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

Brno University Hospital90 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

conservative treatment of stress urinary incontinence - pelvic floor muscle trainingPROCEDURE

evaluation of pelvic floor muscle rehabilitation to change the clinical severity of urinary incontinence

vaginal device Aniball INCODEVICE

the firt group - the pelvic floor muscle training with vaginal device Aniball INCO according manual after education by the urogynecologist, who is educated in pelvic floor dysfunction. the second group - the pelvic floor muscle training without vaginal device, the education was performed by certified physiotherapist trained in pelvic floor disorder.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Brno

Brno, Czech Republic, Czechia

RECRUITING

Outcomes

Primary Outcomes

International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire

Assessment of pelvic floor muscle rehabilitation training to change the clinical severity of urinary incontinence using the questionnaire - International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-UI SF - range 0 to 21) at at time of initial urogynecology examination / after 8 weaks of training / and after 4 months of training/ at the time of output urogynecology examination - in the group with home exercises using the medical device Aniball-inco ( 1st group) vs. exercise of the pelvic floor muscles after education by a physiotherapist (2nd group).

Time frame: baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination

Secondary Outcomes

objective urodynamics parameters

evaluation of changes in urodynamic parameters before pelvic floor muscle training at at time of initial urogynecology examination and after 4 months of training at the time of output urogynecology examination. We will assess the rate of maximum urethral closure pressure (MUCP cmH2O) in two monitored groups.

Time frame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination

objective measured parameters of urine leakage.

Evaluation of the rate of urine leakage using a one-hour pad-weight test (grams). The test is standardised by ICS (International Continence Society). The total amount of urine leaked is determined by weighing the pad. The test is performed before training before pelvic floor muscle training at time of initial urogynecology examination and after 4 months of training at the time of output urogynecology examination.

Time frame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination

Central Contacts

Martina Szypulova

CONTACT

+420 773882260 szypulova.martina@fnbrno.cz

Martin Huser

CONTACT

+420 532233843 huser.martin@fnbrno.cz

Data from ClinicalTrials.gov

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