Urinary RetentionNCT02643849

Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men

A study testing The Spanner Temporary Prostatic Stent in people with Urinary Retention, run by SRS Medical at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Urinary Retention
What is being tested?: The Spanner Temporary Prostatic Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 6 sitesUnited States
Study dates: Aug 2016to Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 45 years;
In urinary retention and catheterized (indwelling or intermittent) for less than 180 days;
Documented diagnostic history (within 180 days of study) of detrusor contractility (>= 15 cmH2O) confirmed via pressure-flow test;
Negative Urinalysis on Visit 1;
Not a candidate for pharmacologic, minimally invasive or surgical treatment of the prostate;
Charlson Weighted Index of Comorbidity Score >= 1;

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Willing and able to sign the Informed Consent Form;
Willing and able to complete the follow-up protocol requirements;
Experiencing catheter-induced discomfort.

Who cannot join

Current use of a urinary catheter daily for greater than 180 consecutive days immediately preceding entering into the study;
Positive Urinalysis on Visit 1;
Current or recent (within the last 6 months) urinary tract disease including urethral stricture, bladder stones, and other significant urological conditions or surgery;
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect the function of the lower urinary tract;
History of conditions associated with neurogenic bladder, including spinal cord injury, multiple sclerosis, or Parkinson's disease;
Use of anticholinergic medication;

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Gross hematuria when catheter is removed on Visit 1;
Known or suspected prostate cancer;
Prior pelvic irradiation therapy;
Prostatic urethral length < 4 cm or > 9 cm (combined length from the top proximal side of the bladder neck to the bottom distal side of the external sphincter);
Intravesical enlargement of the median lobe of the prostate.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Brooklyn Urology Research Group
Brooklyn, New York, 11215
Atlantic Urology
Daytona Beach, Florida, 32114
Greater Boston Urology
Hingham, Massachusetts, 02043
Advanced Urology Specialists
Oxford, Florida, 34484
Urology Specialists of West Florida
Palm Harbor, Florida, 34684
Pinellas Urology Inc
South Pasadena, Florida, 33707

Other trials in United States

About this study

Official title: Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments

The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.

Conditions: Urinary Retention
Being tested: The Spanner Temporary Prostatic Stent
Medical subject headings: Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Spanner Temporary Prostatic StentDevice

Study groups in NCT02643849
Study group	Role	What they receive
Spanner	Experimental	Not described Receives: Device: The Spanner Temporary Prostatic Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.
Measured: 90 days

Secondary outcomes (1)

Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days
To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Feb 2019

First posted31 Dec 2015 (estimated)
Study startAug 2016
Primary completionJan 2019
Study completionFeb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643849
Sponsor's protocol ID: SRS 1.0
Status last verified: Nov 2020
First submitted: 22 Dec 2015
Last updated: 19 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer

All Urinary Retention trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments
ClinicalTrials.gov ID: NCT02643849
Acronym / sponsor ID: SRS 1.0
Conditions: Urinary Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: SRS MedicalIndustry (pharma, biotech, devices)
Study start: Aug 2016 (actual)
Primary completion: Jan 2019 (actual)
Study completion: Feb 2019 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Posted 19 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Spanner	Experimental	Device: The Spanner Temporary Prostatic Stent

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age > 45 years;
In urinary retention and catheterized (indwelling or intermittent) for less than 180 days;
Documented diagnostic history (within 180 days of study) of detrusor contractility (>= 15 cmH2O) confirmed via pressure-flow test;
Negative Urinalysis on Visit 1;
Not a candidate for pharmacologic, minimally invasive or surgical treatment of the prostate;

Key exclusion criteria (11 listed)

Current use of a urinary catheter daily for greater than 180 consecutive days immediately preceding entering into the study;
Positive Urinalysis on Visit 1;
Current or recent (within the last 6 months) urinary tract disease including urethral stricture, bladder stones, and other significant urological conditions or surgery;
Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affect the function of the lower urinary tract;
History of conditions associated with neurogenic bladder, including spinal cord injury, multiple sclerosis, or Parkinson's disease;

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
The Spanner Temporary Prostatic Stent	Device	Spanner

Primary outcome

Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
Time frame: 90 days
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.

1 secondary outcome

Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days
Time frame: 30 days

Results and safety

Results posted to the registry on 19 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spanner	107	82

Primary outcome: Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Spanner n = 107
Value	79

Population analysed: Intent to Treat Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AE Data was collected from time of enrollment through 14 days after the final stent was removed, up to 4 months.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spanner	15 of 107 (14%)	81 of 107 (75.7%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Urinary Retention

Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Spanner Temporary Prostatic Stent in people with Urinary Retention, run by SRS Medical at 6 sites 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02643849.

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 19 Nov 2020; AzTrials last refreshed its copy on 4 Nov 2026.