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Painful Bladder Syndrome clinical trials

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NCT ID: NCT06299683 Recruiting - Clinical trials for Interstitial Cystitis

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

Start date: May 1, 2024
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. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

NCT ID: NCT06096597 Not yet recruiting - Clinical trials for Interstitial Cystitis

Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome

Start date: July 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency. The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.

NCT ID: NCT05754190 Recruiting - Chronic Pain Clinical Trials

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA

Start date: June 20, 2023
Phase:
Study type: Observational

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

NCT ID: NCT05726786 Recruiting - Bladder Cancer Clinical Trials

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

INCyst
Start date: April 10, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN. This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.

NCT ID: NCT05223244 Completed - Clinical trials for Interstitial Cystitis

Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC

Start date: October 1, 2011
Phase: Phase 4
Study type: Interventional

A comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (IC) is lacking in the literature. Furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. Change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in IC symptoms in women with newly diagnosed IC when treated with either dimethyl sulfoxide (DMSO) or bupivacaine, triamcinolone, and heparin (BTH) instillations. The secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. Our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.

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: NCT03755375 Completed - Clinical trials for Interstitial Cystitis

Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome

Start date: February 5, 2018
Phase: N/A
Study type: Interventional

Related to urological and gynecological systems, patients with Bladdeer Pain Syndrome (BPS) often present pain, pressure and chronic discomfort in suprapubic and perineal area associated with low urinary tract symptoms. This condition can generates a negative impact in cognitive, social, behavioral and sexual quality of life. As Bladder Pain Syndrome originates from different causes and includes the genitourinary, gastrointestinal, musculoskeletal and neuropsychological systems, a multidisciplinary approach is needed with doctors,physiotherapists, psychologists and others. Physiotherapeutic interventions are recommended as a conservative treatment for patients with BPS. The physiotherapeutic interventions include the use of Biofeedback to relax the pelvic floor muscles and manual therapy (myofascial trigger points release) to decrease muscle tension. Transcutaneous electrostimulation (TENS) is used to decrease the pain and postural exercises to improve the pelvic mobility. In this study, our hypothesis was that women with BPS presented musculoskeletal dysfunction, and we tested a different physiotherapy approach that was not being used. The reason for that understanding was the presence of refractory urinary and pain symptoms notwithstanding the physiotherapy conventional treatment, such as manual therapy and biofeedback. To test our hypothesis, we decided to add either TENS or postural exercises to the conventional treatment. The objective of this study was to verify the effects of biofeedback (BF) and manual therapy (MT) associated with transcutaneous electrical nerve stimulation (TENS) or postural exercises (PE) in the treatment of bladder pain syndrome (BPS) in women regarding pain and urinary symptoms.

NCT ID: NCT03143920 Terminated - Clinical trials for Painful Bladder Syndrome

Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

HBOTCICrUTI
Start date: November 1, 2017
Phase: Early Phase 1
Study type: Interventional

Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible therapy as it has proven successful an another type of chronic inflammatory condition of the urinary bladder known as "radiation cystitis". The study will determine if patients will consider this an acceptable treatment for their conditions and that it is well tolerated.