Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05710718
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2023-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PureWick™ France and U.S. At-Home Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053206', 'term': 'Nocturnal Enuresis'}], 'ancestors': [{'id': 'D004775', 'term': 'Enuresis'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kirsten.Hammitt@bd.com', 'phone': '551-225-1164', 'title': 'Director Clinical Affairs and Medical Affairs Strategy', 'organization': 'Becton, Dickinson and Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 days during each treatment phase', 'eventGroups': [{'id': 'EG000', 'title': 'PureWick System', 'description': '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.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Rash', 'notes': 'Rash - unknown cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'seriousEvents': [{'term': 'Urinary Tract Infection', 'notes': 'Participant was hospitalized for UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dehydration', 'notes': 'Participant was hospitalized for dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Death', 'notes': 'Unknown cause of death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Daily Average Urine Capture Rate (Percentage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.4', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '49.4', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'paired T-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.'}], 'paramType': 'MEAN', 'timeFrame': 'Daily for 28 days during each treatment phase', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).\n\nPrior 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.\n\nCapture 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.\n\nThe primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.', 'unitOfMeasure': 'Percentage of urine captured', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the endpoint analysis (ITT Population)'}, {'type': 'PRIMARY', 'title': 'Daily Average Skin Irritation Score Using the Draize Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily for 28 days during each treatment phase', 'description': 'Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding.\n\nThe primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the endpoint analysis (ITT Population)'}, {'type': 'SECONDARY', 'title': 'Nocturia Quality of Life (N-QOL) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 1-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 1-2 change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.5', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 3-4 change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '30.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Starting at baseline and then every 2 weeks during each treatment phase', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS Sleep Disturbance - Short Form 4a Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57.9', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '52.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 change from Baseline', 'categories': [{'measurements': [{'value': '-5.5', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '50.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 change from Baseline', 'categories': [{'measurements': [{'value': '-7.4', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '54.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '63.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 22 change from Baseline', 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '54.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '57.9', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 change from Baseline', 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Starting at baseline and then every 7 days during each treatment phase', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': "Participant's Tolerability of Device/Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Treatment Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': "Participant's tolerability is determined by the number of days of actual device use.", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the endpoint analysis (ITT Population)'}, {'type': 'SECONDARY', 'title': "Participant's Comfort Level Associated With Device/Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Comfort of Device Placement', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Comfort of Device During Sleep', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Comfort of Device Removal', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Likelihood to Recommend Device', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the endpoint analysis (ITT Population)'}, {'type': 'SECONDARY', 'title': "Participant's Opinion of Ease of Device Use", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PureWick System', 'description': '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.'}, {'id': 'OG001', 'title': 'Hollister Female Urinary Pouch External Collection Device', 'description': '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.'}], 'classes': [{'title': 'Ease of Device Placement', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Device Removal', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Dryness Experienced', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': '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.\n\nThe 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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled and randomized participants were included in the endpoint analysis (ITT Population)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PureWick System, Then Hollister Female Urinary Pouch', 'description': 'The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch.\n\nPureWick™ 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.\n\nHollister® 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.'}, {'id': 'FG001', 'title': 'Hollister Female Urinary Pouch, Then PureWick System', 'description': 'The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.\n\nPureWick™ 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.\n\nHollister® 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Completed Treatment 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Completed Treatment 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Potential subjects were identified and enrolled by the participating clinical research sites.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PureWick, Then Hollister Female Urinary Pouch', 'description': 'The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch.'}, {'id': 'BG001', 'title': 'Hollister Female Urinary Pouch, Then PureWick', 'description': 'The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '76.3', 'spread': '18.0', 'groupId': 'BG001'}, {'value': '75.3', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants were randomized and treated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-16', 'size': 1805871, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-29T17:01', 'hasProtocol': True}, {'date': '2024-09-11', 'size': 712804, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-29T17:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '1:1 Crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2023-01-04', 'resultsFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-27', 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Average Urine Capture Rate (Percentage)', 'timeFrame': 'Daily for 28 days during each treatment phase', 'description': 'Capture rate following void (captured as % of urine captured by device and collected in canister, measured by weight).\n\nPrior 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.\n\nCapture 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.\n\nThe primary efficacy endpoint of urine capture rate is derived by computing the mean of daily capture rate during each study phase.'}, {'measure': 'Daily Average Skin Irritation Score Using the Draize Scale', 'timeFrame': 'Daily for 28 days during each treatment phase', 'description': 'Draize Scale is a 5 point scale where 0 is no erythema, edema, or bleeding and 4 is severe erythema, edema, and/or bleeding.\n\nThe primary safety endpoint of skin irritation score is derived by computing the mean of Draize Scale scores assessed daily during each study phase.'}], 'secondaryOutcomes': [{'measure': 'Nocturia Quality of Life (N-QOL) Score', 'timeFrame': 'Starting at baseline and then every 2 weeks during each treatment phase', 'description': '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.'}, {'measure': 'PROMIS Sleep Disturbance - Short Form 4a Score', 'timeFrame': 'Starting at baseline and then every 7 days during each treatment phase', 'description': '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.'}, {'measure': "Participant's Tolerability of Device/Treatment", 'timeFrame': 'After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': "Participant's tolerability is determined by the number of days of actual device use."}, {'measure': "Participant's Comfort Level Associated With Device/Treatment", 'timeFrame': 'After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': '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.\n\nThe 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.'}, {'measure': "Participant's Opinion of Ease of Device Use", 'timeFrame': 'After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.', 'description': '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.\n\nThe 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'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nocturnal Enuresis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nApproximately 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult Female Participants \\>18 years of age at the time of signing the informed consent.\n2. Currently use diapers or equivalent at night for urine capture ("Change complet"(French term))\n3. Willing to comply with all study procedures in the protocol\n4. Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Has frequent episodes of bowel incontinence without a fecal management system in place; or\n2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or\n3. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or\n4. Has Urinary retention; or\n5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or\n6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or\n7. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or\n8. Is known to be pregnant at time of enrollment (for women of childbearing age); or\n9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.\n10. Is under supervision of a legally authorized representative.'}, 'identificationModule': {'nctId': 'NCT05710718', 'briefTitle': 'PureWick™ France and U.S. At-Home Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'C. R. Bard'}, 'officialTitle': 'A Comparative Crossover Study on the Safety, Efficacy, and Patient Quality of Life Comparing PureWick™ System With an Established Comparator in the Home Setting for Incontinence Overnight', 'orgStudyIdInfo': {'id': 'UCC-8007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Sequence 1', 'description': 'The PureWick™ System is used for the first 4 weeks, followed by cross-over to the Hollister Female Urinary Pouch.', 'interventionNames': ['Device: PureWick™ System', 'Device: Hollister® Female Urinary Pouch External Collection Device']}, {'type': 'OTHER', 'label': 'Treatment Sequence 2', 'description': 'The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System.', 'interventionNames': ['Device: PureWick™ System', 'Device: Hollister® Female Urinary Pouch External Collection Device']}], 'interventions': [{'name': 'PureWick™ System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment Sequence 1', 'Treatment Sequence 2']}, {'name': 'Hollister® Female Urinary Pouch External Collection Device', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment Sequence 1', 'Treatment Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30338', 'city': 'Dunwoody', 'state': 'Georgia', 'country': 'United States', 'facility': 'Smiths Medical Center', 'geoPoint': {'lat': 33.94621, 'lon': -84.33465}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. R. Bard', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}