Nocturnal Enuresis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPureWick™ 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.
DEVICEHollister® 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.
Sponsors
Becton, Dickinson and Company
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
1:1 Crossover
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult Female Participants \>18 years of age at the time of signing the informed consent. 2. Currently use diapers or equivalent at night for urine capture (Change complet(French term)) 3. Willing to comply with all study procedures in the protocol 4. Provision of signed and dated informed consent form
Exclusion criteria
1. Has frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or 3. Has Urinary tract, vaginal or other chronic infections, active genital herpes; or 4. Has Urinary retention; or 5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or 6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 7. 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 8. Is known to be pregnant at time of enrollment (for women of childbearing age); or 9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study. 10. Is under supervision of a legally authorized representative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Average Urine Capture Rate (Percentage) | Daily for 28 days during each treatment phase | 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 Average Skin Irritation Score Using the Draize Scale | Daily for 28 days during each treatment phase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Tolerability of Device/Treatment | After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. | Participant's tolerability is determined by the number of days of actual device use. |
| Nocturia Quality of Life (N-QOL) Score | Starting at baseline and then every 2 weeks during each treatment phase | 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. |
| Participant's Opinion of Ease of Device Use | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. | 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 |
| Participant's Comfort Level Associated With Device/Treatment | After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first. | 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. |
| PROMIS Sleep Disturbance - Short Form 4a Score | Starting at baseline and then every 7 days during each treatment phase | 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. |
Countries
United States
Participant flow
Recruitment details
Potential subjects were identified and enrolled by the participating clinical research sites.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Hollister Female Urinary Pouch, Then PureWick The Hollister Female Urinary Pouch is used for the first 4 weeks, followed by cross-over to the PureWick™ System. | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | PureWick, Then Hollister Female Urinary Pouch | Hollister Female Urinary Pouch, Then PureWick | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 74.3 years STANDARD_DEVIATION 11.1 | 76.3 years STANDARD_DEVIATION 18 | 75.3 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 1 / 5 |
| other Total, other adverse events | 1 / 11 | 0 / 5 |
| serious Total, serious adverse events | 1 / 11 | 1 / 5 |
Outcome results
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.
Time frame: Daily for 28 days during each treatment phase
Population: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PureWick System | Daily Average Skin Irritation Score Using the Draize Scale | 0.06 score on a scale | Standard Deviation 0.12 |
| Hollister Female Urinary Pouch External Collection Device | Daily Average Skin Irritation Score Using the Draize Scale | 0.03 score on a scale | Standard Deviation 0.05 |
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.
Time frame: Daily for 28 days during each treatment phase
Population: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | Daily Average Urine Capture Rate (Percentage) | Overall | 79.3 Percentage of urine captured | Standard Deviation 7.2 |
| PureWick System | Daily Average Urine Capture Rate (Percentage) | Treatment Phase 1 | 82.4 Percentage of urine captured | Standard Deviation 6 |
| PureWick System | Daily Average Urine Capture Rate (Percentage) | Treatment Phase 2 | 75.6 Percentage of urine captured | Standard Deviation 7.3 |
| Hollister Female Urinary Pouch External Collection Device | Daily Average Urine Capture Rate (Percentage) | Overall | 34.3 Percentage of urine captured | Standard Deviation 18.5 |
| Hollister Female Urinary Pouch External Collection Device | Daily Average Urine Capture Rate (Percentage) | Treatment Phase 1 | 24.2 Percentage of urine captured | Standard Deviation 3.2 |
| Hollister Female Urinary Pouch External Collection Device | Daily Average Urine Capture Rate (Percentage) | Treatment Phase 2 | 49.4 Percentage of urine captured | Standard Deviation 24.2 |
p-value: 0.076paired T-test
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.
Time frame: Starting at baseline and then every 2 weeks during each treatment phase
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | Nocturia Quality of Life (N-QOL) Score | Week 1-2 | 60.0 score on a scale | Standard Deviation 29.5 |
| PureWick System | Nocturia Quality of Life (N-QOL) Score | Week 3-4 | 65.5 score on a scale | Standard Deviation 23.1 |
| PureWick System | Nocturia Quality of Life (N-QOL) Score | Week 1-2 change from Baseline | 6.7 score on a scale | Standard Deviation 17.9 |
| PureWick System | Nocturia Quality of Life (N-QOL) Score | Week 3-4 change from Baseline | 12.3 score on a scale | Standard Deviation 15.4 |
| PureWick System | Nocturia Quality of Life (N-QOL) Score | Baseline | 54.4 score on a scale | Standard Deviation 25.8 |
| Hollister Female Urinary Pouch External Collection Device | Nocturia Quality of Life (N-QOL) Score | Week 3-4 change from Baseline | -1.0 score on a scale | Standard Deviation 30.9 |
| Hollister Female Urinary Pouch External Collection Device | Nocturia Quality of Life (N-QOL) Score | Baseline | 55.7 score on a scale | Standard Deviation 23.6 |
| Hollister Female Urinary Pouch External Collection Device | Nocturia Quality of Life (N-QOL) Score | Week 1-2 | 64.6 score on a scale | Standard Deviation 2.9 |
| Hollister Female Urinary Pouch External Collection Device | Nocturia Quality of Life (N-QOL) Score | Week 1-2 change from Baseline | 15.6 score on a scale | Standard Deviation 25 |
| Hollister Female Urinary Pouch External Collection Device | Nocturia Quality of Life (N-QOL) Score | Week 3-4 | 47.9 score on a scale | Standard Deviation 2.9 |
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.
Time frame: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Population: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device Placement | 4.3 score on a scale | Standard Deviation 0.7 |
| PureWick System | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device During Sleep | 4.2 score on a scale | Standard Deviation 1 |
| PureWick System | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device Removal | 4.3 score on a scale | Standard Deviation 0.5 |
| PureWick System | Participant's Comfort Level Associated With Device/Treatment | Likelihood to Recommend Device | 4.5 score on a scale | Standard Deviation 1 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Comfort Level Associated With Device/Treatment | Likelihood to Recommend Device | 1.0 score on a scale | Standard Deviation 0 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device Placement | 2.5 score on a scale | Standard Deviation 1.7 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device Removal | 1.0 score on a scale | Standard Deviation 0 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Comfort Level Associated With Device/Treatment | Comfort of Device During Sleep | 3.0 score on a scale | Standard Deviation 1.4 |
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
Time frame: After completion of each 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Population: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | Participant's Opinion of Ease of Device Use | Ease of Device Placement | 4.4 score on a scale | Standard Deviation 0.8 |
| PureWick System | Participant's Opinion of Ease of Device Use | Ease of Device Removal | 4.4 score on a scale | Standard Deviation 0.8 |
| PureWick System | Participant's Opinion of Ease of Device Use | Dryness Experienced | 2.8 score on a scale | Standard Deviation 1.1 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Opinion of Ease of Device Use | Ease of Device Placement | 2.0 score on a scale | Standard Deviation 0.8 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Opinion of Ease of Device Use | Ease of Device Removal | 2.0 score on a scale | Standard Deviation 1.4 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Opinion of Ease of Device Use | Dryness Experienced | 1.3 score on a scale | Standard Deviation 0.5 |
Secondary
Participant's Tolerability of Device/Treatment
Participant's tolerability is determined by the number of days of actual device use.
Time frame: After completion of the 28-day treatment phase or at the time of treatment discontinuation, whichever comes first.
Population: All enrolled and randomized participants were included in the endpoint analysis (ITT Population)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | Participant's Tolerability of Device/Treatment | Treatment Phase 1 | 23.8 days | Standard Deviation 9.3 |
| PureWick System | Participant's Tolerability of Device/Treatment | Treatment Phase 2 | 23.2 days | Standard Deviation 8.2 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Tolerability of Device/Treatment | Treatment Phase 1 | 10.7 days | Standard Deviation 13.4 |
| Hollister Female Urinary Pouch External Collection Device | Participant's Tolerability of Device/Treatment | Treatment Phase 2 | 22.0 days | Standard Deviation 7.1 |
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.
Time frame: Starting at baseline and then every 7 days during each treatment phase
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 8 | 52.4 score on a scale | Standard Error 3.4 |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 22 | 54.3 score on a scale | Standard Error 3.4 |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 15 | 50.5 score on a scale | Standard Error 3.4 |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 22 change from Baseline | -3.6 score on a scale | — |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Baseline | 57.9 score on a scale | Standard Error 3.3 |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 29 | 54.3 score on a scale | Standard Error 3.4 |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 15 change from Baseline | -7.4 score on a scale | — |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 29 change from Baseline | -3.6 score on a scale | — |
| PureWick System | PROMIS Sleep Disturbance - Short Form 4a Score | Day 8 change from Baseline | -5.5 score on a scale | — |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 29 change from Baseline | 3.6 score on a scale | — |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Baseline | 54.3 score on a scale | Standard Error 3.4 |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 8 | 59.8 score on a scale | Standard Error 3.3 |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 8 change from Baseline | 5.5 score on a scale | — |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 15 | 56.1 score on a scale | Standard Error 3.4 |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 15 change from Baseline | 1.8 score on a scale | — |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 22 | 63.8 score on a scale | Standard Error 3.4 |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 22 change from Baseline | 9.5 score on a scale | — |
| Hollister Female Urinary Pouch External Collection Device | PROMIS Sleep Disturbance - Short Form 4a Score | Day 29 | 57.9 score on a scale | Standard Error 3.3 |