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POSSIBILITIES OF COMBINATION TREATMENT FOR PRESERVING THE SEXUAL FUNCTION IN PATIENTS AFTER RADICAL PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER (1)

Prostate cancer (PC) is one of the most common malignant tumors in the middle-aged and elderly male population, occupying the 4th place in terms of cancer morbidity in Russia [1]. In the past decade, the PC incidence rate has increased by more than 120.5% [2].

Surgery is known to be the main and most widely used method for treating localized prostate cancer. Surgical treatment provides onco-specific survival compared to watchful waiting [3].

According to the clinical guidelines of the European Association of Urology, radical prostatectomy (RPE) is a standard therapy for localized prostate cancer if the life expectancy of a patient exceeds 10 and more years [4, 5].

The problem of increasing the life expectancy of patients after RPE is inseparably associated with the problem of improving the quality of life. It has been established that RPE entails a number of complications that affect the quality of life, such as lowered libido, erectile dysfunction, shortening and bending of the penis, ejaculation problems [6, 7].

Sexual function recovery after RPE has been studied for a long time. However, despite the published findings, neither national nor foreign authors have reached a unanimous opinion concerning the state of erectile function after RPE [8, 9, 10, 11, 12, 13]. A significant influence of erectile function on quality of life causes the necessity and urgency of further investigation of the erectile function state in patients who have undergone RPE [14, 15, 16, 17].

RESEARCH GOAL: evaluating the possibility of combination treatment for sexual function in patients after radical prostatectomy to treat localized prostate cancer as a factor in increasing quality of life.

MATERIALS AND METHODS:

The present research includes 60 men of the average age of 64.6±4,7 years with verified localized prostate cancer, who underwent treatment in the urology department of ФГБУ ГНЦ ФМБЦ им. А.И. Бурназяна ФМБА России , Moscow.

All research studies with the participation of patients complied with the ethical standards of the Bioethical Committee developed in accordance with the World Medical Association's Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”. Patients signed a voluntary informed consent to participate in the research study.

The research entry criteria were men not older than 70 years old having no heavy somatic pathology or diabetes and being interested in preservation of sexual function after the surgery.

In the course of the study, the International Index of Erectile Function of all the patients was evaluated in accordance with IIEF-5, and the patients’ quality of life was assessed in accordance with the QOL (Quality of Life) questionnaire. Also, the length of non-erect penis (L) of all the patients was measured three times and averaged, and the penile rigidity was evaluated according to the penile erection hardness scale (EHS) (table 1).

Table 1. The penile erection hardness scale (EHS)

Degree
1 2 3 4
The penis is increased in size but not hard enough. The penis is hard but not hard enough for penetration. The penis is hard enough for penetration but still not completely hard. The penis is completely hard and fully rigid.

Control measurements were carried out before the surgery, on the 7th, 30th and 90th day after the surgical intervention.

Initially, none of the patients participating in the research study had any significant differences in clinico-anamnestic features. According to the research design, patients were arbitrarily divided into three groups using a random number table. The patients in the first group (control group, n=20) did not receive any specific preventive medication for preserving penile length and erectile function. The second group of patients (n=20) took PDE-5 inhibitors daily in a dose of 5 mg during 3 months in the postoperative period; the third group of patients (n=20) combined the intake of PDE-5 inhibitor in a dose of 5 mg with the use of a vacuum extender for three months. The vacuum apparatus PeniMaster®PRO was used as an extender in the research study, the patients of the third group carried the extender daily for not less than three hours a day during three months.

The obtained data were statistically processed using the STATISTICA 6.0 software. The normal distribution hypothesis was checked with the aid of the Shapiro-Wilk test. An average value (M) and a standard deviation (SD) are given for each of the continuous quantities exhibiting normal distribution.

Values of p<0.05 were statistically significant. The three groups were compared using the N-criterion of the Kruskal-Wallis test; at p<0.05, a paired comparison of groups was used employing the Mann-Whitney test with the application of the Bonferroni adjustment. The dynamics parameters were evaluated using the Wilcoxon criteria.

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REFERENCE LIST
Penimaster Pro Studie
M. V. Shamin1, E. V. Pomeshkin1, P. S. Kyzlasov2, V. Ya. Farbirovich1, R. R. Pogosyan2, V. P. Sergeev2 MBHI (Municipal Budgetary Healthcare Institution)
“Municipal Clinical Hospital No. 3 M. A. Podgorbunsky”, Kemerovo, ФГБУ ГНЦ ФМБЦ им. А.И. Бурназяна ФМБА России [(Federal State Budgetary Institution State Research Center Federal Medical Biophysical Center) A. I. Burnazyan FMBA (Federal Medical-Biological Agency) of Russia], Moscow2
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PeniMasterPRO for post-operative treatment of prostate cancer
Clinical study 2015/2016
  • Prostate cancer: widespread tumour among men of middle age and older.
  • Number of diseases risen by more than 120% within 10 years.
  • Removal of the prostate (prostatectomy) is an established and life-prolonging process in the event of prostate cancer.
  • Frequent and significant side effects:
    • Libido (sexual longing) and erectile capacity suffer under the removal of the prostate.
    • The length of the penis decreases (the penis becomes shorter).
    • Ejaculation problems.
  • Objective of the study: to study the possibilities for improving quality of life after prostatectomy.
  • Participants in the clinical study: 60 men between 60 and 69 years of age, after cancer-induced removal of the prostate.
  • Clinical study according to international ethical clinical standards.
  • Erectile dysfunction in the case of prostate cancer was also investigated as part of the study.
  • There were three comparative groups, each comprising 20 men:
    • Group 1: received no preventative treatment for the preservation of the length of the penis and of erectile function.
    • Group 2: received PDE5 inhibitors for three months after the operation
    • Group 3: additionally used the penis expander PeniMasterPRO for at least three hours every day.