Topics

The Nolix Feasibility Efficacy and Safety Study

2019-11-03 15:10:53 | BioPortfolio

Summary

This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.

Description

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.

Study Design

Conditions

Stress Urinary Incontinence

Intervention

Nolix Device

Location

Carmel Medical Center
Haifa
Israel

Status

Recruiting

Source

Gynamics LTD

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-03T15:10:53-0500

Clinical Trials [2178 Associated Clinical Trials listed on BioPortfolio]

Solace Stress Urinary inContinence Control Efficacy and Safety Study

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.

InTone for Urinary Incontinence

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...

Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

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...

Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

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 ...

Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.

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...

PubMed Articles [9186 Associated PubMed Articles listed on BioPortfolio]

URINARY INCONTINENCE RESEARCH: COMPLIANCE WITH RESEARCH STANDARDS FOR CLINICAL STUDIES.

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...

PREDICTORS OF UNSUCCESSFUL OF TREATMENT FOR FECAL INCONTINENCE BIOFEEDBACK FOR FECAL INCONTINENCE IN FEMALE.

Biofeedback is an effective method of treatment for fecal incontinence but there is controversy regarding factors that may be correlated with its effectiveness.

Stress Urinary Incontinence and Female Sexual Dysfunction: The Role of Pelvic Floor Rehabilitation.

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...

Incidence and remission of stress, urge, and mixed urinary incontinence in midlife and older women: A longitudinal cohort study.

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.

Preliminary outcome of non-ablative vaginal Erbium laser treatment for female stress and mixed urinary incontinence.

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 ...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "The Nolix Feasibility Efficacy and Safety Study"

Quick Search

Relevant Topics

Stress
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
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'...


Searches Linking to this Trial