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Cystitis clinical trials

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NCT ID: NCT05485207 Active, not recruiting - Clinical trials for Interstitial Cystitis

Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

T3STOPBPS
Start date: April 4, 2022
Phase: Early Phase 1
Study type: Interventional

Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.

NCT ID: NCT05456308 Enrolling by invitation - Clinical trials for Interstitial Cystitis

What is the Optimal Technique for Hydrodistention?

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This research study is being done to learn what is the best way to perform hydrodistention. Eligible participants will be enrolled and have follow-up for three months after surgery. The study team hypothesizes that changes in hydrodistention technique, including pressure, number of distention, and duration of distention, leads to no or minimal changes in symptom improvement for patients with Interstitial cystitis/bladder pain syndrome (IC/BPS).

NCT ID: NCT05414305 Active, not recruiting - Clinical trials for Microbial Colonization

The Female Microbiome in Patients Undergoing Bladder Instillation Therapy

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

The underlying pathophysiology for BPS/IC is currently an active area of research. There is speculation that there may be alteration in the bladder and vaginal microbiome that contributes to the symptomatology of BPS/IC, however existing literature is limited and contradictory. Nickel et al (2015) studied the bladder microbiota in women with IC/BPS during a flare versus nonflare. The study collected initial stream and midstream urine specimens and detected overall, there was no significant differences in the species composition. However, a greater prevalence of fungi (Candida and Saccharomyces) was seen in the flare group (15.7%) versus the non-flare group (3.9%) midstream urine specimens. Pearce et al (2015) sought to characterize the urinary microbiome via catheterized specimens from women with urgency urinary incontinence, a condition that can present similarly as IC/BPS. The study found that more than half of the patients were sequence positive, most commonly for Lactobacillus (45%) or Gardnerella (17%), with 25% made up of various other bacteria. In contrast, Abernethy et al (2017) showed via catheterized urine specimens from patients with IC/BPS that the urinary microbiome is less diverse and less likely to contain Lactobacillus species. There have been two recent studies investigating the female urinary microbiome in patients with IC/BPS. Nickel et al (2019) found no differences in species composition between urine from patients with IC/BPS versus controls. Meriwether et al (2019) reported similar findings, and additionally found no differences when comparing the vaginal bacterial microbiome in patients with IC/BPS versus controls. However, in evaluating the bladder microbiome, both studies utilized uncatheterized urine specimens. Wolfe et al (2012) showed microbiome differences between clean-catch and catheterized urine specimens, therefore vaginal contamination in both studies cannot be ruled out.

NCT ID: NCT05360914 Recruiting - Pneumonia Clinical Trials

Hospital at Home for Elderly Acute Ill Patients

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Many elderly patients with uncomplicated treatment courses are admitted unnecessarily, which is a burden for the patient and society. Studies show that Hospital at Home (HaH) treatment is an alternative to hospitalization. The patient's risk of delirium, infection and loss of function is reduced when the patient avoids the hospital stay. HaH treatment is expected to be more cost-effective, improve patients' functional abilities and patients' satisfaction. Three municipalities, general practitioners, pre-hospital service and an emergency department (ED) in Central Denmark Region have organized the first HaH treatment model across disciplines and sectors. Specialists in the ED and the municipal acute teams provide HaH treatment for elderly acute ill patients. However, the model has not yet been evaluated. The aim of this study is to optimize the HaH treatment model for elderly acute ill patients. The objective is to increase patient satisfaction and optimize the use of resources in healthcare by avoiding unnecessary hospitalizations that impair and prolong treatment. This study is an open label randomized controlled trial (RCT) with a 1:2 allocation ratio of acute hospital admission versus HaH. During a pilot period, we tested and adapted the patient pathway of HaH to the practical reality, before we start the randomization for the RCT study. We will investigate the clinical effects and health economic consequences of HaH treatment compared with standard hospital treatment.

NCT ID: NCT05348239 Recruiting - Clinical trials for Hemorrhagic Cystitis

Chlorophyllin Tablets for Urinary Bleeding Following Radiation Therapy for Cancers of Pelvic Organs

CLARITY
Start date: March 26, 2022
Phase: Phase 2
Study type: Interventional

To assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

NCT ID: NCT05337813 Recruiting - Overactive Bladder Clinical Trials

Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction

Start date: April 10, 2020
Phase: N/A
Study type: Interventional

1. This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence. 2. LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

NCT ID: NCT05276466 Recruiting - Clinical trials for Interstitial Cystitis

Assessment of Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or cystitis-like symptoms.

NCT ID: NCT05275647 Recruiting - Clinical trials for Interstitial Cystitis

Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial Cystitis

Start date: May 18, 2021
Phase: Phase 2
Study type: Interventional

Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of nonbacterial prostatitis and chronic pelvic pain syndrome. LESW reduced pain behavior and down-regulated the NGF expression, suppressed bladder overactivity by decreasing inflammation, IL-6 and COX2 expression and NGF expression. Previous rat interstitial cystitis (IC) models have shown LESW could increase urothelial permeability, facilitate intravesical botulinum toxin A (BoNT-A) delivery and block acetic acid induced hyperactive bladder, suggesting LESW might be a potential therapeutic candidate for relieving bladder inflammatory conditions and overactivity. A double-blind, randomized, placebo-controlled physician-initiated study revealed LESW treatment was associated with a statistically significant decrease in O'Leary-Saint Symptom Score and visual analog scale of pain in patients with interstitial cystitis/bladder pain syndrome (IC/BPS), but the improvement was not superior to the sham LESW treatment. Previous studies found the urothelial dysfunction and deficits of cell differentiation are fundamental pathophysiology of IC/BPS. Through intravesical platelet-rich plasma injections, the chronic inflammation in IC/BPS bladders could be reduced and improved cell differentiation of urothelium. Botox injection or liposome encapsulated Botox could also inhibit inflammation and improve IC/BPS symptoms. However, the Botox injection needs anesthesia and certain complications might occur. There is no study to test if LESW plus Botox intravesical instillation could improve bladder inflammation and relieve IC/BPS symptoms. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS refractory to conventional treatments.

NCT ID: NCT05260554 Completed - Cystitis Clinical Trials

Effect of Cranberry Extract on the Urinary System

Start date: January 26, 2022
Phase:
Study type: Observational

In this study, we will try to emphasize the effects of using cranberry tablets, which is an alternative to antibiotic therapy, during uncomplicated urinary tract infections (only urinary tract, bladder and kidney infections did not).

NCT ID: NCT05260112 Completed - Clinical trials for Cystitis, Interstitial

Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide

ERICA
Start date: November 5, 2021
Phase: N/A
Study type: Interventional

To implement and assess clinical efficacy of a text message and multimedia-based program that (i) remotely delivers first- and second-line American Urological Association (AUA) treatments of IC/BPS; (ii) integrates treatment of biological (neuropathic pain, pelvic floor dysfunction), psychological (symptom-related fear and anxiety) and social (barriers in access to care, limited patient-provider communication) domains of IC/BPS; (iii) uses clinically validated messages to provide guidance and support.