Interstitial CystitisPhase 2NCT02591199

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

A Phase 2 study testing URG101, Lidocaine and Heparin in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Urigen at 11 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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?: URG101, Lidocaine and Heparin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 11 sitesUnited States
Study dates: Sep 2015to 18 Jun 2018
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

Subjects diagnosed with interstitial cystitis/bladder pain syndrome must meet all of the following criteria to participate in the study:
Have provided written informed consent to participate in this trial
Be male or female, ≥ 18 years of age
Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
May or may not have received a cystoscopy in association with their diagnosis of interstitial cystitis/bladder pain syndrome prior to or at time of screening
Have a score of ≥ 15 and < 30 on the PUF questionnaire, completed at screening
A minimum score of 5 is required on the VAS
Have been using a stable dose of hormone therapy for ≥ 3 months, if female and currently taking hormone therapy

Who cannot join

Pregnant or breastfeeding. For females of child bearing potential and males, if sexually active, must be willing to commit to an acceptable method of birth control for the duration of the study.
Have a known hypersensitivity to heparin or lidocaine
Have used any local anesthetic by any route within 24 hours prior to study drug administration, or used a lidocaine patch within 14 days prior to study drug administration
Have used a tricyclic antidepressant or a gamma-Aminobutyric acid (GABA) analogue (gabapentin or pregabalin) unless taking the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day.
Have used any pain medication within 6 hours prior to study drug administration
Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry (generic names: fentanyl, hydrocodone, hydromorphone, levorphanol, medical marijuana, methadone, morphine, oxycodone, propoxyphene, tramadol). Subjects who have received codeine within this time period may be admitted if the use is not chronic, and not within 6 hours of enrollment, such that they are not at risk for GI or opiate withdrawal symptoms that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results.

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Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results
Have a known clinically significant abnormal laboratory test value defined by the investigator
Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)
Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain
Have severe depression, bipolar disorder, schizophrenia, anxiety, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results
Had bladder instillation therapy within 7 days prior to study entry or had a prior bladder instillation with heparin and lidocaine and did not respond
Had dilatation (hydrodistention) of bladder within 3 months of study entry
Evidence or suspected presence of cancer detected during cystoscopy prior to or at time of initial screening.
Has received any investigational drug or device within 30 days prior to screening
Is currently enrolled in another investigational drug or device study
Is unwilling or unable to abide by the requirements of the study
Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
Have had any of the following: bacterial, chemical (including ketamine and cyclophosphamide) or radiation cystitis; gynecological, urological or rectal cancer; current chemotherapy; tuberculous cystitis; urinary schistosomiasis; bladder or uretal calculi; vaginitis or genital herpes; urethral diverticulum or bladder fistulae.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Georgia Urology
Cartersville, Georgia, 30120
Medical University of South Carolina
Charleston, South Carolina, 29425
MetroHealth System, Center for Advanced Gynecology
Cleveland, Ohio, 44109
IC Study, LLC
Escondido, California, 92025
The Arthur Smith Institue for Urology- North Shore Long Island Jewish Health System
Lake Success, New York, 11042
Rutgers Women's Health Clinic
New Brunswick, New Jersey, 08901
The Urogynecology Center
Overland Park, Kansas, 66209
University of California San Diego
San Diego, California, 92103
Sanford Research
Sioux Falls, South Dakota, 57105
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

Read the detailed description

This is a Phase 2a, randomized, double-blind, placebo controlled, multicenter, single-dose, pharmacokinetic study designed to determine the efficacy and safety of the combination product (URG101) compared with its individual components (Heparin Sodium and Lidocaine Hydrochloride).

Eligible subjects exhibiting moderate to severe symptoms of bladder pain associated with their diagnosis of interstitial cystitis/bladder pain syndrome who have signed informed consent, will be screened and provisionally enrolled for intravesical treatment.

On the day of study drug administration subjects will be randomized (2:1:2:1; URG101:placebo:lidocaine:heparin) and will receive a single administration of one of four intravesical treatments in a blinded fashion, based on random assignment:

URG101 (buffered lidocaine-heparin)
Placebo (phosphate buffer)
Lidocaine hydrocholoride buffered alone
Heparin sodium buffered alone

Efficacy and safety assessments will be completed for 24 hours after study drug administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after study drug administration.

Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Being tested: URG101, Placebo, Lidocaine, Heparin
Medical subject headings: Cystitis, Interstitial

What participants receive

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

URG101Drug
PlaceboDrug
LidocaineDrug
HeparinDrug

Study groups in NCT02591199
Study group	Role	What they receive
URG101	Experimental	A single 15 mL dose of URG101,a mix of buffered Lidocaine (200 mg) and Heparin (50,000 IU), delivered to the bladder via catheter. Receives: Drug: URG101
Placebo	Placebo comparator	A single 15 mL dose of placebo delivered to the bladder via catheter. Receives: Drug: Placebo
Lidocaine	Experimental	A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Receives: Drug: Lidocaine
Heparin	Experimental	A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Receives: Drug: Heparin

What is being measured

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

Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity
A calculation of average bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12). A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The average SPID-12 is calculated by multiplying the Pain Intensity Difference score at each time point by the duration since the preceding time point and then summing these values over the specific time period. A lower, negative average SPID-12 difference is better and indicates a reduction in pain intensity compared to the baseline score, whereas a positive score indicates an increase in pain intensity compared to baseline. The full range of results of the average SPID-12 difference could be -119 to +59.
Measured: 12 hours
Change of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity
A calculation of bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12) after administration of URG101 compared with the SPID-12 after administration of lidocaine alone, heparin alone, and placebo. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. A negative value indicates lower SPID-12 values for URG101. The full range of results of the average SPID-12 difference could be -119 to +59.
Measured: 12 hours

Timeline

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

Sep 201518 Jun 2018

First posted29 Oct 2015 (estimated)
Study startSep 2015
Primary completion14 May 2018
Study completion18 Jun 2018

Why it stopped: Prematurely terminated due to data inconsistent with the experimental plan and lack of funding

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.
Other trials for Interstitial CystitisStudies 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02591199
Sponsor's protocol ID: URG101-105
Status last verified: Jan 2026
First submitted: 28 Oct 2015
Last updated: 3 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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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All Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
ClinicalTrials.gov ID: NCT02591199
Acronym / sponsor ID: URG101-105
Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Prematurely terminated due to data inconsistent with the experimental plan and lack of funding
Enrolment: 91 participants (actual)
Lead sponsor: UrigenIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: 14 May 2018 (actual)
Study completion: 18 Jun 2018 (actual)
First posted: 29 Oct 2015 (estimated)
Results: Posted 3 Feb 2026

Clinical summary

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

Detailed description

URG101 (buffered lidocaine-heparin)
Placebo (phosphate buffer)
Lidocaine hydrocholoride buffered alone
Heparin sodium buffered alone

Efficacy and safety assessments will be completed for 24 hours after study drug administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after study drug administration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
URG101	Experimental	Drug: URG101A single 15 mL dose of URG101,a mix of buffered Lidocaine (200 mg) and Heparin (50,000 IU), delivered to the bladder via catheter.
Placebo	Placebo comparator	Drug: PlaceboA single 15 mL dose of placebo delivered to the bladder via catheter.
Lidocaine	Experimental	Drug: LidocaineA single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter.
Heparin	Experimental	Drug: HeparinA single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder.

Who may qualify

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

Key inclusion criteria (8 listed)

Subjects diagnosed with interstitial cystitis/bladder pain syndrome must meet all of the following criteria to participate in the study:
Have provided written informed consent to participate in this trial
Be male or female, ≥ 18 years of age
Have moderate-to-severe symptoms of bladder pain of bladder origin for at least 9 months prior to the study
May or may not have received a cystoscopy in association with their diagnosis of interstitial cystitis/bladder pain syndrome prior to or at time of screening

Key exclusion criteria (20 listed)

Pregnant or breastfeeding. For females of child bearing potential and males, if sexually active, must be willing to commit to an acceptable method of birth control for the duration of the study.
Have a known hypersensitivity to heparin or lidocaine
Have used any local anesthetic by any route within 24 hours prior to study drug administration, or used a lidocaine patch within 14 days prior to study drug administration
Have used a tricyclic antidepressant or a gamma-Aminobutyric acid (GABA) analogue (gabapentin or pregabalin) unless taking the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day.
Have used any pain medication within 6 hours prior to study drug administration

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
URG101	Drug	URG101
Placebo	Drug	Placebo
Lidocaine	Drug	Lidocaine
Heparin	Drug	Heparin

Primary outcome

Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity
Time frame: 12 hours
A calculation of average bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12). A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The average SPID-12 is calculated by multiplying the Pain Intensity Difference score at each time point by the duration since the preceding time point and then summing these values over the specific time period. A lower, negative average SPID-12 difference is better and indicates a reduction in pain intensity compared to the baseline score, whereas a positive score indicates an increase in pain intensity compared to baseline. The full range of results of the average SPID-12 difference could be -119 to +59.
Change of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity
Time frame: 12 hours
A calculation of bladder Sum of Pain Intensity Differences from Baseline to 12 hours (SPID-12) after administration of URG101 compared with the SPID-12 after administration of lidocaine alone, heparin alone, and placebo. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. A negative value indicates lower SPID-12 values for URG101. The full range of results of the average SPID-12 difference could be -119 to +59.

Results and safety

Results posted to the registry on 3 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
URG101	31	31
Heparin	15	15
Lidocaine	29	29
Placebo	16	16

Primary outcome: Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity

Time frame: 12 hours. Mean (Standard Deviation). Unit: units on a scale*hours

Measure	URG101 n = 31	Heparin n = 15	Lidocaine n = 29	Placebo n = 16
Intent to Treat / Safety Population	-30.81 (21.641)	-22.50 (25.918)	-27.50 (26.121)	-19.63 (18.558)
Per Protocol Population	-33.41 (20.89)	-24.11 (26.11)	-26.43 (26.76)	-15.42 (17.74)
Per Protocol-Instillation (history of receiving bladder instillations) Population	-37.51 (18.06)	-12.38 (22.38)	-23.27 (25.96)	-16.28 (19.66)

Population analysed: Subjects included in this analysis must have received a dose of the applicable study treatment and completed through the 12 hour SPID collection timepoint. Intent to Treat / Safety Population includes all subjects who received the relevant dose; Per Protocol Population includes all subjects who met entrance criteria; Per Protocol Instillation History includes a subset of the Per Protocol Population who previously received at least one instillation treatment.

Primary outcome: Change of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity

Time frame: 12 hours. Least squares mean (95% Confidence Interval). Unit: units on a scale*hours

Measure	URG101 Minus Heparin n = 46	URG101 Minus Lidocaine n = 60	URG101 Minus Placebo n = 47
Intent-to-Treat / Safety Population	-11.65 (-25.61 to 2.31)	-4.31 (-16.00 to 7.38)	-12.46 (-26.59 to 1.68)
Per Protocol Population	-15.69 (-29.57 to -1.81)	-9.21 (-21.13 to 2.72)	-21.28 (-36.07 to -6.49)
Per Protocol-Instillation (history of receiving bladder instillations) Population	-26.02 (-43.62 to -8.43)	-14.64 (-31.47 to 2.20)	-26.04 (-44.07 to -8.01)

Population analysed: Overall numbers of participants reflects all participants who received at least one dose of study drug (URG101), comparators (Heparin or Lidocaine), or placebo. The above arm numbers compare URG101 to its individual components of heparin, lidocaine, and placebo, respectively.

Adverse events

Time frame: From the time of study drug administration through 72 hours post-dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
URG101	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31
Heparin	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Lidocaine	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29
Placebo	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16

Limitations and caveats (from the sponsor): The IDMC reported a trend toward significance for URG101; but it was determined that \>300 subjects would be required to reach significance. The data showed inconsistencies between different sites that could affect the ability to pool the data and could not be explained in a blinded analysis. Therefore, at 92 subjects enrolled, the study was terminated early due to data inconsistent with the experimental plan, lack of funding. There is no SAP. Results are limited to primary endpoint and safety.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Interstitial Cystitis

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Enrolling by invitationObservational study
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Recruiting
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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.

C. Lowell Parsons, MD study chair

Urigen

11 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, Lidocaine and Heparin in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Urigen at 11 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 8 inclusion and 20 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. Some participants in this study may receive a placebo. 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 3 Feb 2026). 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?

Average of Bladder Sum of Pain Intensity Differences From Baseline to 12 Hours (SPID-12) as Determined Using an 11-point Numeric Rating Scale (NRS) for Pain Intensity (time frame: 12 hours). The study lists 2 primary outcomes in all. 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 NCT02591199.

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 3 Feb 2026.