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Overactive Bladder clinical trials

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NCT ID: NCT04031014 Recruiting - Overactive Bladder Clinical Trials

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will have looking at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.

NCT ID: NCT04020510 Recruiting - Overactive Bladder Clinical Trials

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.

NCT ID: NCT03888001 Recruiting - Overactive Bladder Clinical Trials

The Efficacy of Botulinum Toxin in OVERACTIVE Bladder

Start date: January 1, 2018
Phase:
Study type: Observational

To assess the efficacy of botulinum toxin injection in overactive bladder.

NCT ID: NCT03829137 Recruiting - Overactive Bladder Clinical Trials

The Clinical Effects of Laser Acupuncture Therapy for OAB Women.

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence, daytime frequency and nocturia. Urgency incontinence is more common in older women and may be associated with comorbid conditions that occur with age. The standard OAB medical treatments may induced several intolerable side effects including dry mouth, constipation, and so on, therefore alternative therapies are often considered. Acupuncture had been proved effective to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser acupuncture has minimal side effects comparing to conventional acupuncture, but its effects against OAB had never been examined. Experiments with laser acupuncture are expected to be another way to relieve OAB symptoms.

NCT ID: NCT03742206 Recruiting - Overactive Bladder Clinical Trials

Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

Start date: January 25, 2018
Phase: N/A
Study type: Interventional

Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women. Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.

NCT ID: NCT03727711 Recruiting - Overactive Bladder Clinical Trials

TPTNS: Home vs Hospital Treatment for Overactive Bladder

Start date: September 3, 2018
Phase: N/A
Study type: Interventional

Comparison of home versus hospital Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS). TPTNS has been shown to be an effective treatment of overactive bladder in hospital. We aim to see if this effect is replicated at home. 80 patients will be recruited, 40 into each arm. Inclusion criteria: 1. Women aged ≥18 years 2. Clinical diagnosis of Overactive Bladder (OAB) 3. Post-void residual urine volume of < 100ml 4. Able to do questionnaires 5. Able to consent and willing to participate Exclusion Criteria 1. Cardiac pacemaker in situ 2. Leg ulcer/skin condition affecting both lower legs 3. Diagnosed peripheral vascular disease 4. Absent sensation at the electrode site 5. Current Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study 6. Pregnancy 7. Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS) course 8. Previous intravesical botox treatment 9. Unable to complete questionnaires TPTNS will be taught to the home group and delivered to the participants in the hospital group in individual appointments: 12 treatment sessions of 30 minutes duration, delivered twice weekly over a 6 week period. Two surface electrodes are applied to the right ankle. These electrodes are attached to an electrical stimulator, programmed to safely deliver electric pulses. On completion of 6 sessions, all participants will be contacted and asked to do a Patient Global Impression of Improvement Scale (PGIIS) and Patient Perception of Bladder Condition (PPBC). After 12 sessions (the final treatment session) all participants will be reviewed by the investigators in the hospital and the outcome measures repeated. Participants receiving home treatment will be posted out a 3 day bladder diary to complete. At this point the participants receiving home treatment will return the machine. All participants will complete and return a 72-hour bladder diary and validated questionnaires routinely used at the study centre to measure lower urinary tract symptoms - The International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) long form, the International Consultation of Incontinence Modular Questionnaire - Urinary Incontinence questionnaire (ICIQ-UI short-form. The Hospital Anxiety and Depression Scale (HADS) and the European Quality of Life - 5D Questionnaire (EQ-5D) will also be measured.

NCT ID: NCT03695692 Recruiting - Overactive Bladder Clinical Trials

Effects of Connective Tissue Massage in Women With Overactive Bladder

Start date: May 2, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to compare the effects of pelvic floor muscle trainig with connective tissue massage and only pelvic floor muscle training in women with overactive bladder

NCT ID: NCT03614767 Recruiting - Overactive Bladder Clinical Trials

Sacral Neuromodulation & Urodynamics

Start date: August 1, 2017
Phase:
Study type: Observational

In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR). Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy

NCT ID: NCT03516292 Recruiting - Overactive Bladder Clinical Trials

Assessment of Potential Biomarkers in Women With Symptoms of Overactive Bladder and Pelvic Organ Prolapse

Start date: January 29, 2018
Phase:
Study type: Observational

The objective of this study is to investigate the role of certain biomarkers in the initial assessment of women with overactive bladder (OAB). Nerve Growth Factor (NGF) levels, measured in urine samples, and bladder wall thickness (BWT), determined by two-dimensional transvaginal ultrasound, are two of those markers. The investigators hypothesize that the pre-operative determination of these biomarkers in women suffering from genital prolapse and overactive bladder could lead to a more accurate prognosis of the post-operative course of overactive bladder symptoms in women undergoing surgical treatment of prolapse.

NCT ID: NCT03435991 Recruiting - Overactive Bladder Clinical Trials

Experience Sampling Method in OAB Patients

Start date: August 6, 2018
Phase:
Study type: Observational

Rationale: The overactive bladder syndrome is diagnosed clinically by using the ICS criteria of ≥8 micturitions and at least 1 urgency episode per 24 hours. To determine whether patients fit the criteria, micturition diaries ('sensation-related bladder diaries') and other symptom questionnaires with considerable limitations are used. This makes it difficult to get a good impression of the fluctuation of complaints during the day / week. These limitations are overcome using the Experience Sampling Method (ESM). This is an electronic questioning method which is characterized by repeated and random, momentary assessments in the subject's current environment and state. This study follows other successful ESM studies done within the Gastroenterology and Psychiatry Department. The aim of this study is to evaluate if the ESM is more accurate in the assessment of urological complaints in OAB compared to the current assessment with the use of the sensations-related bladder diaries (SR-BDs) and retrospective questionnaires. Furthermore the aim is to assess the reliability and validity of this OAB-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and assessment of triggers for symptoms in OAB. Objective: To evaluate the accuracy of the ESM to assess urological complaints in OAB compared to SR-BDs and retrospective questionnaires. To assess content validity, reliability and the accuracy to validate the developed ePRO in OAB patients. Study design: The ESM study is a multicentre, prospective, cross-sectional study. Study population: 66 OAB patients will be recruited at the outpatient Pelvic Care Centre in Maastricht UMC+, Zuyderland Hospital and University Hospital Antwerp, 66 healthy volunteers will be recruited as well. Methods: In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period. Main study endpoints: The main study outcome comprehends the psychometric properties of the PROM for symptom assessment of OAB symptoms. Secondary outcomes are increase in ESM score for OAB symptoms and environmental and psychosocial factors (e.g. as measured by the PROM) from one time point (t-1) to the next (t).