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Cystitis, Interstitial clinical trials

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NCT ID: NCT01990898 Completed - Clinical trials for Interstitial Cystitis

Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action

CIC
Start date: November 2013
Phase: Phase 2
Study type: Interventional

This is a study for patients that have a condition called Interstitial Cystitis, also known as Painful Bladder Syndrome. Patients would have tried at least two different therapies, unsuccessfully,(eg. medications, pelvic floor physical therapy) The purpose of this research project is to study the immunosuppressive drug Cyclosporine in patients with Interstitial Cystitis to assess how well it works, what the side effects are and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for Interstitial Cystitis. Several research studies have been published showing that Cyclosporine can improve the symptoms of Interstitial Cystitis, that it works better than a placebo ("sugar pill" or inert treatment) and that it works more effectively than Pentosan Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in these studies on Interstitial Cystitis are much lower that the doses used to prevent rejection in transplant patients. Based on these studies, the American Urological Association has recently published treatment guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure of other more conservative therapies and medications. Nevertheless, much is not known about using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the ideal dose, how best to monitor for side effects and in particular whether kidney damage can occur at the low doses used in these studies. In this study, to examine the mechanism of action, blood and urine samples will be collected before, during and after therapy to look at "biomarkers", chemical substances that can be associated with inflammation and tissue injury. We will also test effects of therapy on skin sensation and pain perception because the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct pain signals. This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis.

NCT ID: NCT01985880 Completed - Clinical trials for Interstitial Cystitis

The Efficacy of Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome

Start date: November 19, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome

NCT ID: NCT01969773 Completed - Clinical trials for Interstitial Cystitis

Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.

NCT ID: NCT01963988 Completed - Clinical trials for Bladder Pain Syndrome

Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients

Start date: June 2012
Phase: N/A
Study type: Observational

On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer. But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients. We assume TUR have a more therapeutic effect than TUC.

NCT ID: NCT01895153 Completed - Clinical trials for Bladder Pain Syndrome

Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

Start date: April 2012
Phase:
Study type: Observational

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

NCT ID: NCT01882543 Completed - Clinical trials for Interstitial Cystitis

Efficacy and Safety of AQX-1125 in IC/BPS

LEADERSHIP
Start date: June 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

NCT ID: NCT01879930 Terminated - Clinical trials for Bladder Pain Syndrome

Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective Study

Start date: November 2012
Phase: Phase 4
Study type: Interventional

Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urgency or frequency in the absence of an identifiable cause. Chronic bladder pain syndrome severely decreases an individual's quality of life and represents a significant financial burden to those affected by it. Currently, multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum of presumptive triggers, a large number of therapeutic approaches are propagated, however most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the ideal therapy remains to be elucidated. Microorganisms such as Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms may well be involved in the pathogenesis of chronic bladder pain syndrome. The investigators hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can significantly relieve symptoms in women with chronic bladder pain syndrome

NCT ID: NCT01879683 Completed - Clinical trials for Chronic Interstitial Cystitis

A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.

NCT ID: NCT01838486 Recruiting - Clinical trials for Interstitial Cystitis

Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

IC
Start date: June 2012
Phase: N/A
Study type: Interventional

Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

NCT ID: NCT01824303 Terminated - Clinical trials for Interstitial Cystitis

Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.