Prostatic urethral lift for subjects in urinary retention (PULSAR): 12-Month results of a prospective controlled trial compared with real-world outcomes.

Objective: To examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real-world setting (Real-World Retrospective study). Materials and methods: PULSAR was a 12-month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha-blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter-dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure. Results: Seventy-three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post-PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter-independent rates (80%) were seen in RWRr patients; variables that influenced success included age <70 years, lower baseline prostate-specific antigen (PSA), lower baseline post-void residual (PVR) and shorter pre-procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age <70 years and higher bladder voiding efficiency (BVE) were associated with success. Conclusions: Lower baseline PSA and PVR, younger age and shorter pre-procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post-PUL voiding efficiencies may help ascertain long-term response to treatment.

Preliminary report on the effect of urethral diverticulum magnetic resonance imaging configuration on the incidence of new onset urodynamic stress urinary incontinence following excision.

CONTEXT: Excision of urethral diverticulum in females has been reported to be associated with new onset urodynamic stress urinary incontinence (USUI) in up to 49%. AIMS: We have assessed the incidence of new onset USUI in all patients having urethral diverticulum excision with Martius fat pad interposition under the care of a single surgeon between May 1, 2007, and December 1, 2011. The incidence of new onset USUI has been correlated with the preoperative magnetic resonance imaging (MRI) appearance of the urethral diverticulum. PATIENTS AND METHODS: All 33 patients (mean age 42) having urethral diverticulum with Martius fat pad interposition had prospective data tabulated on demographics, preoperative MRI appearance, and pre- and post-operative videocystometrogram. STATISTICAL ANALYSIS USED: Statistical analysis was performed by Chi-squared and Fisher's exact. RESULTS: Of the 33 patients, 10 (30%) had preoperative USUI and have been excluded from this study. Other preoperative urodynamic findings included idiopathic detrusor overactivity in ten (30%) and bladder outflow obstruction in five (16%). Two (10%) of the patients had a simple diverticulum, 16 (73%) had a horseshoe diverticulum, and 5 (17%) had a circumferential diverticulum. The rate of new onset USUI was 0% for simple, 6% for saddle, and 20% for circumferential. CONCLUSIONS: New onset USUI occurs in 9% of patients having excision of urethral diverticulum with Martius fat pad interposition. The incidence appears to increase with increasing complexity of urethral diverticulum on preoperative MRI - rising from 0% following simple urethral diverticulum excision to 20% following circumferential diverticulum excision.

Beneath the tip of the iceberg: using electronic referrals to map the unquantified burden of clinical activity in a urology service.

INTRODUCTION: The aim of this study was to inform health policy by demonstrating the benefits of an electronic referral (e-referral) system to study inpatient referrals to urology departments. METHODS: London North West Healthcare NHS Trust has over 800 beds and several secondary and tertiary care services. In January 2014, we designed an e-referral form to requisition urology input for in-patients using the Integrated Clinical Environment™ (ICE) platform. We retrospectively reviewed e-referral records from February to December 2014 for patient demography, the referring service and disease groups triggering a referral. RESULTS: There were 1192 referrals. There was a median of 107 e-referrals per month (IQR 97-123, range 91-132) and 4 per day (IQR 2-6, range 0-12). Weekend e-referrals were 127 (median 1, IQR 0-2, range 0-5) with 1065 e-referrals on weekdays (median 4, IQR 3-6, range 0-12). A total of 848 (71.1 %) patients were male, and 344 (28.9 %) were female. Patients' mean age was 63 (SD 21) years. Almost half (550, 46 %) were acute referrals. Amongst the acute referrals, the majority (466, 84.7 %) arose from A&E. From the non-acute conditions, 381 (59.3 %) patients were from the medical specialities and 246 (38.3 %) from surgical disciplines. The three largest disease categories were urolithiasis (287, 24.1 %), haematuria (185, 15.5 %) and for ex-catheterisation (102, 8.6 %). A qualitative review showed the strengths and weaknesses of the system, enabling improvements in operational efficiency. CONCLUSION: An e-referral system monitors activity accurately. Systemic improvement in referral pathways would lead to better patient care and enable services to factor in the unseen component of workload and prompt realistic staffing.

The case of the migrating IUD.

A 30-year-old lady presented to the gynaecologist with persistent vaginal bleeding following insertion of an IUD. At the time, abdominal examination was unremarkable and speculum examination revealed normal external genitalia and cervix. A transvaginal ultrasound showed a normal uterus, normal ovaries and no adnexal masses or free fluid. It was assumed that the IUD had fallen out. Around the same time she presented to her GP with a short history of dysuria, intermittent visible haematuria and recurrent urinary tract infections. After initial management in general practice for 12 months, she was referred to the urology department for further investigation. She underwent flexible cystoscopy, which showed the presence of an IUD within the bladder. Under general anaesthesia, it was found that the body of the IUD had penetrated the bladder mucosa and become embedded in the right lateral wall of the bladder. The IUD was markedly calcified but was easily removed endoscopically as a whole unit with grasping forceps. A three-week postoperative cystogram ruled out the presence of a fistula. At the six-week postoperative review she was asymptomatic and well.

The use of botulinum toxin for the treatment of urologic pain.

PURPOSE OF REVIEW: Botulinum toxin injections into the bladder have become established in the management of refractory detrusor overactivity and overactive bladder. Mechanism of action of the toxin appears to involve both efferent and afferent nerve pathways, as well as having an antinociceptive effect. Over the years, several reports of its use in refractory bladder pain syndrome and interstitial cystitis have emerged. We review the literature with a view to assessing efficacy and adverse events in this setting. RECENT FINDINGS: Small open-labelled studies have suggested botulinum neurotoxin serotype A (BoNT-A) to be an effective treatment for the majority of patients with refractory bladder pain syndrome/interstitial cystitis. A single set of injections result in demonstrable improvements in symptom scores and bladder pain, although some studies suggest repeated injections may be better. BoNT-A is more effective in nonulcer-type patients. In chronic pelvic pain syndrome, a recent placebo-controlled trial showed only a modest benefit for BoNT-A over placebo with a response rate of 30%. SUMMARY: Although botulinum neurotoxin for refractory bladder pain syndrome/interstitial cystitis appears promising, larger-scale studies with adequate follow-up and in particular randomized placebo-controlled studies are required to confirm these findings.

Ergonomic use of the fourth arm to oversew the dorsal vascular complex (DVC) during robot-assisted laparoscopic prostatectomy (RALP).

OBJECTIVE: To demonstrate an ergonomic fourth arm technique to oversew the dorsal vascular complex (DVC) during robot-assisted laparoscopic prostatectomy (RALP). PATIENTS AND METHODS: Balloon of a Foley catheter inflated in the bulbar urethra. Fourth arm cranial traction via suture in the tip of the catheter. DVC oversewn under direct vision. RESULTS: Oversew of DVC with minimal patient-side surgical assistance. About a 50% reduction in apical positive margin rate. CONCLUSION: A useful, ergonomic method of oversewing the DVC during RALP.

A functional magnetic resonance imaging study of the effect of sacral neuromodulation on brain responses in women with Fowler's syndrome.

STUDY TYPE: Aetiology (case series). LEVEL OF EVIDENCE: 4. OBJECTIVE: To examine brain responses to bladder filling in young women with Fowler's syndrome (FS, a sphincter abnormality manifested by impaired voiding and bladder sensation), treated with sacral neuromodulation (SNM). PATIENTS AND METHODS: Six women, aged 18-39 years with FS underwent functional brain magnetic resonance imaging (fMRI) immediately after SNM and when untreated (baseline). Data were collected at four sessions: after SNM with an empty and a full bladder, and at baseline with an empty and a full bladder. In each session, 280 whole-brain scans were acquired while repeatedly infusing and withdrawing 50 mL of saline, using push-buttons to report changing desire to void. Data were analysed using Statistical Parametric Mapping. RESULTS: At baseline with an empty bladder, extensive responses (contrast = infusion-withdrawal) were almost exclusively negative ('deactivations'), e.g. in the right insula, seat of visceral sensation. Increased bladder volume and/or SNM treatment reduced deactivations and strengthened normal (positive) responses, e.g. in the periaqueductal grey (PAG) terminus of ascending spinal afferents. At baseline, there was significant correlation of brain responses with maximum urethral closure pressure. CONCLUSION: These data show that brain responses to bladder filling are abnormal in FS. The explanation for this that best explains the evidence is that the primary abnormality is an overactive urethra that generates abnormally strong inhibitory afferent signals, so effectively blocking bladder afferent activity at the sacral level and deactivating the PAG and higher centres, with consequent loss of bladder sensation and ability to void. Apparently, a normal mechanism for suppression of incontinence involving the striated urethral sphincter becomes exaggerated in FS and prevents voiding. SNM seems to act at the sacral level, by blocking inhibition by urethral afferents.

Sacral neurostimulation for urinary retention: 10-year experience from one UK centre.

OBJECTIVES: To report our 10-year experience of sacral neurostimulation (SNS) for women in urinary retention, comparing the original one-stage with the newer two-stage technique, as SNS therapy is a well-established treatment for urinary retention secondary to urethral sphincter overactivity (Fowler's syndrome). PATIENTS AND METHODS: Between 1996 and 2006, 60 patients with urinary retention had a SNS device inserted; their case records were reviewed and data on efficacy, follow-up, need for continued clean intermittent self-catheterization (CISC), complications and operative revision rate were assessed. RESULTS: Overall, 43 of 60 (72%) women were voiding spontaneously, with a mean postvoid residual volume of 100 mL; 30 (50%) no longer needed to use CISC. During a total of 2878 months of SNS experience, adverse event episodes included lead migration in 20, 'box-site' pain in 19, leg pain/numbness in 18 and loss of response/failure in 18 patients; 53% of the women required a surgical revision related to their implanted stimulator. The efficacy of the two-stage was similar to that of the one-stage procedure (73% vs 70%). Women with a normal urethral sphincter electromyogram had worse outcomes than women with an abnormal test (43% vs 76%). Although the efficacy was no different in those taking analgesia/antidepressant medication, this group of women had a higher surgical revision rate. Failure and complications for the one-stage procedure were not restricted to the early follow-up period. The mean battery life of the implant was 7.31 years. CONCLUSIONS: SNS has sustained long-term efficacy but the procedure has a significant complication rate. At present, the two-stage technique has comparable efficacy to the one-stage technique but a longer-term follow-up is required. The National Institute of Clinical Excellence recommended the use of SNS in women with urinary incontinence who fail to respond adequately to anticholinergic therapy, but patients choosing this treatment should be made aware of the high complication rate associated with the procedure.

Cerebral mechanisms and voiding function.

Some of the most recent work investigating the cerebral mechanisms involved in bladder control has been very helpful in adding to our understanding of bladder dysfunction. The group behind this work, from London, presents a mini-review which will help to update our knowledge in this area. Authors from Australia present a review describing the interactions between bone and prostate cancer cells in metastatic disease. This area has generated much interest and is something for which we should develop a full understanding, to optimise our treatments for this condition.

Results of double-blind placebo-controlled crossover study of sildenafil citrate (Viagra) in women suffering from obstructed voiding or retention associated with the primary disorder of sphincter relaxation (Fowler's Syndrome).

OBJECTIVES: Women with the primary disorder of sphincter relaxation find voiding difficult. Studies have identified neuronal nitric oxide synthase in the female urethral sphincter, and nitric oxide donors have been shown to decrease sphincter pressures. The aim of our study was to determine if sildenafil could improve sphincter relaxation and thereby increase flow rates and improve bladder emptying. METHODS: Twenty women with complete (5), partial retention or obstructed voiding (15) with a maximum flow rate (Qmax) of less than 15 ml/min with an elevated maximal urethral closure pressure (92--age cm H(2)O) and sphincter volume (>1.6 cm(3)) were included in the study. The study was a double-blind, randomised, placebo-control, crossover design, with patients taking sildenafil or placebo, and with measurement of flow rate and residual volume at baseline and after each treatment phase. Voiding diary, quality of life, and International Prostate Symptom Score (IPSS) data were also collected. RESULTS: No statistical significant difference was seen in any voiding parameters and diaries when sildenafil citrate was compared with placebo. There was a significant mean decrease in IPSS of 3.64 between baseline and the sildenafil phase (p=0.0083), but not when compared with placebo. In the subgroup of women with partial retention and obstructed voiding (15/20), there was a statistically significant increase in Qmax of 4.7 ml/sec (p=0.025) between sildenafil and baseline; however this difference was not seen when compared with placebo. CONCLUSIONS: This is the first study looking at sildenafil in voiding dysfunction in women. Clinical improvements with sildenafil were not significant when compared with placebo. Sildenafil was not effective as a therapeutic pharmacologic agent in this group of patients.

Urinary retention in women: its causes and management.

OBJECTIVE: To report the experience of the last 4 years from a centre to which women with voiding difficulties and urinary retention were referred nationally, describing what investigations were helpful in making a diagnosis and the management strategies used. PATIENTS AND METHODS: Women with voiding difficulties and urinary retention remain a diagnostic and management challenge, and those with no anatomical or neurological basis for their symptoms may be dismissed, assuming that their retention has a psychogenic basis. The finding of an electromyographic (EMG) abnormality of the striated urethral sphincter explaining their disorder (Fowler's syndrome) has led to the referral of women for consideration of that diagnosis. Thus we audited the referrals to the centre over a 4-year period of such women. RESULTS: In all, 247 women (mean age 35 years) with complete (42%) or partial retention (58%) were referred; 175 (71%) had urethral pressure profilometry, 141 (57%) had a transvaginal ultrasonographic measurement of the sphincter volume, and 95 (39%) had sphincter EMG. The mean maximum urethral closure pressure difference between patients with an EMG abnormality (101.5 cmH(2)O) and the patients with known other causes of voiding dysfunction (66.2 cmH(2)O) was 35.3 cmH(2)O (P < 0.05). In patients with complete retention there was a significant difference in sphincter volume between those who were EMG-positive (2.14 mL) or EMG-negative (1.64 mL) (P < 0.05). CONCLUSION: These investigations helped to classify the cause of retention in two-thirds of cases. The commonest diagnosis was Fowler's syndrome, in which sacral nerve stimulation is the only intervention that restores voiding.

Cost-consequence analysis evaluating the use of botulinum neurotoxin-A in patients with detrusor overactivity based on clinical outcomes observed at a single UK centre.

OBJECTIVE(S): This study aimed to assess the resource utilisation, health benefits and cost-effectiveness of intra-detrusor injections of botulinum neurotoxin-A (BoNT/A) in patients with overactive bladder (OAB). METHODS: 101 patients with urodynamically-proven detrusor overactivity of either neurogenic (NDO; n = 63) or idiopathic (IDO; n = 38) origin received intra-detrusor injections of 200-300 units of BoNT/A in 20-30 ml saline as part of a research protocol. Twenty-nine patients received repeat injections after 7-26 months. Symptom severity and urodynamic parameters were assessed at 0, 4 and 16 weeks. The cost of therapy was quantified based on the NHS resources used by typical patients and was used to calculate the cost-effectiveness of BoNT/A compared with standard care from the perspective of the UK NHS. RESULTS: In an intent-to-treat analysis, 82% of patients showed a 25% or greater improvement in at least two out of five parameters (urinary frequency, urgency, urgency incontinence episodes, maximum cystometric capacity and maximum detrusor pressure) four weeks after treatment, reducing to 65% after 16 weeks. A 50% or greater improvement in the frequency of micturition, urgency or urgency incontinence was seen in 73% of patients at four weeks and 54% at 16 weeks. There were no significant differences between IDO and NDO patients in the proportion meeting these endpoints. Therapy cost pounds 826 per patient, with a cost-effectiveness ratio of pounds 617 per patient-year with > or = 25% clinical improvement. CONCLUSION(S): This study demonstrates that intra-detrusor BoNT/A is an effective treatment for OAB that is highly likely to be cost-effective in both idiopathic and neurogenic disease.

Functional imaging and the central control of the bladder.

The central control of the bladder is a complex, multilevel process. Recent advances in functional brain imaging have allowed research into this control in humans. This article reviews the functional imaging studies published to date and discusses the regions of the brain that have been implicated in the central control of continence. Brain regions that have been implicated include the pons (pontine micturition center, PMC), periaqueductal gray (PAG), thalamus, insula, anterior cingulate gyrus, and prefrontal cortices. The PMC and the PAG are thought to be key in the supraspinal control of continence and micturition. Higher centers such as the insula, anterior cingulate gyrus, and prefrontal regions are probably involved in the modulation of this control and cognition of bladder sensations, and in the case of the insula and anterior cingulate, modulation of autonomic function. Further work should aim to examine how the regions interact to achieve urinary continence.

Overactive bladder.

Overactive bladder (OAB) is defined as urgency, with or without urge incontinence, usually with frequency and nocturia, in the absence of local pathological or hormonal factors. It is a common complaint of men and women alike, with estimates of 22 million sufferers. ApproximateLy 70% of men with bladder outflow obstruction will have some symptoms of OAB. The exact pathophysiology of OAB in bladder outflow obstruction is yet to be elucidated; evidence to date points to changes in both the efferent and afferent innervation and the detrusor. Management of OAB can be is generally with pharmacological agents such as anticholinergics or operative measures such as the 'Clam' cystoplasty. More recent treatment modalities include intravesicaL oxybutynin, intradetrusor botulinum toxin and neuromodulation. More specific treatment options for OAB in bladder outflow obstruction include relief of the obstruction with surgical (e.g. transurethraL resection of prostate) or pharmaceutical (e.g. a blockers) methods.