Actively Recruiting
Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Led by Brno University Hospital · Updated on 2024-11-05
90
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of pelvic floor muscle training (PFMT) in women with stress urinary incontinence. The study compares two conservative therapy methods: home exercise training using a medical vaginal device called Aniball INCO versus standard pelvic floor muscle training exercises without the device. This research aims to improve treatment options for women experiencing this condition. Participants are randomly assigned to one of two groups. The first group performs pelvic floor muscle training using the Aniball INCO vaginal device following education by a urogynecologist. The second group receives pelvic floor muscle training without the device, guided by a certified physiotherapist trained in pelvic floor disorders. Both groups follow their respective training programs over several months. During the study, participants complete questionnaires like the International Consultation on Incontinence Questionnaire (ICIQ-SF) at the start, after 8 weeks, and after 4 months. Objective urodynamic tests and measurements of urine leakage are conducted at baseline and after 4 months. Researchers monitor clinical severity changes and the effectiveness of the treatments, with the total participation lasting around 4 months. Safety and adherence are also observed throughout the study.
CONDITIONS
Brief Title
Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with stress urinary incontinence
- Age between 18 and 80 years
You will not qualify if you...
- Age under 18 or over 80 years
- Intrinsic Sphincter Deficiency (ISD)
- Descent of the pelvic organs stage 2 or higher by POP-Q
- Urgent incontinence as ruled out by questionnaires
- Overactive bladder treated with anticholinergics
- Pregnant women or women up to 6 months after childbirth
- Active pelvic cancer
- Degenerative neurological or myofascial diseases
- Reduced cognitive function preventing study understanding
- Inability to contract pelvic floor muscles (mm. levatores ani)
- Recurrent vaginal inflammation
- Atrophic vulvovaginitis
- Irregular bleeding
- Contraindications listed by the Aniball INCO device manufacturer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants undergo pelvic floor muscle training either with the vaginal device Aniball INCO or without the device guided by a certified physiotherapist, aiming to improve stress urinary incontinence.
Visits at baseline, after 8 weeks, and at 4 months for assessments
Trial Site Locations
Total: 1 location
1
University Hospital Brno
Brno, Czech Republic, Czechia, 62500
Actively Recruiting
Research Team
M
Martina Szypulova
M
Martin Huser
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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