Vesair Balloon Confirmatory Trial (VECTOR)
Stress Urinary IncontinenceMulticenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.
OnabotulinumtoxinA Bladder Injection Study
Overactive BladderOveractive Bladder Syndrome5 morePatients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.
Incontinence Ring on Stress Urinary Incontinence
Stress Urinary IncontinenceUrinary IncontinenceThis study aims as defining success rate of the incontinence ring in women with test proven stress urinary incontinence and determining factors associated with successful use.
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder...
Urinary IncontinenceUrgeThe purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a...
Urinary IncontinenceStressThe purpose of this study is to determine the objective (urodynamic) cure rates and effect on patient quality of life after six months of treatment for two different nonsurgical management options for genuine stress urinary incontinence in females: weighted vaginal cones and formal supervised pelvic floor physiotherapy with biofeedback. Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are as effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for the treatment of uncomplicated genuine stress urinary incontinence in females.
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
Urinary IncontinenceUrinary Incontinence3 moreEvaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.
Refractory Urge Incontinence and Botox Injections
Urinary IncontinenceDetrusor Overactivity2 moreThe purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Vesair Clinical Trial
Stress Urinary IncontinenceSingle-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Pelvic Floor DisordersObstetric Trauma7 moreThis is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS). Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis. Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records. The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women. PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.
Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
Urinary IncontinenceThe objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)