Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence (Aniball-inco)

Brno University Hospital

Status: Enrolling

Conditions: Stress Urinary Incontinence

Treatments: Procedure: conservative treatment of stress urinary incontinence - pelvic floor muscle training; Device: vaginal device Aniball INCO

Study type: Interventional

Funder types: Other

Identifiers

NCT06673875

Aniball inco

Details and patient eligibility

About

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

Full description

The first group were using vaginal device - commercial name Aniball INCO®, which is controlled by the Czech State Institute of Drug Control which is registered by the European Medical Device Nomenclature (EMDN) with Unique Device Identifier - Device Identifier (UDI-DI) - 859418371002LA

The second group - the education was provided by certified physiotherapist trained in pelvic floor disroder

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Aniball-inco

Experimental group

Description:

training muscles with vaginal device to excercise of pelvic floor muscle.

Treatment:

Device: vaginal device Aniball INCO

RHB

Active Comparator group

Description:

training muscles without device to excercise of pelvic floor muscle.

Treatment:

Procedure: conservative treatment of stress urinary incontinence - pelvic floor muscle training