LAPAROSCOPIC & ROBOTIC UROLOGY Comparison of the Effectiveness and Safety of Transvesical Open Prostatectomy versus Transurethral Resection of the Prostate in Patients with Benign Prostatic Hyperplasia with a Prostate Weight of 65-40 Gram Heshmatollah Sofimajidpour1,2, Aida Khoshyar3, Bushra Zareie2,4, Hooshmand Sofimajidpour5, Mohammad Aziz Rasouli2* Purpose: The aim of this study was to evaluate the efficacy of transvesical open prostatectomy (OP) compared with transurethral resection of the prostate (TURP) in patients with benign prostate hyperplasia (BPH) with a prostate weight of 40-65 grams. The short-term and long-term complications of these two procedures were also assessed. Materials and Methods: In this retrospective study, we included 160 consecutive patients with BPH who had undergone TURP (n=80) or OP surgery (n=80) from 2006 to 2017. Inclusion criteria were positive history of BPH, definite indication for prostatectomy, and prostate weight between 40 to 65 grams. Patients were evaluated for duration of hospitalization, need for re-operation, short-term and long-term postoperative complications, urinary flow rate, peak flow rate (Q max) and international prostate symptom score (IPSS). Results: The mean age ± Standard Deviation (SD) of patients’ age was 62.4 ± 3.7 and 67.2 ± 4.6 years in the TURP and OP groups, respectively. Four (5%) and seven (8.7%) patients required transfusion in the TURP group and OP groups, respectively. Dysuria was significantly more frequent in the TURP group from week two to 12 months af- ter surgery as compared with the OP group (P < .001). Hemodynamic changes and decrease in serum sodium level were not reported in either group. However, the urinary retention and need for urinary catheterization in the first year was significantly different between the two groups with 10 cases (12.5%) in the TURP group and no cases in the OP group (P<0.001). The need for reoperation in the TURP group was reported (27 procedures on 19 patients) (33.7%) of patients. Furthermore, retrograde ejaculation (RE) was reported in 65 (81.2%) and 80 patients (100%) of the TURP and OP group, respectively. Conclusion: Despite the fact that TURP is the standard method of treatment for BPH when the prostate weighs between 40-65 grams, the results of our study showed that OP is a more efficient and safe surgery for these patients and is associated with less complications. Furthermore, the need for re-operation seems to be higher in patients with TURP. Keywords: Iran; open transvesical prostate surgery; prostate; transurethral resection of the prostate INTRODUCTION Benign prostatic hyperplasia (BPH) is the most common benign tumor in men, leading to prob- lems such as disturbance in the urinary flow. The best treatment modality for this disease depends on different factors such as severity of symptoms, size of the pros- tate and patient’s general condition(1-3). These treatment modalities range from medical and pharmacological therapies to surgical procedures such as transurethral resection of the prostate (TURP), open prostatectomy (OP) or minimally invasive surgeries(1-3). TURP and OP and laser prostatectomy (HoLEP) is currently a stand- ard treatment are three standard surgical procedures in 1Department of Urology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran 2Clinical Research Development Center, Kowsar Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran. 3Student Research Committee, Kurdistan University of Medical Sciences, Sanandaj, Iran. 4Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran. 5Student Research Committee, Shahid beheshti University of Medical Sciences, Sanandaj, Iran *Correspondence: Clinical Research development Center, Kowsar Hospital, Kurdistan University of Medical Sciences, Pasdaran Ave, Sanandaj, Iran. Tel: +988733131366, Email: Rasouli1010@gmail.com. Received June 2020 & Accepted October 2020 patients with BPH(2,4,5). For patients with BPH who have a prostate weight of less than 70-80 grams, TURP has been recommended as the standard method of treatment. For larger pros- tates or in the case of presence of large bladder stones, open prostatectomy has been suggested as the preferred method(6-8). However, there have been few studies di- rectly comparing OP and TURP in a parallel study for prostate sizes of 40-65 grams(7,9). Herein, we aim to compare the safety and efficiency of transvesical open prostatectomy versus TURP in patients with BPH and a prostate weight of 40-65 grams. Urology Journal/Vol 18 No. 3/ May-June 2021/ pp. 289-294. [DOI:10.22037/uj.v16i7.6342] MATERIALS AND METHODS Study design and participants This was a retrospective study performed on 160 con- secutive patients with BPH who had undergone TURP (n=80) or OP surgery (n=80) during 2006-2017 in Tohid and Kowsar hospitals, Sanandaj, Iran. Inclusion criteria were: confirmed presence of BPH, definite in- dication for prostatectomy, prostate weight between 40- 65 grams, and consent to participate in the study. Indi- cations for prostate surgery included recurrent urinary tract infection, persistent lower urinary tract symptom despite medical treatment, increased creatinine and bi- lateral hydronephrosis that significant reduce following urinary catheterization, frequent urinary retention (need to evacuate and catheterize the patient after surgery for one year), and hematuria due to prostate enlargement despite receiving medical treatment. Criteria for being excluded from the study included: previous history of urinary tract surgery, prostate surgery or concurrent presence of bladder stones, patients with diabetes, pa- tients with a history of discopathy and known cases of bladder neurogenesis. Patients’ data including age, prostate weight and vol- Effectiveness and Safety of OP versus TURP-Sofimajidpour et al. Endourology and Stones diseases 130 ume, length of hospital stay, and need for re-operation was collected. The volume (cc) of the prostate was measured by ultrasound before surgery and the weight (gram) of the prostate was assessed post-surgery. Short- term post-operative complications such as fever, dy- suria, requirement for blood transfusion, clot formation and need for catheter replacement within the first three days after surgery as well as long-term complications such as urinary retention, urinary incontinence, impo- tence, retrograde ejaculation (RE) and urinary cathe- terization within the first year after surgery were also investigated. Furthermore, patients’ peak flow rate (Q max) and international prostate symptom score (IPSS) was assessed at different time points: before surgery un- til 12 months post-surgery. Patients’ medical history and physical examination (including digital rectal exam) was evaluated by the same urologist. Laboratory parameters including plas- ma creatinine (CR), blood urea nitrogen (BUN), com- plete blood count (CBC), serum sodium and potassium, urinary analysis (U/A), urinary culture (U/C), pros- tate-specific-antigen (PSA) were measured. In addition, renal, bladder and prostate transabdominal ultrasound were performed to determine prostate volume and size Table 1. Comparing operative and postoperative variables in OP and TURP patients. Variable TURP (N=80) OP (N=80) P- value Age (year), Mean ± SD 62.4 ± 3.7 (57-76) 67.2 ± 4.6 (62-78) < 0.001 Body mass index (BMI) 23.7 ± 3.2 24.1 ± 3.7 .46 Prostate weight, Mean ± SD 46.6 ± 5.7 (45-65) 45.3 ± 4.8 (40-65) .10 Prostate size, g, Mean ± SD 41.6 ± 2.7 (30-65) 42.1 ± 3.6 (40-65) .32 Duration of Hospitalization (Hour) 36.2 ± 2.8 (24-50) 73.1 ± 2.6 (72-120) < 0.001 Cr 1.40 ± 0.27 (1.2- 1.6) 1.38 ± 0.33 (1.1-1.6) .83 PSA 3.61 ± 0.44 (3-4.2) 3.72 ± 0.51 (3.1-4.3) .14 Short Complications after surgery Postoperative fever, N (%) 52 (65) 47 (58.7) .41 Blood transfusion 4 (5) 7 (8.7) .25 Dysuria Week 2 27 (33.7) 3 (3.7) < 0.001 Week 4 26 (32.5) 4 (5) < 0.001 Week 8 24 (30) 3 (3.7) < 0.001 Month 3 26 (32.5) 5 (6.2) < 0.001 Month 4 22 (27.5) 3 (3.7) < 0.001 Month 5 21 (26.2) 2 (2.5) < 0.001 Month 6 22 (33.8) 2 (2.5) < 0.001 Month 12 27 (33.7) 1 (1.3) < 0.001 Clot retention and need for catheter replacement 6 (7.5) 0 (0) .01 within the first three days after surgery hemodynamic changes and decrease in serum 0 (0) 0 (0) - sodium level Long-term complications after surgery Urinary retention and requirement for urinary 10 (12.5) 0 (0) < 0.01 catheterization (Year 1) Incontinence after 3 months 0 (0) 0 (0) - Impotence after 3 months 0 (0) 0 (0) - Retrograde ejaculation 65 (81.2) 80 (100) < 0.01 Re-operation (27 procedures on 19 patients) 27 (33.7) 0 (0) < 0.01 Peak flow rate (Q max), Mean ± SD (Range) Before 9.3 ± 1.2 (8-11) 9.2 ± 1.3 (8-11) .61 After 1 month 14.1±1.6 (10-17) 14.3 ± 1.5 (13-16) .41 After 3 month 13.3 ± 1.5 (11-15) 16.4 ± 2.3 (15-18) < 0.001 After 6 month 13.3 ± 2.2 (11-13) 17.2 ± 2.4 (16-19) < 0.001 After 9 month 12.6 ± 1.7 (11-13) 17.1 ± 2.2 (16-19) < 0.001 After 12 month 13.4 ± 2.2 (12-15) 17.3 ± 1.6 (16-19) < 0.001 International prostate symptom score (IPSS) Before 28.4 ± 3.2 (23-30) 29.2 ± 3.1 (27-32) .11 After 3 month 21.3 ± 2.8 (19-23) 18.4 ± 2.6 (16-20) < 0.001 After 6 month 21 ± 3.1 (19-23) 17.5 ± 2.4 (16-20) < 0.001 After 12 month 21.6 ± 2.5 (18-23) 17.3 ± 2.4 (16-20) < 0.001 Abbreviations: OP, open prostatectomy; TURP, transurethral resection of the prostate; SD, standard deviation; IPSS, International prostate symptom score Robotic and Laparoscopic Urology 290 Vol 18 No 3 May-June 2021 291 before surgery. On the day of surgery, cystoscopy was performed for all patients and the approximate size of the prostate was recorded. Foley catheter was removed in TURP group after lightening of urine color 3-5 days after surgery. In the OP group, Skin incision of 7-10 cm was given, sutures was removed on the tenth day. No wound infection or dehiscence was seen in the suture line. The cystostomy was removed on day 2 or 3 after confirming the absence of clot and Foley catheter was removed on day 7-9 after surgery. In the TURP group, an average of 25 mg of pethidine was given (first day) to relieve pain, and in the OP group, 50 mg of pethi- dine was given to relieve the patients' pain (first day) and then oral acetaminophen 500 mg, 4 times a day for 7-10 days was administered similarly in both groups. Patients were followed up for at least one year. OP and TURP were performed by the same experienced urolo- gist with more than 25 years of experience and history of performing more than 4000 TUR operations. Ethical considerations This study was approved by the ethics committee of Kurdistan University of Medical Sciences (IR.MUK. REC.1398.174). Statistical analysis Categorical variables are expressed as frequency (per- centage) and continuous variables are reported as mean ± Standard Deviation (SD). T-test was used for compar- ison of continuous data and categorical was compared by using Chi-square test and Fisher exact test. All statis- tical analysis was performed by STATA software ver- sion 14. P-value <0.05 was considered as statistically significant. RESULTS The mean ± SD age of patients in the TURP and OP groups was 62.4 ± 3.7 and 67.2 ± 4.6 years old, respec- tively. The mean ±SD prostate weight in the TURP and OP groups was 46.6 ± 5.7 and 45.3 ± 4.5 grams, re- spectively and the mean prostate volume was 41.1 and 42.5 cc (respectively). The mean duration of hospitali- zation was 36.2 hours in the TURP and 73.1 hours in the OP group. There were no differences between the two groups in terms of postoperative complications in- cluding: hemodynamic changes and decrease in serum sodium level was not reported in either group, fever, the need for transfusion was reported in four cases (5%) in the TURP group and seven cases (8.7%) who underwent open surgery. Dysuria was reported more frequently in the TURP group compared with the OP group from week two to 12 months post-surgery, show- ing a statistically significant difference between the two groups (Table 1). We observed six cases (7.5%) with clot retention and need for catheter replacement with- in the first three days after surgery in the TURP group while no cases developed this complication in the OP group. Regarding long-term complications, the frequency of urinary retention and requirement for urinary cathe- terization within the first year was significantly differ- ent between the two groups with 10 cases (12.5%) in the TURP group and no cases in the OP group (P < .001). In the TURP group, 19 patients underwent reop- eration in 27 procedures, including three patients with meatal stenosis who underwent meatotomy. Nine pa- tients were diagnosed with bulbar uretheral stenosis, for whom three patients underwent dilatation and internal uretherotomy once, and for six patients, for whom dila- tation and internal uretherotomy were performed twice. Two patients had residual tissue in prostatic fossa who underwent Re-TUR in the fourth month. Five patients were diagnosed with bladder neck fibrosis. Two pa- tients underwent TUIP, one patient underwent bladder neck dilatation once and two patients underwent blad- der neck dilatation twice. Of note, no patients in the OP group required a second surgery. Urinary incontinence and impotence was not reported in any patients of both groups. RE was observed in 65 cases (81.2%) of the TURP group and 80 cases (100%) of the OP group. If the TURP group includes all patients, Q Max shows a significant difference with the open group in 1, 3, 6, 9 and 12 months (Table 1). However, if 19 patients in the TURP group who need reoperation are removed from this group, the rate of Q Max in the two groups is not significantly different (Table 2). Based on the IPSS, a significant improvement in symp- toms was seen after surgery in the OP group compared with the TURP group, (the TURP group includes all pa- tients) (Table 1). However, if 19 patients in the TURP group who need reoperation are removed from this group, the rate of IPSS in the two groups is not signifi- cantly different (Table 2). Table 2. Comparing Peak flow rate (Q max) and International prostate symptom score (IPSS) variables in OP and TURP group without Re-operation. Variable TURP (N=61) OP (N=80) P- value Peak flow rate (Q max), Mean ± SD (Range) Before 9.1 ± 1.3 (8-11) 9.2 ± 1.3 (8-11) 0.61 After 1 month 14.2 ± 1.5 (10-16) 14.3 ± 1.5 (13-16) 0.99 After 3 month 16 ± 1.6 (13-17) 16.4 ± 2.3 (15-18) 0.25 After 6 month 16.7 ± 2.2 (13-18) 17.2 ± 2.4 (16-19) 0.48 After 9 month 16.7 ± 1.9 (14-18) 17.1 ± 2.2 (16-19) 0.23 After 12 month 17 ± 2.4 (14-19) 17.3 ± 1.6 (16-19) 0.14 International prostate symptom score (IPSS) Before 28.4 ± 3.2 (23-30) 29.2 ± 3.1 (27-32) 0.11 After 3 month 19.3 ± 2.8 (17-22) 18.4 ± 2.6 (16-20) 0.53 After 6 month 17.6 ± 3.1 (15-19) 17.5 ± 2.4 (16-20) 0.93 After 12 month 17.5 ± 2.5 (15-19) 17.3 ± 2.4 (16-20) 0.82 Abbreviations: OP, open prostatectomy; TURP, transurethral resection of the prostate; SD, standard deviation; IPSS, International prostate symptom score Effectiveness and Safety of OP versus TURP-Sofimajidpour et al. In order to relieve the pain at the incision site and the surgical site in the OP group, on the first day, pethidine injection of 25 mg more than the TURP group was re- quired, and then oral acetaminophen 500 mg, 4 times a day for 7-10 days was administered similarly in both groups. At monthly follow-up of patients, no incision site pain was reported in patients. At monthly follow-up of patients, pain at the incision site was not reported in patients in the OP group. DISCUSSION TURP and OP are two accepted surgical procedures in patients with BPH(7). TURP is one of the most common methods, performed in 60 to 97% of cases with BPH (7,10). Due to the high prevalence of benign prostatic hy- perplasia and the importance of this issue, in this study, we aimed to investigate the efficacy and safety of these two surgical approaches in comparison with each other. The results of our study showed that the mean prostate weight and volume was not significantly different be- tween the two groups who underwent TURP and OP. This finding was consistent with the results of a pre- vious study conducted by Simforoosh et al.(7). In an- other study by Nnabugwu and colleagues, the prostate volume was significantly different between TURP and OP groups(11). In the present study, patients with similar prostate weight and volume were selected so that selec- tion bias could be minimized. In the present study, the duration of hospitalization in individuals with TURP and OP methods was 36.2 and 73.1 hours, respectively, which was comparable with the results of another study by Ou et al.(12). In a simi- lar study by Kwon et al., the duration of hospitalization in patients who underwent monopolar TURP, bipolar TURP and OP was 9.4, 6.3 and 12 days, respectively (1); however, in accordance with our study, the mean hospi- tal stay in the OP group was higher than that of TURP group. However, in our opinion and in the opinion of our patients, 36 hours of longer hospitalization was not important for this age group under prostate surgery. The results of the present study showed that the need for re-operation was significantly higher in the TURP group compared with patients who underwent open surgery that is consistent with the results of a study by Simforoosh et al.(7). Some studies have reported the rate of reoperation as less than 5% per year, depending on the duration of follow-up period and number study showed that the need for reoperation in the TURP group was higher than the open method and this difference was statistically significant. It was consistent with the results of a study by Simforoosh et al.(7). In some other studies, reoperation was reported to be less than 5% per year, which varied according to the patient's follow-up period and the number of recurrences(13,14). In this study, urinary incontinence and impotence was not reported in any patients of either groups at three months post-surgery but RE was higher in the OP group compared with the TURP group. Dysuria was a more frequent complaint in patients of the TURP group from week two to one-year post surgery; 27 cases (33.7%) of the TURP group versus one case (1.3%) in the OP group had dysuria at the first-year after surgery which was statistically significant. In line with this finding, in a study by Simforoosh et al.(7), a significant difference existed between the two groups, with 28% of cases suffering from dysuria in the OP group compared with 71% in the TURP group. Urinary incontinence was statistically significant, which is consistent with the re- sults of the present study(7). In a study by Long et al., incontinence and urinary tract infection was more prev- alent in patients with OP compared with transurethral plasmakinetic resection of the prostate (PKRP) while the need for catheterization method was more frequent- ly reported in the PKRP group than the TVP group. Based on the findings of this study, the main reason for temporary urinary incontinence may be related to local inflammation and edema, difficulties with the external sphincter mechanism, instability or decreased blad- der adaptation or excessive stretching of the external sphincter(15). Urinary incontinence and other irritative symptoms have been reported in some other studies and in patients undergoing TURP surgery(16,17). In general, irritative symptoms are a major problem after surgery of damaged tissues and these symptoms may become resistant to treatment(7). Recovery time and resolution of these symptoms depends on the type and duration of the operation and also patients’ general condition and amount of compliance. In our study, If the TURP group includes all patients, Q Max shows a significant difference with the open group in 1, 3, 6, 9 and 12 months. However, if 19 patients in the TURP group who need reoperation are removed from this group, the rate of Q Max in the two groups is not significantly different. In the study by Long and colleagues, it was shown that during the follow-up peri- od, Q max improved in both of the study groups (PKRP and TVP)(15). Park argued that the reason for higher Q max in the OP method compared with TURP is that with complete removal of the adenoma, the proximal duct becomes wider and more symmetrical(18). Ou et al. demonstrated that at six and 12 months post-surgery, there was no significant difference between TURP and OP groups in terms of Q max rate(12). The results of these studies, in agreement with the results of our study. In the present study, the need for transfusion in the OP group was slightly higher. In the study by Park, only 0.8% of patients in the TURP group required blood transfusions(18). In the study of Kwon et al., need for transfusion with monopolar TURP, bipolar TURP and OP was observed in 15.7%, zero and 33.3% of patients, respectively, showing a statistically significant differ- ence (1). In the study of Kader et al., the need for trans- fusion in the TURP and Transurethral incision of the prostate (TUIP) groups was 5% and 0%, respectively; however, this difference was not statistically significant (19). In the present study, clot formation and catheter re- placement within the first three days of surgery was more frequently observed in the TURP group in com- parison with the OP group. Gupta et al reported this rate as 8% in patients who underwent TURP and 0% with open surgery (20). Simforoosh and colleagues found this rate to be 12% in the TURP group and 0% in the OP group(7). These reports are consistent with the re- sults of our study. Based on the IPSS, a significant improvement in symp- toms was seen after surgery in the OP group compared with the TURP group, (the TURP group includes all pa- tients). However, if 19 patients in the TURP group who need reoperation are removed from this group, the rate of IPSS in the two groups is not significantly different. Nnabugwu and colleagues showed no difference be- Effectiveness and Safety of OP versus TURP-Sofimajidpour et al. Laparoscopic and Robotic Urology 292 Vol 18 No 3 May-June 2021 293 tween TURP and OP at 12 months after surgery (11). In the study of Simforoosh et al., IPSS did not have a sta- tistically significant difference between OP and TURP groups(7). CONCLUSIONS Although TURP is the standard method of treatment for BPH in patients with a prostate weight between 40- 65 grams, the results of our study showed that OP is a safer and more effective method with less short-term and long-term complications compared with TURP. Furthermore, the need for re-operation seems to be sig- nificantly higher in patients with TURP. OP has an easy learning curve and does not require specialized equip- ment and apparatuses. Thus, we recommend open sur- gery as the preferred method for treatment of BPH in prostate weighing between 40-65 grams. ACKNOWLEDGEMENT The study was sponsored by the deputy of research and technology of Kurdistan University of Medical Scienc- es, Sanandaj, Iran. The Authors wish to thank the Clin- ical Research Development Center at Kowsar Hospital, Sanandaj, Iran for their collaboration. CONFLICT ON INTEREST The authors declare that there is no conflict of interest. REFERENCES 1. Kwon JS, Lee JW, Lee SW, Choi HY, Moon HS. 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