Jul 30, 2008

Benign prostatic syndrome: Relevance of less invasive surgical procedures remains unclear

Individual patient preferences could determine the type of surgery

Urination symptoms caused by a benign enlargement of the prostate occur relatively frequently in older men. These symptoms can cause so much distress that affected men opt for a surgical intervention. Various surgical treatment options have become available for the treatment of benign prostatic syndrome (BPS).

The Institute for Quality and Efficiency in Health Care (IQWiG) therefore undertook a comparative assessment of the benefits of surgical procedures for the treatment of BPS. Concerning symptom relief, there is no scientific evidence that newer interventions, which are often referred to as being less burdensome for patients, are superior or at least equivalent to surgical procedures recognised as the standard interventions. However, there are indications that with some of the less invasive procedures, patients can be discharged from hospital earlier and certain serious adverse events possibly occur less frequently.

This is the result of the final report of the Institute published on 30 July 2008.

Various therapy options are available

The treatments currently available range from monitoring to see if symptoms resolve spontaneously, to various surgical techniques in which the prostate is (partially) removed. Recognised surgical procedures include the transurethral resection of the prostate (TURP) or the removal of the prostate gland (prostatectomy), which is sometimes performed in patients with BPS who have a very large prostate. In TURP, prostatic tissue is mechanically ablated with a resection loop inserted through the urethra. This tissue is subsequently flushed out. TURP is the reference standard and the results of this procedure are used as a benchmark for other interventions. Laser technology often plays a role in newer, less invasive procedures. Tissue is either resected with a laser probe or heated to such an extent that it becomes necrotic. Other approaches achieve overheating by means of microwaves or ultrasound.

The report, which was prepared in collaboration with external experts, compares the benefits of these procedures with regard to patient-relevant therapy goals. From the patient's point of view, treatment should primarily relieve urination symptoms and improve quality of life, and at the same time cause as few adverse events as possible. It is also relevant for a patient whether hospitalisation is necessary, how long he has to stay in hospital, and whether or for how long he needs a urinary catheter.

Interpretation of study results is limited

A total of 56 studies were included in which about 6000 men with an average age of at least 60 years had participated. In 55 of these studies, patients were randomly allocated to a treatment group (randomisation). Despite this large number, the evidential value of the studies is limited. This is due to the fact that mistakes were made in the collection, analysis or the type of data-reporting. The results are therefore susceptible to bias. This refers in particular to adverse events such as late complications, which were not systematically recorded and reported.

Benefit of some alternative procedures shown, but no additional benefit for symptom relief

Standard procedures, such as TURP, were compared with a total of 15 other interventions. None of these 15 comparisons provided proof, or even indications, that the less invasive procedures resulted in improved or at least equivalent symptom relief. However, the fact that an overall additional benefit was not demonstrated does not mean that alternative procedures offer no benefit at all.

One procedure (transurethral microwave thermotherapy, TUMT) showed greater symptom relief compared with a sham intervention. Another procedure (visual laser ablation of the prostate, VLAP) provided an indication for greater symptom relief compared with no intervention (watchful waiting). On the basis of indirect comparisons, this conclusion can also be assumed for 2 further alternative procedures (holmium laser resection of the prostate, HoLRP; holmium laser enucleation of the prostate, HoLEP).

Longer hospitalisation times with standard therapy

However, standard therapy may have some disadvantages with regard to hospitalisation time. One of the alternative procedures, TUMT, can even be performed on an outpatient basis and does not require a general anaesthetic. Concerning quality of life and catheterisation time, the studies do not allow consistent conclusions. This also applies to adverse events. However, there are indications that, on the one hand, some of the less invasive procedures (e.g. VLAP) require repeated interventions at a later point in time, but, on the other, that serious adverse events, such as major bleeding, occur less frequently compared with standard therapy.

In IQWiG's opinion, if the main objective for the patient is reliable relief for urination symptoms, one of the standard therapies should be used. However, if other aspects are prioritised, such as the length of hospital stay or the avoidance of specific adverse events, an alternative procedure may be preferred by the patient. In IQWiG's opinion, it is necessary to inform patients comprehensively about the advantages and disadvantages of each surgical procedure available. In particular this refers to the prospects of success with regard to symptom relief. Patients will only be able to make their own decision on the choice of surgical procedure if they have been provided with this information.

Procedure of report production

The preliminary report (version 2.0) was published on 23 October 2007. Comments on this report could be submitted within a period of 4 weeks. In a scientific debate on 11 December 2007, unclear aspects of these comments were discussed with regard to their relevance to the final report with those persons who had submitted comments. Meeting minutes of the debate as well as written comments have been published in a separate document together with the final report. The arguments presented in the comments are addressed in detail, particularly in the report's discussion section (pp. 434-461).

The following executive summary (PDF, 42 kB) provides an overview of the background, methods, and additional results of the final report.

Contact: Tel. ++49 (0)221-35685-0, info@iqwig.de

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