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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases. The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate.
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence using two devices (PureWick™ System and Hollister® Female Urinary Pouch External Collection Device) and followed for approximately 10 weeks through 2 treatment phases.
Approximately 30 female participants from 2 sites will be enrolled into the study. Those meeting eligibility criteria will be treated according to the treatment sequence assigned during randomization. Participants will view the standardized training video for the applicable product at the beginning of each treatment phase and have access to the Information for Use document (IFU) to review during each treatment phase. The total expected duration of subject participation is approximately 10 weeks. Participants will use the device assigned in treatment phase 1 overnight while sleeping for 4 weeks (28 days) before transitioning to the second assigned device in treatment phase 2. There will be a minimum washout period of 2 weeks (not to exceed 4 weeks) between treatment phases and a re-screening of eligibility criteria before the second phase. In both treatment phases, participants will independently place and remove the FEC (female external catheter) or FUP (Female Urinary Pouch) after standardized teaching is completed on the first day of the treatment phase.
The primary objectives are to evaluate safety (skin injury) and efficacy (capture rate). Safety will be assessed using the Draize Scale and efficacy will be measured based on daily urine capture rate. Health Care Providers (HCPs) will visit participants' homes daily to perform a skin assessment and collect urine measurements during the treatment phases. Participants will be withdrawn from the treatment phase if grade 4 is achieved in any category on the Draize skin irritation scale.
The secondary objectives are to assess quality of life, tolerability, comfort and ease of use. Quality of life and comfort and ease of use will be measured using self-reported changes in quality of life via the validated Nocturia Quality of Life (N-Qol) tool & the PROMIS Sleep Disturbance Short-form 4a survey, and subjective evaluation of the therapy via participant survey, respectively. Tolerability will be measured by number of days of actual use of both devices, and discontinuation rate attributed to the device's discomfort or inconvenience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Other | The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch. |
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| Treatment Sequence 2 | Other | The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PureWick™ System | Device | The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Average Urine Capture Rate (Percentage) | Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100. The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase. | Daily for 28 days during each treatment phase |
| Daily Average Skin Irritation Score Using the Draize Scale | Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase. | Daily for 28 days during each treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturia Quality of Life (N-QOL) Score | N-QOL is a standardized tool used to explore 13 items that might be affected by nocturia (e.g., concentration, productiveness, and low energy). Transformed Total Score is computed from the core 12 item summary scores and ranges from 0-100 with higher scores indicating better quality of life. | Starting at baseline and then every 2 weeks during each treatment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smiths Medical Center | Dunwoody | Georgia | 30338 | United States | ||
| Weill Cornell Medical Center |
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All enrolled participants were randomized to a treatment assignment; however, four (4) participants discontinued prior to starting treatment. The number of Started participants (13) represents those participants that were randomized and treated.
Potential subjects were identified and enrolled by the participating clinical research sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | PureWick System, Then Hollister Female Urinary Pouch | The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch. PureWick™ System: The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. Hollister® Female Urinary Pouch External Collection Device: The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. |
| FG001 | Hollister Female Urinary Pouch, Then PureWick System | The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System. PureWick™ System: The PureWick™ FEC is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. Hollister® Female Urinary Pouch External Collection Device: The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | PureWick, Then Hollister Female Urinary Pouch | The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch. |
| BG001 | Hollister Female Urinary Pouch, Then PureWick |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Average Urine Capture Rate (Percentage) | Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight). Prior to each nightly use, the weight of the empty urine collection canister and the weight of a dry absorbent pad are collected. Participants use the device overnight while sleeping with the absorbent pad underneath them. The next morning, the post-void weight of the urine collection canister and the post-void weight of the absorbent pad are collected. Capture rate is calculated as the weight of captured urine (post-void canister weight - pre-void canister weight) / total urine volume (captured urine (post-void canister weight - pre-void canister weight) + leaked urine (post-void pad weight - pre-void pad weight)) * 100. The primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | Percentage of urine captured | Daily for 28 days during each treatment phase |
|
28 days during each treatment phase
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PureWick System | PureWick™ System: The PureWick™ Female External Catheter (FEC) is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment | Participant was hospitalized for UTI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment | Rash - unknown cause |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Affairs and Medical Affairs Strategy | Becton, Dickinson and Company | 551-225-1164 | Kirsten.Hammitt@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2024 | Apr 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2024 | Apr 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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1:1 Crossover
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| Hollister® Female Urinary Pouch External Collection Device | Device | The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. |
|
| PROMIS Sleep Disturbance - Short Form 4a Score | The PROMIS Sleep Disturbance Short Form 4a consists of 4 questions that each have 5 response options, with 1 indicating the least sleep disturbance and 5 indicating the most sleep disturbance. Total raw scores are translated into a T-score ranging from 32.0 to 73.3, with higher scores indicating worse outcome. | Starting at baseline and then every 7 days during each treatment phase |
| Participant's Tolerability of Device/Treatment | Participant's tolerability is determined by the number of days of actual device use. | After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| Participant's Comfort Level Associated With Device/Treatment | Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable nor Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely nor Unlikely, 4 = Likely, and 5 = Very Likely. | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| Participant's Opinion of Ease of Device Use | Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy. The last question related to dryness experienced with the device during sleep ranged from 1-4 with higher scores indicating a better outcome, where 1 = Never Dry, 2 = Sometimes Dry, 3 = Usually Dry, 4 = Always dry to mostly always dry | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
| New York |
| New York |
| 10065 |
| United States |
| Death |
|
The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Description |
|---|
| OG000 | PureWick System | PureWick™ System: The PureWick™ Female External Catheter (FEC) is intended for non-invasive urine output management in female patients. The PureWick™ FEC is a flexible, contoured external catheter that is positioned against the area where urine exits the female body. The PureWick™ FEC is connected to the PureWick™ Urine Collection System (PUCS) via connector tubing. The PUCS uses suction (not felt by the user) to pull voided urine through the device, regardless of the urine flow rate. Urine continues through vinyl tubing until it reaches a collection canister, away from the body. |
| OG001 | Hollister Female Urinary Pouch External Collection Device | Hollister® Female Urinary Pouch External Collection Device: The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. |
|
|
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| Primary | Daily Average Skin Irritation Score Using the Draize Scale | Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding. The primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | score on a scale | Daily for 28 days during each treatment phase |
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|
|
| Secondary | Nocturia Quality of Life (N-QOL) Score | N-QOL is a standardized tool used to explore 13 items that might be affected by nocturia (e.g., concentration, productiveness, and low energy). Transformed Total Score is computed from the core 12 item summary scores and ranges from 0-100 with higher scores indicating better quality of life. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population). NQOL total scores were only analyzable for patients that missed up to 1 question. If more than 1 question was missed, total score could not be analyzed. Change in number analyzed over time is due to participant premature discontinuation. | Posted | Mean | Standard Deviation | score on a scale | Starting at baseline and then every 2 weeks during each treatment phase |
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| Secondary | PROMIS Sleep Disturbance - Short Form 4a Score | The PROMIS Sleep Disturbance Short Form 4a consists of 4 questions that each have 5 response options, with 1 indicating the least sleep disturbance and 5 indicating the most sleep disturbance. Total raw scores are translated into a T-score ranging from 32.0 to 73.3, with higher scores indicating worse outcome. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population). The PROMIS sleep disturbance questionnaire was added to the study in a protocol amendment; therefore, only one (1) participant was analyzed in each treatment group. | Posted | Mean | Standard Error | score on a scale | Starting at baseline and then every 7 days during each treatment phase |
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| Secondary | Participant's Tolerability of Device/Treatment | Participant's tolerability is determined by the number of days of actual device use. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | days | After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
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| Secondary | Participant's Comfort Level Associated With Device/Treatment | Overall comfort on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Uncomfortable, 2 = Uncomfortable, 3 = Neither Comfortable nor Uncomfortable, 4 = Comfortable, and 5 = Very Comfortable. The last question related to likelihood to recommend the device ranged from 1-5 with higher scores indicating a better outcome, where 1 = Very Unlikely, 2 = Unlikely, 3 = Neither Likely nor Unlikely, 4 = Likely, and 5 = Very Likely. | All enrolled and randomized participants were included in the endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | score on a scale | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
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| Secondary | Participant's Opinion of Ease of Device Use | Ease of use score on a 5-point Likert scale ranging from 1- 5 with higher scores indicating a better outcome, where 1 = Very Difficult, 2 = Somewhat Difficult, 3 = Average Difficulty, 4 = Somewhat Easy, and 5 = Very Easy. The last question related to dryness experienced with the device during sleep ranged from 1-4 with higher scores indicating a better outcome, where 1 = Never Dry, 2 = Sometimes Dry, 3 = Usually Dry, 4 = Always dry to mostly always dry | All enrolled and randomized participants were included in the endpoint analysis (ITT Population) | Posted | Mean | Standard Deviation | score on a scale | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. |
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| 0 |
| 11 |
| 1 |
| 11 |
| 1 |
| 11 |
| EG001 | Hollister Female Urinary Pouch External Collection Device | Hollister® Female Urinary Pouch External Collection Device: The Hollister Female Urinary Pouch External Collection Device is intended to collect and contain urine for individuals with urinary incontinence. It is designed to be emptied and should be attached to a drainage bag. The FUP is made with hydrocolloid skin adhesive and polymer/copolymer plastics. | 1 | 5 | 1 | 5 | 0 | 5 |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment | Participant was hospitalized for dehydration |
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| Death | General disorders | MedDRA (26.0) | Non-systematic Assessment | Unknown cause of death |
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| Urinary Tract Infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| Week 1-2 |
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| Week 1-2 change from Baseline |
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| Week 3-4 |
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| Week 3-4 change from Baseline |
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| Day 8 change from Baseline |
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| Day 15 |
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| Day 22 |
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| Day 22 change from Baseline |
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| Day 29 |
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| Day 29 change from Baseline |
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| Treatment Phase 2 |
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| Comfort of Device Removal |
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| Likelihood to Recommend Device |
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| Dryness Experienced |
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