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This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
Stress Urinary Incontinence
Carmel Medical Center
Published on BioPortfolio: 2019-11-03T15:10:53-0500
The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using elec...
We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress ur...
Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies. Ustrap is a new adjustable-pressure 4-arm device. The ...
After birth, the perineum has to be trained in order to recover its functions. This study is designed to assess the quality of life evolution with the EMY connected device. The secondary...
To perform an updated literature review to assess compliance with outcomes use and reporting guidelines. In 1997, the Urodynamics Society recommended standards of efficacy to be used for evaluation of...
Biofeedback is an effective method of treatment for fecal incontinence but there is controversy regarding factors that may be correlated with its effectiveness.
The prevalence of urinary incontinence in Portuguese women is 21.4% and has a very negative impact on quality of life including women's sexual activity. Pelvic floor rehabilitation is the first line t...
To analyze factors related to the incidence and remission of stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence (MUI) among women at midlife.
This prospective study presents a preliminary result to compare the clinical efficacy of patients with stress urinary incontinence and mixed urinary incontinence using minimal invasive Er:YAG vaginal ...
Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.
Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.
An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.
Support structures, made from natural or synthetic materials, that are implanted below the URETHRA to treat URINARY STRESS INCONTINENCE.
Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...