NCT06673875

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Brno University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2023-03-23
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: Czechia