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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorBrno University Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • conservative treatment of stress urinary incontinence - pelvic floor muscle training

    Procedure/Surgery

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

  • vaginal device Aniball INCO

    Device

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Aniball-incoExperimental treatment 1 intervention
Group B: RHBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

1

Ultrasound parameters

Ultrasound parameters are evaluated at the time of input urogynecology examination before training and after finishing the study. Parameters are: The mobility of the ureterovesical junction - lines h (millimetr). Gamma angle rotation (°) of urethra. Line p (mm) - diameter of line urethrovesical junction and caudal point of symphysis pubis. Changes in the area of the genital hiatus (Genital hiatus/Genital hiatus volume) - values in square centimetr. Every parameter was measered at rest and at maximum Valsalva manevr. It will be measered before training at time of initial urogynecology examination and after finishing training at time of output urogynecology examination. These will be evaluated as optional tertiary parameters.

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

Sponsors and contacts

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