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Urinary Incontinence clinical trials

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NCT ID: NCT06348342 Enrolling by invitation - Menopause Clinical Trials

Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the "Pelvic Floor Distress Scale (PFDI)" and "Pelvic Floor Impact Questionnaire (PFIQ)" will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman's correlation, and regression analyzes will be used in the analysis of research data.

NCT ID: NCT06316778 Enrolling by invitation - Clinical trials for Urinary Incontinence

Pelvic Floor Muscle Training for Women With Myotonic Dystrophy

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population.

NCT ID: NCT06209307 Enrolling by invitation - Clinical trials for Stress Urinary Incontinence

Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate

Start date: February 8, 2024
Phase: N/A
Study type: Interventional

Holmium laser enucleation of the prostate (HoLEP) is a surgical procedure used to treat benign prostatic hyperplasia (BPH). HoLEP involves the removal of obstructive prostatic tissue via an endoscopic approach to relieve bothersome urinary symptoms. HoLEP is recommended by the American Urological Association (AUA) as a size-independent treatment for BPH. While the surgery is highly durable and versatile, post-operative stress urinary incontinence (SUI) has been reported following HoLEP, up to 44%. Pelvic floor physical therapy (PFPT) is a therapeutic strategy with low cost and risk to patients used to treat SUI following prostate surgery. However, data on the efficacy of conducting PFPT prior to HoLEP in minimizing or eliminating post-operative urinary incontinence is limited. The investigators will recruit patients who have already agreed to undergo HoLEP for this study. Participants will be randomized into two groups: The intervention group will begin standardized PFPT before surgery and will continue PFPT after surgery, and the second group will begin PFPT after surgery only (current practice). Both groups will continue with PFPT following surgery until urinary continence is regained. Investigators will compare the time required to regain urinary continence and patient-reported outcomes between the two groups.

NCT ID: NCT06189443 Enrolling by invitation - Clinical trials for Stress Urinary Incontinence

Abdominal-Kegel Exercise and the Effect of Telemedicine in Stress Urinary Incontinence

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Urinary incontinence is a very common health problem that reduces the quality of life mostly in women. Behavioral therapy (lifestyle changes, abdominal-Kegel exercises) is recommended as the first choice in the treatment of the disease. It is known that surgical and medical treatment cannot give a definite result. The application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. In this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.

NCT ID: NCT06161324 Enrolling by invitation - Clinical trials for Urinary Incontinence

Tele-rehabilitation for Women With Urinary Incontinence: A Randomized Controlled Trial

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

We are conducting a study in Greece, where the prevalence of urinary incontinence (UI) in the female Greek population is 1 to 3 women (27%) . PFM training is effective for UI treatment, when occurs intensively (daily), with physiotherapy supervision for at least 3 months. However, adhearance to such intense treatment is very often compromised. We therefore believe that a telerehabilitation programme, such as a mobile application (app) in collaboration with a pelvic floor muscle sensor and with the simultaneous supervision of the physiotherapist (via the mobile app), will provide sufficient motivation for the patient to adhere with daily exercises. The development of tele-rehabilitation programs through mobile applications (mobile apps) has been a breakthrough for UI treatment. The pelvic floor muscle (PFM) exercise programs through mobile apps, provide optimal health care services by offering to the patients a therapy program in the convenient environment of their homes, with safety and less expense. Moreover, the majority of the existence mobile apps, work as simple verbal instructions, do not being tailored in patients' individual needs, and they are not able to assess the right direction of PFM contraction (inwardly and towards the navel), which is necessary for the successful implementation of the PFM exercises. Therefore the main purpose of the study is to investigate the effectiveness of a tele-rehabilitation program, through a novel, innovative mobile app in cooperation with a pelvic floor muscle sensor, indicating the direction of the PFM contraction in real time, which might be effective in UI treatment. The mobile app as well as the pelvic floor sensor will be created for the needs of the present study. A secondary objective of the study will be to investigate the degree of adherence to PFM exercises and the degree of supervision, which needs in the tele-rehabilitation program. The present study is designed to be conducted as a prospective randomized controlled clinical trial (RCT) with three arms. We believe that the contribution of the current research has a social and economic impact on the life of the Greek woman with incontinence and this lies in the fact that, it is a fast, easy-to-use, modern approach opening new horizons in the field of rehabilitation. In addition, the patient maintains her interest in the exercises, performs them safely, more economically in her own time and in a familiar environment of her choice. Finally, rehabilitation through the mobile app in cooperation with the pelvic floor transperineal sensor is an extremely useful clinical "tool" for Physiotherapists and patients, giving the opportunity to patients with mobility problems or with lack of transport or to them who live in remote areas, to treat their incontinence.

NCT ID: NCT06085846 Enrolling by invitation - Clinical trials for Urinary Incontinence

Real-World Registry - The Vivally® System

Start date: July 14, 2023
Phase:
Study type: Observational [Patient Registry]

This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to: Therapy compliance and stimulation metrics Diary entries provided by patients Various questionnaires Participants have the option to opt out of allowing their data to be part of any publication at any time.

NCT ID: NCT05952258 Enrolling by invitation - Clinical trials for Stress Urinary Incontinence

Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

NCT ID: NCT05929300 Enrolling by invitation - Prostate Cancer Clinical Trials

A Yoga Program for Patients Undergoing Prostate Cancer Surgery

Start date: October 18, 2023
Phase: N/A
Study type: Interventional

Men with localized prostate cancer (PCa) are often treated with surgery, a treatment that is associated with high rates of side effects such as erectile dysfunction (ED) and urinary incontinence (UI) which impact quality of life. Yoga may improve control of UI and improve ED by bringing awareness to and strengthening the pelvic floor musculature. The randomized controlled pilot study is to assess the feasibility of an innovative hybrid (in-person and virtual) twice-weekly yoga program that includes a prehabilitation component and to obtain preliminary data that will help assess its potential effectiveness in alleviating PCa treatment symptom burden (primarily ED and UI). The long-term goal is to develop a scalable and sustainable yoga program that helps cancer survivors manage their treatment side effects.

NCT ID: NCT05832268 Enrolling by invitation - Clinical trials for Urinary Incontinence

Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

PFF
Start date: September 19, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury. The main questions we want to answer is: - can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life? - can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction? - should we recommend these women to have a caesarian section instead of a new vaginal delivery? Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction. Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.

NCT ID: NCT05404386 Enrolling by invitation - Quality of Life Clinical Trials

Effect of Mobile Application on Urinary Incontinence

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The first phase was designed in a methodological pattern in order to develop, usability, and performance of mobile application (mobileapp) called "My Fight with Incontinence". Aim of the second phase of the study was to evaluate the effect of mobileapp developed according to the health belief model on incontinence symptoms, Kegel exercise compliance, health belief and quality of life towards UI and kegel exercises in women with UI. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 3-month follow-up period. The research will be carried out in the Urology service and polyclinics of Eskişehir Osmangazi University Health Practice and Research Hospital. The study population of the research consists of 203 female patients over the age of 18 who were followed up with the diagnosis of Stress, Urge, and Mixed Type UI. Sample selection will not be made in the first stage of the study, and mobileapp will be tested on people aged 18 and over who can be reached, working, studying, or receiving treatment at Eskişehir Osmangazi University Training, Application and Research Hospital and Eskişehir Osmangazi University. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 96 individuals, 48 in each group, with an increase of 20%, will form the research group. In the second stage of the study, "Incontinence Severity Index Questionnaire", "International Urinary Incontinence Inquiry Form-Short Form (ICIQ-SF)", "Kegel Exercise Compliance Follow-up Form", "Health Belief Scale for Urinary Incontinence and Kegel Exercise", "Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7)" will be used. Control group will be given a training booklet called "My Fight with Incontinence", which includes healthy lifestyle behaviors, bladder training, and Kegel exercises related to UI after the pre-tests are applied. After pre-tests are applied to the study group, "My Fight with Incontinence" mobileapp will be installed on their mobile phones by researcher. Reminders will be sent to the patients on a regular basis via the mobileapp. Participants in both the control and study groups will be provided with the link of the survey form created via google forms in the 6th and 12th weeks by sending an SMS.