1.1 Medical Ethics Statement
The present study was approved by the Xuzhou Central Hospital Ethics Committee and the approval number was XZXY-LJ-20140412-021.
1.2 Patients and preoperational observation indexes
A prospective study was performed to compare the effects and complications of patients treated with or without indwelling D-J tubes after TSV. Seventy patients who had obstructive azoospermia and received TSV therapy from May 2014 to July 2016 were enrolled in this study. This experiment obtained written consent from all participants.
General information and TSV surgical parameters, including age, preoperational antibiotics, length of disease (LOD), body mass index (BMI), history of urinary tract disease (HUTD), surgical time length (STL), findings during surgery (FDS) and complications during surgery, were collected and compared as baseline information. All the participating patients had recurrent hematospermia (over 3 months) and had multiple relapses. All the subjects underwent preoperative imaging tests like CT or MRI.
1.3 Surgical procedure for indwelling D-J tube placement during TSV
The patient is placed in a lithotomy position after sacral canal anesthesia or general anesthesia. The 4.5/6.5-F Wolf seminal cystoscope was used to perform a standard procedure for TSV. For patients not treated with indwelling D-J tubes, a 16-F, two-way Foley catheter was placed. For patients treated with indwelling D-J tubes, after the seminal cystoscope had successfully entered the seminal vesicles, a Boston Sensor hybrid guide wire was placed. After the seminal cystoscope was inserted to the seminal vesicle, the length it was inserted was recorded, and then the seminal cystoscope was retrieved. When switching to a ureteroscope the ureteroscope was guided into the prostatic utricle with the guidance of the guide wire (Fig. 1A). The soft tip of the hybrid guide wire was placed into the left seminal vesicle and inserted to the end of the seminal vesicle (Fig. 1B); then, a 5-F D-J tube was inserted along the guide wire with the curled ends completely within the seminal vesicle (Fig. 1C). The D-J tube was held in place with the push rod while the guide wire and ureteroscope were pulled out. Then, the length of the D-J tube outside the urethra was observed (Fig. 1D). A D-J tube was placed in the right seminal vesicle in the same manner. Figure 1E shows a view of the prostatic utricle with D-J tubes in both seminal vesicles. The length of the left D-J tube was measured and then inserted with caution during the procedure. After placement of the D-J tubes, a 16-F, ordinary two-way Foley catheter was placed to fix the D-J tubes (Fig. 1F). Postoperative kidney, ureter, and bladder (KUB) examination and naked eye observation were performed to confirm that the bilateral D-J tubes stayed as expected 7 days after the operation. Pelvic view (Fig. 2A). Pelvic oblique view (Fig. 2B). Changes in the position of the D-J tubes and catheter were observed before planning to remove the catheter 3 days after the operation (Fig. 2C). After that, the catheter was removed, and the D-J tubes were removed at the same time. After the removal of the catheter, the patient was instructed to ejaculate multiple times. All surgical procedures were performed by the same group of surgeons.
Figure 1 (A) After the guide wire was placed into the prostatic utricle, the ureteroscope was inserted. (B) The guide wire was placed into the end of the seminal vesicle. (C) After the guide wire was inserted into the seminal vesicle, a D-J tube was inserted along the guide wire. (D) After the D-J tube was placed, the length of the D-J tube left outside the urethra was measured. (E) D-J tubes were placed in both seminal vesicles. This view is of the prostatic utricle. (F) A 16-F, ordinary two-way Foley catheter was placed after completion of bilateral indwelling D-J tube placement.
Figure 2 KUB examinations were performed to observe the position of the D-J tubes and urinary catheter 3 days after the operation. (A) Pelvic view. (B) Pelvic oblique view. (C) Changes in the position of the D-J tubes and catheter were observed before planning to remove the catheter 3 days after the operation.
1.4 Intraoperative and postoperative observation indexes
Intraoperative findings of TSV procedure was observed such as calculus, seminal vesiculitis, and prostatic utricle cyst. Complications during surgery included rectal injury and persist bleeding in seminal vesicles. Postoperative complications like watery ejaculation and epididymitis, the postoperative length of hospital stay, and the recurrence rate of obstructive azoospermia were compared between the two groups. Sperm can be detected in semen after operation, and sperm can not be detected in later follow-up, which is regarded as recurrence. Postoperative complications included D-J tube shedding, haematuria, ejaculation disorder and severe pain. Postoperative complications including D-J tube shedding, haematuria, ejaculation disorder and secale score (VAS).
1.4 Statistical analysis and follow-up
Data were analyzed using SAS v9.04 software (SAS Institute, Inc., Cary, NC, USA). Continuous data are presented as the mean ± standard deviation (M±SD), and categorical data are presented using percentage. Comparisons of continuous data between the two groups were performed using Student’s t test. Categorical data were compared using the chi-square test. If half of the cells contained a count of less than 5, a continuity adjustment chi-square test was performed. The patients were followed up for 4 years in order to record obstructive azoospermia symptom recurrence in terms of the postoperative month (complete data). If there was no recurrence or loss to follow-up, the data were recorded as censored data. These data were estimated using the Kaplan-Meier method. Statistical significance was considered at p < 0.05.