Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationship between percent of resected tissue and symptom improvement after surgical treatment of benign prostatic hyperplasia.
Scientific title
Impact of the percent of resected tissue on the symptom improvement at surgical treatment of benign prostatic hyperplasia. A prospective analysis.
Secondary ID [1] 281559 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment of benign prostate hyperplasia 287841 0
Condition category
Condition code
Renal and Urogenital 288185 288185 0 0
Other renal and urogenital disorders

Study type
Description of intervention(s) / exposure
Surgical resection of prostate by one of the following surgical techniques (three different interventions)
1. TURP (transurethral resection of prostate, one hour duration)
2. Freyer's prostatectomy (open transvesical prostatectomy, one and a half hour duration)
3. Millin prostatectomy (open retropubic transcapsular resection of prostate, one and a half hour duration)
Intervention code [1] 286075 0
Treatment: Surgery
Comparator / control treatment
Trnasurethral Resection of Prostate (TURP)
Control group

Primary outcome [1] 288384 0
Estimate the percent of resected tissue and collerate this with the improvement on urinary symptoms
Timepoint [1] 288384 0
The percent of resected tissue is going to be calculated as the resected tissue weight divided by the preoperative prostate weight x 100. The preoperative prostate weight is going to be estimated as the preoperative prostate volume x specific gravity of prostate. The prostate tissue collected at resection is going to be weighed and multiplied by 1.2 to compensate for 'shrinkage' (resected tissue weight).
The improvement on symptoms is going to be assessed with the questionnaire of International Prostate Symptom Score (IPSS), the extra question for quality of life (QoL), the post-void residual (PVR) urine volume and the Qmax in uroflowmetry. All these are going to be estimated preoperatively and three (3) months after the procedure.
Secondary outcome [1] 300010 0
If the increased amount of removed tissue influence the spontaneous detection of prostate cancer during surgical treatment of BPH(Benign Prostate Hyperplasia).
Timepoint [1] 300010 0
Postoperatively with the histopathologic examination. As it is known, prostate cancer more frequently is developed in the peripheral zone of prostate. So by increasing the amount of tissue resected, theoritically get closed to the peripheral zone of the prostate.

Key inclusion criteria
1. Patients with moderate or severe LUTS (lower urinary tracts symptoms) due to BPH (benign prostatic hyperplasia) that are refractory to medical treatment
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
1. Patients with prostatic carcinoma
2. Patients with neurogenic bladder
3. Patients with Foley catheter that are going to be treated due to urinary retention

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4734 0
State/province [1] 4734 0

Funding & Sponsors
Funding source category [1] 286380 0
Self funded/Unfunded
Name [1] 286380 0
Address [1] 286380 0
Country [1] 286380 0
Primary sponsor type
Gennimatas General Hospital of Thessaloniki
41 Ethnikis Aminis, Thessaloniki, 54643
Secondary sponsor category [1] 285168 0
Name [1] 285168 0
Address [1] 285168 0
Country [1] 285168 0

Ethics approval
Ethics application status

Brief summary
Changes in prostate volume before and after
surgical treatment for BPH have been reported, but only few
studies have assessed the correlation between the percent of resected tissue and the clinical outcome. To evaluate this colleration in men treated either with TURP or open prostatectomy.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34966 0
Dr Kampantais Spyridon
Address 34966 0
12 Gennimata street, Thessaloniki, 55132
Country 34966 0
Phone 34966 0
Fax 34966 0
Email 34966 0
Contact person for public queries
Name 18213 0
Dr Kampantais Spyridon
Address 18213 0
12 Gennimata street, Thessaloniki, 55132
Country 18213 0
Phone 18213 0
Fax 18213 0
Email 18213 0
Contact person for scientific queries
Name 9141 0
Dr Kampantais Spyridon
Address 9141 0
12 Gennimata street, Thessaloniki, 55132
Country 9141 0
Phone 9141 0
Fax 9141 0
Email 9141 0

No information has been provided regarding IPD availability
Summary results
No Results