Clinical trial NCT06673875: Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Official title: Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
physiotherapy of pelvic floor
conservative treatment
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

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.

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire
timeFrame: baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination
Secondary outcomes:
measure: objective urodynamics parameters
timeFrame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination
measure: objective measured parameters of urine leakage.
timeFrame: baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination
Other outcomes:
measure: Ultrasound parameters
timeFrame: baseline at time of urogynecologic check visit/ after 4 months at time of output urogynecology examination
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Czech Republic
Study officials:
affiliation: Investigator
name: Martina Szypulova
role: PRINCIPAL_INVESTIGATOR
References: