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Urinary Incontinence clinical trials

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NCT ID: NCT02636387 Terminated - Anemia, Sickle Cell Clinical Trials

Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease

Start date: August 26, 2015
Phase:
Study type: Observational

This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

NCT ID: NCT02505607 Terminated - Clinical trials for Urinary Bladder, Overactive

Overactive Bladder Education

Start date: July 2015
Phase: N/A
Study type: Interventional

Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence. Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction. This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed "Overactive Bladder Plan of Care" information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician. At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge. Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.

NCT ID: NCT02357784 Terminated - Clinical trials for Urinary Incontinence

Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment

SaNDI
Start date: January 2015
Phase: N/A
Study type: Interventional

Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, DI is the result of a failure of communication between the brain and the sacral nerve, which controls the bladder, bowel, and pelvic floor. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is a standard of care treatment that involves surgically implanting a device in to a patient's body to target communication issues between their brain and bladder/bowel. Because the exact mechanism of action of SNM remains unclear, this study aims to better understand how SNM affects the nerves of patients with DI. Patients who are already planning on undergoing SNM device implantation will be recruited to this study. Study participants will undergo Current Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum to measure and quantify the amount of physical stimuli required for the nerves in the pelvic floor to sense a stimulus. By learning more about nerve function in patients with DI, the investigators hope to find a way to screen patients before treatment with SNM to make sure the treatment will be effective for that individual.

NCT ID: NCT02129816 Terminated - Overactive Bladder Clinical Trials

Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder

BryoSoliP
Start date: May 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Overactive bladder (OAB) is an enigmatic condition that is treated symptomatically with anticholinergic drugs (gold standard 2013). In a clinical pilot study was found to be a trend for a higher reduction of the micturition frequency in the Bryophyllum pinnatum group - treated with chewing tablets containing 50% of dried BP leaf press juice - than in the placebo group (n=20, p=0.064) Hypothesis: To test the superior effectivity of Bryophyllum versus Placebo in the treatment of OAB with the needed number (Purpose 1) and to assess in an experimental arm the side effects of BP in comparison to the standard drug (Vesicare) in a clincial trial (Purpose 2).

NCT ID: NCT02097121 Terminated - Clinical trials for Urinary Incontinence

OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

Start date: May 23, 2014
Phase: Phase 3
Study type: Interventional

This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.

NCT ID: NCT01563653 Terminated - Clinical trials for Urinary Incontinence, Stress

Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

IEUF
Start date: February 20, 2014
Phase: N/A
Study type: Interventional

The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence. The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).

NCT ID: NCT01500603 Terminated - Clinical trials for Stress Urinary Incontinence

Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence

BALLANCE
Start date: March 2013
Phase: N/A
Study type: Interventional

Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness. Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up. Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up. Secondary objectives: - Comprehensive comparative medical evaluation of the two devices in terms of efficacy - Complete evaluation of the side effects of the two techniques - Evaluation of the quality of life - Evaluation of patient satisfaction - Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g). Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat. Medical evaluation: Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI. Secondary outcome criteria - pad usage per day - quantitative reduction of the 24hr-pad test - complications (infection, erosion, hematoma, acute urinary retention) - number of re-interventions or re-admissions during follow-up - quality of life measured by the ICIQ-SF questionnaire - patient satisfaction by the PGI-I questionnaire Economic evaluation: - Study of the total cost over one year in each case - Adjustment of cost of each device to quality of life (QALY evaluation) - Cost effectiveness study - Proposals will be made to state at which level the two devices should be covered by the healthcare system.

NCT ID: NCT01464372 Terminated - Clinical trials for Urinary Incontinence, Urge

Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder

ELEC STIM
Start date: October 2011
Phase: Phase 3
Study type: Interventional

The 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.

NCT ID: NCT01366066 Terminated - Clinical trials for Stress Urinary Incontinence

Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Start date: May 2011
Phase: Phase 3
Study type: Interventional

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. The present study aims to treat urinary incontinence and includes 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications. The stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests. If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.

NCT ID: NCT01358214 Terminated - Clinical trials for Urinary Incontinence, Stress

Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)

Start date: May 2011
Phase: N/A
Study type: Observational

Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.