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72 active trials for Urinary Incontinence

Kegel Exercise Pregnant Training mHealth App

This pilot feasibility study protocol is to assess the feasibility in the future definitive trial that is the Kegel Exercise Pregnancy Training app (KEPT-app) trial. The aim of this study as follows: (1) to evaluate the recruitment capability of the pregnant women, (2) to evaluate the acceptability of the KEPT-app, (3) to determine the implementation feasibility of using KEPT-app, and (4) to determine the preliminary effectiveness of KEPT-app to improve PFMT skills of pregnant women.

Start: April 2021

Feasibility Study of an Individualized Exergame Training for Older Adults With MI and/or UI (VITAAL)

This study examines the feasibility of an individualized video game training (VITAAL Exergame) for older adults with mobility impairments and/or urinary incontinence. In addition, the effect of the newly developed training program on motor and cognitive functions is examined. This study is a national study. The development of the exergame was carried out at the Fraunhofer AICOS research center in Portugal and further studies are being conducted in international collaboration with the University of Montréal in Canada, KU Leuven in Belgium and ETH Zurich. The Exergame consists of a video game based training, which is performed with step movements. These movements are detected by two sensors on the feet. The video game should make the training fun and motivate to train. The training will include specific cognitive and physical functions. Special emphasis will be put on a continuous interaction and integration of motor and cognitive functions. An intact cognitive-motor interaction as well as balance and strength form the basis for all everyday performances, especially for safe and accident-free movement in older adults. In the Exergame VITAAL, balance is trained with step-based games. Strength, especially leg strength, is trained through Tai-Chi-like movements/exercises. The pelvic floor training takes place using a vaginal probe that measures the contractions of the pelvic floor. The training games on the VITAAL Exergame have been adapted for this purpose and are controlled via the probe. All participants receive an individually tailored training session that is optimally adapted to their needs based on the results of the pre-measurement. Participants with urinary incontinence also receive an integrated pelvic floor training. The study includes 32-52 seniors with mobility impairments and 8-28 older adults with urinary incontinence. Balance and strength, gait pattern, cognitive functions and pelvic floor specific functions will be measured before and after the training in order to detect any changes. The training should be carried out during 12 weeks, with a maximum of two weeks break/holidays. There are two measurement dates with all examinations, whereby one measurement date lasts approx. 1.5 hours. All study participants can continue their everyday life as usual.

Start: October 2020

Ancillary Study of the Lessening Incontinence With Low-impact Activity Study

The parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 50 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal yoga or muscle stretching/strengthening programs, are willing to temporarily forgo other clinical treatments for incontinence, are able to walk to and use the bathroom without assistance, and meet other eligibility criteria are being recruited from multiple locations surrounding the San Francisco Bay area. Following a series of telephone- and then clinic-based screening assessments, including a voiding diary to confirm the frequency and clinical type of incontinence, eligible women are randomized in a 1:1 ratio to participate in either a 3-month yoga program (N~110) or a time-equivalent, non-specific muscle stretching and strengthening control program (N~110). During the 3-month intervention period, participants participate in structured intervention programs (either yoga-specific or muscle stretching-strengthening) consisting of twice weekly, 90-minute group classes led by trained instructors). They are also be instructed to practice their assigned intervention for at least an additional hour per week, with the assistance of participant manuals created by the study team and a set of home yoga or stretching/strengthening exercise props. For this ancillary trial research, the investigators are examining ancillary measures of a) physical performance status, b)perceived stress, depression, and anxiety symptoms, and c) sleep quality, duration, and continuity, already incorporated by the principal investigator into the parent trial. The investigators will examine prospective relationships between these ancillary measures and participant-reported urinary incontinence frequency/severity/impact, examine intervention effects on these ancillary outcomes, and assess the extent to which these ancillary outcomes mediate intervention effects on incontinence frequency/severity/impact.

Start: December 2018

Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.

Start: January 2020

Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation

The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective. For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities. Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep. It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.

Start: July 2019

LATITUDE An Observational Study of Patient Choice and the Urethral Bulking Agent, Bulkamid®

Latitude is an observational study exploring how effective Bulkamid ® is as a first line treatment for women with stress urinary incontinence. Women who choose to have Bulkamid as part of their standard clinical care will be asked to complete questionnaires before and after their surgery so that we can assess how their urinary symptoms change. As a second part of the study, we are asking all patients having any first line treatment for stress incontinence to complete a short questionnaire telling us how they decided what treatment to have. A small number of these women will be contacted via telephone and asked whether they would mind being interviewed to tell us more about this. We will also interview a number of doctors taking part in Latitude to find out how they counsel patients about different treatment options for stress urinary incontinence.

Start: June 2017

Remote Access to Urinary Incontinence Treatment for Women Veterans

This study is about assessing the helpfulness of two treatment delivery methods for bladder leakage or urinary incontinence. It is being funded by the Department of Veterans Affairs. By doing this study, the investigators hope to learn which treatment method is the most helpful remote delivery method for treating bladder leakage. The total participation time in this research is 6 months. During the first 8 -12 weeks of the study, you will receive standard of care from an online educational program (MyHealtheBladder) or a video visit with a provider through VA Video Connect. You will be selected by chance to receive MyHealtheBladder or VA Video Connect. About half-way through the study, the investigators will ask you about your bladder symptoms. If your bladder symptoms are not better, you will be selected by chance to continue the previous treatment or receive an initial or booster video session with a provider. Throughout the study, you will be asked to answer questions related to your health, bladder leakage, costs due to bladder leakage, and track your behavioral training.

Start: April 2020

Prevalence and Consequences of Urinary Incontinence in People With Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation

Urinary incontinence is a frequent chronic condition in general population. It is even more frequent in people with chronic respiratory disease due to several factors, including but not limited to frequent cough. Urinary incontinence may be more frequent during exercise so that it may contribute to the general deconditioning associated with chronic respiratory disease. Although pulmonary rehabilitation is a cornerstone in the management of people with chronic respiratory disease to break this spiral of worsening dyspnea, little is known about the prevalence of urinary incontinence among those people referred for pulmonary rehabilitation nor about its impact on the effects of the program.

Start: May 2020

Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD

Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

Start: June 2020

Urinary Disorders in Subacute Patients After Stroke

This observational study will address urinary disorders in subacute stroke patients. Patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.

Start: June 2019

Fistula Reintegration Pilot

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.

Start: March 2021

Evaluation of a New Bladder Health Mobile Application in Pregnancy

Millions of women experience involuntary loss of urine called urinary incontinence (UI). UI can be slightly bothersome or totally debilitating. Women experience UI twice as often as men. Urinary incontinence can also be a persistent condition caused by underlying physical problems or changes, including pregnancy and childbirth. UI symptom severity progress dynamically and are also sustained over time. High quality evidence shows that pelvic floor muscle training (PFMT) during pregnancy effectively reduces the risk of UI during pregnancy and the postpartum period. There is a critical need for a low cost and easily accessible program to prevent UI in pregnancy and postpartum that can reach a large number of women. A mobile health application that teaches UI preventive program during pregnancy has the potential of being a cost effective tool to reach a large number of pregnant women. The Bladder Health Mobile Application (BHmApp) will teach pregnant women new habits and exercises that will keep their bladder healthy during pregnancy and decrease the risk of UI during this period of a woman's life that is considered high risk for developing UI. In this pilot study, it is proposed to evaluate the understand and effectively use the BHmApp, and the feasibility of using the BHmApp during pregnancy.

Start: July 2021

Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms

Lower urinary tract symptoms is quite frequent in men and women. To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). In this study we aim to validate the LURN-29 score to Turkish language

Start: January 2021

Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function

Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.

Start: May 2019

rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.

Start: June 2019

Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients

The aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.

Start: April 2022

Detectability of the Bladder With an Early Prototype of the Bladder Sensor

This is an explorative, monocentric, feasibility study to evaluate the detectability of the bladder in healthy subjects by ultrasound monitoring with the early prototype of a future bladder sensor, which is intended for use for an individual suffering from urinary incontinence.

Start: April 2021

tDCS and Female Urinary Incontinence

Urinary incontinence (UI) is defined as any involuntary loss of urine and can be divided into three types: urgency, stress and mixed. Pelvic floor exercises are considered the main non pharmacological choice for UI treatment. Its mechanisms are not fully understood, however there are some evidence that central mechanisms play an important role in the continence control. In this context, neuromodulatory techniques, such as transcranial direct current stimulation (tDCS), that address cortical targets has been demonstrated promising results in different health conditions. However, few studies have investigated the efficacy of adding tDCS to exercise therapies for women with UI.

Start: November 2019

Physiotherapy to Treat Urinary Incontinence in Athletes

Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes. UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues. Evidence suggests athletes have stronger pelvic floors than non-athletes. If the pelvic floor is overactive, general advice regarding pelvic floor strengthening will not improve UI, and may make it worse. This study will explore the feasibility of conducting a larger trial to identify cost effectiveness and benefits of treating athletes with physiotherapy and how this might differ from current practice. 15 -20 athletic women will complete questionnaires regarding their UI and its effects on them. They will receive physiotherapy; the assessment will include a history and internal examination of their pelvic floor. This will inform a tailored rehabilitation program. Interviews will be conducted with some of these women to explore their response to the intervention. Interviews with health professionals will establish current practice for this patient group. The results will tell us how likely it is for athletes to volunteer and take part in a future study and which outcomes are useful.

Start: August 2019

Urinary Incontinence and Endocrine Factors. A Part of Lolland-Falster Health Study (LOFUS).

Previous studies have shown an increase in the prevalence of urgency and urgency incontinence in women with diabetes. Regarding the condition urinary stress incontinence, the literature is diverted. The purpose of the PhD project is investigate the prevalence of urinary incontinence and the association to diabetes and thyroid disease in a mainly rual population in Lolland and Falster. Further to investigate if there is any difference in the bladder function in incontinent women with and without diabetes. Psychometric validation of the questionnaire used to assess urinary incontinence was also performed.

Start: January 2016