Jae Hoon Chung1, Kyu Shik Kim2, Jae Duck Choi3, Tae Hyo Kim4, Ki Soo Lee4, Cheol Young Oh5, Joon Hwa Noh6, Jun Seok Kim6, Won Tae Kim7, Seung Hwan Lee8, Jae Heon Kim9, Tae Nam Kim10, Wan Huh11, Seung Wook Lee2. 1. Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 2. Department of Urology, Hanyang University College of Medicine, Seoul, South Korea. 3. Department of Urology, Eulji Medical Center, Eulji University School of Medicine, Seoul, South Korea. 4. Departments of Urology, College of Medicine, Dong-A University College of Medicine, Busan, South Korea. 5. Department of Urology, Hallym University College of Medicine, Seoul, South Korea. 6. Department of Urology, Kwangju Christian Hospital, Gwangju, South Korea. 7. Department of Urology, College of Medicine, Chungbuk National University, Cheongju, South Korea. 8. Department of Urology, Yonsei University College of Medicine, Seoul, South Korea. 9. Department of Urology, Soonchunhyang University College of Medicine, Seoul, South Korea. 10. Department of Urology, Pusan National University Hospital, Busan, South Korea. 11. Daewoong Pharmaceutical Co. Ltd, Seoul, South Korea.
Abstract
OBJECTIVE: To evaluate the effectiveness of poloxamer-based thermo-sensitive sol-gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture. PATIENTS AND METHODS: In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer-based thermo-sensitive sol-gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer-based thermo-sensitive sol-gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), maximum urinary flow rate (Qmax ), post-void residual urine volume (PVR), and cystoscopy. RESULTS: Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS-QoL and OAB-q between the groups. However, Qmax was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023). CONCLUSIONS:Poloxamer-based thermo-sensitive sol-gel instillation after TURP lowered the incidence of urethral stricture.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of poloxamer-based thermo-sensitive sol-gel instillation, after transurethral resection of the prostate (TURP), for preventing urethral stricture. PATIENTS AND METHODS: In all, 198 patients underwent TURP for benign prostatic hyperplasia. Recruited patients were randomly divided into two groups: groups A and B. Patients in Group A (100 patients, experimental group) received poloxamer-based thermo-sensitive sol-gel instillation and patients in the Group B (98 patients, control group) received lubricant instillation after TURP. Each patient was evaluated at 4 (V1), 12 (V2), and 24 weeks (V3) after TURP. The effectiveness of poloxamer-based thermo-sensitive sol-gel instillation was evaluated based on the International Prostate Symptom Score (IPSS), IPSS-Quality of Life (QoL), Overactive bladder questionnaire (OAB-q), maximum urinary flow rate (Qmax ), post-void residual urine volume (PVR), and cystoscopy. RESULTS: Amongst the initial 198 participants, 80 patients in Group A and 83 in Group B completed the study. There were no significant differences in IPSS-QoL and OAB-q between the groups. However, Qmax was significantly different between groups A and B, at a mean (SD) of 18.92 (9.98) vs 15.58 (9.24) mL/s (P = 0.028) at 24 weeks after TURP. On cystoscopic examination, urethral stricture after TURP was found in two of the 80 patients in Group A and 10 of 83 in Group B (P = 0.023). CONCLUSIONS:Poloxamer-based thermo-sensitive sol-gel instillation after TURP lowered the incidence of urethral stricture.