Efficacy of Bladder Neck Incision (BNI) Versus Transurethral Resection of Prostate (TURP) in Management of Benign Prostatic Hyperplasia (BPH) Causing Obstruction: A Randomised Controlled Study

Objective: To compare the efficacy of bladder neck incision (BNI) with transurethral resection of prostate (TURP) in the treatment of patients with urinary obstruction caused by benign prostatic hyperplasia (BPH) on the basis of short term follow up of 4 months. Patient and Methods: The study was conducted in Department of General Surgery in Maulana Azad Medical College, New Delhi. 60 men with proven clinical diagnosis of BPH of size 30 grams and less presenting with symptoms of bladder outlet obstruction (BOO) were randomised prospectively to undergo either of the two operative modalities. Preoperatively size of the prostate, symptom scoring (IPSS), peak flow rate (Qmax) were assessed. Postoperatively and during 4 months follow up the following data were collected—operative time, catheterisation period, hospital stay, blood loss, Qmax and IPSS. Results: Preoperative parameters in both the groups showed no statistically significant differences with respect to prostate size, Qmax and IPSS Scoring. At 4 months follow up Qmax increased from (6.35 ± 4.49) to (16.41 ± 2.28) in TURP group and (4.51 ± 3.57) to (15.95 ± 2.58) in BNI group. IPSS decreased from 18.70 to 5.7 in TURP group and 18.90 to 6.00 in BNI group. All differences were statistically significant. There was a statistically significant difference in operative time, blood loss, hospital stay, catheterisation timing favouring BNI. Conclusion: TURP and BNI are equally effective in providing symptomatic improvement. BNI has an upper hand in reference to operative time, hospital stay, duration of catheterisation and blood loss.


Introduction
Surgical treatment of BPH is classically by TURP and is the gold standard in treatment of symptomatic BPH which has withstood the test of time [1]. However, in the last two decades, the role of TURP as gold standard therapy for patients with LUTS due to BPH has increasingly been challenged by the development of medical (5 alpha reductase inhibitors, alpha 1 receptor blockers) and less invasive interventional alternatives. The main driving force behind this development was a high prevalence of disease and importantly the apparently unchanged morbidity of TURP [2].
Transurethral incision of prostate (TUIP) or Bladder neck incision (BNI) is an endoscopic surgical procedure which is relatively simple, quick and technically easier. It has been asserted that BNI is an underused procedure [3] and at least half of the patients who currently undergo TURP for small BPH causing obstruction can be treated effectively with BNI thereby avoiding many of the risks of the former procedure [4]. However, it did not gain popularity due to emerging techniques like HoLEP.
The TUIP was first described by Botini in 1887 but it was revisited and popularised by Orandi in 1973 [4]. TUIP has shown to be less invasive than TURP with minimal complications.
There is a general consensus that a patient whose estimated prostate gland is 30 g or less, is an ideal candidate for BNI [5]. Therefore, there is a need to compare the results of BNI as a treatment modality with that of TURP in patients will small prostate having severe obstructive symptoms.

Aims and Objectives
To compare bladder neck incision to transurethral resection of the prostate in the management of benign prostatic hyperplasia with reference to: 1) Efficacy in relieving obstructive symptoms in terms of peak urinary flow rates and IPSS scoring being the primary objective.
The secondary objectives being 1) Operative time 2) Duration of hospital stay

Materials and Methods
From  The values are derived from mean and standard deviation outcomes of previous study [6]. According to these values the sample size is 7.84 in each group and we took 30 patients in each group.
Randomisation: Patients were randomised into two groups using computer generated random numbers which were kept in 60 sealed envelopes. Envelopes were opened just before the start of surgery by paramedics not involved in surgery.
Out of two groups, Group A underwent TURP while Group B underwent Bladder neck incision, BNI.
Methodology: Informed written consent was taken from all the patients before enrolment to participate in the study. Patients had the option to opt out of the study at any point of time without compromising right of treatment. Complete clinical history in-Open Journal of Urology cluding smoking, neurological symptoms, medication history and comorbidities were asked for. Physical examination along with DRE and IPSS scoring was done. They were also evaluated clinically for symptoms arising out of neurogenic bladder.
Baseline investigations were carried out including complete blood count, urine analysis and culture, blood sugar, urea, creatinine, serum electrolytes, investigations for anesthesia fitness and serum PSA. Uroflowmetry was done for each patient to find out peak and average flow rate for a voided volume of more than 200 ml on 2 occasions. Peak flow rate < 10 ml/s was taken as a sign of obstruction and those with peak flow rate lying in between 10 and 15 ml/s were treated with alpha blocker Tamsulosin for 12 weeks before deciding about their eligibility for this study. USG KUBP and TRUS done for each patient to estimate the size of prostate and PVRU. Preliminary urethrocystoscopic evaluations were made in every case to rule out any concomitant bladder pathology and to grade prostate enlargement.
A 26 Fr continuous flow Karl Storz resectoscope was used in all procedures under spinal regional anesthesia. 1.5% Glycine was used as irrigation fluid. At the end of procedure, a 22F 3 way Foley catheter was inserted and kept in bladder, balloon was inflated with 30 ml of saline and connected to a closed drainage system after application of traction.
In TURP group, resection was done circumferentially up to anatomical capsule of the prostate, using Nesbit technique. First, the middle lobe was resected and an excavation between 5 and 7 o'clock up to the surgical capsule was formed. Successively, after middle lobe, the lateral lobes and then ventral tissues of the gland were resected. The apical parts of the gland are resected last. Extreme care was taken to preserve verumontanum and not go beyond it.
In TUIP group, two deep incisions at 5 and 7 o'clock position were made using Collin's knife. Incision was made from the trigone below the ureteric orifices, cutting the bladder neck and prostate to the sides of proximal end of verumontanum. Incisions were deepened till the fibres of prostatic capsules were seen.
Record of the time taken for surgery was noted. Postoperatively, continuous bladder wash with normal saline was continued as long as washout was blood stained. In every patient, total operating time, amount of irrigation fluid used in litres and number of packed cell volumes (in bags) transfusions required was recorded. Postoperative catheterisation period was noted. Every patient was followed up in surgical OPD at 1 week, 1 month and at 4 months post operatively. In follow up, patients were studied for subjective evaluation of outcome of operation, uroflowmetry and detailed symptom score (IPSS [7]).
All the data were recorded in predesigned data collection sheets and subjected

Results
Total 60 patients were included in the study who fulfilled inclusion criteria and there were no lost to follow up cases. This was a randomized controlled study where the patients were divided into two groups, one group underwent BNI and the other underwent TURP. There were 30 patients in each group. Pre-operative data of both groups are compared in Table 1.  Table 1 shows that there is no statistical significant difference in pre-operative variables in TURP and BNI groups and the randomisation had generated a well-matched group for the study. This indicates the there was no bias in the participant selection process.  Table 3 shows that operating time, blood loss post-operative hospital stay are less in BNI group than that of TURP group and the statistically high difference was seen as noted by p value < 0.001.

Discussion
Transurethral resection of the prostate (TURP) and Bladder neck incision (BNI) both are accepted treatment for small size prostate causing obstruction. TURP has for many years been the most commonly performed transurethral operative procedure for resection of obstructing prostatic adenoma [8]. This randomised controlled study compares the subjective and objective improvement resulting from BNI with that of TURP. Statistical analysis was done on collected data and found that there was no statistically significant difference in subjective and objective parameters in between two groups preoperatively.  [10] in a review of 3885 TURPs, reported an average resected prostatic weight of 22 g of tissue. In 65% of the TURPs less than 20 g was resected. According to these data, most BEP surgically treated cases would be eligible for BNI if the procedure was aimed at patients with estimated resected prostatic weight of less than 20 g. as demonstrated in this article, the increased use of BNI as opposed to TURP is clinically indicated, and BNI's potential to reduce the health service costs is substantial.
We compared intraoperative variable procedure time which had shown statistically significant advantage for BNI ( There was significant improvement of symptoms in both the groups but both groups were found to be equally efficacious as difference in IPSS score and Qmax improvement was statistically significant amongst two groups. Compared to baseline/pre-op, the post-operative IPSS were lower statistically at all follow up visits after both TURP and BNI. Mean improvement in TURP group was 8, 12.8 and 13.0 after 1 week, 1 month and 4 months of surgery respectively and the mean improvement in BNI group was 7.9, 12.7 and 12.9 respectively which were comparable with no statistical significance. These indicate that both the procedures are equally effective in reducing symptom score. These confirm the experience of Lourenco et al. [12] (2010) Jahnson et al. (1998) [4], Riehmann et al. [8] (1995) who found no significant difference in symptom score improvement between the groups.
In our study, pre-operative mean Q max were 6.35 ml/s and 4.51 ml/s respectively in TURP and BNI group. There were significant improvements (p < 0. There is insignificant difference between the two groups (p > 0.1). these results agree with those of Christensen et al. [13] (1990), Riehmann et al. [8] (1995). Dorflinger et al. [14] (1987) found the change from 10.1 ml/s and 9.2 ml/s pre-operatively to 15 ml/s and 19 ml/s post-operatively in TURP and BNI group respectively. In Larsen et al. (1987) series these changes were 7.4 ml/s and 8.6 ml/s to 18.5 ml/s and 20.6 ml/s; however one study showed significant difference between the groups (Jahnsen et al. [4]). They postulated that the removal of gland resulted in crea- Open Journal of Urology which shows no statistical significance and correlated with the reference studies. The mean improvement in Q max at 1 week of TURP was 14.27 as compared to 13.64 after BNI. The percentage improvement of the same parameters was 67.71 ± 30.09 with TURP and 148.91 ± 99.09 in BNI group, the p value of which is 0.025, statistically significant. So, there was significantly much more increase in Q max in BNI group. The mean percentage improvement at 1 month of TURP and BNI were comparable and not statistically significant. The mean percentage improvement in Q max at 4 months of TURP was 95.25 ± 40.99 and 207.91 ± 153.89 with BNI. p value of which is 0.048, proving it to be statistically significant. There was much more improvement in Q max in BNI group at 4 months in comparison to TURP group.
IN TURP arm, all the patients were able to pass urine and none of them required recatheterisation. In BNI group, 1 patient did not void after decatheterisation. He was recatheterised but was having clot retention which didn't clear even on irrigation. Clot evacuation was done for him and Foley's was removed the next day and patient could void clear urine. One patient in BNI group had urinary incontinence after the decatheterisation. He was managed medically by anticholinergic therapy and pelvic floor exercises (Kegel's exercises). He was on Foley's pre-operatively for long time which might be the reason for his incontinence. Three patients in both the groups had symptoms of urgency which was managed by anticholinergic therapy. Mean post-operative hospital stay in our study was 2.70 days and 1.50 days for TURP and BNI respectively. The difference was statistically significant (p < 0.001) and is in favour of BNI. In Soonawalla et al. [11] (1992) series the mean post-operative hospital stay was 7.16 days and 6.03 days respectively in TURP and BNI groups. In Riehmann et al. (1992) series it was 4.3 and 3 days respectively for TURP and BNI groups.in a meta-analysis by Yang et al. [3]  The treatment of BEP is aimed at total regression or satisfactory alleviation of symptoms, which results in improvement of quality of life, allowing adequate emptying of bladder freely and under low pressure [15].
The limitation of our study was that of a small sample size and large-scale, multicentric randomized controlled trial is now required to evaluate comprehensively the effectiveness, impact on quality of life and overall cost of transurethral prostatic incision compared with transurethral prostatic resection.

Conclusions
In our study, outcome assessed by comparing difference (improvement) in variables which shows BNI is equally efficacious to TURP in small size BEP (less than 30 g). Intra operative variable shows significant reduction in operative time.
The post-operative hospital stay after BNI was significantly shorter than after TURP and this finding is consistent with the results from other studies. There was much more improvement in Q max in BNI group at 4 months in comparison to TURP group. BNI is also applicable in patients in urinary retention, has a shorter operative time, and can be performed under local anesthesia. In the present study, the time of indwelling transurethral catheter after TUIP was significantly shorter than after TURP and this may minimize the risk of urinary tract infection.
TUIP can be a better choice in selected group of patients like those not fit for prolonged anesthesia due to age or those who will not withstand hemodynamic instability caused by fluid overload on irrigation during lengthy procedure like TURP.

Conflicts of Interest
The authors declare no conflicts of interest regarding the publication of this paper.