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Interstitial Cystitis clinical trials

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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: NCT03480477 Terminated - Clinical trials for Urinary Incontinence

Adverse Childhood Experiences in Urogynecologic Patients

ACE-UP
Start date: April 9, 2018
Phase:
Study type: Observational

Adverse Childhood Experiences (ACEs) have been associated with negative health outcomes, yet scant information exists regarding the relationship between ACEs, Pelvic floor disorders, and Chronic Pelvic Pain. Pelvic floor disorders (dysfunction of pelvic floor structures) are increasingly common in women, negatively affect their quality of life, and certain of these are refractory to treatment. Despite scattered reports suggesting an association between childhood abuse and specific pelvic floor disorders, the overall association between ACEs & the spectrum of pelvic floor disorders is unknown. The investigators' previous work suggests that ACEs may be associated with urgency incontinence and work by others suggest ACEs may be associated with Interstitial Cystitis/Bladder Pain Syndrome. These reports are few in number and comprehensive evaluations of ACEs relative to pelvic floor disorders are lacking. The investigators long-term objective is to investigate the relationship between ACEs in patients in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions to the development of their symptomatology. The current Urogynecology study's Primary Aims are to--1a) Describe the overall prevalence of ACEs, frequency and type of ACEs in a population of women with pelvic floor disorders 1b) Describe differences in ACE prevalence compared to the general population. Secondary Aims are to-2a) Describe ACE types/domains of controls relative to specific pelvic floor diagnoses 2b) Describe their relationship with pelvic floor disorder symptom severity. The investigators central hypothesis is that ACEs are common in women with pelvic floor disorders, that ACE frequency varies by pelvic floor diagnoses, and that ACEs may have profound effects on adult women's quality of life and responsiveness to treatment. The Chronic Pelvic Pain aims, are to 1a) describe the prevalence of ACEs in women with chronic pelvic pain. 1b) To compare the prevalence of ACEs in chronic pain patients to controls. Secondary aims are to 2a) compare the frequency and ACE type/domain of controls relative to chronic pelvic pain patients. 2b) Describe their relationship to depression/anxiety and symptom severity.The positive outcome of this prospective, cross-sectional cohort study will be its description of ACE prevalence in women with pelvic floor disorders and Chronic Pelvic Pain.

NCT ID: NCT02591199 Terminated - Clinical trials for Interstitial Cystitis

Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received.

NCT ID: NCT02547298 Terminated - Clinical trials for Interstitial Cystitis

Interstitial Cystitis (IC)-Like Findings With Hydrodistension

Start date: June 2015
Phase:
Study type: Observational

Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy (a lighted scope is used to look inside the bladder) under anesthesia will be approached to participate in the study. Once prospective study subjects are consented, they will be requested to complete the study questionnaires. At the time of the procedure, during the cystoscopy, patients will undergo hydrodistension (stretching the bladder with fluid). Photographic images of the bladder will be collected, to be later analyzed by examiners. Patients who have positive findings for interstitial cystitis during cystoscopy with hydrodistension, will be notified of the findings after the procedure. They will be asked to fill out an additional, previously completed questionnaire at the time of a follow-up visit, during a phone interview or responding to the questionnaire via a secure web site. These patients will be treated for interstitial cystitis by their primary providers as clinically indicated.

NCT ID: NCT02517996 Terminated - Clinical trials for Interstitial Cystitis

Use of Preemptive Pudendal Nerve Block Prior to Hydrodistention for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

Start date: February 2015
Phase: N/A
Study type: Interventional

Interstitial cystitis/Painful bladder syndrome (IC/PBS) is a chronic debilitating condition that severely impacts between 2.7 and 6.5 percent of women in the United States. Despite its public health importance the pathogenesis of IC/PBS is not well understood and there is no consensus on the optimal treatment approach for this condition. Hydrodistention is the most commonly used therapy for this condition; but it is limited by severe immediate postoperative bladder pain and its short duration of action. It has been postulated that hydrodistention works by disrupting the sensory nerves within the bladder that may be contributing to bladder pain. Recent evidence has provided support for the use of preemptive pudendal nerve block as a way to blunt immediate postoperative pain. The investigators hypothesize that preemptive pudendal nerve block prior to hydrodistention will result in lower postoperative pain after hydrodistention compared to placebo. This is a prospective double- blinded randomized study and patients will be randomized to receive preemptive bilateral pudendal nerve block with either 1% lidocaine or placebo. Bladder pain will be compared at baseline, 2 hours, 2 weeks, 6 weeks and 3 months using the Visual Analog Scale, O'Leary-Sant questionnaire and the Pelvic Pain Urgency and Frequency questionnaire.

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.

NCT ID: NCT01813565 Terminated - Clinical trials for Interstitial Cystitis

The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

Start date: March 20, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.

NCT ID: NCT01678911 Terminated - Ulcerative Colitis Clinical Trials

Efficacy of Gralise® for Chronic Pelvic Pain

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

This study is done to investigate the pain relieving effects of the study drug Gralise (a novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be recruited. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions, particularly in neuropathic pain. About 36 subjects will take part in this study.

NCT ID: NCT01475253 Terminated - Clinical trials for Interstitial Cystitis

Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

NCT ID: NCT01280864 Terminated - Clinical trials for Irritable Bowel Syndrome

MAPP Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS

Start date: March 2010
Phase:
Study type: Observational

Hypotheses: 1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical evoked potentials and efferent cortically-induced (magnetic) anorectal motor evoked potentials. 2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal visceral hypersensitivity and anorectal sensory-motor dysfunction.