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Cystitis, Interstitial clinical trials

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NCT ID: NCT04313972 Completed - Clinical trials for Interstitial Cystitis

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone

Start date: September 7, 2021
Phase: Phase 4
Study type: Interventional

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia. Several treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia. The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes. This will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary. Participants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study participants will also receive first-line behavioral therapy for IC/PBS of a bladder diet and bladder drills. After six weeks, participants will complete a second bladder diary. They will then complete the exit study questionnaires, have a second liver function test, return any unused medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.

NCT ID: NCT04275297 Completed - Clinical trials for Interstitial Cystitis

Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body's pain processing influences outcomes.

NCT ID: NCT04268810 Terminated - Clinical trials for Interstitial Cystitis

Prospective Trial Comparing Intravesical Chondroitin Sulphate 2% and DMSO in the Treatment of PBS/Interstitial Cystitis

Start date: March 2010
Phase: Phase 4
Study type: Interventional

Painful bladder syndrome/interstitial cystitis (PBS/IC)is a disease of unknown origin with a significant impact on the quality of life. Next to oral treatment with tricyclic antidepressants or pentosan polysulphate, intravesical treatment can be used as well. The purpose of this treatment is to restore the protective lining of the bladder that consists of glycan structures (GAG). Currently only dimethylsulfoxide (DMSO) is FDA approved for this. Several other compounds have been introduced. We want to compare a solution of chondroitin sulphate 2% with the standard DMSO solution. We will compare the patient perception of benefit,but also pain scores, quality of life and micturition diaries.

NCT ID: NCT04208087 Completed - Clinical trials for Interstitial Cystitis

PK and Safety of SI-722 in IC/BPS

Start date: March 30, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

NCT ID: NCT04118946 Recruiting - Clinical trials for Interstitial Cystitis

Platelet Enriched Plasma for Treatment of Interstitial Cystitis

Start date: March 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .

NCT ID: NCT04010513 Completed - Clinical trials for Interstitial Cystitis

Hypnosis for Bladder Pain Syndrome

Start date: October 3, 2019
Phase: N/A
Study type: Interventional

This is a pilot randomized control trial of 30 women with interstitial cystitis/bladder pain syndrome to determine the feasibility of delivering a hypnosis intervention or usual care on bladder pain (primary outcome) and cerebral blood flow (secondary outcome). Women in the hypnosis group will undergo treatment with three hypnotherapy sessions in addition to a mobile web-based hypnosis application. Neuroimagning (fMRI) will occur after the first follow up visit.

NCT ID: NCT04001244 Completed - Chronic Pain Clinical Trials

Translational Research in Pelvic Pain

TRiPP
Start date: September 1, 2019
Phase:
Study type: Observational

This study aims to better understand the pathways leading to pain in women with two types of pelvic pain condition (endometriosis-associated pain and bladder pain syndrome) and determine whether these pathways can be used to subgroup patients.

NCT ID: NCT03987594 Completed - Clinical trials for Interstitial Cystitis

Comparing the Effect of Fulguration Versus Fulguration and Hydrodistension in Interstitial Cystitis/Bladder Pain Syndrome

Start date: August 1, 2015
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial. Subject population is adult patients with Hunner-type interstitial cystitis. The objective of this study is to compare the therapeutic effect between the two surgical modality; TUF (transurethral fulguration of the Hunner lesion) versus TUF+HD(addition of bladder hydrodistension prior to transurethral fulguration of the Hunner lesion).

NCT ID: NCT03931538 Completed - Clinical trials for Urinary Tract Infections

Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study

RapIDMixAR
Start date: July 17, 2018
Phase: N/A
Study type: Interventional

In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.

NCT ID: NCT03844581 Completed - Clinical trials for Interstitial Cystitis

Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis

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

A total of 40 volunteers women with a diagnosis of interstitial cystitis. Their ages ranged from 25 to 40 years old; their body mass index was > 30 kg/m2 and were randomly assigned to a group (A) received interferential current at the lower abdomen, and also received traditional medicine or group (B) received traditional medicine for 8 successive weeks. Both of the groups received the treatment program for 8 successive weeks. Assessment of pain perception and disability level for all patients in both groups (A&B) were done through Visual analogue scale, O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI) and blood cortisol concentration were done before and after the treatment program.