Foundation TrustCompleted
Clinical Trials on pelvic floor exercises, nutritional instructions
-
Cairo UniversityCompleted
-
Gazi UniversityCompletedMultiple Sclerosis | Pelvic Floor Muscle Exercise | Neurogenic Bladder DisorderTurkey (Türkiye)
-
eman elhosaryUnknownStress Urinary Incontinence
-
Texas Woman's UniversityTerminatedStress Urinary IncontinenceUnited States
-
Bandırma Onyedi Eylül UniversityEbru Kaya MutluActive, not recruitingPrevention Pelvic Muscle DysfunctionTurkey
-
Centre Hospitalier Universitaire de la RéunionInstitut National de la Santé Et de la Recherche Médicale, France; CIC-EC RéunionCompletedUrinary Incontinence | Anal Incontinence | Genital ProlapseFrance
-
Hatice Gulsah KurneRecruitingSexual Dysfunction | Pelvic Floor Muscle Weakness | Postmenopausal SymptomsTurkey
-
Instituto de Investigación Sanitaria de la Fundación...Universidad Rey Juan CarlosCompletedUrinary Incontinence | Relapsing-Remitting Multiple SclerosisSpain
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingStress Urinary Incontinence
-
Riphah International UniversityCompletedUrinary IncontinencePakistan