Results after Millin prostatectomy in patients with benign prostate enlargement.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000413820
• Date of registration: 13/04/2012
• Prospective Registration: Yes
• Primary sponsor: Gennimatas General Hospital of Thessaloniki
• 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.
• Date of first enrolment: 01/06/2012
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12612000413820.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;

Countries of recruitment

Greece

Contacts

• Name: Kampantais Spyridon

• Name: Kampantais Spyridon

Key inclusion & exclusion criteria

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)
Exclusion criteria: 1. Other urinary diseases (e.g. Peyronie's disease, prostate cancer, urethral stricture, neurogenic bladder).

Age minimum: 50 Years
Age maximum: No limit
Gender: Males

Health Condition(s) or Problem(s) studied

Benign prostate hypertrophy;
Benign prostate hypertrophy

Renal and Urogenital - Other renal and urogenital disorders

Intervention(s)

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.

Primary Outcome(s)

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)"[On day before the surgery and on 6 months.]

Erectile function before and after Millin prostatectomy. This is going to be assessed using the International Index of Erectile Function (IIEF) questionnaire.[On day before the surgery and on 6 months.]

Urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.[On day before the surgery and on 6 months.]

Secondary Outcome(s)

Obstructive urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.[On day before the surgery and on 6 months.]

Irritative urinary symptoms before and after Millin prostatectomy. This is going to be assessed using the International Prostate Symptom Score (IPSS) questionnaire.[On day before the surgery and on 6 months.]

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.[On day before the surgery and on 6 months.]

Secondary ID(s)

Nil