An observational study in Interstitial Cystitis and Chronic Prostatitis, sponsored by University of Pennsylvania. Completed at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by University of Pennsylvania · Observational
Among 139 studies in Cystitis, Interstitial with a site in United States — 17 open to participants now, 21 under way, 1 of them phase 3. Cystitis, Interstitial · United States.
Among the 139 studies in Cystitis, Interstitial with a site in United States, this one is the 8th largest by planned enrollment of the 37 observational ones that give a count, is one of 10 that started in 2015, is one of 38 observational ones, and was the 77th registered.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
Browse Cystitis, Interstitial studies →17 of the 139 studies in Cystitis, Interstitial with a site in United States are open now. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Ages 18–80
University Hospitals Cleveland Medical Center · Sites in United States
Ages 18–89
Vaneltix Pharma, Inc. · Sites in United States
Ages 18+
Walter Reed National Military Medical Center · Sites in United States
Ages 18–99 · Women only · Healthy volunteers
David Sheyn · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Cystitis, Interstitial studies recruiting now, 15 (60%) set no upper age limit and 5 (20%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
139 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 35 · Phase 3 10 · Phase 4 13
First in 1995; this study’s year is marked. 10 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 640 is above the median of 100 across 63 observational studies indexed under Cystitis, Interstitial.
Median enrollment 46 across the 101 interventional studies, 160 across the 37 observational. Of the 105 that completed or were terminated, 46 (44%) have results posted.
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36 of 139 have an industry lead sponsor. The 10 most frequent:
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 234 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 110 (70%) have results posted.
University of Pennsylvania has 7 studies filed under Cystitis, Interstitial — fewer than ten, so there is no comparison to draw.
8 of the studies in Cystitis, Interstitial with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06096597Phase 3David SheynAmniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome | 2027-05-01 |
| NCT06204874Walter Reed National Military Medical CenterNew Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome | 2026-12 |
| NCT05149573Wake Forest University Health SciencesInvestigation of PEMF Therapy for Female Patients With IC/BPS | 2027-01 |
| NCT04734106Wake Forest University Health SciencesSafety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis | 2027-04 |
| NCT06299683Vanderbilt University Medical CenterPain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment | 2027-04-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 139 studies in Cystitis, Interstitial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
To better understand the etiology and treated natural history of UCPPS, and to identify clinical factors and research measurements to define clinically relevant sub-groups of these patients for future clinical trials, and to inform symptom management, the NIDDK established the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network in 20089 (http://www.mappnetwork.org/). The primary clinical research effort carried out by this network in Phase I was a prospective cohort study, the Trans-MAPP Epidemiology/Phenotyping (EP) Study.10 From 12/14/2009 through 12/14/2012 1,039 men and women were enrolled, including persons with UCPPS (n=424); persons with other co-morbid illnesses, including fibromyalgia, irritable bowel syndrome, and chronic fatigue syndrome (n=200 for all conditions); and healthy controls (n=415). Study participants were extensively characterized (i.e., phenotyped) at baseline, and UCPPS participants were followed for 12 months. During follow-up, using a web-based symptom data capture system, a small battery of self-report questionnaires were repeated on a bi-weekly schedule for 48 weeks. In addition, neuroimaging was performed in a subset of participants (n=279) at baseline, and biological samples were collected on all participants at baseline and follow-up for studies to identify plasma and urine biomarkers and potential infectious agents. This study was complemented by a number of Discovery Site-Specific clinical research studies (i.e., studies generally conducted at a single site) and investigations of animal models developed by multiple sites to mimic symptoms of human UCPPS.
Initial analyses of these data have identified a number of provocative findings. There are strong indications those certain subgroups of participants (albeit with small sample sizes) with urinary and non-urinary symptoms tend to improve over time; whereas other subgroups tend to worsen over time. These patterns of improving or worsening are differentially expressed according to sex, subtype of bladder pain syndrome (BPS), and pain location (localized to the pelvic region vs pain reported in the pelvic region and beyond).
The second phase of the MAPP Network is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS). This follow-up study will have pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
This proposed MAPP Phase II SPS also presents the opportunity to apply many of the most promising research methods in the pain field (e.g. functional, chemical and structural neuroimaging, quantitative sensory testing) during the course of the study (at baseline and then longitudinally) to better characterize men and women with UCPPS. Most of these measures were only collected at a single point in time in the Trans-MAPP Epidemiology/Phenotyping Study of Phase I, and within a sample of UCPPS patients not enriched with predefined subgroups. Further phenotyping in the second phase study will allow us to better determine which of these measures, or any other measures identified during Phase I (e.g., urinary or serum biomarkers), might identify individuals most likely to have spontaneous improvement of their symptoms, versus transition to a more "peripheral" (pelvic pain only) or "centralized" form (pelvic pain and beyond) of urinary and non-urinary pain.
Eligible participants will be asked to participate in the study for up to 36 months. During which they will be asked to complete a series of in-clinic study visits that will at various time points a neuroimaging scan and quantitative sensory tests, online internet-based questionnaires in clinic and off site/at home (assessing symptoms, health care utilization, flare status, and quality of life), a physical exam, a pelvic exam, and prostate massage (optional for males only).
The Trans-MAPP SPS study will include adults 18 years and older with urological pelvic pain syndromes. Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of Pelvis pain only.
Inclusion Criteria:
Patients are eligible for the SPS if they meet the following criteria:
Participant has signed and dated the appropriate document.
Exclusion Criteria:
Any patient meeting any one of the following criteria will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the exclusion criteria.
Exclusion Criteria for Males Only
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants in this study are men or women who have been diagnosed with Urologic Chronic Pelvic Pain Syndrome (UCPPS). Approximately one-half of the participants will be male, and one-half will be enriched to meet the body map pain location criteria of pelvic pain (PP) only. In addition, enrichment recruitment of 240 UCPPS patients (120 males; 120 females) will also be targeted for those who answer "no" to questionaire question about specific Bladder pain symptoms.
Pain Severity Score
The Pain severity Score is constructed from the GUPI pain subscale score (0-23) and ICSI Q4: Bladder pain score (0-5), summed to create a primary outcome for UCPPS pain, ranging from 0 to 28.
Time frame: 48 weeks
Urinary Severity Score
The Urinary Severity Score is constructed from the GUPI urinary subscale score (0-10) and sum of ICSI Q1: Strong need to urinate (0-5), ICSI Q2: Frequency (0-5), and ICSI Q3: Frequency at night (0-5), summed to create a primary outcome for urinary symptoms, ranging from 0 to 25.
Time frame: 48 weeks
Ran from Jul 2015 to primary completion in Mar 2019, 44 months.
Of 21 observational studies under Cystitis, Interstitial, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 69. This study's 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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