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NCT Number: NCT06673875

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

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

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conservative treatment of stress urinary incontinence - pelvic floor muscle training

Procedure

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. objective urodynamics parameters

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

    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.

  2. objective measured parameters of urine leakage.

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

    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.

Other outcomes

  1. Ultrasound parameters

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Huser

CONTACT

[email protected]

+420 532233843

Martina Szypulova

CONTACT

[email protected]

+420 773882260

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Acronym: Aniball-inco

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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