Urethral StricturePhase 3NCT00270504
Memokath® 044TW Stent for Treatment of Urethral Stricture
A Phase 3 study testing Memokath stenting in people with Urethral Stricture, run by Pnn Medical DK at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Memokath stenting
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2002to Nov 2009
- Phase
- Phase 3
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males > 21 years of age
- Recurrent stricture of the bulbar urethra:
- < 50 mm in length on urethrography; and which
- has a segment unable to accommodate a 16Fr flexible cystoscope
- Healthy tissue on both sides of stent
- Urinary flow in the abnormal range of the Siroky nomogram.
- Written informed consent obtained prior to participation in the study
- Patients must be available for all follow-up visits.
Who cannot join
- Strictures:
- outside the bulbous urethra
- associated with, or suspected to be, urethral carcinoma
- secondary to pelvic distraction injuries
- Inability to enlarge the bulbar urethral stricture to > 26 Fr.
- Presence of any other urologic implant
Show all 18Show fewer
- Presence of urethral diverticuli
- History of hypospadias repair
- Presence or prior history of balanitis xerotica obliterans.
- Uncontrolled bleeding disorder
- Active urinary tract infection
- Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation.
- Serum creatinine > 2.0 mg/dl or evidence of progressive renal disease
- Concurrent participation in another clinical investigation
- Current illness that might confound the results of this investigation
- Inability to participate in all of the necessary study activities
- Inability or unwillingness to return for all required follow-up visits
- Inability or unwillingness to sign the patient informed consent document
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, 19010
Cleveland Clinic
Cleveland, Ohio, 44195
Mississippi Urology
Jackson, Mississippi, 39202
Devine-Tidewater Urology
Norfolk, Virginia, 23510
University Urological Associates
Providence, Rhode Island, 02904
Jack McAninch
San Francisco, California, 94110
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Prospective, Randomized, Controlled, Multicenter Trial of the Memokath® 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.
Read the detailed description
Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided.
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.
- Conditions
- Urethral Stricture
- Being tested
- Memokath stenting
- Keywords
- Memokath, Urethral stricture, urethral stent, Bulbar urethral stricture
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memokath stentingDevice
Urethral Stenting
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent/control effectiveness - urethral patency
Measured: 1 year
Secondary outcomes (5)
Peak urinary flow rate
Measured: Immediate
Re-intervention
Measured: Short term
Standard survey instruments (QOL, IPSS etc.)
Measured: 15 mos
Stent placement success
Measured: immediate
Stent removal success
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startDec 2002
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pnn Medical DK
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerry Jordan, MD, Principal investigator, Sentara/Engineers and Doctors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270504
- Sponsor's protocol ID
- 1-044TWUS
- Status last verified
- Dec 2008
- First submitted
- 23 Dec 2005
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter Trial of the Memokath® 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra
- ClinicalTrials.gov ID
- NCT00270504
- Acronym / sponsor ID
- 1-044TWUS
- Conditions
- Urethral Stricture
- Keywords
- Memokath, Urethral stricture, urethral stent, Bulbar urethral stricture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Pnn Medical DKIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Dec 2005 (estimated)
- 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 purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.
Detailed description
Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided.
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males > 21 years of age
- Recurrent stricture of the bulbar urethra:
- Healthy tissue on both sides of stent
- Urinary flow in the abnormal range of the Siroky nomogram.
- Written informed consent obtained prior to participation in the study
Key exclusion criteria (18 listed)
- Strictures:
- Inability to enlarge the bulbar urethral stricture to > 26 Fr.
- Presence of any other urologic implant
- Presence of urethral diverticuli
- History of hypospadias repair
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 |
|---|---|---|
| Memokath stentingUrethral Stenting | Device | – |
Primary outcome
Stent/control effectiveness - urethral patency
Time frame: 1 year
5 secondary outcomes
Peak urinary flow rate
Time frame: Immediate
Re-intervention
Time frame: Short term
Standard survey instruments (QOL, IPSS etc.)
Time frame: 15 mos
Stent placement success
Time frame: immediate
Stent removal success
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
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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.
Gerry Jordan, MD principal investigator
Sentara/Engineers and Doctors
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memokath stenting in people with Urethral Stricture, run by Pnn Medical DK at 7 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 8 inclusion and 18 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 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stent/control effectiveness - urethral patency (time frame: 1 year). 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 18 Nov 2009.