An interventional study of M3 "MINI CATHETER" in Urinary Retention, sponsored by Dr. Gaines W. Hammond Jr. MD FACS. Status unknown at 1 site in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Dr. Gaines W. Hammond Jr. MD FACS · Not applicable, Interventional, and Treatment
Among 98 studies in Urinary Retention with a site in United States — 13 open to participants now, 18 under way, 1 of them phase 3. Urinary Retention · United States.
Among the 98 studies in Urinary Retention with a site in United States, this one is the 54th largest by planned enrollment of the 81 interventional ones, is one of 12 that started in 2017, is one of 53 with no phase, and was the 44th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →13 of the 98 studies in Urinary Retention with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 31 Urinary Retention studies recruiting now, 23 (74%) set no upper age limit and 5 (16%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 50 Years and older · male · healthy volunteers too.
The full table on the hub →98 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 12 started in 2017.
Median enrollment 88 across the 81 interventional studies, 90 across the 17 observational. Of the 69 that completed or were terminated, 35 (51%) have results posted.
18 of 98 have an industry lead sponsor. The 10 most frequent:
Dr. Gaines W. Hammond Jr. MD FACS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Dr. Gaines W. Hammond Jr. MD FACS has 2 studies filed under Urinary Retention — fewer than ten, so there is no comparison to draw.
8 of the studies in Urinary Retention with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06179654The Cleveland ClinicPreoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate | 2026-11-30 |
| NCT04597372Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
| NCT07174349Mayo ClinicUroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery | 2027-01-31 |
| NCT06918067Wake Forest University Health SciencesComparison of Urinary Flow Study | 2027-03 |
Among the 98 studies in Urinary Retention with a site in United States, from their registry updates:
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.
This single arm, prospective study is designed to produce valid scientific evidence regarding:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: 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."
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.
Time frame: 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.
Time frame: Weekly from time of placement up to 28 days.
Measurement of Bladder Drainage
The Post Void Residual after M3 placement
Time frame: 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.
Time frame: At time of placement and weekly up to 28 days.
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
Time frame: From time of Placement up to 28 days.
Plan to share: Yes — There is a plan to make IPD and related data dictionaries available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After completion of the study anticipated to be in March 2018 for a 2 year period of time.
Access criteria: Appropriate credentials to access material with the identifying markers of patients identity withheld.
No publications or documents are linked to this record.
Started Jul 2017 (actual). Primary completion is estimated for Mar 2018, 8 months after the start.
Of 70 non-industry interventional studies with no phase under Urinary Retention, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 8 months is below that.
Counting every sponsor, half of 82 studies reached it within 18 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dr. Gaines W. Hammond Jr. MD FACS