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Urinary Incontinence clinical trials

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NCT ID: NCT06336564 Not yet recruiting - Clinical trials for Urinary Incontinence

Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause

Start date: August 2024
Phase: N/A
Study type: Interventional

Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM.

NCT ID: NCT06334848 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Start date: April 2024
Phase: N/A
Study type: Interventional

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

NCT ID: NCT06291441 Not yet recruiting - Clinical trials for Female Urinary Incontinence

Women Urinary Incontinence Prevalence Study (WUIPS)

Start date: June 28, 2024
Phase:
Study type: Observational

The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).

NCT ID: NCT06285292 Not yet recruiting - Clinical trials for Urinary Incontinence

Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.

PRIME
Start date: June 2024
Phase: N/A
Study type: Interventional

Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.

NCT ID: NCT06265896 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients.

NCT ID: NCT06247241 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

A Phase 2a Study To Evaluate VMB-100 In Females With Stress Urinary Incontinence

Start date: April 2024
Phase: Phase 2
Study type: Interventional

The study drug VMB-100 is an mRNA encoding for IGF-1. It is administered by injection into the urethra sphincter, and taken up by the muscle cells. The IGF-1 acts to promote muscle regeneration in the sphincter, which is expected to improve the function of the sphincter and thereby alleviate incontinence (urinary leakage).

NCT ID: NCT06210477 Not yet recruiting - Clinical trials for Urinary Incontinence

Association With Low Compliance Bladder in Women With LUTS

Start date: January 31, 2024
Phase:
Study type: Observational

Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association. Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.

NCT ID: NCT06111209 Not yet recruiting - Menopause Clinical Trials

The Anabolic Effect of Testosterone on Pelvic Floor Muscles

Start date: May 2024
Phase: Phase 2
Study type: Interventional

Stress urinary incontinence is the most common female pelvic floor disorder encountered in clinical practice with significant negative impact on quality of life. The prevalence of urinary incontinence increases with aging, and weakness of the pelvic floor muscles contributes to the development of stress urinary incontinence. Given that androgen receptors are expressed throughout the pelvic floor, the anabolic effects of androgens on pelvic floor muscles may provide a therapeutic option in women with stress urinary incontinence. The investigators are conducting a randomized, double-blind, placebo-controlled proof-of-concept trial in older postmenopausal women with stress urinary incontinence to assess whether testosterone therapy can increase pelvic floor muscles and improve urinary function.

NCT ID: NCT06109623 Not yet recruiting - Clinical trials for Urinary Incontinence,Stress

Correlation Between Changes in Sex Hormone Levels and Stress Urinary Incontinence in Women

Start date: November 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the relationship between stress urinary incontinence and endogenous steroids in women, especially its occurrence and severity with androgens and estrogens. The main questions it aims to answer are: - Association between stress urinary incontinence and endogenous steroids in women - Risk factors associated with stress urinary incontinence in women Participants will be asked to provide basic clinical information as well as results of measurements of serum steroid hormone levels. Researchers will compare Stress urinary incontinence group and control group to see if the changes of sex hormone levels were statistically significant.

NCT ID: NCT06094543 Not yet recruiting - Clinical trials for Urinary Incontinence

Improving Overactive Bladder Treatment Access and Adherence

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.