Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000413820
Ethics application status
Approved
Date submitted
8/04/2012
Date registered
13/04/2012
Date last updated
13/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Results after Millin prostatectomy in patients with benign prostate enlargement.
Scientific title
Quality of life, urinary symptoms and erectile function in patients with benign prostate enlargement before and after Millin prostatectomy.
Secondary ID [1] 280287 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign prostate hypertrophy 286245 0
Condition category
Condition code
Renal and Urogenital 286460 286460 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Millin prostatectomy for benign prostate enlargement. The approximate duration of the procedure is anticipated to be 60-90 minutes. Millin prostatectomy involves a transcapsular dissection of the prostatic adenoma, instead of a transvesical approach.
Intervention code [1] 284640 0
Treatment: Surgery
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286908 0
Quality of life before and after Millin prostatectomy. This is going to be assessed by a single question: "If you were to spend the rest of your life with your urinary condition the way it is now, how yould you feel about that? Delighted (0) / Pleased (1) / Mostly satisfied (2) / Mixed about equally satisfied and disatisfied (3) / Mostly disatified (4) / Unhappy (5) / Terrible (6)"
Timepoint [1] 286908 0
On day before the surgery and on 6 months.
Primary outcome [2] 286909 0
Urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.
Timepoint [2] 286909 0
On day before the surgery and on 6 months.
Primary outcome [3] 286910 0
Erectile function before and after Millin prostatectomy. This is going to be assessed using the International Index of Erectile Function (IIEF) questionnaire.
Timepoint [3] 286910 0
On day before the surgery and on 6 months.
Secondary outcome [1] 296972 0
Irritative urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.
Timepoint [1] 296972 0
On day before the surgery and on 6 months.
Secondary outcome [2] 296973 0
Obstructive urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.
Timepoint [2] 296973 0
On day before the surgery and on 6 months.
Secondary outcome [3] 296974 0
Identification of the most important prognostic factors for the outcome (age, tobacco use, dibetes mellitus, coronary disease, alcohol). This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire, the International Index of Erectile Function (IIEF) questionnaire and performing statistical analysis.
Timepoint [3] 296974 0
On day before the surgery and on 6 months.

Eligibility
Key inclusion criteria
1. An ability to communicate
2. An ability to understand and comply with study requirements.
3. Prostatic adenoma greater than 80 ml estimated by transrectal ultrasound (TRUS)
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other urinary diseases (e.g. Peyronie's disease, prostate cancer, urethral stricture, neurogenic bladder).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4246 0
Greece
State/province [1] 4246 0

Funding & Sponsors
Funding source category [1] 285056 0
Self funded/Unfunded
Name [1] 285056 0
Country [1] 285056 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 283920 0
None
Name [1] 283920 0
Address [1] 283920 0
Country [1] 283920 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Benign prostatic enlargement is a common condition in men and one surgical approach in its treatment is Millin prostatectomy, especially for large adenomas. In this study we are going to evaluate urinary symptoms, erectile function and quality of life in men before and after Millin prostatectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34034 0
Address 34034 0
Country 34034 0
Phone 34034 0
Fax 34034 0
Email 34034 0
Contact person for public queries
Name 17281 0
Kampantais Spyridon
Address 17281 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 17281 0
Greece
Phone 17281 0
+30 6945375525
Fax 17281 0
Email 17281 0
[email protected]
Contact person for scientific queries
Name 8209 0
Kampantais Spyridon
Address 8209 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 8209 0
Greece
Phone 8209 0
+30 6945375525
Fax 8209 0
Email 8209 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.