Pessaries (mechanical devices) for managing pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse.  This is an update of a Cochrane Review first published in 2003 and last published in 2013. OBJECTIVES: To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary. MAIN RESULTS: We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms.   The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.

The incidence, causes, and management of lower urinary tract injury during total laparoscopic hysterectomy.

OBJECTIVES: Determining the incidence and causes of lower urinary tract injury in patients undergoing total laparoscopic hysterectomy and examining the procedures applied for management. METHODS: Patients who underwent total laparoscopic hysterectomy in a large referral center between 1 January 2015 and 31 October 2017 for benign gynecological reasons were included in the study. Patients who underwent laparoscopic supracervical hysterectomy, laparoscopy-assisted vaginal hysterectomy and robot-assisted laparoscopic hysterectomy were not included in this study. The hospital records of all patients included in the study were examined and the incidence, causes and management of lower urinary tract injuries were reviewed. RESULTS: Total lower urinary tract injury rate was found as 2.01%, and these injuries were evaluated separately as bladder and ureter injuries. All the bladder injuries had occurred on the posterior wall of the bladder during vesicouterine dissection; six cases were intraoperatively detected and one case was detected on the first postoperative day. Most of ureteral injury cases were detected in the early postoperative period (75%). The rates of previous cesarean section and endometriosis were significantly higher in patients with injury to the bladder and ureter than in the control group (p<0,001). There was no significant difference between the patients with lower urinary tract injury and the control group regarding uterine weight, estimated blood loss, bilateral salpingo-oophorectomy, the presence and location of fibroids, and laparoscopic or vaginal closure of the vaginal cuff. CONCLUSION: Laparoscopic hysterectomy may be a good option in appropriate patients, but in case of previous cesarean section and endometriosis cases, patients should be informed about the possible complications in detail before the operation and care should be taken during dissection.

Intermittent self catheterisation with hydrophilic, gel reservoir, and non-coated catheters: a systematic review and cost effectiveness analysis.

OBJECTIVE: To determine the most effective and cost effective type of catheter for patients performing intermittent self catheterisation in the community. DESIGN: Systematic review and meta-analysis. Results were incorporated into a probabilistic Markov model to compare lifetime costs and quality adjusted life years (QALYs). DATA SOURCES: We searched Medline, Embase, and Cochrane and Cinahl databases from 2002 to 18 April 2011 to identify studies comparing hydrophilic, gel reservoir, and non-coated intermittent catheters. Earlier guidelines were used to identify papers published before 2002. To capture studies comparing clean and sterile non-coated intermittent self catheterisation, each database was searched from its date of inception to 18 April 2011. MAIN OUTCOME MEASURES: Clinical outcomes included symptomatic urinary tract infection (UTI), bacteraemia, mortality, patient preference or comfort, and number of catheters used. The economic model included downstream complications of UTI and cost effectiveness was calculated as incremental cost per QALY gained. RESULTS: Eight studies were included in the systematic review. Most were conducted in patients with spinal cord injuries, and most of the included patients were men. People using gel reservoir and hydrophilic catheters were significantly less likely to report one or more UTIs compared with sterile non-coated catheters (absolute effect for gel reservoir = 149 fewer per 1000 (95% confidence interval -7 to 198), P=0.04; absolute effect for hydrophilic = 153 fewer per 1000 (-8 to 268), P=0.04). However, there was no difference between hydrophilic and sterile non-coated catheters when outcomes were measured as mean monthly UTIs (mean difference = 0.01 (-0.11 to 0.09), P=0.84) or total UTIs at 1 year (mean difference = 0.18 (-0.50 to 0.86), P=0.60). There was little difference in the incidence of one or more UTIs for people using clean versus sterile non-coated catheters (absolute effect = 12 fewer per 1000 (-134 to 146), P=0.86). Although the most effective, gel reservoir catheters cost >£54,350 per QALY gained and are therefore not cost effective compared with clean non-coated self catheterisation. CONCLUSION: The type of catheter used for intermittent self catheterisation seems to make little difference to the risk of symptomatic UTI. Given large differences in resource use, clean non-coated catheters are most cost effective. However, because of limitations and gaps in the evidence base and the designation of non-coated catheters as single use devices, we recommend a precautionary principle should be adopted and that patients should be offered a choice between hydrophilic and gel reservoir catheters.

[Assessment of contracted bladder following intravesical instillation of BCG (Japan)].

We assessed a situation concerning contracted bladder following intravesical instillation of BCG(Japan), to investigate how the disease could be prevented. Between March 1997 and June 2010, we selected 20 patients with clinically or pathologically confirmed contracted bladder to participate in the study. The incidence of contracted bladder tended to be higher for patients who had received more than 5 doses of BCG. Repeated severe bladder irritation caused by intravesical BCG instillation was suggested to be the major factor leading to contracted bladder. To prevent the onset of contracted bladder and its progression resulting in total cystectomy, BCG instillation should be discontinued in patients who have received the instillation many times and have developed persistent severe bladder irritation with significantly reduced bladder capacity. It is necessary to consider the administration of antituberculotic and steroid therapy for these patients quickly.

Nocturia in adults: draft New Zealand guidelines for its assessment and management in primary care.

Nocturia is a common bothersome condition. An ad hoc group of interested clinicians from a variety of backgrounds has developed draft guidelines for the assessment and management of this condition in primary care in New Zealand. The guidelines propose four steps in the assessment and management: clinical evaluation; simple investigations; assignment of a provisional diagnosis; and management based on the provisional diagnosis. For nocturnal polyuria-associated nocturia, the draft guidelines recommend that: lifestyle measures should be used as part of the management; if a patient complaining of nocturia has other features of overactive bladder, then bladder retraining and/or anticholinergics can be used; hypnosedatives should not be used to treat nocturia in older adults because of the increased risk of falls; loop diuretics given in the afternoon should be considered for the treatment; and desmopressin can be considered in the management of nocturnal polyuria associated nocturia but that it should be used cautiously in people aged over 65 because of the risk of hyponatraemia. A draft algorithm based on international guidelines is presented.

Bladder dysfunction in Parkinsonism: mechanisms, prevalence, symptoms, and management.

The advent of functional imaging methods has increased our understanding of the neural control of the bladder. This review examines current concepts of the role of brain function in urinary control with particular emphasis on the putative role of dopamine receptors. Dopaminergic mechanisms play a profound role in normal bladder control and the dysfunction of these may result in symptoms of overactive bladder in Parkinsonism. The importance of this nonmotor disorder has been overlooked. We address the problem of bladder dysfunction as it presents to patients and their neurologist. The prevalence of bladder symptoms in Parkinson's disease is high; the most common complaint is nocturia followed by frequency and urgency. In multiple-system atrophy, the combination of urge and urge incontinence and poor emptying may result in a complex combination of complaints. The management of bladder dysfunction in Parkinsonism addresses treatment of overactive detrusor as well as incontinence.

High intensity focused ultrasound: surgery of the future?

For 50 years, high intensity focused ultrasound (HIFU) has been a subject of interest for medical research. HIFU causes selective tissue necrosis in a very well defined volume, at a variable distance from the transducer, through heating or cavitation. Over the past decade, the use of HIFU has been investigated in many clinical settings. This literature review aims to summarize recent advances made in the field. A Medline-based literature search (1965-2002) was conducted using the keywords "HIFU" and "high intensity focused ultrasound". Additional literature was obtained from original papers and published meeting abstracts. The most abundant clinical trial data comes from studies investigating its use in the treatment of prostatic disease, although early research looked at applications in neurosurgery. More recently horizons have been broadened, and the potential of HIFU as a non-invasive surgical tool has been demonstrated in many settings including the treatment of tumours of the liver, kidney, breast, bone, uterus and pancreas, as well as conduction defects in the heart, for surgical haemostasis, and the relief of chronic pain of malignant origin. Further clinical evaluation will follow, but recent technological development suggests that HIFU is likely to play a significant role in future surgical practice.

Urinary catheters for intermittent use.

Intermittent catheterisation is suitable for a range of patients and has a high level of patient satisfaction. Careful education is required to minimise the risk of complications and nurses should be aware of the various types of catheter available.

Drug-induced bladder and urinary disorders. Incidence, prevention and management.

The bladder is vulnerable to the adverse effects of drugs because of its complex control and the frequent excretion of drug metabolites in the urine. Incontinence results when bladder pressure exceeds sphincter resistance. Stress incontinence because of sphincter weakness occurs with antipsychotics and alpha-blockers, especially in women. Urge incontinence and irritative symptoms may be caused by drugs. Anticholinergics, anaesthetics and analgesics cause urinary retention because of failure of bladder contraction. They are more likely to cause retention in men because of prostatic enlargement. Cyclophosphamide and tiaprofenic acid can cause chemical cystitis, and should be withdrawn if a patient develops irritative symptoms or haematuria. Cyclophosphamide may also induce bladder tumours. Adverse effects of cyclophosphamide can be reduced with prophylactic administration of mesna and adequate hydration. Mitomycin, doxorubicin or bacillus Calmette-Guerin (BCG) instilled locally to treat bladder tumours can cause cystitis, contracture and calcification. Their administration should be limited to 1 hour per week for a maximum of 8 weeks. Retroperitoneal fibrosis and urine discolouration may be caused by drugs. Ureteric calculi may result from any drug causing nephrolithiasis.

Assessment of the long-term results of subtrigonal phenolisation.

Long-term follow-up was conducted on 97 patients who had undergone subtrigonal phenolisation for detrusor instability, bladder hypersensitivity, detrusor hyper-reflexia or interstitial cystitis. The procedure failed to alleviate lower urinary tract dysfunction in 57% of patients; it had an unsustained benefit in 24% and long-term success was experienced by only 19%. It was most effective in the hypersensitive bladder of unknown cause. The incidence of complications (17%) suggests that the procedure should only be undertaken if more invasive measures are the only available alternative, and the possibility of these complications should be explained to the patient.

An assessment of the Frewen regime in the treatment of detrusor dysfunction in females.

Twenty-seven women with symptoms of frequency, urgency and urge incontinence were assessed urodynamically. Their detrusor behavior fell into three groups: 1. Reduced detrusor compliance, 2. Uninhibited detrusor contractions, and 3. Detrusor stability. Each patient was treated by Frewen's regime of bladder drill, detrusor inhibitory drugs, sedation and simple psychological counseling. At three months symptoms were markedly improved or cured in 86 per cent of patients. Reduced compliance was the only detrusor abnormality which was reversible.

An objective assessment of the unstable bladder of psychosomatic origin.

An objective assessment of 40 female patients with an unstable bladder was made. An organic or structural cause had previously been eliminated. In all patients an emotive or psychogenic origin for their urinary symptoms was discovered. The diagnosis of detrusor instability was confirmed by cystometry and bladder drill retraining was employed for 3 months. Cystometric investigation was then repeated and the patient was reassessed from the symptomatic point of view. The cure rate was 82.5%.