Trial Outcomes & Findings for Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (NCT NCT02591199)

Last Updated: 2026-02-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

12 hours

Results posted on

2026-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	URG101 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. URG101	Heparin A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Heparin	Lidocaine A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Lidocaine	Placebo A single 15 mL dose of placebo delivered to the bladder via catheter. Placebo
Overall Study STARTED	31	15	29	16
Overall Study COMPLETED	31	15	29	16
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	URG101 n=31 Participants 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. URG101	Heparin n=15 Participants A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Heparin	Lidocaine n=29 Participants A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Lidocaine	Placebo n=16 Participants A single 15 mL dose of placebo delivered to the bladder via catheter. Placebo	Total n=91 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 15.06 • n=13 Participants	52.2 years STANDARD_DEVIATION 16.86 • n=15 Participants	45.3 years STANDARD_DEVIATION 15.41 • n=28 Participants	50.2 years STANDARD_DEVIATION 16.15 • n=2 Participants	47.8 years STANDARD_DEVIATION 15.66 • n=32 Participants
Sex: Female, Male Female	30 Participants n=13 Participants	14 Participants n=15 Participants	28 Participants n=28 Participants	13 Participants n=2 Participants	85 Participants n=32 Participants
Sex: Female, Male Male	1 Participants n=13 Participants	1 Participants n=15 Participants	1 Participants n=28 Participants	3 Participants n=2 Participants	6 Participants n=32 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=13 Participants	1 Participants n=15 Participants	5 Participants n=28 Participants	4 Participants n=2 Participants	15 Participants n=32 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=13 Participants	14 Participants n=15 Participants	24 Participants n=28 Participants	12 Participants n=2 Participants	76 Participants n=32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Asian	2 Participants n=13 Participants	2 Participants n=15 Participants	1 Participants n=28 Participants	0 Participants n=2 Participants	5 Participants n=32 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Black or African American	2 Participants n=13 Participants	5 Participants n=15 Participants	0 Participants n=28 Participants	1 Participants n=2 Participants	8 Participants n=32 Participants
Race (NIH/OMB) White	27 Participants n=13 Participants	8 Participants n=15 Participants	28 Participants n=28 Participants	15 Participants n=2 Participants	78 Participants n=32 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants

PRIMARY outcome

Timeframe: 12 hours

Population: 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.

Outcome measures

Outcome measures
Measure	URG101 n=31 Participants 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. URG101	Heparin n=15 Participants A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Heparin	Lidocaine n=29 Participants A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Lidocaine	Placebo n=16 Participants A single 15 mL dose of placebo delivered to the bladder via catheter. Placebo
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 Intent to Treat / Safety Population	-30.81 units on a scale*hours Standard Deviation 21.641	-22.50 units on a scale*hours Standard Deviation 25.918	-27.50 units on a scale*hours Standard Deviation 26.121	-19.63 units on a scale*hours Standard Deviation 18.558
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 Per Protocol Population	-33.41 units on a scale*hours Standard Deviation 20.89	-24.11 units on a scale*hours Standard Deviation 26.11	-26.43 units on a scale*hours Standard Deviation 26.76	-15.42 units on a scale*hours Standard Deviation 17.74
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 Per Protocol-Instillation (history of receiving bladder instillations) Population	-37.51 units on a scale*hours Standard Deviation 18.06	-12.38 units on a scale*hours Standard Deviation 22.38	-23.27 units on a scale*hours Standard Deviation 25.96	-16.28 units on a scale*hours Standard Deviation 19.66

PRIMARY outcome

Timeframe: 12 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	URG101 n=46 Participants 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. URG101	Heparin n=60 Participants A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Heparin	Lidocaine n=47 Participants A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Lidocaine	Placebo A single 15 mL dose of placebo delivered to the bladder via catheter. Placebo
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 Intent-to-Treat / Safety Population	-11.65 units on a scale*hours Interval -25.61 to 2.31	-4.31 units on a scale*hours Interval -16.0 to 7.38	-12.46 units on a scale*hours Interval -26.59 to 1.68	—
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 Per Protocol Population	-15.69 units on a scale*hours Interval -29.57 to -1.81	-9.21 units on a scale*hours Interval -21.13 to 2.72	-21.28 units on a scale*hours Interval -36.07 to -6.49	—
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 Per Protocol-Instillation (history of receiving bladder instillations) Population	-26.02 units on a scale*hours Interval -43.62 to -8.43	-14.64 units on a scale*hours Interval -31.47 to 2.2	-26.04 units on a scale*hours Interval -44.07 to -8.01	—

Adverse Events

URG101

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Heparin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	URG101 n=31 participants at risk 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. URG101	Heparin n=15 participants at risk A single 15 mL dose of buffered Heparin (50,000 IU) delivered to the bladder. Heparin	Lidocaine n=29 participants at risk A single 15 mL dose of buffered Lidocaine (200 mg) delivered to the bladder via catheter. Lidocaine	Placebo n=16 participants at risk A single 15 mL dose of placebo delivered to the bladder via catheter. Placebo
Gastrointestinal disorders Nausea	6.5% 2/31 • From the time of study drug administration through 72 hours post-dose	0.00% 0/15 • From the time of study drug administration through 72 hours post-dose	6.9% 2/29 • From the time of study drug administration through 72 hours post-dose	0.00% 0/16 • From the time of study drug administration through 72 hours post-dose
Gastrointestinal disorders Vomiting	0.00% 0/31 • From the time of study drug administration through 72 hours post-dose	0.00% 0/15 • From the time of study drug administration through 72 hours post-dose	0.00% 0/29 • From the time of study drug administration through 72 hours post-dose	6.2% 1/16 • From the time of study drug administration through 72 hours post-dose
Nervous system disorders Vertigo	0.00% 0/31 • From the time of study drug administration through 72 hours post-dose	0.00% 0/15 • From the time of study drug administration through 72 hours post-dose	3.4% 1/29 • From the time of study drug administration through 72 hours post-dose	6.2% 1/16 • From the time of study drug administration through 72 hours post-dose
Nervous system disorders Headache	6.5% 2/31 • From the time of study drug administration through 72 hours post-dose	6.7% 1/15 • From the time of study drug administration through 72 hours post-dose	6.9% 2/29 • From the time of study drug administration through 72 hours post-dose	6.2% 1/16 • From the time of study drug administration through 72 hours post-dose
Renal and urinary disorders Burning in Bladder	0.00% 0/31 • From the time of study drug administration through 72 hours post-dose	6.7% 1/15 • From the time of study drug administration through 72 hours post-dose	0.00% 0/29 • From the time of study drug administration through 72 hours post-dose	0.00% 0/16 • From the time of study drug administration through 72 hours post-dose
Renal and urinary disorders Pain with Urination	0.00% 0/31 • From the time of study drug administration through 72 hours post-dose	6.7% 1/15 • From the time of study drug administration through 72 hours post-dose	0.00% 0/29 • From the time of study drug administration through 72 hours post-dose	0.00% 0/16 • From the time of study drug administration through 72 hours post-dose

Additional Information

CEO

Vaneltix Pharma, Inc.

Phone: 732-354-3217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place