Painful Bladder SyndromePhase 2NCT00517868

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

A Phase 2 study testing URG101 in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Urigen at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?: URG101
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 6 sitesUnited States
Study dates: 28 Aug 2007to 28 Feb 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

male and female subjects >= 18 years of age
moderate to severe symptoms of PBS/IC
minimum pain/urgency/frequency scores
female subjects on hormone therapy must be on stable dose for >= 3 months

Who cannot join

positive pregnancy test or pregnant or lactating
narcotics or medical marijuana within 3 months
use of any investigational drug or device within 30 days
bacterial cystitis within 30 days

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Georgia Urology
Cartersville, Georgia, 30120
Citrus Valley Medical Research
Glendora, California, 91741
Urology San Antonio Research, P.A.
San Antonio, Texas, 78229
SD Uro-Research
San Diego, California, 92103
University of California, San Diego
San Diego, California, 92103
Scripps Clinic Medical Group
San Diego, California, 92130

Other trials in United States

About this study

Official title: URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Conditions: Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome
Being tested: URG101, Placebo
Keywords: bladder, pain, urgency, frequency
Medical subject headings: Cystitis, Interstitial, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

URG101Drug
Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.
PlaceboDrug
Liquid formulation without active URG101 drug components

Study groups in NCT00517868
Study group	Role	What they receive
Crossover	Other	Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 Receives: Drug: URG101; Drug: Placebo
Crossover 2	Other	URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2 Receives: Drug: URG101; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Daytime Bladder Pain Intensity
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.
Measured: Through 12 hours

Secondary outcomes (3)

Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms gone (100% improvement).
Measured: Through 12 hours
Change in Total Symptom Score
A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Measured: Through 12 hours
Change in Daytime Urinary Urgency Score
A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.
Measured: Through 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 200728 Feb 2008

First posted17 Aug 2007 (estimated)
Study start28 Aug 2007
Primary completion28 Feb 2008
Study completion28 Feb 2008

Why it stopped: The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Painful Bladder SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00517868
Sponsor's protocol ID: URG101-104
Status last verified: Aug 2024
First submitted: 15 Aug 2007
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.
PubMed 22082303

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
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Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

All Painful Bladder Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.
ClinicalTrials.gov ID: NCT00517868
Acronym / sponsor ID: URG101-104
Conditions: Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome
Keywords: bladder, pain, urgency, frequency
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.
Enrolment: 28 participants (actual)
Lead sponsor: UrigenIndustry (pharma, biotech, devices)
Study start: 28 Aug 2007 (actual)
Primary completion: 28 Feb 2008 (actual)
Study completion: 28 Feb 2008 (actual)
First posted: 17 Aug 2007 (estimated)
Results: Posted 23 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Crossover	Other	Drug: URG101, Drug: PlaceboPlacebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2
Crossover 2	Other	Drug: URG101, Drug: PlaceboURG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

male and female subjects >= 18 years of age
moderate to severe symptoms of PBS/IC
minimum pain/urgency/frequency scores
female subjects on hormone therapy must be on stable dose for >= 3 months

Key exclusion criteria (4 listed)

positive pregnancy test or pregnant or lactating
narcotics or medical marijuana within 3 months
use of any investigational drug or device within 30 days
bacterial cystitis within 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
URG101Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.	Drug	Crossover, Crossover 2
PlaceboLiquid formulation without active URG101 drug components	Drug	Crossover, Crossover 2

Primary outcome

Change in Daytime Bladder Pain Intensity
Time frame: Through 12 hours
A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.

3 secondary outcomes

Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire
Time frame: Through 12 hours
Change in Total Symptom Score
Time frame: Through 12 hours
Change in Daytime Urinary Urgency Score
Time frame: Through 12 hours

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crossover Group 1	18	16
Crossover Group 2	10	10

Primary outcome: Change in Daytime Bladder Pain Intensity

Time frame: Through 12 hours. Mean (95% Confidence Interval). Unit: Percentage of pain scale change

Measure	Placebo n = 18	URG101 n = 18
Value	20.73 (5.04 to 36.41)	41.86 (27.64 to 56.08)

Placebo vs URG101: Mean Difference (Final Values): -21.14 (95% CI -44.43 to 2.16), p = 0.0363, t-test, 1 sided

Population analysed: Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event (AE) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 24 hours post-last dose of placebo or study drug Serious Adverse Event (SAE) and All-Cause Mortality (ACM) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 30 days post-last dose of placebo or study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 28 (0%)	8 of 28 (28.6%)	0 of 28
URG101	1 of 28 (3.6%)	21 of 28 (75%)	0 of 28
Total	1 of 28 (3.6%)	28 of 28 (100%)	0 of 28

Limitations and caveats (from the sponsor): The study was intended to include 40 subjects, but it had to be terminated early because the Food and Drug Administration (FDA) unexpectedly recalled the heparin used in the trial due to a possible contamination. Of the 28 subjects enrolled, limited demographic information is available, and the available data are reported for all subjects as a single group. Of the 28 subjects enrolled, there were 18 evaluable full-crossover subjects for the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22082303Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14.
Individual participant dataSharing planned: No

Related trials for Painful Bladder Syndrome

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Proctor, M.D. principal investigator

Georgia Urology

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing URG101 in people with Painful Bladder Syndrome and Interstitial Cystitis, run by Urigen at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Daytime Bladder Pain Intensity (time frame: Through 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00517868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.