Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial.



Fetal lower urinary tract obstruction (LUTO) is associated with high perinatal and long-term childhood mortality and morbidity. We aimed to assess the effectiveness of vesicoamniotic shunting for treatment of LUTO.


In a randomised trial in the UK, Ireland, and the Netherlands, women whose pregnancies with a male fetus were complicated by isolated LUTO were randomly assigned by a central telephone and web-based randomisation service to receive either the intervention (placement of vesicoamniotic shunt) or conservative management. Allocation could not be masked from clinicians or participants because of the invasive nature of the intervention. Diagnosis was by prenatal ultrasound. The primary outcome was survival of the baby to 28 days postnatally. All primary analyses were done on an intention-to-treat basis, but these results were compared with those of an as-treated analysis to investigate the effect of a fairly large proportion of crossovers. We used Bayesian methods to estimate the posterior probability distribution of the effectiveness of vesicoamniotic shunting at 28 days. The study is registered with the ISRCTN Register, number ISRCTN53328556.


31 women with singleton pregnancies complicated by LUTO were included in the trial and main analysis, with 16 allocated to the vesicoamniotic shunt group and 15 to the conservative management group. The study closed early because of poor recruitment. There were 12 livebirths in each group. In the vesicoamniotic shunt group one intrauterine death occurred and three pregnancies were terminated. In the conservative management group one intrauterine death occurred and two pregnancies were terminated. Of the 16 pregnancies randomly assigned to vesicoamniotic shunting, eight neonates survived to 28 days, compared with four from the 15 pregnancies assigned to conservative management (intention-to-treat relative risk [RR] 1·88, 95% CI 0·71—4·96; p=0·27). Analysis based on treatment received showed a larger effect (3·20, 1·06—9·62; p=0·03). All 12 deaths were caused by pulmonary hypoplasia in the early neonatal period. Sensitivity analysis in which non-treatment-related terminations of pregnancy were excluded made some slight changes to point estimates only. Bayesian analysis in which the trial data were combined with elicited priors from experts suggested an 86% probability that vesicoamniotic shunting increased survival at 28 days and a 25% probability that it had a large, clinically important effect (defined as a relative increase of 55% or more in the proportion of neonates who survived). There was substantial short-term and long-term morbidity in both groups, including poor renal function—only two babies (both in the shunt group) survived to 2 years with normal renal function. Seven complications occurred in six fetuses from the shunt group, including spontaneous ruptured membranes, shunt blockage, and dislodgement. These complications resulted in four pregnancy losses.


Survival seemed to be higher in the fetuses receiving vesicoamniotic shunting, but the size and direction of the effect remained uncertain, such that benefit could not be conclusively proven. Our results suggest that the chance of newborn babies surviving with normal renal function is very low irrespective of whether or not vesicoamniotic shunting is done.

Source: Lancet


Lower urinary tract symptoms affect more than half of older men. Options for bothersome symptoms include α- adrenergic-receptor blockers, 5α-reductase inhibitors, phosphodiesterase-5 inhibitor therapy, and antimuscarinic therapy. Read the latest Clinical Practice article on this topic. BPH, a histologic diagnosis, is a condition that occurs with aging; the prevalence increases from 25% among men 40 to 49 years of age to more than 80% among men 70 to 79 years of age.

Clinical Pearls

What are the lower urinary tract symptoms associated with BPH?

The symptoms are classified as obstructive voiding or bladder storage symptoms. Obstructive voiding symptoms include urinary hesitancy, delay in initiating micturition, intermittency, involuntary interruption of voiding, weak urinary stream, straining to void, a sensation of incomplete emptying, and terminal dribbling. Storage symptoms include urinary frequency, nocturia, urgency, incontinence, and bladder pain or dysuria.

What are the risk factors for developing BPH?

In addition to increased age, additional risk factors include black (vs. white) race, obesity, diabetes, high levels of alcohol consumption, and physical inactivity; mechanisms underlying these associations remain poorly understood. Physiological markers associated with an increased risk of benign prostatic hyperplasia include levels of endogenous testosterone and dihydrotestosterone as well as increased levels of dehydroepiandrosterone and estradiol, insulin-like growth factors, and inflammatory markers (e.g., C-reactive protein).

Morning Report Questions

Q: What office evaluation should be performed when a diagnosis of BPH is being considered?

A: Evaluation includes a complete history to rule out alternative causes of lower urinary tract symptoms, including consideration of excess fluid and caffeine intake and the use of diuretics or medications with antihistaminic effects that may weaken bladder detrusor function. A digital examination of the prostate should be performed and a PSA measurement obtained. A urinalysis should be ordered to screen for urinary tract infection and to look for hematuria, which might indicate urolithiasis or cancer of the kidney, bladder, or prostate. Urinary tract infections should be treated. Evaluation should also include the use of the American Urological Association Symptom Index, a quantitative measure of the severity of lower urinary tract symptoms. If the patient reports a sense of incomplete bladder emptying or has a palpable bladder on abdominal examination, a post-voiding residual urine measurement should be obtained to rule out “silent” urinary retention (normal residual urine volume, <100 ml).

Q: How does one approach the treatment of BPH?

A: A reasonable approach would be to initiate an alpha-blocker (doxazosin), and then to increase the dose based on symptom response. If symptoms are still bothersome, a 5(alpha)-reductase inhibitor can be added as long as the PSA level is higher than 1.5 ng per milliliter (indicating prostatic enlargement). Another option, particularly if the patient also has erectile dysfunction for which he desires treatment, would be to prescribe a phosphodiesterase-5 inhibitor (currently only tadalafil is approved for these symptoms), since this agent could address both problems. In a randomized, placebo-controlled trial comparing doxazosin, a 5(alpha)-reductase inhibitor (finasteride), and the combination of the two, type 15(alpha)-reductase inhibitors (with or without alpha-blocker therapy), but not alpha-blocker therapy alone, significantly reduced rates of secondary outcomes of urinary retention and the need for invasive therapy for BPH.



Source: NEJM.