Urinary Catheter-Related DiscomfortNCT03341468
Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort
A study testing Urethral catheter immobilization in people with Urinary Catheter-Related Discomfort, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized controlled study to determine the efficacy and safety of a patented urethral catheter support device designed to reduce discomfort associated with urethral catheter mobility in males. Movement of a catheter within the urethra is a source of discomfort for patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Catheter-Related Discomfort
- What is being tested?
- Urethral catheter immobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo radical prostatectomy at the Massachusetts General Hospital
- Anticipated intra-operative placement of an 18 or 20 French, latex or silicone urethral catheter at the conclusion of the operation (standard of care)
- At least 18 years of age
Who cannot join
- Inability to speak, read or understand English
- Apparent sore, rash, or infection on the penis
- Anatomic abnormalities that would prevent proper application and use of the device
- Patients with significant physical or mental disability that, in the opinion of the treating surgeon, might prevent safe placement or removal of the device, or completion of the symptom-based survey.
- Patients with fragile skin
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Use of a Urethral Catheter Immobilization Device to Reduce Pain and Discomfort Associated With Catheter Mobility in Post-Prostatectomy Patients
This is a randomized controlled study to determine the efficacy and safety of a patented urethral catheter support device designed to reduce discomfort associated with urethral catheter mobility in males.
Movement of a catheter within the urethra is a source of discomfort for patients. The investigators hypothesize that this discomfort can be reduced by using an external device designed to securely fasten the catheter to the penis.
Read the detailed description
Indwelling urethral catheters are a source of discomfort and pain in males, particularly when in place for extended periods of time. All patients require catheterization for a minimum of 10 days following radical prostatectomy. Currently, catheters are secured to the patient's leg using tape or an elastic leg strap. This point of securing, however, allows the tip of the penis and the urethral meatus to move in different vectors from the catheter. Data demonstrating urethral catheter hypermobility as an etiology of pain and discomfort have not been reported. However, clinical experience suggests that this type of catheter mobility is associated with significant discomfort.
It is predicted that the use of an external urethral catheter immobilization device (Patent: Simpson et al., US8500719, 2013) designed to secure/minimize catheter movement relative to the tip of the penis will greatly improve catheter associated pain and discomfort in men undergoing radical prostatectomy. The catheter immobilization device is an FDA-approved, 510(k) exempt, pliant tubular structure comprised of Suprazote Foam (Zotefoams) that surrounds the penile shaft. The foam support has a rigidity greater than that of the flaccid penis. It is bi- lobed (i.e., two identical halves) that hinge together to close around the tip of the penis with an aperture aligned with the urethra. The catheter extends through this opening and is secured to the device does not alter the urethral catheter in any fashion. The device limits catheter movement radial to the axis of the catheter. This, in turn, keeps the catheter in line with the urethra, reducing abrasion and traction to the meatus and urethra.
To test the hypothesis, a randomized-controlled trial will be performed in male patients who underwent radical prostatectomy. These men will be randomized to two arms: one arm will have the device fitted around their catheter after surgery is complete while the other will not have the device fitted. Outcome measures involving catheter-related pain and discomfort will then be assessed until the urethral catheter is removed per standard of care after radical prostatectomy.
- Conditions
- Urinary Catheter-Related Discomfort
- Being tested
- Urethral catheter immobilization
- Keywords
- Urethral catheter discomfort, Urethral catheter pain, Urethral catheter immobilization device, Prolonged urethral catheterization, Foley catheter, Urinary catheter, Indwelling urethral catheter support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethral catheter immobilizationDevice
Also called Indwelling urethral catheter support
Subjects assigned to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial.
Subjects will be asked to fill out a symptom-based questionnaire prior to leaving the office. This will conclude their participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Urethral catheter immobilization | Experimental | Subjects randomized to the intervention group will undergo radical prostatectomy with placement of the urethral catheter per the standard of care. The urethral catheter immobilization device will be applied in the operating room prior to the patient being transported to the recovery room. Subjects will be informed on safe use of the device and must demonstrate competency in removing and replacing the device prior to discharge. Subjects will also be given an elastic leg strap, which they may use concurrently with the device. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care, at which the device will no longer be needed. Receives: Device: Urethral catheter immobilization |
| No urethral catheter immobilization | No intervention | Subjects randomized to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral catheter related pain/discomfort
To be assessed via a proprietary questionnaire that is multiple choice and designed to determine the nature of catheter related pain/discomfort. Pain is to be measured on a scale of 1 to 10. Subsequent descriptions of the pain (location, aggravating factors, relieving factors, etc.) and impact are to be answered as multiple choice questions so as to structure the responses without limiting the response.
Measured: At follow-up visit for foley removal (10 days after surgery)
Secondary outcomes (1)
Adverse events secondary to urethral immobilization
Complications related to the urethral catheterization immobilization device will be assessed including pain/discomfort related to the device itself, urinary tract infection, skin rash, compromised skin integrity, skin infection, penile edema, restricted blood flow to penis, penile necrosis secondary to restricted blood flow, tightness or discomfort during erection, etc.
Measured: Through post-operative day # 1 and at follow-up visit for foley removal (10 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Apr 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: PI confirmed no subjects consented and stated study not started due to insufficient staffing and once staff on board, the COVID-19 public health emergency occurred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Catheter-Related DiscomfortStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahin Tabatabaei, Massachusetts General Hospital
- Investigators
- Shahin Tabatabaei, MD, Principal investigator, Massachusetts General Hospital, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341468
- Sponsor's protocol ID
- 2017P001343
- Status last verified
- May 2021
- First submitted
- 16 Oct 2017
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Urethral Catheter Immobilization Device to Reduce Pain and Discomfort Associated With Catheter Mobility in Post-Prostatectomy Patients
- ClinicalTrials.gov ID
- NCT03341468
- Acronym / sponsor ID
- 2017P001343
- Conditions
- Urinary Catheter-Related Discomfort
- Keywords
- Urethral catheter discomfort, Urethral catheter pain, Urethral catheter immobilization device, Prolonged urethral catheterization, Foley catheter, Urinary catheter, Indwelling urethral catheter support
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI confirmed no subjects consented and stated study not started due to insufficient staffing and once staff on board, the COVID-19 public health emergency occurred.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study to determine the efficacy and safety of a patented urethral catheter support device designed to reduce discomfort associated with urethral catheter mobility in males.
Movement of a catheter within the urethra is a source of discomfort for patients. The investigators hypothesize that this discomfort can be reduced by using an external device designed to securely fasten the catheter to the penis.
Detailed description
Indwelling urethral catheters are a source of discomfort and pain in males, particularly when in place for extended periods of time. All patients require catheterization for a minimum of 10 days following radical prostatectomy. Currently, catheters are secured to the patient's leg using tape or an elastic leg strap. This point of securing, however, allows the tip of the penis and the urethral meatus to move in different vectors from the catheter. Data demonstrating urethral catheter hypermobility as an etiology of pain and discomfort have not been reported. However, clinical experience suggests that this type of catheter mobility is associated with significant discomfort.
It is predicted that the use of an external urethral catheter immobilization device (Patent: Simpson et al., US8500719, 2013) designed to secure/minimize catheter movement relative to the tip of the penis will greatly improve catheter associated pain and discomfort in men undergoing radical prostatectomy. The catheter immobilization device is an FDA-approved, 510(k) exempt, pliant tubular structure comprised of Suprazote Foam (Zotefoams) that surrounds the penile shaft. The foam support has a rigidity greater than that of the flaccid penis. It is bi- lobed (i.e., two identical halves) that hinge together to close around the tip of the penis with an aperture aligned with the urethra. The catheter extends through this opening and is secured to the device does not alter the urethral catheter in any fashion. The device limits catheter movement radial to the axis of the catheter. This, in turn, keeps the catheter in line with the urethra, reducing abrasion and traction to the meatus and urethra.
To test the hypothesis, a randomized-controlled trial will be performed in male patients who underwent radical prostatectomy. These men will be randomized to two arms: one arm will have the device fitted around their catheter after surgery is complete while the other will not have the device fitted. Outcome measures involving catheter-related pain and discomfort will then be assessed until the urethral catheter is removed per standard of care after radical prostatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urethral catheter immobilization | Experimental | Device: Urethral catheter immobilizationSubjects randomized to the intervention group will undergo radical prostatectomy with placement of the urethral catheter per the standard of care. The urethral catheter immobilization device will be applied in the operating room prior to the patient being transported to the recovery room. Subjects will be informed on safe use of the device and must demonstrate competency in removing and replacing the device prior to discharge. Subjects will also be given an elastic leg strap, which they may use concurrently with the device. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care, at which the device will no longer be needed. |
| No urethral catheter immobilization | No intervention | –Subjects randomized to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo radical prostatectomy at the Massachusetts General Hospital
- Anticipated intra-operative placement of an 18 or 20 French, latex or silicone urethral catheter at the conclusion of the operation (standard of care)
- At least 18 years of age
Key exclusion criteria (5 listed)
- Inability to speak, read or understand English
- Apparent sore, rash, or infection on the penis
- Anatomic abnormalities that would prevent proper application and use of the device
- Patients with significant physical or mental disability that, in the opinion of the treating surgeon, might prevent safe placement or removal of the device, or completion of the symptom-based survey.
- Patients with fragile skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urethral catheter immobilizationAlso: Indwelling urethral catheter supportSubjects assigned to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial. Subjects will be asked to fill out a symptom-based questionnaire prior to leaving the office. This will conclude their participation in the study. | Device | Urethral catheter immobilization |
Primary outcome
Urethral catheter related pain/discomfort
Time frame: At follow-up visit for foley removal (10 days after surgery)
To be assessed via a proprietary questionnaire that is multiple choice and designed to determine the nature of catheter related pain/discomfort. Pain is to be measured on a scale of 1 to 10. Subsequent descriptions of the pain (location, aggravating factors, relieving factors, etc.) and impact are to be answered as multiple choice questions so as to structure the responses without limiting the response.
1 secondary outcome
Adverse events secondary to urethral immobilization
Time frame: Through post-operative day # 1 and at follow-up visit for foley removal (10 days after surgery)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahin Tabatabaei, MD principal investigator
Massachusetts General Hospital, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethral catheter immobilization in people with Urinary Catheter-Related Discomfort, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethral catheter related pain/discomfort (time frame: At follow-up visit for foley removal (10 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.