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Tundra lists 17 Urinary Incontinence (UI) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07520916
The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy
This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Patients scheduled for radical prostatectomy will be assigned to either an intervention group or a control group. The intervention group will receive standard care plus a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education modules, reminders, and follow-up components. The control group will receive routine perioperative care and standard patient education. Data will be collected preoperatively, after urinary catheter removal, and at 1 month and 3 months after surgery. The primary outcomes are urinary incontinence and erectile function, assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Index of Erectile Function-5 (IIEF-5), and a 24-hour pad assessment. Secondary outcomes include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and system usability assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV)
Gender: MALE
Ages: 18 Years - Any
Updated: 2026-04-09
1 state
NCT06798311
Reducing Disparities in Urinary Control Symptoms for Minority Women
The study is designed to address the disparity in available conservative/behavioral treatments for UI/LUTS. The program was developed by experts from urogynecology, psychology, and physical therapy then modified based on focus group feedback from racially minoritized women. The study team created a patient-centered, culturally adapted, self-directed, 8-week, home-based module for women with LUTS/UI. The SUPPORT program combines multiple evidence-based conservative treatments for LUTS/UI including cognitive behavioral therapy, behavioral modifications, and home physical therapy exercise. Progression through the home-based program is supported by research staff. This prospective interventional study aims to evaluate the feasibility and acceptability of the SUPPORT program and its impact on patient-centered treatment outcomes, while enabling comparisons across race and ethnicity. This approach will provide a comprehensive understanding of how to effectively deliver self-management strategies for pelvic floor disorders. At the start of the 8 week SUPPORT course participants will also be given access to a custom programmed GPT trained on the SUPPORT workbook and given instructions on empathetic communication techniques and assisting patients in performing the SUPPORT exercises as outlined in the program. At the end of 8 weeks patients will fill out a survey assessing the frequency of use and interactions with the LLM.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-04-07
1 state
NCT07425015
Ambulatory Long Length URodynamics Evaluation
A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.
Gender: All
Ages: 22 Years - Any
Updated: 2026-04-03
6 states
NCT07319247
Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence
The aim of this study was to investigate the effects of Pelvic Floor Muscle Training (PFMT) in addition to high-intensity laser therapy (HILT) on pelvic floor dysfunction, sexual dysfunction, and quality of life in women with stress urinary incontinence. Women with SUI will be randomly assigned to PFMT (Group I), Laser + PFMT (Group II), and placebo laser (Group III). PFMT will be administered twice weekly for 10 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HFMT will be applied to six points in the perineal region (2 minutes per point). The intensity will be 6W, the energy density will be 120J/cm2, and three sessions will be administered weekly for a total of six sessions. Women included in the study will be evaluated twice, at the beginning and at the end of the treatment, with the Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Female Sexual Function Scale-(FSFI), and Global Pelvic Floor Impact Questionnaire (GPTRA).
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-03-30
1 state
NCT07489794
URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS
This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.
Gender: FEMALE
Ages: 30 Years - 50 Years
Updated: 2026-03-24
NCT07427693
Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI
This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will: 1. assess usability and participant feedback on the Oups! app, identifying improvements; 2. evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and 3. measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.
Gender: FEMALE
Ages: 55 Years - Any
Updated: 2026-02-23
1 state
NCT07134400
Prevalence and Functional Impact of Urinary Incontinence in Women With Chronic Obstructive Pulmonary Disease Undergoing Rehabilitation: a Cross-sectional Study
Chronic Obstructive Pulmonary Disease (COPD) is a pathology characterized by progressive bronchial obstruction associated with an abnormal inflammatory response, leading to chronic cough, increased bronchial secretions, and irreversible destruction of alveolar walls according to the French-Language Pulmonology Society, in 2023, over 1.3 million patients were treated for this condition in France. The World Health Organization ranks COPD as the third leading cause of mortality worldwide. Historically, COPD predominantly affected men due to higher smoking rates. However, with the rise in smoking among women, recent studies have shown that the prevalence of COPD in women increased from 28 to41 perr 10,000 between 2006 and 2015. Moreover, the clinical presentation of the disease differs between genders. For equivalent smoking exposure, women appear to be more severely affected than men, experiencing greater dyspnea and a higher risk of exacerbations, leading to more frequent hospitalizations and a generally poorer quality of life. Beyond pulmonary impairment, another clinically significant but often underestimated symptom affecting quality of life is urinary incontinence. It appears more common in individuals with COPD, particularly due to chronic cough, repeated abdominal hyperpressure, and pelvic floor muscle imbalance. A few studies have investigated the prevalence of urinary incontinence in people with COPD. One study, involving 995 individuals with COPD, suggested that 34.9% experienced urinary leakage. However, this was a subjective measure based on self-reported data via a simple questionnaire in a case-control study. Another Swedish study estimated the prevalence of urinary incontinence in individuals with COPD at 49.6% in women and 30.3% in men, indicating that women may be at higher risk of developing this symptom. Beyond these studies, the current scientific literature remains relatively limited on this topic, while the impact on patients' quality of life appears to be significant. Among the available studies, one of the most comprehensive was published in 2013 and relied solely on self-administered questionnaires distributed to a broad population (across all disease stages) outside the rehabilitation setting. This overlapping symptomatology-combining COPD and urinary incontinence-profoundly affects patients' quality of life, physically, psychologically, as well as socially. The consequences include limited activities, social withdrawal, diminished self-esteem, and persistent discomfort in daily interactions. This situation can lead to social anxiety or fear of leakage, resulting in absenteeism or abandonment of pulmonary rehabilitation sessions, thereby compromising the effectiveness of treatment. Reduced participation in physical activity perpetuates a vicious cycle: muscle deconditioning, sarcopenia, or even malnutrition, which worsens dyspnea, loss of autonomy, and increases the risks of frailty, infections, and hospitalizations. The study by M. A. Ramon et al. (2018) illustrates this "vicious cycle," where impaired respiratory and physical capacities are self-sustaining. Without specific screening or management strategies for urinary incontinence in this context, breaking this downward spiral and improving overall care trajectories becomes challenging. Raising awareness about the importance of screening for stress urinary incontinence in women with COPD-particularly during pulmonary rehabilitation sessions, where these symptoms are often overlooked due to lack of knowledge and available treatments-is crucial. Such screening would enhance our understanding of the link between chronic cough, stress urinary incontinence, and quality of life. Establishing a correlation between these factors would allow for tailored care pathways and referral of certain patients to targeted pelvic floor rehabilitation. A better understanding of this phenomenon is essential to improve functional assessment and propose adapted therapeutic approaches, which could be the subject of an interventional study in the future. This study thus represents an initial exploratory step aimed at better understanding the prevalence of urinary incontinence in women with COPD undergoing rehabilitation, as well as its impact on quality of life and cough function. It is a preliminary, observational study whose results will lay the foundation for future interventional research.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-02-02
NCT07351851
Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence
Urinary incontinence (UI), Chronic low back pain (CLBP) in women are prevalent and often coexist. Multiple conditions when coexist, it leads to reduced Quality of life in turn causing physical and mental impairment. Musculoskeletal structures and fascial restrictions is one of the attribute to the coexistence of urinary incontinence and chronic back pain in women. External myofascial mobilization (EMM) with core exercises have been proven beneficial for conditions in males that is caused by musculoskeletal and fascial structures. However there are limited research which proves the effect of EMM in conditions involving musculoskeletal and fascial structures . Therefore, the aim of the study is to find the effect of MFTs in reducing the disability in women with CLBP and UI PRIMARY OBJECTIVE To evaluate the effectiveness of PEMM treatment in reducing disability, pain and improving mental health in women with CLBP and UI Study design : Simple randomization Sampling method: Simple Random sampling Random numbers will be generated in Excel, then random numbers will be presented in a concealed envelope for the participants to choose Sample Size : 130 (Experimental 65, Control 65) Sample size was determined using expected effect size i.e., mean change in the primary outcome variable disability index reported in the recent research study . With effect size (change in the disability index score) 3.5 and standard deviation of the change in the outcome 6.45, statistical power 80% and level of significance 5%, the required sample size would be n=55 participants in each group. However, to accounts for multiple secondary outcome measures, possible dropouts and non-response it would be good to increase an additional 20% in calculated sample size i.e., a total of 130 participants (65 participants in each group) will be included in this study. The following sample size equation was used to determine adequate sample size:n = \[2 (Z?/2 + Z?)2 \* ?2\] / (m1-m2)2 Where Z? and Z? are the values standard normal variate e.g., at 5% level of significance Z?/2 = 1.96, and with 80% power the value of Z?= 0.84; ? is the polled Standard deviation and m1 and m2 are the mean outcome values s in group 1 and group 2 respectively. Blinding: Single blinding: patient will be blinded to the group allocation. The assessor is blinded to the treatment Material and tools : Theragun - Theragun Elite, 20 V, Myofascial tools - foam roll, foam ball, Questionnaires - SF 3642,43,44, Oswestry Low back pain questionnaire (ODI)45 and The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF)46 PROCEDURE In the course of the study the total number of patients referred to physiotherapy department with LBP will be interviewed to identify patients with or without UI having LBP. The data obtained from this will be recoded as prevalence in results. The documents of the patients having LBP with UI will be reviewed to check who fulfills the inclusion criteria. All who meets the inclusion criteria will be approached face to face with the aim of the study. Informed consent form will be given to patients who are volunteering to participate in the study. The data of the participants who do not wish to participate in the study will also be recorded. The participants who have consented to participate in the study will be then assessed. Since the participants has UI she will be directed to a Urologist for an assessment. After urologist assessment, patients will be randomly allocated to experimental and control groups. Random allocation will be administered by the random numbers generated and will be presented in a concealed envelope for the participants to choose. 1st week, the demographic data and Outcome measure of pain, SF36, ODI, ICIQ-UI-SF will be recorded (1st time) on the day of assessment. The outcome measures will be printed on paper and will be given to the patients to fill up with a pen, all questionnaires are self reported outcome measures. Treatment will commence a week after, where experimental group will undergo PEMM therapy with strengthening for 6 weeks duration and the control group will have conventional symptomatic pain treatment with strengthening (2nd to 7th week). Treatment will be given for 6 weeks (1 sessions in a week). The treatment day may vary any day between 4th and 7th day post one session. After 6 sessions of treatment, patient will be advised HEP (Home exercise program) to continue at home. Reassessment will be done on the 8th week where the outcome measures of pain, SF36, ODI, ICIQ-UI-SF will be recorded. Participants will be educated and advised regarding HEP. Exercises will be taught to the patient by explanation, demonstration, teach-back method, and printed sheet of exercise. Compliance to HEP will be recorded before final Outcome measure
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2026-01-20
1 state
NCT07271862
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%. Up to 20% of women require surgical intervention during their lifetime due to genital prolapse or urinary incontinence. Surgical correction of prolapse provides an immediate effect by restoring the anatomical and physiological position of the pelvic organs, while also improving women's daily quality of life. Approximately 80-90% of women report satisfaction with the outcomes of prolapse surgery. However, there is still no global consensus regarding the optimal technique for performing colposacropexy. Multiple surgical approaches are currently in use, which prevents a definitive evaluation of the best method for surgical management of this condition. The classical laparoscopic sacrocolpopexy technique, while effective, does not eliminate the risk of mesh-related complications, particularly when synthetic implants are placed along the full length of the anterior and posterior vaginal walls. Therefore, there is a strong rationale for developing a novel, simplified surgical approach for prolapse correction, derived from the original laparoscopic apical promontofixation, with simultaneous correction of cystocele and rectocele. This could potentially improve surgical outcomes for patients with pelvic organ prolapse while reducing the risk of complications associated with synthetic mesh implantation.
Gender: FEMALE
Ages: 30 Years - 80 Years
Updated: 2025-12-09
NCT07260604
HIFEM for Incontinence After Menopause High-Intensity Focused Electromagnetic (HIFEM)
It is not difficult to imagine that leaking urine affects life in many contexts. Unfortunately, it is everyday life for far too many people in our society. According to the National Board of Health and Welfare, incontinence primarily affects older people, and both women and men are vulnerable. In Sweden, just over 530,000 people over the age of 65 have problems and almost 80 percent of all people in special housing have such urine leakage that they need to use incontinence aids. First-line treatment for women with incontinence is local estrogen and pelvic floor training. Surgery may also be considered if this treatment does not provide sufficient effect. A new type of treatment for stress, urge and mixed incontinence is now on the market, High-Intensity Focused Electromagnetic (HIFEM®) treatment. This involves electromagnetic stimulation that causes contractions in the pelvic floor muscles. The treatment is not painful or invasive and the patient sits clothed in the treatment chair. In Sweden, HIFEM® is mainly available outside of traditional healthcare and is very expensive. It is also often given by unauthorized actors. We are now planning a study whose purpose is to evaluate the effect of HIFEM® on women over 65 years of age with stress incontinence. A group of 100 women will be randomized to: 1. Standard treatment, i.e. physiotherapy-led pelvic floor training 2. As above with the addition of 10 treatments of 30 minutes with HIFEM®. The evaluation will be carried out regarding leakage, need for incontinence aids and pelvic floor strength immediately and six months after the intervention. The women will also rate their incontinence symptoms, physical activity level, physical function and quality of life. A group will also be interviewed about their experiences of living with incontinence and the treatment. Before the study start, a case study will be performed in which 10 women will be included. They will receive 10 treatments and measure, with the same outcomes, the effects. Alternative treatment methods are important to meet the care needs we have today but also in the future. If treatment with HIFEM® can be effective for women over 65, it could, in addition to reducing incontinence problems and the consequences of these problems, also lead to reduced costs for society regarding care and incontinence products, as well as reduced environmental impact.
Gender: FEMALE
Ages: 65 Years - 85 Years
Updated: 2025-12-03
NCT07183800
Trampoline-Induced Changes in Pelvic Structure and Continence
The goal of this clinical trial is to evaluate whether a short bout of high-intensity trampoline jumping induces urinary leakage or measurable changes in pelvic floor morphology in active females aged 18-40 who do not report symptoms of urinary incontinence. The main questions it aims to answer are: Hypothesis 1: Does a single 10-minute trampoline protocol result in acute changes in pelvic floor structure, including bladder neck position, levator plate length, and/or posterior urethrovesical angle (PUVA)? Hypothesis 2: Do participants report any urinary leakage during the jumping protocol, despite being asymptomatic at baseline? Hypothesis 3: Do pelvic morphology changes recover within 30 minutes post-jumping, or do alterations persist? Researchers will perform within-subject comparisons at multiple time points (pre-jump, immediately post-jump, and 30 minutes post-jump) using transperineal ultrasound imaging to assess structural changes. Participants will: * Attend one laboratory visit * Complete baseline pelvic health questionnaires (ICIQ-UI Short Form and PFD Sentinel). * Undergo 2D transperineal ultrasound imaging in the standing position at rest, immediately post-jumping, and 30 minutes post-jumping. * Perform a 10-minute high-intensity jumping protocol on a mini-trampoline, while heart rate and perceived exertion are monitored. * Verbally report any urine leakage during jumping using standardized descriptors.
Gender: FEMALE
Ages: 18 Years - 40 Years
Updated: 2025-10-03
1 state
NCT07124390
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Brief Summary The goal of this clinical trial is to learn whether electroacupuncture (EA) is as effective and acceptable as percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder (OAB) in adult women. The main questions it aims to answer are: Does electroacupuncture reduce OAB symptoms to a similar extent as PTNS? Is electroacupuncture an acceptable and accessible treatment option for women with OAB? Researchers will compare EA and PTNS with a third group receiving sham acupuncture to see whether EA offers similar or better symptom relief and is more acceptable to participants. Participants will: Be randomly assigned to one of three groups: EA, PTNS, or sham acupuncture Receive one treatment session per week for 12 weeks Complete symptom diaries, quality-of-life questionnaires, and feedback on treatment acceptability Attend follow-up assessments after treatment ends The study will take place at Chelsea and Westminster NHS Foundation Trust, with support from the hospital's Physiotherapy and Urology departments. It is funded by the Chelsea and Westminster Hospital Joint Research Committee (JRC) and Supported by Imperial Collage London.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2025-08-15
1 state
NCT07045415
The Effect of Pelvic Floor Muscle Exercises After Radical Prostatectomy
Cancer, a major public health problem worldwide, was one of the leading causes of mortality in 2020, accounting for approximately 10 million deaths. With 1.41 million new cases reported in the same year, prostate cancer is the fourth most common cancer type globally (Ferlay et al., 2021). Prostate cancer is not only one of the most common types of cancer in men, but it also ranks second among cancer-related deaths in men worldwide (Rahnama'i et al., 2021). Radical prostatectomy (RP) is a treatment method that involves the surgical removal of the prostate gland and surrounding tissues, to stop the progression of the disease and improve the patient's quality of life (Göktas et al., 2015; Litwin and Tan, 2017). Following radical prostatectomy, a curative treatment method commonly used to prevent metastasis, mortality rates remain low; however, the procedure carries a relatively high risk of morbidity (Akarken et al., 2020; Evren and Taşcı, 2021). The most common complication encountered by patients after RP is urinary incontinence (Choiniere et al., 2022; Rahnama'i et al., 2021). UI arises due to factors such as damage to the internal sphincter, external rhabdosphincter, and supportive structures of the urethra during surgery, as well as the involvement of the neurovascular bundle and the development of postoperative fibrosis (Castellan et al., 2023). Urinary incontinence (UI) developing after radical prostatectomy significantly reduces patients' quality of life and negatively affects their social adaptation. Therefore, understanding the factors influencing the development of UI after radical prostatectomy is of great importance in determining appropriate treatment approaches and optimizing management (Bernardes et al., 2019; Storås et al., 2020). In the literature, the incidence rates of incontinence after radical prostatectomy range from 0.8% to 87%, and these differences are attributed to various factors such as surgical technique, patient characteristics, and evaluation methods (Boorjian et al., 2012; Hodges et al., 2019; Grise et al., 2017; Pastero et al., 2017). In the majority of patients, moderate to severe urinary incontinence is observed in the first few weeks after surgery. In some patients, this condition may persist for months or even years. Urinary incontinence can lead to various psychosocial effects such as shame, loss of self-esteem, impaired mental well-being, anxiety, relationship and sexual dysfunction, and social isolation (Kadono et al., 2016; Zachovajeviene et al., 2017). This condition has a significant impact on patients' physical, social, and emotional well-being, as well as their daily activities, and can contribute to social isolation by causing feelings of embarrassment (Castellan et al., 2023; Ouanes et al., 2022). Nurses play an important role in the management of urinary incontinence that develops after RP. Nurses can educate patients about urinary incontinence, teach conservative treatment methods such as pelvic floor muscle exercises (PFME), and provide psychological support to make the process more manageable (Milios et al., 2019; Tosunöz et al., 2018; Wang et al., 2018). PBME is an effective method that stands out in the rehabilitation of incontinence after RP, and it is one of the most common practices aimed at increasing the strength of the pelvic floor muscles to eliminate sphincter weakness (Castellan et al., 2023; Chitre and Kulkarni, 2023; Pratiwi et al., 2020). Studies on the effectiveness of PTKE indicate that these exercises can improve patients' urinary control (Azal et al., 2022). Nurses play a significant role in promoting pelvic floor muscle health by providing information and implementing educational programs and practices to ensure that these exercises are taught and performed correctly (Jalalinia et al., 2020; Storås et al., 2020). This study aims to evaluate the effects of preoperative and postoperative nursing interventions on urinary incontinence management and quality of life in patients who have undergone RP. In this context, the effects of nursing interventions (education, pelvic floor muscle exercises, bladder training, etc.) on urinary incontinence severity, quality of life, and patient satisfaction will be examined comparatively. The study aims to identify the most effective nursing interventions in the management of urinary incontinence after RP and to integrate these interventions into clinical practice.
Gender: MALE
Ages: 40 Years - 90 Years
Updated: 2025-07-01
NCT06957795
Preoperative Pelvic Floor Muscle Training in Female Urinary Incontinence
Pelvic floor muscles (PFM) play a crucial role in supporting pelvic organs and maintaining continence. Weakness in these muscles can lead to dysfunctions such as pelvic organ prolapse, urinary incontinence (UI), and sexual or anorectal disorders. UI, defined as the involuntary loss of urine, is common globally and classified as stress, urge, or mixed incontinence. Stress urinary incontinence (SUI) - the most prevalent type among women - occurs during activities that increase intra-abdominal pressure. Risk factors include female sex, aging, obesity, smoking, chronic constipation, previous gynecological surgeries, and childbirth. Treatment options for SUI include conservative and surgical methods. Pelvic floor training (PFT), first described by Arnold Kegel in 1948, is a conservative approach that strengthens PFM and alleviates symptoms. Although surgery is often used for SUI, with over 200 procedures described, this study aims to evaluate the preoperative effectiveness of intensive PFT in women with SUI. It will assess changes in muscle function and symptoms before surgery, guiding pelvic rehabilitation strategies to potentially reduce surgical burden and improve outcomes.
Gender: FEMALE
Ages: 18 Years - 65 Years
Updated: 2025-05-08
NCT06951022
The Effect of Sujok Therapy on Urinary Incontinence and Quality of Life in Postmenopausal Women
This study aims to investigate the effect of Su Jok therapy, a complementary medicine practice, on urinary incontinence and quality of life among postmenopausal women. A total of 120 participants will be included in the study, with 60 in the intervention group and 60 in the control group. Participants in the intervention group will receive Su Jok seed therapy applied to the hand reflex points corresponding to the bladder. The therapy will be administered by the researcher and then taught to the participants, who will continue the application for 15 days. Assessments will be conducted at baseline, day 15, and day 30 using validated questionnaires.
Gender: FEMALE
Ages: Any - 65 Years
Updated: 2025-04-30
1 state
NCT06933407
Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women
Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations. This prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs): * internal urethral orifice (IUO) level * midurethra (MU) level * external urethral orifice (EUO) level The adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region. Descriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups. It is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls. Pathophysiological focus: The study will explore key mechanisms underlying SUI, including: * Weakened bladder neck support * Impaired urethral stabilization due to increased tissue elasticity and collagen degradation * While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods. Standardization and Protocol The study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include: * Minimal probe compression during introital ultrasound to avoid artifacts * Bladder emptying prior to examination to eliminate confounding effects * Carefully standardized ROI placement across all patients * Controlled image acquisition conditions to reduce variability Future Directions * Future research based on this study will aim to: * Optimize SE protocols and refine ROI placement strategies * Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women * Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics * Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI
Gender: FEMALE
Ages: 18 Years - 99 Years
Updated: 2025-04-18
NCT06866834
Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urinary Incontinence
Urinary incontinence (UI), a common issue, is the involuntary leakage of urine that negatively affects individuals socially, physically, and psychologically, leading to a decreased quality of life. Nocturia, which is often seen alongside UI, has similar adverse effects. Nocturia refers to the number of urinations during the main sleep period, and it should be accompanied by the intention to fall back asleep after waking up. Nocturia can arise from factors such as sleep disorders and circadian rhythm disturbances. The circadian rhythm regulates the body's biological functions, and this rhythm varies from person to person, creating chronotypes. There is a strong relationship between sleep and nocturia because nocturia leads to deep sleep loss, an increased risk of metabolic diseases, decreased sleep quality and sleep efficiency, and an increase in the number of awakenings after sleep onset. It is necessary to distinguish whether nocturia, which has a comprehensive impact, affects pelvic floor symptoms, chronotype, sleep quality, fatigue, sleepiness, and quality of life in women with UI. Therefore, the aim of this study is to examine the effect of nocturia on pelvic floor symptoms, chronotype, sleepiness, sleep quality, fatigue, and quality of life in women with UI.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2025-03-10
1 state