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72 active trials for Urinary Incontinence

Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy

Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable. Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues. In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.

NîmesStart: September 2021
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence

Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical activity is affected. The time spent on physical activity is reduced in postmenopausal women. Studies have shown that physical activity acts in a bidirectional manner, exerting either a preventive or an aggravating effect on urinary incontinence. Individuals with sedentary lifestyle and insufficient physical activity (< 150 min/week) are at risk of developing UI, and regular physical activity exerts a protective effect in preventing UI, but the optimal type, duration, and intensity of exercise for the female older adult population remain unknown. In addition, objective measurements of pelvic floor muscle function is needed as the use of self-reported measures may cause response bias. The aim of the study is to investigate the effect of different intensity of exercise on pelvic floor muscle function and HRQoL in postmenopausal women with UI. The investigators hypothesize that (a) both high- and low-intensity physical activities can improve pelvic floor muscle strength and HRQoL in postmenopausal women with UI, and (b) the improvement in high-intensity group is higher than that in low-intensity group. A randomized trial will be conducted to compare the effect of different exercise intensity on pelvic floor muscle function in postmenopausal women with urinary incontinence (n=90).

TainanStart: March 2020
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.

Gdańsk, PomorskieStart: June 2021