BPHNCT03239951
Study to Assess the Efficacy, Safety and Tolerability of (iTind)
A study testing iTind in people with BPH, run by Medi-Tate Ltd. at 3 sites in United Kingdom.
Trial summary
Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria. A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system. Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- BPH
- What is being tested?
- iTind
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 27 Feb 2018to 31 Mar 2020
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male with AUR secondary to BPO
- Age ≥40 years
- Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
- Ability to sign an informed consent form
- Prostate volume <80 ml
- Life expectancy >1 year.
Who cannot join
- Suspected malignant disease of the lower urinary tract including prostate or bladder cancer
- Chronic retention of urine with history of either retention volume greater than one liter or upper tract obstruction
- Known neurogenic bladder
- Immunosuppression
- Suspected urethral strictures, bladder neck contracture, Urinary bladder stones
- An obstructive or protruding median lobe of the prostate
Show all 10Show fewer
- An active symptomatic urinary tract infection
- Enrolled in another treatment trial for any disease
- Previous pelvic irradiation or radical pelvic surgery
- Any previous prostate surgery.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Firmly Park Hospital
Frimley
King's college
London, SE1 9RT
Norwich University Hospital
Norwich
About this study
Official title: One-arm, Controlled, Multi-Center Prospective Study to Assess the Efficacy, Safety and Tolerability of Medi-Tate Temporary Implantable Nitinol Device (iTind) in Subjects With Acute Urinary Retention Secondary to (BPO)
Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.
A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system.
Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.
Read the detailed description
Spontaneous acute urinary retention (AUR) is one of the most significant complications of long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate indication for surgery. Between 25% and 30% of men who underwent transurethral prostatectomy (TURP) had AUR as their main indication in older series and today most subjects failing to void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an important and feared event from the viewpoint of the subject. The subject originally has inability to urinate, with increasing pain, and eventually a visit to the emergency room, catheterization, follow-up visits to the physicians, an attempt at catheter removal, and eventual recovery or surgery, which is both painful and time consuming.
After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC) and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that are refractory to medical management will be considered for surgery.
In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of the first episode and 76% to 83% in men with diagnosed BPH.
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten percent of men in their seventies and 30% in their eighties will have AUR within the next five years.
Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with AUR.
In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for men aged 40-49 years and 10% at 70-79 years.
- Conditions
- BPH
- Being tested
- iTind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTindDevice
temporary implant
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Temporary implant (iTind) Receives: Device: iTind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to void without catheter
TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start27 Feb 2018
- Primary completion20 Jan 2020
- Study completion31 Mar 2020
Why it stopped: Due to the COVID-19 outbreak and the overall low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Muir, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239951
- Sponsor's protocol ID
- MT-04
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Controlled, Multi-Center Prospective Study to Assess the Efficacy, Safety and Tolerability of Medi-Tate Temporary Implantable Nitinol Device (iTind) in Subjects With Acute Urinary Retention Secondary to (BPO)
- ClinicalTrials.gov ID
- NCT03239951
- Acronym / sponsor ID
- MT-04
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 outbreak and the overall low recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Aug 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.
Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.
A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system.
Study duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.
Detailed description
Spontaneous acute urinary retention (AUR) is one of the most significant complications of long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate indication for surgery. Between 25% and 30% of men who underwent transurethral prostatectomy (TURP) had AUR as their main indication in older series and today most subjects failing to void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an important and feared event from the viewpoint of the subject. The subject originally has inability to urinate, with increasing pain, and eventually a visit to the emergency room, catheterization, follow-up visits to the physicians, an attempt at catheter removal, and eventual recovery or surgery, which is both painful and time consuming.
After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC) and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that are refractory to medical management will be considered for surgery.
In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of the first episode and 76% to 83% in men with diagnosed BPH.
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten percent of men in their seventies and 30% in their eighties will have AUR within the next five years.
Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with AUR.
In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for men aged 40-49 years and 10% at 70-79 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: iTindTemporary implant (iTind) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male with AUR secondary to BPO
- Age ≥40 years
- Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
- Ability to sign an informed consent form
- Prostate volume <80 ml
Key exclusion criteria (10 listed)
- Suspected malignant disease of the lower urinary tract including prostate or bladder cancer
- Chronic retention of urine with history of either retention volume greater than one liter or upper tract obstruction
- Known neurogenic bladder
- Immunosuppression
- Suspected urethral strictures, bladder neck contracture, Urinary bladder stones
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 |
|---|---|---|
| iTindtemporary implant | Device | Device |
Primary outcome
Ability to void without catheter
Time frame: 2 weeks
TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.
Results and safety
The study was stopped early (reason given: Due to the COVID-19 outbreak and the overall low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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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.
Gordon Muir, MD principal investigator
King's College Hospital NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTind in people with BPH, run by Medi-Tate Ltd. at 3 sites in United Kingdom.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 stopped early (reason given: Due to the COVID-19 outbreak and the overall low recruitment). Results are not available in the source record.
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?
Ability to void without catheter (time frame: 2 weeks). 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 22 Jul 2020.