Consumer Evaluation of an Investigational Intermittent Catheter

This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use.

Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference.

The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.

Study Overview

• Status: Recruiting
• Conditions: Urinary Retention; Neurogenic Bladder
• Intervention / Treatment: Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Detailed Description

This is a prospective, single-arm, fixed-sequence, within-participant clinical evaluation of an investigational intermittent catheter. Eligible adult male participants in the United States who currently use hydrophilic intermittent catheters will first use 30 of their usual catheters and then 30 study catheters. During both catheter-use periods, participants will complete daily questionnaires regarding catheter use and health changes and will complete evaluation forms assessing ease of use, catheter performance, comfort, confidence, satisfaction, and comparative preference. Safety will be evaluated through reported health changes and adverse events. The study is intended to provide descriptive information regarding the initial safety, usability, and performance of the investigational catheter relative to participants' current intermittent catheter products.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Recruiting
      • Hollister Incorporated
      • Contact: Hollister Incorporated; Phone Number: (847) 680-1000; Email: researchstudy@hollister.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• is living in the USA
• is male
• is at least 22 years of age
• can speak, read, and write in English
• is self-catheterizing 3 or more times a day
• has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month

• currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:

  1. Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144)
  2. Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144)
  3. Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)
  4. Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
  5. Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
  6. Hollister Incorporated Onli Nelaton (SKU: 82144-30)
  7. Hollister Incorporated Onli Coudé (SKU: 85144)
  8. Wellspect LoFric Origo Nelaton (SKU: 443 14 40)
  9. Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40)
  10. Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40)
  11. Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40)
  12. Coloplast SpeediCath Standard Male (SKU: 28414)
  13. Coloplast SpeediCath Male Coudé Tip (SKU: 28494)
  14. Coloplast SpeediCath Flex Coudé Pro (SKU: 20014)
  15. Convatec GentleCath Glide Male Straight Tip (SKU: 421567)
  16. Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910)
  17. Convatec GentleCath Air Male Straight Tip (SKU:510690)
  18. Convatec GentleCath Air Male Coude Tip (SKU:510696)
  19. Convatec GentleCath Hydrophilic, 14FR, Straight (SKU: 508996)
  20. Convatec GentleCath Hydrophilic, 14FR, Coude (SKU: 509001)
  21. Convatec Cure - Hydrophilic Cure Catheter Straight Tip (SKU: HM14)
  22. Convatec Cure - Hydrophilic Cure Catheter Coudé Tip (SKU: HM14C)
  23. Bard - Magic3® Go Male, 14FR, Straight (SKU:53814G)
  24. Bard - Magic3® Go Male, 14FR, Coude (SKU:50814G)
  25. Bard - Magic3®, 14FR, Straight (SKU: 53614G)
  26. Bard - Magic3®, 14FR, Straight (SKU: 53614) aa. Bard - Magic3®, 14FR, Coude (SKU: 50614)
• is willing and able to follow the study protocol procedures including completing online questionnaires as demonstrated by signing the Informed Consent
• is willing to switch from their current, typical intermittent catheter to the study-provided study products (e.g., study catheters) during the latter portion of the study
• is willing to provide permission via the study informed consent and HIPAA Authorization Form for study staff to contact prescribing healthcare provider for a copy of their active prescription. Alternatively subject can opt to provide study staff with their active prescription.

Exclusion Criteria:

• is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)
• is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)

• is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:

  1. Acthar Gel
  2. corticotropin
  3. Agamree
  4. vamorolone
  5. budesonide
  6. Cortef
  7. hydrocortisone
  8. Cortrophin Gel
  9. corticotrophin
  10. dexamethasone
  11. deflazacort
  12. prednisone
  13. Emflaza
  14. Eohilia
  15. fludrocortisone
  16. Jaythari
  17. Orapred ODT
  18. prednisolone
  19. Pyquvi
  20. Rayos
  21. Tarpeyo
  22. Uceris
• currently has urinary tract infection (UTI) symptoms or has been diagnosed with a UTI by a healthcare provider in the last 2 weeks
• has a retracted penis
• has skin irritation or lesions (sores) on the penis
• Performs non-urethral catheterization
• Has participated in a study involving actual use of a study urethral IC (i.e. inserting/removing) within the last 30 days
• Is currently an employee of Hollister Incorporated or any other intermittent catheter manufacturer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Catheter; Participants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context.	Device: An intermittent urethral urinary catheter with a tip, tube and drainage eyelets; An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use	Number and nature of participant-reported health changes and adverse events collected during both the control-catheter period and the study-catheter period. Safety events will be categorized by incidence, severity, and relatedness.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Ease of Use of the Catheter	Participant-reported overall ease of use of the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier overall use.	Through completion of both catheter-use periods, approximately 6 to 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening	Participant-reported ease of inserting the protective tip into the urethral opening, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier insertion. Applicable for the study catheter and usual catheters with a protective tip.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening	Participant-reported ease of inserting the catheter itself into the urethral opening for usual catheters without a protective tip, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier insertion.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra	Participant-reported ease of advancing the catheter through the protective tip into the urethra, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier advancement.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder	Participant-reported ease of advancing the catheter through the urethra to the bladder, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier advancement.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Drainage and Bladder Emptying	Participant-reported ease of draining the bladder with the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier bladder drainage and emptying.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder	Assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Higher scores indicate less worry and a more favorable response.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Urine Flow Restarting Before Complete Catheter Removal	Participant-reported occurrence of urine starting to flow again before the catheter was completely removed from the urethra/body. Assessed as Yes or No.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter	Participant-reported occurrence of pausing to allow remaining urine to drain through the catheter during removal. Assessed as Yes or No.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter	Participant-reported actions taken to help remaining urine drain through the catheter, assessed as a check-all-that-apply item. Each response option will be summarized separately by number of participants selecting it.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ease of Withdrawing the Catheter From the Urethra	Participant-reported ease of withdrawing the catheter from the urethra, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier withdrawal.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability to Insert the Catheter Without Contaminating or Touching the Portion That Enters the Body	Participant-reported agreement with the statement that the catheter can be inserted without contaminating or touching the portion that enters the body, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate a more favorable response.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule	Participant-reported agreement with the statement that the catheter helps the participant follow the catheterization schedule recommended by a doctor or nurse, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate a more favorable response.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Insertion	Participant-reported discomfort during catheter insertion, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Type of Discomfort During Catheter Insertion	Participant-reported type of discomfort experienced during catheter insertion, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.	Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Insertion	Participant-reported frequency of discomfort during catheter insertion, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Coughing or Deep Breathing to Assist Catheter Insertion Into the Bladder	Participant-reported occurrence of coughing and/or taking a deep breath to help the catheter enter the bladder during insertion. Assessed by categorical response: Cough, Deep Breath, Both, or Neither.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra	Participant-reported occurrence of turning or twisting the catheter during advancement through the urethra. Assessed as Yes or No.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Actions Taken During Catheter Insertion	Participant-reported actions taken during catheter insertion, assessed as a check-all-that-apply item. Each response option will be summarized separately by number of participants selecting it.	Through completion of both catheter-use periods, approximately 6 to 20 days
Correct Orientation of the Funnel Notch Before Insertion Among Participants Using a Curved-Tip Catheter	Among participants using a curved-tip catheter, participant-reported frequency of lining up the notch on the funnel so the tip pointed up before insertion, assessed by ordinal categorical response ranging from all the time to not at all, plus categories for not knowing about the notch or not using a coudé catheter.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder	Among participants using a curved-tip catheter, participant-reported occurrence/frequency of turning the catheter during advancement into the bladder, assessed by ordinal categorical response ranging from all the time to not at all.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter	Participant-reported burden associated with lining up the funnel notch and/or turning a curved-tip catheter during insertion, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Much more burdensome, 2 = Moderately more burdensome, 3 = A little more burdensome, and 4 = Not more burdensome. Lower scores indicate greater burden.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder	Participant-reported difficulty/ease of pushing the catheter through the urethra into the bladder, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier passage.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Bladder Drainage	Participant-reported discomfort during bladder drainage, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Bladder Drainage	Participant-reported frequency of discomfort during bladder drainage, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Bladder Drainage	Participant-reported discomfort symptoms during bladder drainage, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.	Through completion of both catheter-use periods, approximately 6 to 20 days
Occurrence of Discomfort During Catheter Removal	Participant-reported discomfort during catheter removal, assessed on a 5-point ordinal scale coded 1 to 5: 1 = No discomfort, 2 = A little discomfort, 3 = Some discomfort, 4 = A lot of discomfort, and 5 = Extreme discomfort. Higher scores indicate worse discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Frequency of Discomfort During Catheter Removal	Participant-reported frequency of discomfort during catheter removal, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Always, 2 = Often, 3 = Sometimes, and 4 = Rarely. Lower scores indicate more frequent discomfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Discomfort Symptoms During Catheter Removal	Participant-reported discomfort symptoms during catheter removal, assessed as a check-all-that-apply item. Each symptom category will be summarized separately by number of participants selecting it.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Comfort Using the Catheter	Participant-reported agreement with the statement "I feel comfortable using the catheter," assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater comfort.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Comfortably With Each Use	Participant-reported agreement with the statement that the catheter will slide in comfortably every time it is used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Will Slide in Easily With Each Use	Participant-reported agreement with the statement that the catheter will slide in easily every time it is used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully	Participant-reported agreement with the statement that the catheter allows the bladder to empty fully, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence in Successfully Using the Catheter	Participant-reported agreement with the statement "I am confident I can successfully use the catheter," assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Time to Participant-Reported Confidence in Using the Catheter	Participant-reported time required to feel confident using the catheter, assessed on an 11-category ordinal scale: Less than 1 day, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 1 week to 10 days, More than 10 days, or I still do not feel confident. Lower categories indicate earlier confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Support Confidence During Use	Participant-reported agreement with the statement that the catheter allows the participant to feel confident, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Confidence When the Catheter Was Inserted	Participant-reported confidence when the catheter was inserted, assessed on a 4-point ordinal scale coded 1 to 4: 1 = Very confident, 2 = Somewhat confident, 3 = A little confident, and 4 = Not confident. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Ability of the Catheter to Help the Participant Feel Confident When Used	Participant-reported agreement with the statement that the catheter helps the participant feel confident when used, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Strongly Agree, 2 = Agree, 3 = Neither Agree nor Disagree, 4 = Disagree, and 5 = Strongly Disagree. Lower scores indicate greater confidence.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Overall Satisfaction With the Catheter	Participant-reported overall satisfaction with the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, and 5 = Very dissatisfied. Lower scores indicate greater satisfaction.	Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-Reported Bladder Emptying Time With the Investigational Catheter Compared With the Participant's Current Intermittent Catheter	Participant-reported comparison of how long it took to empty the bladder with the investigational catheter relative to the participant's current intermittent catheter. Assessed by categorical comparative response.	At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Advancement Performance of the Investigational Catheter Compared With the Participant's Current Intermittent Catheter	Participant-reported comparison of how the investigational catheter performed when advancing through the urethra into the bladder to drain urine relative to the participant's current intermittent catheter. Assessed by categorical comparative response.	At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Likelihood of Using the Investigational Catheter if Commercially Available in the Participant's Usual Type and Package	Participant-reported likelihood of using the investigational catheter if it were commercially available in the participant's usual type and package, assessed by ordinal categorical response. More favorable responses indicate greater likelihood of use.	At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period
Participant-Reported Overall Catheter Preference Between the Investigational Catheter and the Participant's Current Intermittent Catheter	Participant-reported overall preference between the investigational catheter and the participant's current intermittent catheter, assessed by categorical response indicating preferred catheter.	At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Investigators: Principal Investigator: Jessica Simmons, Hollister Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Retention; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 6049-CONT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Will individual participant data be available (including data dictionaries)? No

What data in particular will be shared? Not available

What other documents will be available? Not available

When will data be available (start and end dates)? N/A

With whom? N/A

For what types of analyses? N/A

By what mechanism will data be made available? N/A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No