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Recruiting NCT06673875

NCT06673875 Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence

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Clinical Trial Summary
NCT ID NCT06673875
Status Recruiting
Phase
Sponsor Brno University Hospital
Condition Stress Urinary Incontinence
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2023-03-23
Primary Completion 2025-12

Trial Parameters

Condition Stress Urinary Incontinence
Sponsor Brno University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex FEMALE
Min Age 18 Years
Max Age 80 Years
Start Date 2023-03-23
Completion 2025-12
Interventions
conservative treatment of stress urinary incontinence - pelvic floor muscle trainingvaginal device Aniball INCO

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Brief Summary

The eim is to evaluate the clinical effectiveness of pelvic floor muscle training (PFMT) in conservative therapy in women with objective, urodynamic stress urinary incontinence using home exercise training with the medical vaginal device versus standard pelvic floor muscle training-exercises

Eligibility Criteria

Inclusion Criteria: stress urinary incontinence Exclusion Criteria: age under 18, age over 80, ISD (Intrinsic Sphincter Deficiency), descent of the pelvic organs according to POP-Q ≥ 2 (stage), urgent incontinence ruled out using a questionnaire (OAB V8 - overactive bladder \< 7a PPIUS - patient perception of intensity and urgency scale ≤ 1), overactive bladder (OAB) with the use of anticholinergics, pregnant women and women up to 6 months after childbirth, active pelvic cancer, degenerative neurological or myofascial disease, reduced cognitive function that does not allow understanding the principles of the study, impossibility of contraction mm.levatores ani., recurrent vaginal inflammation, atrophic vulvovaginitis, irregular bleeding, contraindications listed by the manufacturer of the medical device Aniball inco.

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