Background
Older men often suffer from urinary complaints such as frequent urination or a weak urine stream. If these symptoms can be blamed on an enlarged prostate gland and lifestyle changes and medications don't help enough, there are surgical procedures that may help. One such procedure is called transurethral resection of the prostate (traditional surgery). This traditional surgery has been widely used for a long time, and is known to work well, but it does require anesthesia and has several unwanted effects. Other 'minimally invasive' surgical procedures have become available. These procedures are said to work similarly well, but with fewer unwanted effects. The five minimally invasive procedures are 'prostatic urethral lift', 'convective radiofrequency water vapor therapy', 'transurethral microwave thermotherapy', 'prostatic arterial embolization', and 'temporary implantable nitinol device'.
Review question
We performed this review to compare five newer treatment forms for men with lower urinary tract symptoms to traditional surgery or 'sham surgery'. In sham surgery, men thought they were getting surgery but really did not have anything done.
Methods
We used recommended Cochrane methods and GRADE to rate the certainty of evidence. We also used a special statistical method called network meta-analysis to compare different treatments.
Search date
The findings of our study are up-to-date until February 2021.
Included studies
We included 27 randomized controlled trials. In this type of study, random 'chance' determined whether men were assigned to receive one of the newer surgical procedures, or traditional surgery (or sham surgery). This method of assigning participants to 'intervention' or 'control' groups helps to reduce bias in research studies.
Men were mostly over 50 years of age and had severe urinary symptoms. Most studies (16 studies) used transurethral microwave thermotherapy. Eleven studies followed men for less than one year and nine studies followed men for one year. Only seven studies followed men for two years or longer.
Funding
Most studies did not report their funding sources, while others reported that those who paid for the study received at least some money for the company that made the device that was used.
Key results
We only report the results for what we thought were the three most important outcomes: urinary symptoms, urinary quality of life, and unwanted effects, comparing these treatments to traditional surgery. The review also includes information on several other outcomes and how they compared to sham surgery.
Prostatic urethral lift and arterial embolization may result in little to no difference in men's symptoms than traditional surgery in the short term (up to 12 months). The other minimally invasive interventions may result in worse symptom scores than traditional surgery at short-term follow-up, but there may be no difference. All treatments may result in little to no difference in the quality of life compared to traditional surgery at short-term follow-up. Transurethral microwave thermotherapy probably results in a large reduction in major adverse events compared to traditional surgery, whereas the other minimally invasive treatments may result in a large reduction in major adverse events. Transurethral microwave thermotherapy may result in higher retreatment rates, but we are uncertain about the other minimally invasive procedures. We are also uncertain of the effects of these interventions on erectile function and ejaculation.
Certainty of evidence
Our level of certainty about the evidence was different for each of the outcomes, but was mostly low or very low. This means that we cannot be sure that the results of this review are accurate. A common reason for grading down the certainty of evidence included flaws in the ways the studies were planned and conducted. Also, the results differed a lot among studies, and the results of studies were often imprecise.
Minimally invasive treatments may result in similar or worse effects concerning urinary symptoms and QoL compared to TURP at short-term follow-up. They may also result in fewer major adverse events. PUL and PAE resulted in better rankings for symptoms scores and PUL may result in fewer retreatments, especially compared to TUMT, which had the highest retreatment rates. We are very uncertain about the effects of these interventions on erectile and ejaculatory function. There was limited long-term data, especially for CRFWVT and TIND. Future high-quality studies with more extended follow-up, comparing different, active treatment modalities, and adequately reporting critical outcomes relevant to patients, including those related to sexual function, could provide more information on the relative effectiveness of these interventions.
A variety of minimally invasive treatments are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). However, it is unclear which treatments provide better results.
Our primary objective was to assess the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH through a network meta‐analysis. Our secondary objective was to obtain an estimate of relative ranking of these minimally invasive treatments, according to their effects.
We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase, Scopus, Web of Science and LILACS), trials registries, other sources of grey literature, and conference proceedings, up to 24 February 2021. We had no restrictions on language of publication or publication status.
We included parallel-group randomized controlled trials assessing the effects of the following minimally invasive treatments, compared to TURP or sham treatment, on men with moderate to severe LUTS due to BPH: convective radiofrequency water vapor therapy (CRFWVT); prostatic arterial embolization (PAE); prostatic urethral lift (PUL); temporary implantable nitinol device (TIND); and transurethral microwave thermotherapy (TUMT).
Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model for pair-wise comparisons and a frequentist network meta-analysis for combined estimates. We interpreted them according to Cochrane methods. We considered a minimally important difference of three points for the International Prostate Symptoms Score[IPSS]. We used the GRADE approach to rate the certainty of evidence.
We included 27 trials involving 3017 men, mostly over age 50, with severe LUTS due to BPH. The overall certainty of evidence was low to very low due to concerns regarding bias, imprecision, inconsistency (heterogeneity), and incoherence. Based on the network meta-analysis, results for our main outcomes were as follows.
Urologic symptoms (19 studies, 1847 participants): PUL and PAE may result in little to no difference in urologic symptoms scores compared to TURP (3 to 12 months; MD of IPSS range 0 to 35; higher scores indicate worse symptoms; PUL: 1.47, 95% CI -4.00 to 6.93; PAE: 1.55, 95% CI -1.23 to 4.33; low-certainty evidence). CRFWVT, TUMT, and TIND may result in worse urologic symptoms scores compared to TURP at short-term follow-up, but the CIs include little to no difference (CRFWVT: 3.6, 95% CI -4.25 to 11.46; TUMT: 3.98, 95% CI 0.85 to 7.10; TIND: 7.5, 95% CI -0.68 to 15.69; low-certainty evidence).
Quality of life (QoL) (13 studies, 1459 participants): All interventions may result in little to no difference in the QoL scores, compared to TURP (3 to 12 months; MD of IPSS-QoL score; MD range 0 to 6; higher scores indicate worse symptoms; PUL: 0.06, 95% CI -1.17 to 1.30; PAE: 0.09, 95% CI -0.57 to 0.75; CRFWVT: 0.37, 95% CI -1.45 to 2.20; TUMT: 0.65, 95% CI -0.48 to 1.78; TIND: 0.87, 95% CI -1.04 to 2.79; low-certainty evidence).
Major adverse events (15 studies, 1573 participants): TUMT probably results in a large reduction of major adverse events compared to TURP (RR 0.20, 95% CI 0.09 to 0.43; moderate-certainty evidence). PUL, CRFWVT, TIND and PAE may also result in a large reduction in major adverse events, but CIs include substantial benefits and harms at three months to 36 months; PUL: RR 0.30, 95% CI 0.04 to 2.22; CRFWVT: RR 0.37, 95% CI 0.01 to 18.62; TIND: RR 0.52, 95% CI 0.01 to 24.46; PAE: RR 0.65, 95% CI 0.25 to 1.68; low-certainty evidence).
Retreatment (10 studies, 799 participants): We are uncertain about the effects of PAE and PUL on retreatment compared to TURP (12 to 60 months; PUL: RR 2.39, 95% CI 0.51 to 11.1; PAE: RR 4.39, 95% CI 1.25 to 15.44; very low-certainty evidence). TUMT may result in higher retreatment rates (RR 9.71, 95% CI 2.35 to 40.13; low-certainty evidence). There was insufficient data to include data on CRFWVT and TIND in this analysis.
Erectile function (six studies, 640 participants): We are very uncertain of the effects of minimally invasive treatments on erectile function (MD of International Index of Erectile Function [IIEF-5]; range 5 to 25; higher scores indicates better function; CRFWVT: 6.49, 95% CI -8.13 to 21.12; TIND: 5.19, 95% CI -9.36 to 19.74; PUL: 3.00, 95% CI -5.45 to 11.44; PAE: -0.03, 95% CI -6.38, 6.32; very low-certainty evidence).
Ejaculatory dysfunction (eight studies, 461 participants): We are uncertain of the effects of PUL, PAE and TUMT on ejaculatory dysfunction compared to TURP (3 to 12 months; PUL: RR 0.05, 95 % CI 0.00 to 1.06; PAE: RR 0.35, 95% CI 0.13 to 0.92; TUMT: RR 0.34, 95% CI 0.17 to 0.68; low-certainty evidence). There was insufficient data to include data on CRFWVT and TIND in this analysis.
TURP is the reference treatment with the highest likelihood of being the most efficacious for urinary symptoms, QoL and retreatment, but the least favorable in terms of major adverse events, erectile function and ejaculatory function. Among minimally invasive procedures with sufficient data for analysis, PUL and PAE have the highest likelihood of being the most efficacious for urinary symptoms and QoL, TUMT for major adverse events, PUL for retreatment, CRFWVT and TIND for erectile function and PUL for ejaculatory function.