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Urinary Incontinence clinical trials

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NCT ID: NCT03027986 Not yet recruiting - Prostate Cancer Clinical Trials

Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy

PROTOMEN
Start date: September 2018
Phase: N/A
Study type: Interventional

Urinary incontinence (UI) is defined by the International Continence Society as "any involuntary loss of urine complained by the patient". The anatomical and histological specificities of the pelvic floor muscles (PFM) give them a key role in the control of urination but also in the control of postural stability. These activities are involuntary automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence are not only due to the loss of voluntary contraction of the pelvic floor muscles. The mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack of evidence to define the best treatment regimen for PFM rehabilitation. Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists. - The first one is made in individual box, in supine position. By analytic contractions of the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This method used voluntary contractions of MPP. - The second is realized in various positions following a gravity progression, in individual and /or common room. This technique aims to restore a stabilization of the entire lumbo-pelvic region by postural recruitment involving synergistic contractions of the PFM. These trials propose to compare these two rehabilitation programs on populations with postoperative follow-up of more than 12 months. We chose to objectify the urine leaks with the pad test (weighing of the protections urinary over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad of 3 times in 24 hours has been used by numerous studies and its reproducibility and reliability are established. Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental health and decreased of physical fitness. We therefore wish to observe these parameters for each of our two randomized groups

NCT ID: NCT02981654 Not yet recruiting - Clinical trials for Female Stress Urinary Incontinence

Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

CO2
Start date: December 2016
Phase: N/A
Study type: Interventional

This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI). Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

NCT ID: NCT02980328 Not yet recruiting - Clinical trials for Urinary Incontinence

Low-level Light Therapy for Overactive Bladder and Urinary Incontinence

Start date: December 2016
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI)

NCT ID: NCT02836145 Not yet recruiting - Clinical trials for Female Urinary Incontinence and Pelvic Organ Prolapse

Biomolecular Messages Associated With the Differentiation of Human Induced Pluripotent Stem Cells to Skeletal Muscle Progenitor Cells

Start date: August 2016
Phase: N/A
Study type: Observational

Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal status. Despite playing a crucial role in the pathophysiology of the above diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment modalities. The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for current research and future cell therapy because of their significant self-renewal, differentiation potential and the relative lack of ethical conflict. With the advent of efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs, researchers can generate personalized lines of cells from which it will be possible to obtain differentiated cells in a less invasive way, introducing opportunities in treating diseases that are now considered incurable. Until very recently, little success has been achieved in terms of skeletal muscle differentiation from hiPSCs. The purpose of this study is to explore the applicability of the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the associated biomolecular messages. It is anticipated that the derived skeletal muscle progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital problems.

NCT ID: NCT02664714 Not yet recruiting - Clinical trials for Urinary Incontinence Stress

Individual Pelvic Floor Muscle Training Versus Individual With Group Versus Group for Stress Urinary Incontinence

Start date: January 2016
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate if the training of pelvic floor muscles, which associates an individualized treatment progressing to a group treatment, would be more effective than an individualized training only or groups only. Methods: Randomized controlled study which will be done from January to December of 2016, on Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil. Inclusion criteria: women with stress UI, older than 18 years old. The sample size calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a sample of 30 women in each group. The volunteers will be assessed before the intervention by a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT scheme and perineometry. After the evaluation will be performed the randomization of the volunteers by a blinded investigator and the volunteers will be allocated into three groups: Group 1: Individualized Training Group 2: Individualized training with progression to group training Group 3: Group training only For all groups it will be used the same protocol that was prepared according to the recommendations of the American College of Sports Medicine. Later, volunteers will be reassessed after 12 treatments, three months and six months (from the discharge date). It will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises Practice. Primary outcome: severity measures of the King's Health Questionnaire. Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS 19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent measures). In order to measure the practical significance of the data, the effect size and the confidence interval (CI) will be calculated. A 5% significance level will be assumed. This study was approved by the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil (Protocol 1207393).

NCT ID: NCT02112591 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Transobturator Subtrigonal Tape vs Transobturator Suburethral Tape for Stress Urinary Incontinence

S-TOTvsTOT
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Introduction: Minimally invasive procedures TOT (tension-free suburethral tape using transobturator approach)have been the standard for correction of SUI. However, around 28% of these patients exhibit alteration of urinary flow. Recently, in 40 patients who underwent open surgery, an abdominal fascia tape was placed in a subtrigonal position with a success rate of 87.5% without obstruction. Our intention is to make the most of the idea of subtrigonal position in minimally invasive procedures with transobturator polypropylene vaginal tape (S-TOT). Object of the Study: To evaluate the efficacy and security of S-TOT compared with TOT. Materials and Methods: Study Population: Patients of the Mexican Institute of Social Security (IMSS) with an SUI diagnosis. Eligibility requirements: history of at least 3 months with symptoms of isolated SUI or symptoms of SUI associated with urge urinary incontinence (mixed UI). The size of the sample was estimated 34 subjects are required per group. Study Design: It is a parallel group randomized clinical trial. Success (efficacy) will be defined as when the SUI has been corrected with negative pad test and normal urinary flow. The results (efficacy) will be compared between the two groups using chi2 (group a/b versus success/lack of success). In all cases, p <0.05 will be considered significant. The data will be obtained with clinical evaluation, laboratory and radiological/imaging tests and the respective questionnaires during the visits before surgery, and at 2 and 6 weeks, and 6, 12, and 24 months after surgery.

NCT ID: NCT01799122 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Trial Comparing Mini-Arc Precise Pro and the Trans Vaginal Obturator Tape for Stress Urinary Incontinence

Start date: n/a
Phase: Phase 3
Study type: Interventional

Randomized comparison of two surgeries for the treatment of female stress urinary incontinence.

NCT ID: NCT01771159 Not yet recruiting - Clinical trials for Urinary Incontinence

Tissue Bonding Cystostomy(TBC)

TBC
Start date: May 2017
Phase: Phase 1
Study type: Interventional

Spinal Cord Injured [SCI] patients typically cannot "pee". Injury to the spinal cord disrupts the in-coming and out-going brain signals that coordinate bladder sensation and the emptying of bladder. SCI typically causes chronic retention of urine with uncontrolled leakage of urine. Some form of tube (catheter) is needed to drain the urine except with the mildest forms of SCI. Two types of tubes to drain the urine have been used for many years. These types are the urethral (inserted into the bladder through the opening usually used to empty the bladder) and abdominal, called suprapubic cystostomy tubes (put into the bladder through the abdomen). Bacteria (germs) normally live on our skin. Bacteria have sticky surfaces and so they stick to catheter surfaces. Bacteria reproduce very rapidly from a few dozen to over a million in 24 hours. In a warm liquid environment, like urine, bacteria can reach a density of 10 million per cubic centimeter in 48 hours which causes infection. Oral drugs and antibiotic-coated catheters delay this process by a week or two, but within a month 100% of patients have bacteria in their urine. Existing drugs cannot eliminate these microbial sanctuaries. The TBC is a 'closed access' abdominal drainage tube that has a 'cuff' or 'anchor'. It is permanently placed in the abdominal muscle to bond with the body's tissue. Another catheter is temporarily connected to the TBC that is easily replaceable in the clinic without anesthesia or special instruments. It locks to form a water-tight system. Many parts of the TBC are coated with an antibacterial substance that will delay the growth of bacteria. The TBC has been used with success in multiple animal studies. This is a Phase I human clinical trial in which the TBC will be used 10 spinal cord injured patients, each of whom will be followed for 12 months or longer. Abdominal catheter exit sites will be photographed monthly and tested periodically to document growth of any bacteria. Every three months, patients will complete satisfaction questionnaires and their urine will be tested for bacteria. Urine will also be tested as clinically indicated.

NCT ID: NCT01066117 Not yet recruiting - Clinical trials for Urinary Incontinence

Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.

NCT ID: NCT00523068 Not yet recruiting - Clinical trials for Urinary Incontinence, Stress

Pharmacological vs Surgical Treatment for Mixed Incontinence

Start date: September 2007
Phase: Phase 4
Study type: Interventional

In patients with symptoms of mixed incontinence (loss of urine associated with coughing/sneezing/laughing, and loss of urine associated with the strong urge to void), is surgical treatment with tension free vaginal tape or pharmacological treatment with tolterodine more effective? What are the parameters predictive of success or failure with either forms of treatment? What are the parameters predictive of the necessity for further treatment after primary treatment? Patients will be randomised to having surgical or pharmacological treatment for their mixed incontinence symptoms. They will be assessed subjectively and objectively pre-treatment and after treatment at intervals up to 3 months.