Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary...
Stress Urinary IncontinenceThis is a confirmatory/bridging study to evaluate the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of stress urinary incontinence (SUI) in adult Japanese female subjects. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
IncontinenceUrge5 moreUrinary incontinence is an increasing medical and socio-economical problem. 44% of the elderly (>65 years) women and 28% of the elderly men suffer from unwilling urine loss. Moreover, this percentages increase with age. Incontinence is a problem with multiple physical, psychological, and financial effects. In addition incontinence has a important impact on the family and healthcare professionals surrounding the elderly. The problem of urinary incontinence is complex and multifactorial. Moreover, diagnostic guidelines are inconsistent leading to a high amount of technical interventions to diagnose and to specify the type of incontinence. Aim of this study is to create a short form of necessary technical investigations to diagnose and evaluate urinary incontinence.
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Urinary Stress IncontinenceThe purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.
Continence Pessary Versus Disposable Intravaginal Device Trial
Female Stress IncontinenceThis is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.
Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate...
Urinary IncontinenceStressStress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.
Pessary Experience Study
Pelvic Organ ProlapseStress Urinary IncontinencePessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.
Ultrasound and Cure Rate Three Months and 15 Years After TOT-procedure
Urinary Incontinence,StressThe study is a cohort study. Between 2005 and 2008, a total of 54 patients were examined with ultrasound before and after TOT surgery. The collected data has not been previously published. Now these same patients are to be examined again with a more advanced ultrasound device. The subjects underwent a urogynecological ultrasound examination before surgery and during the follow-up examination 2-3 months after the procedure. In connection with the follow-up examination, the success of the procedure and the satisfaction of the patients have been evaluated. The data was collected between 2005 and 2008, and the purpose is to invite the patients in question to a research visit, so that the long-term effect of the procedure can be evaluated and the position of the band can be determined with a newer technology ultrasound device. The patients' subjective satisfaction with the procedure is assessed using questionnaires.
Electroacupuncture and Pelvic Floor Muscle Training for Male Stress Urinary Incontinence
Stress Urinary IncontinenceThe goal of this clinical study is to compare the effects of combined electroacupuncture with pelvic floor muscle training (PFMT) versus PFMT alone in the treatment of involuntary urine leakage following prostate removal procedure due to prostate cancer. The main question it aims to answer is that whether adding electroacupuncture to PFMT provides extra benefits in relieve urinary leakage and improves patients' quality of life. All participants will be required to perform daily PFMT for 6 weeks using uniformed standards. During the meantime, those assigned to the experimental group will additionally receive electroacupuncture three times per week for 6 weeks, while those in control group will receive sham treatment with same duration. Researchers will compare the urine leakage severity between the two groups to see if adding electroacupuncture can facilitate the recovery of symptom.
Surgery for Male Stress Urinary Incontinence
Male Stress Urinary IncontinenceThe purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.
Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary...
Stress Urinary IncontinenceAims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being. Design and subjects: A sequential, embedded, experimental mixed-methods design, including a randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. The proposed study will include 142 women with SUI or stress-predominant mixed urinary incontinence. Interventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT alone [control]). The PelviSense group will perform PFMT with assistance from the PelviSense device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone). Outcome measures: International Consultation on Incontinence Questionnaire-Short Form, one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary. Data analysis and expected results: Statistical analysis will be conducted using analysis of covariance. The PelviSense group is expected to report significant improvements in primary and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield cost savings and result in lower health care utility compared with the PFMT alone group.