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Urinary Incontinence clinical trials

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NCT ID: NCT02023502 Completed - Clinical trials for Female Stress Urinary Incontinence

Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study

Start date: November 2013
Phase:
Study type: Observational

Objective: The primary objective of the study is the comparison of protein concentrations between patients with stress urinary incontinence (SUI) and healthy controls. Aim: This pilot study aims to determine a possible altered protein profile in women suffering from SUI, compared to healthy women and therefore to discriminate a potential protein biomarker for SUI. Main outcome measure: mass spectrometric measuring of urinary proteomic secretome in diseased and healthy subjects (sequence coverage and number of identified proteins) Trial design: Prospective case- control study Setting: Department of Gynecology and Obstetrics of the Medical University of Vienna in co- operation with the Core Facilities Proteomics of the Medical University of Vienna Population: Twenty female patients with SUI and twenty healthy patients who attend the outpatient clinic of the Department of Obstetrics and Gynaecology, Medical University of Vienna (sample size calculation FDR 0.05, power of 80%, assumed proportion of true H0 0.95, assumed standardized effect size of 1) Methods: Examinations to be carried out: patient history, provocative stress test, ICIQ short form questionnaire, residual urine volume (ultrasound) and urine analysis (dipstick testing). A urine sample is obtained from the patient after spontaneous micturition, to which protease inhibitor will be added immediately. Two serum blood vials (each 9ml) are taken from a peripheral vein of the patient for routine laboratory and further research. Proteomics analysis will be performed using chromatographic separation (LC) with mass spectrometric detection (MS).

NCT ID: NCT02010788 Completed - Clinical trials for Urinary Incontinence

Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korea

Start date: February 2014
Phase: N/A
Study type: Observational

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by anticholinergic drugs.

NCT ID: NCT02001714 Completed - Clinical trials for Urinary Incontinence, Stress

Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

Gladiolus
Start date: September 2013
Phase: N/A
Study type: Interventional

This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.

NCT ID: NCT01987336 Completed - Clinical trials for Urinary Incontinence

A Prospective Analysis of Biofilm in Urinary Catheters Study

Start date: March 2013
Phase: N/A
Study type: Observational

To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.

NCT ID: NCT01982188 Completed - Clinical trials for Stress Urinary Incontinence (SUI)

Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Start date: September 2012
Phase: N/A
Study type: Observational

This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

NCT ID: NCT01979848 Completed - Prostate Cancer Clinical Trials

MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

Start date: June 2013
Phase: N/A
Study type: Observational

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand: 1. How effectively the tissues for continence and sexual function are cooled within the pelvis. 2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and 3. Determine if the endorectal balloon can be re‐designed for improved QOL outcomes in men. This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non‐invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non‐invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

NCT ID: NCT01978210 Completed - Autism Clinical Trials

Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism

Start date: September 2013
Phase: N/A
Study type: Interventional

This pilot study is designed to investigate the feasibility of comparing a standard behavioral intervention and an innovative intervention that incorporates the use of a wireless moisture alarm in training children with autism how to independently use the toilet for urination. We hypothesize that the study protocol will be feasible, as measured through review of achieved recruitment targets, successful randomization, and >80% retention of subjects with com- plete data collection. Our second hypothesis is that therapists will deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A secondary aim of this study is to examine trends in outcome data by conducting a small RCT (N = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis that the moisture alarm intervention will result in fewer toileting accidents, a higher rate of toileting success and greater parental satisfaction.

NCT ID: NCT01971801 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation in Older Adults With Urinary Incontinence

Start date: January 2014
Phase: N/A
Study type: Interventional

Urinary incontinence (UI) is a common disorder among older women that greatly affects quality of life. Emerging evidence from observational studies links vitamin D insufficiency with UI. Prior to a larger intervention trial of vitamin D among older women with low serum vitamin D levels and urgency UI, we propose a pilot study in 100 older women comparing weekly, oral vitamin D3 50,000 IU to placebo. We hypothesize that adequate vitamin D supplementation will improve UI symptoms in older women with vitamin D deficiency. Changes in UI-episodes will be assessed by a 7-day bladder diary and other validated symptom measures administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored. The expected outcomes will provide new knowledge regarding the impact of vitamin D supplementation on UI symptom improvement and inform a larger, randomized controlled clinical trial involving vitamin D supplementation.

NCT ID: NCT01971437 Completed - Clinical trials for Urinary Incontinence, Urge

Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

Start date: October 2013
Phase: N/A
Study type: Interventional

This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine samples will also be assessed for underlying infected cause of OAB using urinalysis, microscopy and culture and cytokine assays (In collaboration with the University of Kent). We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB.

NCT ID: NCT01960998 Completed - Prostate Cancer Clinical Trials

Perioperative Post-Prostatectomy Incontinence Home Telehealth Program

ProsTel
Start date: August 11, 2014
Phase: N/A
Study type: Interventional

Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform.