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Urinary Incontinence, Stress clinical trials

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NCT ID: NCT06179654 Recruiting - Clinical trials for Lower Urinary Tract Symptoms

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

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to allow us to assess the effectiveness (or success) of starting pelvic floor physical therapy (i.e. exercises for your pelvic muscles) prior to HoLEP (holmium laser enucleation of the prostate) surgery for enlarged prostates in order to manage or prevent urinary incontinence (i.e. leaking) after surgery (i.e. post-operatively). Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool. Traditionally, pelvic floor physical therapy is started after surgery and continued until urinary continence (i.e. no leaking of urine) is regained. We want to assess if beginning pelvic floor physical therapy prior to surgery (and continuing afterwards) reduces the time required to regain urinary continence following HoLEP.

NCT ID: NCT06161506 Recruiting - Clinical trials for Stress Urinary Incontinence

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.

NCT ID: NCT06137326 Recruiting - Clinical trials for Stress Urinary Incontinence

PEMF vs Laser for Stress Urinary Incontinence

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

Stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. Pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. This randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (PEMF) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. The study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. We hypothesize that PEMF and laser acupuncture will both improve stress incontinence, but PEMF will be more effective based on greater pelvic floor stimulation. The study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.

NCT ID: NCT06126757 Recruiting - Clinical trials for Stress Urinary Incontinence

PelviSense, an Innovative, Non-invasive, Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women

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

Background and purpose: The research team developed the PelviSense, a non-invasive biofeedback device paired with wearable EMG sensors for use as a PFMT adjunct. The proposed study aims to (1) investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women, and (2) identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI. Methods: A two-arm, parallel-group RCT will be conducted using 132 non-pregnant women with SUI, aged 18-60 years. The study participants will be randomised into two study groups: PelviSense-assisted PFMT or unassisted PFMT. Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 1:1 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training. The primary outcome will be the severity of urine loss, as measured using the one-hour pad test. Secondary outcomes will include quality of life, SUI symptoms severity, and PFM strength, as measured using the incontinence impact questionnaire, short-form, international consultation on incontinence questionnaire, short-form, and modified Oxford scale, respectively. Mediator variables will include the following: bladder neck elevation and levator hiatus area. Outcomes and mediator variables will be assessed at baseline, 4, and 28 weeks. Statistical analysis: Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes' PROCESS macro, respectively.

NCT ID: NCT06120699 Recruiting - Clinical trials for Stress Urinary Incontinence

360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

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

This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.

NCT ID: NCT06097234 Recruiting - Clinical trials for Stress Urinary Incontinence

Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.

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

The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy. The main questions it aims to answer are: Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy? Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone? Participants will be given one of three treatments: 1. The devices under study alone 2. The device under study plus 4 weekly visits with a pelvic floor physical therapist 3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

NCT ID: NCT06043063 Recruiting - Clinical trials for Stress Urinary Incontinence

Local Anesthesia Before Bulkamid Injection

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

While recommended pre-anesthesia for polyacylamide hydrogel (PAHG, Bulkamid) injections for stress urinary incontinence and intrinsic sphincter deficiency can include intraurethral anesthetic gel with or without periurethral block, there is no existing literature to guide choice of anesthesia. This is a single-blinded randomized control trial to evaluate post-procedure pain with choice of anesthesia before PAHG injection.

NCT ID: NCT06021769 Recruiting - Clinical trials for Pelvic Organ Prolapse

Pessary Experience Study

Start date: June 12, 2023
Phase:
Study type: Observational

Pessaries 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.

NCT ID: NCT05900570 Recruiting - Clinical trials for Stress Urinary Incontinence

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.

NCT ID: NCT05860634 Recruiting - Clinical trials for Pelvic Organ Prolapse

Urinary Catheter Self-Discontinuation After Urogynecology Surgery

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

The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery. Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.