PATIENTS AND METHODS
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- PATIENTS AND METHODS
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In this single-centre, retrospective, cross-sectional observational study, the clinical history of all patients successively operated in the first semester of 1992 and the first semester of 2002 was investigated. After obtaining hospital ethics committee approval, data were collected in accordance with predefined criteria. The following data were recorded: age, general health status, comorbidities and drugs used in relation to comorbidities, the year the symptoms started and their development, and the main references of preoperative status (PSA level, prostate volume, maximum urinary flow rate, Qmax, and residual urine). The medical treatment used for BPH, either continuous, intermittent or combined, was identified either by examining clinical data or by telephone contact with the patients. The drug used, duration of treatment and indication for surgery were analysed. In patients treated with open surgery, the weight of the adenoma removed was recorded, while sample volume was reported in patients having TURP. The hospital stay, complications and other relevant factors related to patient follow-up were also recorded.
The chi-square test was used to assess proportions and differences between means were assessed by a t-test, with the Levene test in the variance comparison.
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Nine patients were excluded from the surgical series, either because BPH was not the main surgical indication (two patients with bladder neck contracture, two with previous prostate surgery) or it was a coincidental surgical procedure (five with bladder tumour). Patients operated in 1992 were significantly younger (Table 1), by a mean of 3.1 years. The commonest indications for surgery in both groups were worsening symptoms, followed by acute urinary retention (AUR), where patients had an indwelling bladder catheter before surgery.
Table 1. The comparison of the two groups treated in the first semesters of 1992 and 2002
|Mean (sd) age, years||69.1 (8.57)||72.3 (7.59)|| +3.1||0.028|
|Surgery for BPH, n||85||70||−17.6%|| |
|Open adenectomy, %||18.8||28.6|| +9.8 (+52%)||0.04|
|Indications for surgery, %|
|Worsening symptoms||48||51|| ||0.669|
|adenoma weight, g (open)||73.8 (37.1)||79.8 (35.4)|| +6.1||0.625|
|volume resected, mL (TURP)||35.7 (26.8)||24.3 (15.2)|| || |
|hospital stay, days:|
|Open||14.1 (6.74)|| 8.7 (4.83)|| ||0.013|
|TURP|| 8.9 (4.05)|| 5.0 (1.22)|| ||<0.01|
|Hypertension||29||27|| || |
|Cardiac diseases|| 11||13|| || |
|Diabetes||10|| 6|| || |
|Respiratory insufficiency|| 7|| 5|| || |
|Parkinsonism, other||20|| || || |
|Stone disease (n at surgery)|| 8 (6)|| 5 (5)|| || |
|Pharmacology, n (%)||39 (46)||58 (82)|| || |
|Type of drugs, %|
|phytotherapy||89|| || || |
|α-blockers|| ||79|| || |
|Mean duration, years||2.5|| 4|| || |
The comorbidity of patients requiring medication is also shown in Table 1 for each group. The age difference at the time of surgery did not significantly influence the incidence and severity of comorbidities among the groups.
Of the 85 patients having surgery for BPH in 1992, 16 had an open retropubic adenectomy and 69 TURP. Similarly, in 2002, 70 patients had surgery, 20 by open surgery and 50 by TURP (Table 1), i.e. a relative increase in open surgery of 52%. The mean sample weight of the BPH tissue removed (open adenectomy) was slightly higher in 2003, but not significantly. The mean tissue volume resected by TURP was greater in 1992 than in 2002, and the mean hospital after open surgery and TURP was longer in 1992 than in 2002. Most common complications detected in patients operated by TURP in both groups were haematuria, needing blood transfusion (four), infection (eight), meatal stenosis (two), epididymitis (one) and renal insufficiency (one), with no significant differences between the groups. Haematuria (two) and wound infection (one) were also the most common complications in the open surgery group, also with no significant differences over time. The most important surgical risk factor detected in the series, more relevant for TURP and influencing both hospital stay and bleeding afterward, was the use of anticoagulation with dicoumarinic agents, despite the change to heparin.
Only 46% of the patients operated in 1992 were taking medical therapy for BPH (Table 1), with most using phytotherapy, sometimes for a long period, although mostly intermittently, and in some cases using different products successively and even combined (Table 1). In 2002, >80% of the patients undergoing surgery were on medical therapy, most of them taking α-antagonists, in most cases continuously and for longer (mean duration 4 years); 14% of patients were taking phytotherapy, 10% were taking finasteride, and two patients used combined therapy.
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There are several factors contributing to the well-documented [2–4] reduction of surgery for BPH, e.g. the efficacy of medical treatment, changes in the indications for surgery, difficulties for patients gaining access to a urologist and the ‘PSA effect’, diverting many patients with BPH to radical prostatectomy or radiotherapy. The parallel increase in the use of pharmacology for BPH indicates that this is the most relevant factor responsible for these changes. Reviews [5,6] show an increase in medical treatment for BPH from the 1990s to the present. Not only are more patients treated, but they are treated for longer; this is clear in the present study, where patients receiving medical therapy almost doubled between 1992 and 2002. This is more noticeable in countries where phytotherapy was not used in the 1980s, with patients and physicians being obliged to decide between watchful waiting or TURP from the first symptoms .
Pharmacology also has a secondary effect on the traditional itinerary of the patient in reaching the specialist. More patients remain in the care of the primary-care physician on their traditional course to the specialist consultation and definitive treatment. In some countries, where the role of the primary physician in shared-care for BPH is important, there is a delay in referring the patient to the urologist. Theoretically, this delay should be paralleled by more patients reaching the hospital with more progressive complications such as AUR. This is the case for Canada, where Borth et al., in 1998, reported receiving 55% of their patients with AUR, whereas in 1988 there were only 23%. In Spain there is no barrier to contacting the urologist at the first symptoms; 41% of the present patients had AUR in 1992, and 37% in 2002, a similar proportion over the decade.
The follow-up of the ‘PSA effect’ on the early detection of prostate cancer in patients receiving treatments for BPH has not been fully evaluated. No doubt significantly many ‘traditional’ patients with BPH and a progressive increase in PSA level are diverted to radical prostatectomy after prostate biopsy . However, the magnitude of this effect on surgery for BPH has not been well explored.
Finally, the changes in indications for BPH surgery are important; at the beginning of the 1990s ‘TURP at the first symptom’ was not unusual [7,9]. The indications for surgery have been displaced to more symptomatic patients. As pharmacology can control LUTS for some years, it is reasonable to infer that changes in indications for surgery for BPH, plus the beneficial effect of pharmacology, are retarding the need for surgery. However, in the present study, there was only a moderate 18% decrease in surgery for BPH over the decade.
In a previous study  we showed that patients are older when they undergo surgery, with a mean age of 67.8 years in 1990, 67.9 in 1995 and 72.3 in 2000. In the present study, the mean age of patients operated in 1992 and 2002 was 69 and 73 years, respectively, a difference of 3.1 years (Table 1). We assume that there is at least a trend to have surgery when older; is this delay caused by the use of pharmacological therapy?
It has been shown in different, well-controlled clinical trials that pharmacology for BPH can prevent or delay BPH progression and its most relevant markers of progression, i.e. AUR and the need for surgery [10–13]. Both adrenergic antagonists and 5α-reductase inhibitors could fulfil this objective, although in a different way; anti-adrenergic drugs do not modify prostate volume, permitting a progressive increase of prostate size, whereas 5α-reductase inhibitors reduce prostate volume significantly and durably. According to several long-term studies, the prostate volume of a patient on watchful waiting, placebo or treated for 5 years with α-blockers could increase by 15–20%[13–16], while in the same man treated with a 5α-reductase inhibitor the prostate volume is reduced by 20–28%[13,16–18]. This means a net difference at the end of 5 years of 35–45% in prostate volume.
The relevant role of prostate volume in BPH progression has been well documented . As most of the present patients in 2002 were treated with α-blockers for a long period (4 years) we expected a higher prostate volume than in 1992. Unfortunately, preoperative ultrasonography was not reliable and we had to use the prostate volume at surgery.
As indications for TURP are traditionally restricted to patients with a prostate volume of <60–70 mL, as estimated by transabdominal ultrasonography, it is reasonable to find a similar amount of tissue resected in different series [7,20–22]. To assess why there are potentially larger adenomas surgically removed at present, it is more informative to determine if the number of open adenectomies is increasing (traditionally indicated when the volume of the adenoma is ultrasonographically estimated at >70 mL) and to confirm if the weight of the removed adenoma is also increasing. We performed 36, 47 and 45 retropubic adenectomies in 1990, 1995 and 2000, with a mean weight of 65, 99 and 74 g, respectively. The proportion of open surgery vs TURP in this period was 17%, 21% and 32%, respectively. During the first semester of 1992 the mean weight of the adenomas removed was 73.8 g, and 79.8 g for 2002 (Table 1), the proportion of open surgery being 18% and 25.7%, respectively. There is a clear trend in favour of delayed surgery being associated with larger adenomas. Again, that pharmacology is used more often, and for longer, with drugs not affecting the progression of prostate volume, could explain this tendency.
Several factors could increase surgical events with delayed surgery: (i) As the patients are older they may have more, and more severe, comorbidities, making surgery for BPH a more risky operation; (ii) there is a potential increase in prostate volume, as noted, which could make TURP more difficult, or indicating to open adenectomy; (iii) there was a significant increase in AUR, high residual volumes with UTI, hydronephrosis, etc. in patients coming to surgery. This latter observation was confirmed by Borth et al., where the age of both groups was similar, but was not detected in the present study. Nor did the older patients (by 3.1 years) in 2002 have more, and more severe, comorbidities at the time of surgery, or a weaker tolerance to the procedure. Indeed, the incidence of complications was similar, with a very significant reduction in hospital stay over time in both groups of patients treated by TURP or open adenectomy.
However, the present study supports the hypothesis of the current dominant use of adrenergic antagonists, because their excellent long-term symptom control allows prostate size to progressively increase, shifting patients traditionally operated by TURP to open adenectomy. This causes a therapeutic paradox; long-term monotherapy with adrenergic antagonists, in good responders, might finally promote more aggressive surgery. The convenience of using drugs that control the progression of prostate volume in long-term therapy for BPH, e.g. 5α-reductase inhibitors, alone or combined with α-blockers, is clearly suggested by the results of the present study.