Urinary RetentionNCT03339076
A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
A study testing M3 "MINI CATHETER" in people with Urinary Retention, run by Dr. Gaines W. Hammond Jr. MD FACS at 1 site in United States.
Trial summary
The Catheter Science M3 "Mini Catheter" has been developed for management of urinary retention. This temporary device allows for normal functioning of the external striated sphincter. The design contributes to its atraumatic insertion and removal. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- M3 "MINI CATHETER"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to Mar 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males > 50 years of age
- Signed subject informed consent (see Appendix "A")
- Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter
- Inclusion will start once the M3 is placed and a functioning bladder is demonstrated.
Who cannot join
- Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture)
- Gross hematuria
- Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Watson Clinic Llp
Lakeland, Florida, 33805
GAINES W HAMMOND, MD, 863-680-7300, GHAMMOND@WATSONCLINIC.COM
ELAYNE HALL, 863-680-7300, EHALL@WATSONCLINIC.COM
About this study
The Catheter Science M3 "Mini Catheter" has been developed for management of urinary retention. This temporary device allows for normal functioning of the external striated sphincter. The design contributes to its atraumatic insertion and removal. It is a short catheter segment which is attached to a monofilament suture which runs thru the lumen of the urethra and is attached to a small plastic "bobber". This study is designed to validate the reduction in these adverse effects: The suture to the outside allows for repositioning should the device slip back into the bladder and facilitates removal. With volitional voiding and competent external sphincter, patients are able to void spontaneously without the need of a collection device and are continent. The design enhances the flow characteristics and reduces post void residual. Since the M3 does not have a tubular segment thru the tip of the penis or sphincter, biofilm production is eliminated.
Read the detailed description
This single arm, prospective study is designed to produce valid scientific evidence regarding:
- Safety and efficacy of the Catheter Science M3 "Mini Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for a period of time up to but less than 28 days in male patients with prostate outlet obstruction who have been dependent on either a Foley catheter or Intermittent Catheterization.
- The study purpose is to measure the rate of catheter-related urinary tract infections in patients with the M3 in place as compared to the known infection rate for patients with a Foley catheter in place over the same period of time.
A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The M3 de-obstructs the prostatic urethra, allows volitional voiding function in patients with a contractile bladder. A Foley catheter, a pre- amendment device, was considered for a control treatment. Although a Foley catheter is used to establish urinary drainage initially with close to 100% efficacy, it does not allow for voluntary micturition as defined with the coordination of contraction of the bladder with the relaxation of the striated external sphincter. The ability of the bladder to fill and contract with a Foley is altered. The M3 allows for the bladder to fill since the sphincter is not bridged. Volitional micturition is initiated with bladder contraction coordinated with a relaxation of the external striated sphincter. The flow of urine is thru and around the M3 rather than only intraluminal in the Foley. The direction of urine flow with the M3 is in one direction in contrast to the Foley catheter and external collection device which is bi-directionally. The flow of urine back into the bladder has long been viewed as a significant contributor to the CAUTI. The Foley is a passive drainage device which simply drains the bladder with negative pressure produced in a closed system aided with gravity. The laterally placed intake eyes of the Foley are vulnerable to occlusion of the bladder mucosa being pulled into the lumen by the negative pressure of the closed system. The requirement of an external collecting bag coupled with the Foley traversing the entire length of the Urethra, severely impairs activities of daily life. The comparative lifestyle changes between the Foley Catheter, Intermittent Catheter and M3 group is not the focus of this study of the Safety and Efficacy characteristics of the M3 vs Foley comparison, but will be obvious to patients and clinicians.
The retention balloon inflation channel impacts the internal diameter of the Foley. The Balloon prevents complete emptying of the bladder with resultant residual of 10-100cc reported. Since there is no consistent flow of urine around a Foley to help "wash out bacteria" the formation of biofilm is accelerated. The Foley violates the anatomical protective points (penile meatus, sphincter, prostatic urethral and bladder neck) which help prevent bacterial contamination. The M3 CAUTI reduction as compared to the Foley and Intermittent Catheter Group is due to a series of important design features. The removal of a retention balloon allows for the internal diameter to be enlarged. The 3 wings Malecott promotes retention of the device as well as preventing bladder mucosal plugging of the lumen during voiding contractions. This design also promotes an improved post void residual compared to a Foley device. The residual urine in the bladder with a Foley as well a slow flow rate promotes encrustations and occlusion of the Foley.
- Conditions
- Urinary Retention
- Being tested
- M3 "MINI CATHETER"
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M3 "MINI CATHETER"Device
Participants in the study are using either a foley catheter or Clean Intermittent Catheter devices to facilitate bladder drainage. The study is an alternative method of facilitating bladder drainage with the M3 "Mini Catheter."
| Study group | Role | What they receive |
|---|---|---|
| For a single-arm trial | Other | Inclusion Criteria with intervention replacing either a foley catheter or self intermittent catheter with the M3 "Mini Catheter"
1. Males > 50 years of age
2. Signed subject informed consent
3. Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter
4. Inclusion will start once the M3 is placed and a functioning bladder is demonstrated.
Exclusion Criteria
1. Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture)
2. Gross hematuria
3. Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction). Receives: Device: M3 "MINI CATHETER" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of Catheter Acquired Urinary Tract Infections with the M3 Mini Catheter.
1.The study purpose is to measure the rate of catheter-related urinary tract infections in patients with the M3 in place as compared to the known infection rate for patients with a Foley catheter in place over the same period of time.
Measured: Time of placement up to 28 days.
The percentage of M3 removed due to encrustation and blockage of the M3.
The percentage of M3 devices removed due to urinary retention caused by device encrustation.
Measured: Weekly from time of placement up to 28 days.
Measurement of Bladder Drainage
The Post Void Residual after M3 placement
Measured: Weekly from time of placement up to 28 days.
Flow Rate after M3 placement
The flow rate after M3 placement with a bladder volume of at least 120 cc.
Measured: At time of placement and weekly up to 28 days.
Secondary outcomes (1)
Failure of the M3 as a choice of bladder drainage over Foley Catheter or Self Intermittent Catheter drainage
The failure of the M3 to drain the bladder with the requirement to reinstitute Foley Drainage or Self Intermittent Catheter by choice versus M3 Mini Catheter
Measured: From time of Placement up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start7 Jul 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the M3 in establishing urinary drainage and allowing the control of micturition when indwelling for \<28 days in male patients. The total study population will initially include 50 subjects with open enrollment of additional subjects. 1\. Study Timeline and Calendar The maximum indwelling time for the DEVICE should be \<28 days, at which time the DEVICE will be removed, and the patient will be offered the option of insertion of a new M3 Catheter or return to the bladder drainage technique used prior to M3 Catheter insertion. All patients will be followed until patient is off study or until end of study, whichever occurs first.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gaines W. Hammond Jr. MD FACS
- Responsible party
- Sponsor-investigator, Dr. Gaines W. Hammond Jr. MD FACS, Hammond, Gaines W., Jr., M.D. FACS
- Investigators
- GAINES W HAMMOND, MD, Principal investigator, Watson Clinic Center for Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339076
- Sponsor's protocol ID
- Study # 17/10/04
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
- ClinicalTrials.gov ID
- NCT03339076
- Acronym / sponsor ID
- Study # 17/10/04
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Gaines W. Hammond Jr. MD FACS
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 13 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.
The Catheter Science M3 "Mini Catheter" has been developed for management of urinary retention. This temporary device allows for normal functioning of the external striated sphincter. The design contributes to its atraumatic insertion and removal. It is a short catheter segment which is attached to a monofilament suture which runs thru the lumen of the urethra and is attached to a small plastic "bobber". This study is designed to validate the reduction in these adverse effects: The suture to the outside allows for repositioning should the device slip back into the bladder and facilitates removal. With volitional voiding and competent external sphincter, patients are able to void spontaneously without the need of a collection device and are continent. The design enhances the flow characteristics and reduces post void residual. Since the M3 does not have a tubular segment thru the tip of the penis or sphincter, biofilm production is eliminated.
Detailed description
This single arm, prospective study is designed to produce valid scientific evidence regarding:
- Safety and efficacy of the Catheter Science M3 "Mini Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for a period of time up to but less than 28 days in male patients with prostate outlet obstruction who have been dependent on either a Foley catheter or Intermittent Catheterization.
- The study purpose is to measure the rate of catheter-related urinary tract infections in patients with the M3 in place as compared to the known infection rate for patients with a Foley catheter in place over the same period of time.
A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The M3 de-obstructs the prostatic urethra, allows volitional voiding function in patients with a contractile bladder. A Foley catheter, a pre- amendment device, was considered for a control treatment. Although a Foley catheter is used to establish urinary drainage initially with close to 100% efficacy, it does not allow for voluntary micturition as defined with the coordination of contraction of the bladder with the relaxation of the striated external sphincter. The ability of the bladder to fill and contract with a Foley is altered. The M3 allows for the bladder to fill since the sphincter is not bridged. Volitional micturition is initiated with bladder contraction coordinated with a relaxation of the external striated sphincter. The flow of urine is thru and around the M3 rather than only intraluminal in the Foley. The direction of urine flow with the M3 is in one direction in contrast to the Foley catheter and external collection device which is bi-directionally. The flow of urine back into the bladder has long been viewed as a significant contributor to the CAUTI. The Foley is a passive drainage device which simply drains the bladder with negative pressure produced in a closed system aided with gravity. The laterally placed intake eyes of the Foley are vulnerable to occlusion of the bladder mucosa being pulled into the lumen by the negative pressure of the closed system. The requirement of an external collecting bag coupled with the Foley traversing the entire length of the Urethra, severely impairs activities of daily life. The comparative lifestyle changes between the Foley Catheter, Intermittent Catheter and M3 group is not the focus of this study of the Safety and Efficacy characteristics of the M3 vs Foley comparison, but will be obvious to patients and clinicians.
The retention balloon inflation channel impacts the internal diameter of the Foley. The Balloon prevents complete emptying of the bladder with resultant residual of 10-100cc reported. Since there is no consistent flow of urine around a Foley to help "wash out bacteria" the formation of biofilm is accelerated. The Foley violates the anatomical protective points (penile meatus, sphincter, prostatic urethral and bladder neck) which help prevent bacterial contamination. The M3 CAUTI reduction as compared to the Foley and Intermittent Catheter Group is due to a series of important design features. The removal of a retention balloon allows for the internal diameter to be enlarged. The 3 wings Malecott promotes retention of the device as well as preventing bladder mucosal plugging of the lumen during voiding contractions. This design also promotes an improved post void residual compared to a Foley device. The residual urine in the bladder with a Foley as well a slow flow rate promotes encrustations and occlusion of the Foley.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the M3 in establishing urinary drainage and allowing the control of micturition when indwelling for <28 days in male patients. The total study population will initially include 50 subjects with open enrollment of additional subjects. 1. Study Timeline and Calendar The maximum indwelling time for the DEVICE should be <28 days, at which time the DEVICE will be removed, and the patient will be offered the option of insertion of a new M3 Catheter or return to the bladder drainage technique used prior to M3 Catheter insertion. All patients will be followed until patient is off study or until end of study, whichever occurs first.
| Arm | Type | Receives |
|---|---|---|
| For a single-arm trial | Other | Device: M3 "MINI CATHETER"Inclusion Criteria with intervention replacing either a foley catheter or self intermittent catheter with the M3 "Mini Catheter" 1. Males > 50 years of age 2. Signed subject informed consent 3. Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter 4. Inclusion will start once the M3 is placed and a functioning bladder is demonstrated. Exclusion Criteria 1. Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture) 2. Gross hematuria 3. Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males > 50 years of age
- Signed subject informed consent (see Appendix "A")
- Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter
- Inclusion will start once the M3 is placed and a functioning bladder is demonstrated.
Key exclusion criteria (3 listed)
- Inability to undergo bladder catheterization with the M3 due to anatomical challenges (i.e. urethral stricture, bladder neck contracture, false passage or false passages or other history of urethral stricture)
- Gross hematuria
- Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the retention with the bridging of the prostate as bladder dysfunction rather than prostate obstruction).
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 |
|---|---|---|
| M3 "MINI CATHETER"Participants in the study are using either a foley catheter or Clean Intermittent Catheter devices to facilitate bladder drainage. The study is an alternative method of facilitating bladder drainage with the M3 "Mini Catheter." | Device | For a single-arm trial |
Primary outcome
The percentage of Catheter Acquired Urinary Tract Infections with the M3 Mini Catheter.
Time frame: Time of placement up to 28 days.
1.The study purpose is to measure the rate of catheter-related urinary tract infections in patients with the M3 in place as compared to the known infection rate for patients with a Foley catheter in place over the same period of time.
The percentage of M3 removed due to encrustation and blockage of the M3.
Time frame: Weekly from time of placement up to 28 days.
The percentage of M3 devices removed due to urinary retention caused by device encrustation.
Measurement of Bladder Drainage
Time frame: Weekly from time of placement up to 28 days.
The Post Void Residual after M3 placement
Flow Rate after M3 placement
Time frame: At time of placement and weekly up to 28 days.
The flow rate after M3 placement with a bladder volume of at least 120 cc.
1 secondary outcome
Failure of the M3 as a choice of bladder drainage over Foley Catheter or Self Intermittent Catheter drainage
Time frame: From time of Placement up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
Related trials for Urinary Retention
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Postpartum Urinary Retention
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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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.
GAINES W HAMMOND, MD principal investigator
Watson Clinic Center for Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M3 "MINI CATHETER" in people with Urinary Retention, run by Dr. Gaines W. Hammond Jr. MD FACS 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GAINES W HAMMOND, MD (863-687-1322, GHAMMOND@WATSONCLINIC.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of Catheter Acquired Urinary Tract Infections with the M3 Mini Catheter. (time frame: Time of placement up to 28 days.). The study lists 4 primary outcomes in all. 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 21 Nov 2017.