OBJECTIVES
To compare the prevalence of frequency and nocturia and the bother they impose in a population‐based sample of men and women using current International Continence Society (ICS) ...definitions of lower urinary tract symptoms (LUTS) and commonly used alternative definitions of these LUTS to emphasize the importance of standardizing the definitions when evaluating overactive bladder (OAB) syndrome; we also describe the spectrum of LUTS and bother they impose in this population with OAB.
SUBJECTS AND METHODS
Several validated disease‐specific measures were used in a population‐based, cross‐sectional telephone survey of adults aged ≥18 years in five countries. The population with OAB was defined as those participants who answered ‘yes’ to questions about urgency or urgency urinary incontinence according to ICS standards. The prevalence of daytime frequency and nocturia within the OAB population was examined using two different criteria for each symptom. Frequency was defined using the current ICS definition (i.e. subject’s perception of whether they urinated too often during the day) or more than eight daytime voids. Nocturia was defined according to the ICS definition of having to wake once or more per night to void and using the threshold of waking twice or more per night to urinate. Urinary symptom bother within the OAB population was compared using the different criteria for frequency and nocturia.
RESULTS
In all, 1434 participants (502 men and 932 women) were classified as having OAB; 31% of men and 25% of women with OAB had daytime frequency consistent with the ICS definition. The ICS‐defined frequency identified a population with a varied distribution of reported daytime voiding frequencies; most respondents reported frequencies below the threshold of nine daytime voids. The ICS‐defined daytime frequency was reported as bothersome by more than half of the OAB population (46% of men, 66% of women). Of the OAB population, ≈75% reported one or more nocturia episodes per night, and ≈40% reported two or more per night. The proportion of the OAB population that was bothered by nocturia increased markedly as the number of nocturia episodes increased. Among those with OAB, the most prevalent combination of OAB symptoms was urgency and nocturia. More than half of those with OAB reported urgency combined with three or more other LUTS (including voiding and postmicturition symptoms), and the number of LUTS reported increased with age. The proportion of the population reporting symptom bother increased as the number of reported LUTS in that population increased.
CONCLUSIONS
The ICS definitions for daytime frequency as ‘the subject’s perception of urinating too often’ and for nocturia as ‘one or more episodes per night’ adequately described bladder symptoms within the OAB population when assessed by the level of symptom bother. Urgency was uncommon in isolation and did not alone impose as high a level of bother as when combined with other LUTS. In this population, the most predominant manifestation of OAB was a combination of urgency with one or more other OAB symptoms. Symptom bother became more common as the number of symptoms reported increased. LUTS other than the defining symptoms of OAB were also highly prevalent within the OAB population.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Lower urinary tract symptoms (LUTS) are a common urological complaint. Transgender and gender diverse (TGD) individuals who have undergone masculinising or feminising genital gender-affirmation ...surgery (gGAS) experience a higher incidence of LUTS. Clinical assessment of LUTS involves symptom questionnaires, which are often gender-binary, and intimate examinations, which can be a source of distress if conducted without appropriate care. Inadequate clinical knowledge of complex anatomy following gGAS can cause further patient discomfort. Urodynamic studies often form an integral part of a urological assessment. These involve multichannel catheterisation. If performed by an inexperienced clinician, this can be a risky procedure for those who have undergone masculinising gGAS, as the reconstructed urethra is more fragile, tortuous and stenosed. The potential consequences of perforation are grave, risking the compromise of the functional and aesthetic outcomes of the original procedure. With this in mind, we highlight key areas during the investigation of LUTS where specific considerations for ensuring TGD inclusivity could be made.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Lower urinary tract symptoms (LUTS), consisting storage, voiding and post-micturition symptoms, is a comprehensive definition involving symptoms that may occur due to several causes. Instead of ...simply focusing on the enlarged prostate, more attention has to be paid to the entire urinary tract as well as multiple system comorbidities. Therefore, prostate surgery alone does not necessarily provide adequate management and cross-disciplinary collaborations are sometimes required. Based on current literature, this paper proposes the “3Bs” concept for managing non-neurogenic male LUTS, namely, “beyond prostate”, “beyond surgery” and “beyond urology”. The clinical application of the “3Bs” enables urologists to carry out integrated, individualized and precise medical care for each non-neurogenic male LUTS patient.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of ...prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness.
Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment.
A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.
International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
An international group of authors present a pooled analysis of data from their phase III multicentre double‐blind clinical trials in patients with overactive bladder, which evaluated the efficacy, ...tolerability and safety of darifenacin. They found the drug, a muscarinic M3 selective receptor antagonist, to be effective in the treatment of this condition, with excellent tolerability and safety.
A paper from Denmark compares the efficacy and safety of alfuzosin and tamsulosin in a large randomized, double‐blind, placebo‐controlled, multicentre study. There were similar improvements in urinary symptoms and maximum urinary flow with the two drugs compared to placebo, but the incidence of sexual function adverse events was higher with tamsulosin than placebo.
OBJECTIVE
To evaluate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), from an analysis of pooled data from three phase III, multicentre, double‐blind clinical trials in patients with overactive bladder (OAB).
PATIENTS AND METHODS
After a 4‐week washout/run‐in period, 1059 adults (85% women) with symptoms of OAB (frequency and urgency with urge incontinence) for ≥ 6 months were randomized to once‐daily oral treatment with darifenacin (7.5 mg, 337; or 15 mg, 334) or matching placebo (388) for 12 weeks. Efficacy was evaluated using electronic patient diaries that recorded incontinence episodes (including those resulting in a change of clothing or pads), frequency and severity of urgency, voiding frequency, and bladder capacity (volume voided). Safety was evaluated by analysis of adverse events (AEs), withdrawal rates and laboratory tests.
RESULTS
Relative to baseline, 12 weeks of treatment with darifenacin resulted in a significant reduction in the median (% change, interquartile range) number of incontinence episodes per week; 7.5 mg (−8.8, −68.4%, −15.1 to −4.4); 15 mg; (−10.6, −76.8%, −17.3 to −5.8: both P < 0.01 vs placebo). There was a significant dose–response trend in each study for which darifenacin 7.5 and 15 mg were evaluated (P < 0.01). There were also significant decreases in the frequency and severity of urgency, voiding frequency, and number of significant leaks (incontinence episodes resulting in a change of clothing or pads; both P ≤ 0.001 vs placebo), together with an increase in bladder capacity (both P < 0.01 vs placebo). Darifenacin was well tolerated; the most common AEs were dry mouth and constipation, although together these resulted in few discontinuations (darifenacin 7.5 mg 0.6% of patients; 15 mg 2.1%; placebo 0.3%). The incidence of peripheral/central nervous system and cardiovascular AEs were comparable with those on placebo.
CONCLUSIONS
Darifenacin (7.5 and 15 mg once daily) is effective in the treatment of patients with OAB. As predicted by its M3 selectivity and associated M1/M2‐sparing profile, darifenacin was well tolerated with no central nervous system or cardiovascular safety concerns.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Despite long-term symptomatic and uroflowmetry studies following transurethral prostate resection (TURP) there are sparse pressure flow data. Consequently there is minimal information to account for ...the long-term symptomatic failure and flow rate decrease seen with time following early improvements after surgery.
Men older than 45 years who were investigated at our department between 1972 and 1986, diagnosed with bladder outlet obstruction and elected surgical intervention were invited for repeat symptomatic and urodynamic assessment. Identical methods were used, allowing direct comparison of results.
A total of 1,068 men were initially diagnosed with bladder outlet obstruction, of whom 428 (40%) died in the interim. Of the men who were followed 217 underwent TURP with a mean followup since surgery of 13.0 years. A significant, sustained decrease in the majority of symptoms and improvements of urodynamic parameters was seen. Long-term symptomatic failure and decreased flow rate were principally associated with detrusor under activity (DUA) rather than obstruction. Presentation predictive factors for the future development of DUA were decreased detrusor contractility and a lesser degree of obstruction.
This unique long-term study provides valuable information on surgically treated bladder outlet obstruction. The association of long-term failure following surgery with DUA emphasizes the importance of pressure flow studies before repeat surgery. However, our faith in the long-term efficacy of TURP is justified.
The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline.
This was a pooled analysis of 4 randomized, placebo-controlled ...12-week, phase 3 studies. Patients received placebo or solifenacin 10
mg once daily (2 studies), or placebo or solifenacin 5
mg or 10
mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24
hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (<8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined.
Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5
mg and 10
mg were significantly (
p
<
0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10
mg was significantly (
p
<
0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (
p
<
0.05) more often with solifenacin 5
mg (37%) and 10
mg (33%) than with placebo (25%). Significantly (
p
<
0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5
mg (29%) and 10
mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5
mg, solifenacin 10
mg, and placebo, respectively (
p
<
0.01 for solifenacin 10
mg versus placebo).
Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Storage lower urinary tract symptoms (LUTS) are characterized by an altered bladder sensation, increased daytime frequency, nocturia, urgency and urgency incontinence. Some evidence underlines the ...role of metabolic factors, pelvic ischemia, prostatic chronic inflammation and associated comorbidities in the pathophysiology of storage LUTS. A detailed evaluation of the severity of storage LUTS, and the concomitance of these symptoms with voiding and postmicturition symptoms, is mandatory for improving the diagnosis and personalizing treatment.
A detailed medical history with comorbidities and associated risk factors, a physical examination, a comprehensive analysis of all the features of LUTS, including their impact on quality of life, and a frequency–volume chart (FVC) or bladder diary, are recommended for men with storage LUTS.
Several drugs are available for the treatment of LUTS secondary to benign prostatic obstruction (BPO). Alpha-blockers (α-blockers), 5-α-reductase inhibitors and phosphodiesterase type 5 inhibitors are commonly used to manage storage LUTS occurring with voiding symptoms associated with BPO.
Muscarinic receptor antagonists and Beta 3-agonists (β3-agonists) alone, or in combination with α-blockers, represent the gold standard of treatment in men with predominant storage LUTS. There is no specific recommendation regarding the best treatment options for storage LUTS after prostatic surgery.