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NCT ID: NCT06469320 Not yet recruiting - Clinical trials for Urinary Stress Incontinence

Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners

IU-TRAIL
Start date: July 2024
Phase:
Study type: Observational

The pelvic floor is a crucial complex for many bodily functions, supporting the pelvic organs and contributing to urinary and anal continence, as well as sexual function. Dysfunction of this structure can lead to a variety of disorders, including urinary incontinence (UI), a common problem in women. Although the prevalence of UI in middle-aged women has been documented at between 20% and 30%, high-impact physical activities, such as certain sports and running, increase the risk of UI. According to the most recently published meta-analysis, the prevalence is 44% [95%CI 30.2-57.8]. Although this subject is often taboo, it can have psychosocial consequences and affect sporting activities. Only 31.7% of female runners talk to a health professional about it. Trail running, a fast-growing discipline, differs from road running in its particular physical demands, which could influence the occurrence of pelvic floor disorders (PFD) and exercise-induced UTIs. The unique characteristics of trail running, such as the technical nature of the terrain, the steep gradients and the variety of distances, place intense demands on the female pelvi-perineal system. Nevertheless, despite the growing popularity of this sport, little epidemiological data exists on the prevalence of stress UTI and pelvic floor disorders among female trail runners.

NCT ID: NCT06450795 Not yet recruiting - Clinical trials for Urinary Incontinence

Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence

Start date: June 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. The individuals to be included in the study will be selected from women with stress urinary incontinence who receive follow-up from Medipol Acıbadem Hospital. Women who meet the inclusion criteria will be explained the details of the study by the responsible researcher and an informed consent form will be presented. The study is planned as two groups: Group 1: Pelvic floor muscle training (PBST) group. Group 2: Pelvic floor muscle training and high intensity functional electromagnetic stimulation (HIFEM) treatment group. Envelope opening method will be used for randomisation of the participants into two groups. They will be included in the first or second group according to the number in the envelope they choose. Each participant will be given a baseline assessment. Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Participants in 2 groups will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment. Research Outcome Measures: Demographic and Clinical Characteristics International Incontinence Consultation Questionnaire-Short Form Urogenital Distress Inventory (UDI-6) Quality of Life King Health Survey Muscle function Emg-Biofeedback

NCT ID: NCT06421428 Not yet recruiting - Clinical trials for Urinary Incontinence

Lived Experienced Incontinence Lived Experienced Incontinence - LEI

LEI
Start date: September 1, 2024
Phase:
Study type: Observational

Study Description: Scientific literature demonstrated the negative influence of Urinary Incontinence (UI) on the quality of life connected to the physical, psychological, and social health of women. However, a limited number of studies investigated in depth the emotional experience of women affected by this disorder, their behaviors, and their experiences in managing the problem. Health professionals need to understand these aspects to offer the best care, also taking into account women's cultural and territorial differences. Research conducted on the topic in the Italian context is lacking, therefore the present study aims to explore, in a Northern Italian context, the experience of adult women affected by UI. Study Design: Qualitative phenomenological study (observational, cross-sectional, monocenter) Objective: To explore, in a Northern Italian context, the experience of women aged ≥ 18 years affected by Urinary Incontinence (UI) Study Population: Women ≥ 18 years old, not pregnant nor having given birth for less than 40 days, suffering from urinary incontinence who access the Pelvic Floor Rehabilitation Outpatient Clinic of the San Raffaele Hospital in Milan. Sample Size: Women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study. These subjects represent a precious resource and are considered "more informative for the researcher" as they testify to the emotions and daily life that influence the symptoms of urinary incontinence, but they are also able to narrate their experience of re-education of the pelvic floor. It is assumed that approximately 20 women will be involved to reach data saturation. Statistical Design: The interviews will be analyzed with the hermeneutic-phenomenological IPA (Interpretative phenomenological analysis) method, which involves the identification of units of meaning, categories and themes in accordance with the language of the speakers. The analysis of qualitative data will be made possible thanks to the use of data management software (NViVO). The socio-demographic data collected will be presented with absolute and relative frequencies

NCT ID: NCT06416982 Not yet recruiting - Pain Clinical Trials

Perineal Massage for Pessary Examinations

Start date: June 2024
Phase: N/A
Study type: Interventional

Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.

NCT ID: NCT06411158 Not yet recruiting - Clinical trials for Urinary Incontinence

Training for Urinary Leakage Improvement After Pregnancy

TULIP
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.

NCT ID: NCT06376903 Not yet recruiting - Clinical trials for Urinary Stress Incontinence

Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

• This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women

NCT ID: NCT06372340 Not yet recruiting - Clinical trials for Urinary Incontinence

Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2)How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive.

NCT ID: NCT06369922 Not yet recruiting - Pain Clinical Trials

TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

TENSUB
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.

NCT ID: NCT06334848 Not yet recruiting - Clinical trials for Stress Urinary Incontinence

Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Start date: April 2024
Phase: N/A
Study type: Interventional

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

NCT ID: NCT06291441 Not yet recruiting - Clinical trials for Female Urinary Incontinence

Women Urinary Incontinence Prevalence Study (WUIPS)

Start date: June 28, 2024
Phase:
Study type: Observational

The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).