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Confirmed effect

The prospective cohort study "Investigating antenatal pelvic floor training using a vaginal balloon device in Czech women"conducted by Dr. Fousek and colleagues, was published after 6 years of intensive research in the prestigious British Journal of Midwifery (February 2023, Vol 31, No 2).

What has the study reassured us about?

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Aniball is safe

Aniball is safe, it does not cause dilation (expansion) of the vagina or incontinence.

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Prevents perineal tears

It helps prevent perineal tears, significantly reduces the risk of episiotomy (British Journal of Midwifery, February 2023, Vol 31, No 2). There is no reason to exceed the recommended balloon size.

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Prevents incontinence

Aniball should also be regularly used after the postpartum period. It helps restore the function of the pelvic floor and prevent incontinence later in life.

The study brief

This study examined the results of births in Czech first-time mothers giving birth vaginally head first and compared the differences between women exercising with Aniball and non-exercising women.

The main results

The study concluded that Aniball helps to prevent injury of the perineum by episiotomy. It also confirmed that Aniball is safe - its use does not increase the risk of damage to the pelvic floor and does not cause urogynaecology problemslater on.

 

There was no difference between the two groups in the incidence of pelvic floor injury (avulsion injury to levator ani muscle). It refuted the opponents' fears that Aniball violated the integrity of the pelvic floor and worsened the quality of a woman’s life after childbirth.

Other important findings

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Exercise frequency

More frequent exercise does not lead to a further reduction in the number of birth injuries or degrees of tears. On the contrary, less frequent exercise (every other day) seems to be more beneficial.

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Circumference of the balloon

The most frequent maximum circumference of the balloon was 25 cm - this confirms that it is not desirable to inflate the balloon further. The aim of the training is to practice the relaxation of the pelvic floor and not to reach the largest circumference of the balloon.

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After childbirth

The practising women did not indicate a decrease in life quality (in terms of incontinence or sexual dysfunction) after childbirth. On the contrary, incontinence and deterioration of love life quality after childbirth were reported by more women who did not exercise: Stress incontinence (p = 0.066) and sexual dysfunction (p = 0.14).

Analysis of the reasons for excluding women from the study after childbirth additionally revealed a non-significant reduction in the number of vaginal extraction operations in women who exercised (6.8% vs. 17.3%, p = 0.0895). This interesting side finding could serve as a stimulus for further research into the potential benefits of using the balloon.

Read carefully the instructions for use and the information related to the safe use of the medical device. 
Aniball is a medical device intended for pre-birth preparation, prevention of perineal injuries and stress urinary incontinence. Aniball Inco is a medical device intended for the prevention and treatment of stress urinary incontinence. We are implementing the project "Aniball INCO Animation" (registration number: 0380000676) in four language versions, focused on customer education, funded by the European Union – Next Generation EU. We are also implementing the project "Brand Woman Wave and related brands" (registration number: 0461000311), which includes the complete rebranding of RR Medical s.r.o., funded by the European Union – Next Generation EU.

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Our company has a quality management system for medical devices according to ISO 13485, which guarantees the highest standards regarding the safety and quality of our products.

 

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