A Phase 4 interventional study of Metoprolol Tartrate Oral Tablet and Placebo Oral Tablet in Interstitial Cystitis/Painful Bladder Syndrome and Myofascial Pelvic Pain, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Virginia Commonwealth University · Phase 4, Interventional, and Other
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 38th largest by enrollment of the 101 interventional ones that give a count, is one of 6 that started in 2017, is one of 13 in phase 4, and was the 91st 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 to 80 Years · female · 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. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 72 is above the median of 51 across 158 interventional 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.
This tab as a report to print or save as PDF → With an account.
36 of 139 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 1 study 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 proposal aims to move the science of chronic pelvic pain (CPP) from simple associations towards an investigation of cause and effect relationships. The investigators will determine whether the striking changes in autonomic nervous system responsiveness (ANS-R) contribute meaningfully to the pathogenesis of CPP.
This multi-site trial will recruit 2 groups of female subjects ages 18-80 years, evenly distributed across decades (10 or 20 per decade as appropriate): Chronic pelvic pain (CPP) and Healthy Controls (HC). The chronic pelvic pain group will be split into 2 sub groups where some participants will receive metopropol then placebo while the other participants in this interventional group will receive placebo then metoprolol.
This proposal aims to move the science of chronic pelvic pain (CPP) from simple associations towards an investigation of cause and effect relationships. We will determine whether the striking changes in ANS-R contribute meaningfully to the pathogenesis of CPP through 3 aims:
Subjects will be pre-screened in person or on the phone. An in-person pre-screen takes place in the MCW Neurology Research Rooms at Froedtert Hospital. If the subject is able to participate, subject will sign the informed consent form before completing a baseline evaluation. The baseline evaluation occurs either following consent or at another date convenient for them. Subjects must complete all baseline activities within 2 weeks, or before their Week 4/Visit 2. The baseline evaluation is comprised of a general examination, a set of questionnaires, background history documenting date of diagnosis, medications tried, duration of each treatment and dosing, surgeries and therapeutic and exploratory procedures performed. A pelvic examination will be performed with CPP subjects patients only. Active Change in Posture (ACP) is administered to the subject. Subjects will complete the uroflow (urine) measurement and Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present.
Observational Substudy:
This substudy is identical to the above with the exception of not taking a beta-blocker or placebo and is only 12 weeks long instead of 24. This is strictly an observational study to monitor subjects who have been diagnosed with IC or MPP. If the screening information shows that the subject meets the requirements, then they will be able to start. If the screening information shows that they cannot be in the research, the research doctor will discuss other options with them and/or refer them back to their regular doctor.
If the subject is able to participate, they will complete 3 regular on-site long-visits at weeks 0, 4, and 12. The first long-visit (baseline evaluation) may occur either today following consent or at another date convenient for them. The baseline evaluation comprises a general and pelvic examination (no speculum), psychological questionnaires and a background history questionnaire.
Weekly Home Checks will occur for 24 weeks (or 12 weeks if in observational sub-study) following consent. Once each a week, subjects will complete a 24-hour heart rate (HR) recording and the ACP recording using the eMotion Faros 360° portable EKG device. A member of the research team will contact the subject each week while they complete the weekly questionnaires and ACP recording. This will ensure compliance and will give the subject the opportunity to ask any questions.The researcher will remain on the phone or via Skype to monitor the subject while the ACP recording is completed from home just prior to the subject's bedtime. The HR recording will be uploaded to MCW's secure server at the subject's next hospital visit. Throughout the study, subjects flare activity will be monitored via phone calls and recording flares in the EMA application on the smartphone. This will be a Daily Flare Question in the EMA which is a set alarmed time to sound as a reminder for the duration of the subject's participation.
The following weeks after each site visit and the night before visit 5, subjects will repeat complete the 24-hr HR recording to ensure comparability of the HRV recording at home to the one performed at the matching on-site visit., Subjects will also complete the 24-h voiding diary, a set of questions using the ICECAN mobile App installed on a pre-loaded smartphone and questionnaires. Deidentified 24-hour HRV and ACP recordings will be sent to Ohio State University for analysis.
Follow-up Visits: Weeks 4, 12, 16, 24, Visits 2-5 (weeks 4 and 12 (Visits 2 and 3) for the observational substudy) Subjects will arrive to MCW Neurology Research Rooms to repeat the following: review of comorbidities, tender points exam, questionnaires, ACP and DNIC tests. Subjects will complete the Valsalva maneuver in the MCW Neurology Research Rooms with a member of the research team present. Chronic Pelvic Pain patients subjects will complete a repeat pelvic examination at Weeks 12 and 24.
CPP aparticipants will be randomized to receive 8 weeks of either placebo (a pill with no active agent), or metoprolol (a pill that reduces the impact of the brain's "fight or flight" circuits). Metoprolol is in the class of "beta-blockers" commonly used for mild blood pressure control, and also commonly used for migraine. Subjects will be administered 8 weeks of metoprolol or placebo starting at their Week 4 Visit. Subjects will complete a 4-week washout period (Week 12-16) and will be administered 8 weeks of crossover (Weeks 16-24).
Blood will be drawn (\~ 50 mL, a little more than 3 tablespoons) at each in-person visit at weeks 0, 4, 12, 16, and 24 for chronic pelvic pain subjects (healthy control only at Baseline and Final visits; 2 draws total). A portion of the blood plasma/serum will be sent to the University of Pittsburgh for additional related analysis. The sample will be labeled by a number and will not contain any information that can be used to directly identify subject. This portion of the study is critical to gather new information about pelvic pain, which is very poorly understood and we highly encourage subjects to participate in this portion of the study; however, it is optional.
Healthy Controls:
60 healthy control subjects will also complete this study in 24 weeks that include 4 long site visits and 6 weekly home check visits. During this first long visit they will complete a general exam and physician evaluation, DNIC, ACP, Valsalva maneuver, and questionnaires. Subjects will complete a 24-hour HR recording from home once a week for 6 weeks total.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Initiation of any new treatment class in the last 30 days, or intent to initiate a new class of treatment in the study. Treatment classes include:
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with chronic pelvic pain will be randomized to either take 8 weeks of Metoprolol Tartrate Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Placebo OR to take 8 weeks of Placebo Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Metoprolol Tartrate Oral Tablet. This intervention aims at determining whether Metoprolol reduces pain in subjects in both groups compared to placebo. Some participants were not randomized and were instead enrolled into the observational sub-study.
Drug: Metoprolol Tartrate Oral Tablet · Drug: Placebo Oral Tablet · Other: No intervention- observational sub-study
Healthy female subjects ages 18-80 with various demographic background who do not have any exclusionary diagnostic or symptomatic criteria will be recruited. Subjects will never receive any randomization or drug treatment during the entire duration of the study
Metoprolol is a beta-blocker commonly used for mild blood pressure control, and also commonly used for migraine. Subjects with IC/BPS or MPP will start metoprolol at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
Also known as: Metoprolol
Subjects with IC/BPS or MPP will start placebo distributed in a double-blind manner. Subjects will take placebo once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
Also known as: Placebo
Participants did not receive placebo or metoprolol during the entire duration of the study.
Total Score on Genitourinary Pain Index (GUPI) Scale
The total GUPI score is calculated from the sum of the 3 scores from the subscales. There is no uniformity in the ranges of scores for the individual questions. The 3 subscales are: pain, urinary, and quality of life. The total score range can go from 0-45. The higher the score indicates more female urinary symptoms. Scores were calculated for each participant at weeks 4 (baseline), 12 (post-first intervention) and 24 (post-second intervention) of their participation in the study.
Time frame: Weeks 4, 12 and 24
Average Score on the First Domain of the Multidimensional Pain Scoring (MPI) Scale
The average score comes from the Pain Experience, the first domain, of the MPI. Domain 1 includes five scales designed to measure important dimensions of the chronic pain experience including; 1) perceived interference of pain in vocational, social/recreational, and family/marital functioning, 2) support or concern from spouse or significant other, 3) pain severity, 4) perceived life control, and 5) affective distress. Higher scores indicate more impactful effects of the pain experience in daily life. Responses from individual questions range from 0-6. 0 indicated no pain/no interference/no change. 6 indicates very intense pain/extreme interference/extreme change. The final total score range is 0-6 with 0 being absent pain and 6 being the worst pain rating. A lower score is better. Scores were calculated for each participant at weeks 4 (baseline), 12 (post-first intervention) and 24 (post-second intervention) of their participation in the study.
Time frame: Weeks 4, 12 and 24
Correlation Between the Change in Autonomic Nervous System Responsiveness (ANS-R) and the Change in the Connectivity Between Prefrontal Cortex (PFC) and Periaqueductal Gray (PAG)
A linear model with connectivity at 24 weeks as outcome, connectivity at baseline as a covariate and change in ANS-R, demographics such as age and group and the interactions of group with other covariate.
Time frame: 24 Weeks
Assessing Central Autonomic Network Connectivity in Subjects With Chronic Pelvic Pain
This exploratory aim for the sub-studyused functional MRI brain imaging to examine the evolution of the connectivity of the main autonomic processing nucleus, the periaqueductal gray region, with other cortical brain regions
Time frame: Baseline, 12 weeks and 24 weeks
The study was modified to report data for participants with IC/BPS and MPP as a single combined chronic pelvic pain group. Please review the pre-assignment details sections to view how participants are being presented in for this group.
| Milestone | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants |
|---|---|---|---|---|
| Started | 23 | 22 | 23 | 4 |
| Completed | 20 | 16 | 18 | 4 |
| Not completed | 3 | 6 | 5 | 0 |
| Withdrew: Withdrawal by subject | 2 | 5 | 2 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Withdrew from study but did not withdraw consent | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 |
| Withdrew: Screenfail | 0 | 0 | 2 | 0 |
The total GUPI score is calculated from the sum of the 3 scores from the subscales. There is no uniformity in the ranges of scores for the individual questions. The 3 subscales are: pain, urinary, and quality of life. The total score range can go from 0-45. The higher the score indicates more female urinary symptoms. Scores were calculated for each participant at weeks 4 (baseline), 12 (post-first intervention) and 24 (post-second intervention) of their participation in the study.
| score on a scale | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants |
|---|---|---|---|---|
| Week 4 | 24.4 ± 8.54 | 22.2 ± 8.94 | 2.35 ± 2.37 | 29.25 ± 7.27 |
| Week 12 | 22.8 ± 11.1 | 21.4 ± 8.88 | 2.42 ± 3.67 | 26.65 ± 9.84 |
| Week 24 | 23.1 ± 12 | 22.1 ± 7.8 | 1.67 ± 1.15 | — |
The average score comes from the Pain Experience, the first domain, of the MPI. Domain 1 includes five scales designed to measure important dimensions of the chronic pain experience including; 1) perceived interference of pain in vocational, social/recreational, and family/marital functioning, 2) support or concern from spouse or significant other, 3) pain severity, 4) perceived life control, and 5) affective distress. Higher scores indicate more impactful effects of the pain experience in daily life. Responses from individual questions range from 0-6. 0 indicated no pain/no interference/no change. 6 indicates very intense pain/extreme interference/extreme change. The final total score range is 0-6 with 0 being absent pain and 6 being the worst pain rating. A lower score is better. Scores were calculated for each participant at weeks 4 (baseline), 12 (post-first intervention) and 24 (post-second intervention) of their participation in the study.
| score on a scale | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants |
|---|---|---|---|---|
| Week 4 | 2.44 ± 1.11 | 2.16 ± 0.878 | 1.28 ± 0.28 | 2.95 ± 1.38 |
| Week 12 | 2.53 ± 1.03 | 1.99 ± 0.863 | 1.41 ± 0.45 | 2.57 ± 1.42 |
| Week 24 | 2.35 ± 1.14 | 2.11 ± 0.747 | 1.13 ± 0.35 | — |
A linear model with connectivity at 24 weeks as outcome, connectivity at baseline as a covariate and change in ANS-R, demographics such as age and group and the interactions of group with other covariate.
Results for this outcome have not been posted.
This exploratory aim for the sub-studyused functional MRI brain imaging to examine the evolution of the connectivity of the main autonomic processing nucleus, the periaqueductal gray region, with other cortical brain regions
Results for this outcome have not been posted.
Collected over 24 weeks (duration of study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metoprolol | 0/43 (0%) | 0/43 (0%) | 22/43 (51.2%) |
| Placebo | 0/42 (0%) | 0/42 (0%) | 25/42 (59.5%) |
| Baseline Period | 0/45 (0%) | 0/45 (0%) | 5/45 (11.1%) |
| Washout Period | 0/40 (0%) | 0/40 (0%) | 4/40 (10%) |
| Observational Participants | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Healthy Control | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Event | Metoprolol | Placebo | Baseline Period | Washout Period | Observational Participants | Healthy Control |
|---|---|---|---|---|---|---|
| fatigueGeneral disorders | 0/43 | 3/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| nauseaGastrointestinal disorders | 2/43 | 2/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| Sleep problemsGeneral disorders | 2/43 | 0/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| Joint painMusculoskeletal and connective tissue disorders | 0/43 | 0/42 | 0/45 | 1/40 | 0/4 | 0/23 |
| Urinary Tract InfectionInfections and infestations | 0/43 | 0/42 | 0/45 | 1/40 | 0/4 | 0/23 |
| Vestibular migraines with vertigoNervous system disorders | 0/43 | 0/42 | 0/45 | 1/40 | 0/4 | 0/23 |
| Fibromyalgia flareNervous system disorders | 0/43 | 1/42 | 0/45 | 1/40 | 0/4 | 0/23 |
| Chest TightnessRespiratory, thoracic and mediastinal disorders | 1/43 | 1/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| Nausea and vomitingGastrointestinal disorders | 0/43 | 1/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| Depressed mood post 1st round of study medicationPsychiatric disorders | 0/43 | 1/42 | 0/45 | 0/40 | 0/4 | 0/23 |
| Age, Categorical(Participants) | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 22 | 22 | 3 | 70 |
| >=65 years | 0 | 0 | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants | Total |
|---|---|---|---|---|---|
| Female | 23 | 22 | 23 | 4 | 72 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 0 | 2 |
| Not Hispanic or Latino | 12 | 14 | 8 | 2 | 36 |
| Unknown or Not Reported | 10 | 7 | 15 | 2 | 34 |
| Race (NIH/OMB)(Participants) | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 0 | 4 |
| White | 12 | 13 | 6 | 2 | 33 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 7 | 15 | 2 | 34 |
| Region of Enrollment(participants) | Metoprolol Then Placebo | Placebo Then Metoprolol | Healthy Control | Observational Participants | Total |
|---|---|---|---|---|---|
| United States | 23 | 22 | 23 | 4 | 72 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All participant data will be de-identified before sharing. Blood and Urine: A portion of the blood plasma/serum and urine will be sent to the University of Pittsburgh for additional related analysis. Heart Rate Variability (HRV): 24-hour HRV and Active Change of Posture recordings will be sent to Ohio State University for analysis.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: The participant's collected data is de-identified immediately. The blood and urine are stored in a freezer until there are enough samples to send out for analysis. Heart rate recordings are uploaded to a secure MCW storage site and shared for analysis throughout the participant's participation.
Access criteria: Participant data will be shared through a secured web dropbox called BOX. BOX access is paid for and controlled by the Medical College of Wisconsin (MCW). The folders containing participant data are password protected and only those who are adding to the folders or performing analysis on collected data are given access through MCW. MCW's other two recruiting sites, NorthShore University HealthSystem and Case Western Reserve University, are able to add participant data to their own site folders, and each site only has access to their participants' data. Ohio State University has access to the folder containing participants' heart rate recording to perform analysis. Blood and Urine samples are deidentified and stored at MCW until a shipment is prepared. They are then sent to the University of Pittsburgh for further analysis.
Ran from Mar 2017 to primary completion in Mar 2022, 60 months.
Results were first posted in Feb 2025, 2 years 11 months after primary completion. A results delay was requested in Feb 2023.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metoprolol
Virginia Commonwealth University →