Trial Outcomes & Findings for Bulking Agents for the Treatment of Stress Urinary Incontinence in Females (NCT NCT00629083)

NCT ID: NCT00629083

Last Updated: 2020-02-07

Results Overview

The number of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and daily number of incontinence episodes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 345 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2020-02-07

Participant Flow

The first subject was enrolled on June 4, 2008, and the last subject was enrolled on June 6, 2011. All participating study centers were in hospitals or clinics in the United States, Canada or France. The sites and investigators were qualified to treat stress urinary incontinence in women by experience and expertise.

Pelvic Organ Prolapse Quantification, upright cystometry, Valsalva Leak Point Pressure, post-void residual measurement, daily number of incontinence episodes and a 24-hour pad test were completed prior to randomization to confirm eligibility in the trial.

Participant milestones

Measure	Bulkamid Hydrogel Bulkamid hydrogel is a proprietary, cross-linked polyacrylamide hydrogel developed for urethral bulking. The hydrogel consists of a backbone of cross-linked polyacrylamide, with water molecules loosely bound to the polymer matrix.	Contigen Injection Contigen is a sterile non-pyrogenic implantable device composed of highly purified bovine dermal collagen that was lightly crosslinked with glutaraldehyde and dispersed in phosphate-buffered physiological saline
Overall Study STARTED	228	117
Overall Study COMPLETED	200	103
Overall Study NOT COMPLETED	28	14

Reasons for withdrawal

Measure	Bulkamid Hydrogel Bulkamid hydrogel is a proprietary, cross-linked polyacrylamide hydrogel developed for urethral bulking. The hydrogel consists of a backbone of cross-linked polyacrylamide, with water molecules loosely bound to the polymer matrix.	Contigen Injection Contigen is a sterile non-pyrogenic implantable device composed of highly purified bovine dermal collagen that was lightly crosslinked with glutaraldehyde and dispersed in phosphate-buffered physiological saline
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	3	1
Overall Study Withdrawal by Subject	10	2
Overall Study Lost to Follow-up	12	8
Overall Study Moved out of country/state	2	1
Overall Study Refused to return for 12 month visit	1	0

Baseline Characteristics

There were 345 subjects enrolled but not all of them provided baseline data for the 24-hour pad test. 223/228 test subjects and 112/117 control subjects provided baseline 24-hour pad test data.

Baseline characteristics by cohort

Measure	Bulkamid Hydrogel Injection n=228 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=117 Participants Contigen: Transurethral bulking injection	Total n=345 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 11.4 • n=228 Participants	57.4 years STANDARD_DEVIATION 14.3 • n=117 Participants	57.8 years STANDARD_DEVIATION 12.4 • n=345 Participants
Sex: Female, Male Female	228 Participants n=228 Participants	117 Participants n=117 Participants	345 Participants n=345 Participants
Sex: Female, Male Male	0 Participants n=228 Participants	0 Participants n=117 Participants	0 Participants n=345 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=228 Participants	11 Participants n=117 Participants	33 Participants n=345 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants n=228 Participants	106 Participants n=117 Participants	312 Participants n=345 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=228 Participants	0 Participants n=117 Participants	0 Participants n=345 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=228 Participants	1 Participants n=117 Participants	3 Participants n=345 Participants
Race (NIH/OMB) Asian	4 Participants n=228 Participants	3 Participants n=117 Participants	7 Participants n=345 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=228 Participants	0 Participants n=117 Participants	0 Participants n=345 Participants
Race (NIH/OMB) Black or African American	2 Participants n=228 Participants	1 Participants n=117 Participants	3 Participants n=345 Participants
Race (NIH/OMB) White	214 Participants n=228 Participants	109 Participants n=117 Participants	323 Participants n=345 Participants
Race (NIH/OMB) More than one race	0 Participants n=228 Participants	0 Participants n=117 Participants	0 Participants n=345 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=228 Participants	3 Participants n=117 Participants	9 Participants n=345 Participants
Region of Enrollment Canada	43 participants n=228 Participants	21 participants n=117 Participants	64 participants n=345 Participants
Region of Enrollment United States	185 participants n=228 Participants	96 participants n=117 Participants	281 participants n=345 Participants
24-hour Pad Test	93.6 g STANDARD_DEVIATION 127.8 • n=223 Participants • There were 345 subjects enrolled but not all of them provided baseline data for the 24-hour pad test. 223/228 test subjects and 112/117 control subjects provided baseline 24-hour pad test data.	115.4 g STANDARD_DEVIATION 245.9 • n=112 Participants • There were 345 subjects enrolled but not all of them provided baseline data for the 24-hour pad test. 223/228 test subjects and 112/117 control subjects provided baseline 24-hour pad test data.	104.5 g STANDARD_DEVIATION 186.7 • n=335 Participants • There were 345 subjects enrolled but not all of them provided baseline data for the 24-hour pad test. 223/228 test subjects and 112/117 control subjects provided baseline 24-hour pad test data.
Daily Number of Incontinence Episodes	4.1 number of daily episodes STANDARD_DEVIATION 2.8 • n=228 Participants	3.5 number of daily episodes STANDARD_DEVIATION 2.4 • n=117 Participants	3.8 number of daily episodes STANDARD_DEVIATION 2.6 • n=345 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Intent-to-treat (ITT) population.

The number of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and daily number of incontinence episodes

Outcome measures

Measure	Bulkamid Hydrogel Injection n=228 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=117 Participants Contigen: Transurethral bulking injection
Primary Effectiveness Endpoint	107 participants	50 participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT

The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.

Outcome measures

Measure	Bulkamid Hydrogel Injection n=228 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=117 Participants Contigen: Transurethral bulking injection
The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).

A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.

Outcome measures

Measure	Bulkamid Hydrogel Injection n=186 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=94 Participants Contigen: Transurethral bulking injection
24hr Pad Test	32.0 grams Standard Deviation 64.2	54.6 grams Standard Deviation 120.3

SECONDARY outcome

Timeframe: 12 months

Population: Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).

At the 12-month primary endpoint follow-up visit, the subject was asked to provide her perception of treatment effectiveness by circling the most accurate description of her condition: cured/dry; much improved; improved; no change; worse. The response was dichotomized into responder or non-responder. A subject was classified as a responder if she reported that the treatment had cured, much improved, or improved her incontinence condition.

Outcome measures

Measure	Bulkamid Hydrogel Injection n=187 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=101 Participants Contigen: Transurethral bulking injection
Number of Subjects Reporting as a Responder	144 Participants	71 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).

The IQoL is a validated instrument consisting of 22 questions grouped into three subscales: avoidance and limiting behaviors; psychosocial impacts, and social embarrassment. It is a subject self-reported quality-of-life measure specific to urinary problems that is used to assess the impact of urinary incontinence and urinary problems and their treatment. The subject scores each question on a scale of 1 to 5 with higher scores indicating more positive responses. The maximum score was 110 points and the minimum score was 22.

Outcome measures

Measure	Bulkamid Hydrogel Injection n=198 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=103 Participants Contigen: Transurethral bulking injection
IQoL	80.3 score on a scale Standard Deviation 20.1	75.2 score on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: 12 months

Population: Complete Case (CC): Randomized subjects with complete data for a specific endpoint at a particular time point (no imputed data).

The ICIQ-UI Short Form assesses the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire consists of three questions with a maximum score of 21 and a minimum score of zero (0). A lower score represents a decrease in the severity of symptoms (i.e., improvement).

Outcome measures

Measure	Bulkamid Hydrogel Injection n=196 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=102 Participants Contigen: Transurethral bulking injection
ICIQ-UI Short Form	7.1 score on a scale Standard Deviation 4.9	7.9 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: 12 months

Population: This analysis was performed on the Complete Case (CC) analysis set.

The total number of incontinence episodes experienced by the subject over three consecutive days.

Outcome measures

Measure	Bulkamid Hydrogel Injection n=195 Participants Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=101 Participants Contigen: Transurethral bulking injection
Number of Incontinence Episodes	1.4 Episodes Standard Deviation 1.7	1.4 Episodes Standard Deviation 1.9

Adverse Events

Bulkamid Hydrogel Injection

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Contigen Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bulkamid Hydrogel Injection n=228 participants at risk Bulkamid: Bulking injection with Bulkamid injection device	Contigen Injection n=117 participants at risk Contigen: Transurethral bulking injection
Gastrointestinal disorders Gastrointestinal disorder	0.88% 2/228 • Number of events 3 • Adverse event data were collected from each participant through her study completion visit, typically at 12 months. The definition of adverse event and/or serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov definitions.	0.00% 0/117 • Adverse event data were collected from each participant through her study completion visit, typically at 12 months. The definition of adverse event and/or serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.3% 3/228 • Number of events 3 • Adverse event data were collected from each participant through her study completion visit, typically at 12 months. The definition of adverse event and/or serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov definitions.	0.00% 0/117 • Adverse event data were collected from each participant through her study completion visit, typically at 12 months. The definition of adverse event and/or serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov definitions.

Other adverse events

Adverse event data not reported

Additional Information

Ieva Ankorina-Stark, Ph D, Chief Scientific Officer

Contura International A/S

Phone: 011 45 8110 0900

Email: ieva.ankorina-stark@contura.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60