Benign Prostatic HyperplasiaPhase 3MISTNCT00064649
Minimally Invasive Surgical Therapy for BPH
A Phase 3 study testing Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA) Therapy and Finasteride and Alfuzosin in people with Benign Prostatic Hyperplasia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in United States.
Trial summary
The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA) Therapy and Finasteride and Alfuzosin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2004to Jun 2006
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed informed consent prior to the performance of any study procedures or discontinuation of any exclusionary medications.
- Male at least 50 years of age.
- AUA symptom severity score >= 10.
- Voided volume >= 100 ml.
- Post-void residual < 350 ml.
- Prostatic length 30-50 mm by cystoscopy (from bladder neck to verumontanum) or 35-60 mm by TRUS (from bladder neck to apex).
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- Prostate volume 25-100 cc by TRUS.
- Prostate transverse diameter 34-80 mm.
- Patient able to complete the study protocol in the opinion of the investigator.
Who cannot join
- Any prior surgical intervention for BPH.
- Enrolled in another treatment trial for any disease within the past 30 days.
- Previously failed to respond to combination therapy with an alpha blocker and a 5-alpha reductase inhibitor.
- Previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to alfuzosin or finasteride.
- On alpha-blocker within the past month.
- On a 5-alpha reductase inhibitor within the past 4 months.
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- On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks.
- On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months.
- Bleeding disorder or taking anticoagulation medication unless patient is able to be off anti-platelet medication for at least 10 days prior to MIST treatment.
- Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (i.e., creatinine > 2.0 mg/dL or AST > 1.5 times the upper limit of institutional norms).
- Serum prostate specific antigen level > 10 ng/ml.
- Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture, or two documented urinary tract infections of any type in the past year (UTI defined as > 100,000 colonies per ml urine from midstream clean catch or catheterized specimen).
- Biopsy of the prostate within the past 6 weeks.
- Daily use of a pad or device for incontinence required or International Continence Society male incontinence symptoms score >= 13.
- Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriches syndrome.
- Orthostatic hypotension defined as drop of > 20 mm Hg in supine to standing SPB or a drop of > 10 mm Hg in supine to standing DBP, in either standing BP reading, or the development of symptoms of postural hypotension (e.g., dizzy or light-headed).
- Penile prosthesis.
- Artificial urinary sphincter or any implant, metallic or nonmetallic, within 1.5 inches of the prostatic urethra.
- History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, or urethral stricture that requires dilation to pass a flexible cystoscope.
- Non-symmetric median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe as determined by cystoscopy.
- Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease, any component of an implantable neurostimulation system, or other neurological diseases known to affect bladder function.
- Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
- Defibrillator or pacemaker that cannot be deactivated during MIST.
- Neurogenic decompensated or atonic bladder in the opinion of the investigator.
- Patient has an interest in future fertility.
- Previous rectal surgery other than hemorrhoidectomy.
- Any serious medical condition likely to impede successful completion of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Colorado Health Sciences Center
Denver, Colorado, 80010
Baylor College of Medicine
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia University
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Minimally Invasive Surgical Therapy Consortium for Benign Prostatic Hyperplasia
The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA) Therapy, Finasteride and Alfuzosin
- Keywords
- prostate, benign disease, TUNA, TUMT, medical therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Microwave Thermotherapy (TUMT)Device
type of minimally invasive surgical therapy for BPH
Transurethral Needle Ablation (TUNA) TherapyDevice
type of minimally invasive surgical therapy for BPH
Finasteride and AlfuzosinDrug
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Transurethral Needle Ablation (TUNA) Receives: Device: Transurethral Needle Ablation (TUNA) Therapy |
| 3 | Active comparator | finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg Receives: Drug: Finasteride and Alfuzosin |
| 1 | Active comparator | Transurethral Microwave Thermotherapy (TUMT) Receives: Device: Transurethral Microwave Thermotherapy (TUMT) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2003 (estimated)
- Study startApr 2004
- Study completionJun 2006
Why it stopped: Inability to recruit required sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Diagnostic Ultrasound, Urologix, Medtronic, Merck Sharp & Dohme LLC, Sanofi-Synthelabo
- Investigators
- Reginald Bruskewitz, M.D., Study chair, University of Wisconsin, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064649
- Sponsor's protocol ID
- MIST (terminated)
- Other IDs
- 5U01DK060817
- Acronym
- MIST
- Status last verified
- Jan 2010
- First submitted
- 10 Jul 2003
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Therapy Consortium for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00064649
- Acronym / sponsor ID
- MIST / MIST (terminated)
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- prostate, benign disease, TUNA, TUMT, medical therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit required sample size.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Diagnostic Ultrasound, Urologix, Medtronic, Merck Sharp & Dohme LLC, Sanofi-Synthelabo
- Study start
- Apr 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 11 Jul 2003 (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 primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Device: Transurethral Needle Ablation (TUNA) TherapyTransurethral Needle Ablation (TUNA) |
| 3 | Active comparator | Drug: Finasteride and Alfuzosinfinasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg |
| 1 | Active comparator | Device: Transurethral Microwave Thermotherapy (TUMT)Transurethral Microwave Thermotherapy (TUMT) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient signed informed consent prior to the performance of any study procedures or discontinuation of any exclusionary medications.
- Male at least 50 years of age.
- AUA symptom severity score >= 10.
- Voided volume >= 100 ml.
- Post-void residual < 350 ml.
Key exclusion criteria (27 listed)
- Any prior surgical intervention for BPH.
- Enrolled in another treatment trial for any disease within the past 30 days.
- Previously failed to respond to combination therapy with an alpha blocker and a 5-alpha reductase inhibitor.
- Previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to alfuzosin or finasteride.
- On alpha-blocker within the past month.
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 |
|---|---|---|
| Transurethral Microwave Thermotherapy (TUMT)type of minimally invasive surgical therapy for BPH | Device | 1 |
| Transurethral Needle Ablation (TUNA) Therapytype of minimally invasive surgical therapy for BPH | Device | 2 |
| Finasteride and Alfuzosinfinasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg | Drug | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Inability to recruit required sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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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.
Reginald Bruskewitz, M.D. study chair
University of Wisconsin, Madison, WI
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 Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA) Therapy and Finasteride and Alfuzosin in people with Benign Prostatic Hyperplasia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 9 inclusion and 27 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 14 Jan 2010. 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 was stopped early (reason given: Inability to recruit required sample size.). 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.
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 14 Jan 2010.