Evaluating pelvic floor muscle training for stress urinary incontinence
Official title: Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence
Run by Brno University Hospital · NCT06673875 · Data updated 2026-11-12
This study is testing whether using a special home exercise device or standard pelvic floor muscle training helps women with stress urinary incontinence feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Brno University Hospital Academic / other |
| Locations | 1 site (Brno, Czech Republic) |
| Status | Recruiting |
| Started | March 23, 2023 |
| Main results expected | December 2025 |
| Study ends | May 2026 |
| Registry record updated | November 5, 2024 |
| Trial ID | NCT06673875 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 80 who experience stress urinary incontinence.
✕Probably not a fit
Patients with intrinsic sphincter deficiency, pelvic organ descent, or other specified exclusions such as active pelvic cancer or recent childbirth may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of pelvic floor muscle training (PFMT) in treating stress urinary incontinence in women. Participants will be divided into two groups: one will use a medical vaginal device called Aniball INCO® for home exercise training, while the other will receive standard PFMT education from a certified physiotherapist. The study will compare the outcomes of both approaches to determine which is more effective in managing this condition.
Why it matters
Potential benefit: If successful, this study could provide a more effective conservative treatment option for women suffering from stress urinary incontinence.
How similar studies have gone: Other studies have shown positive outcomes with pelvic floor muscle training, suggesting that this approach may be effective, though the use of the specific device in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University Hospital Brno
Brno, Czech Republic, Czechia Recruiting
Study contacts
- Principal investigator: Martina Szypulova — Investigator
- Study coordinator: Martina Szypulova
- Email: szypulova.martina@fnbrno.cz
- Phone: +420 773882260
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.