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

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

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: vaginal device Aniball INCO; Procedure: conservative treatment of stress urinary incontinence - pelvic floor muscle training

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martina Szypulova; Phone Number: +420 773882260; Email: szypulova.martina@fnbrno.cz
• Study Contact Backup: Name: Martin Huser; Phone Number: +420 532233843; Email: huser.martin@fnbrno.cz

Study Locations

• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 62500
      • Recruiting
      • University Hospital Brno
      • Contact: Martina Szypulova; Phone Number: +42053223806; Email: szypulova.martina@fnbrno.cz
      • Contact: Martin Huser; Phone Number: +42053223843; Email: huser.martin@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aniball-inco; training muscles with vaginal device to excercise of pelvic floor muscle.	Device: vaginal device Aniball INCO; 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.
Active Comparator: RHB; training muscles without device to excercise of pelvic floor muscle.	Procedure: conservative treatment of stress urinary incontinence - pelvic floor muscle training; evaluation of pelvic floor muscle rehabilitation to change the clinical severity of urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline at time of urogynecologic check visit/ after 4 months at time of output urogynecology examination

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Martina Szypulova, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: stress urinary incontinence; conservative treatment; physiotherapy of pelvic floor
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: Aniball inco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after enrollment and finishing the study, we will share the data of our research analysis.
• IPD Sharing Time Frame: 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No