Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms.

BACKGROUND: Overactive bladder (OAB) syndrome is a symptom complex affecting 12-14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women's social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25-40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. METHODS: FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. DISCUSSION: The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. TRIAL REGISTRATION: ISRCTN63268739 . Registered on 14 September 2017.

A transvaginal approach to rectovaginal fistulae for the colorectal surgeon: technical notes and case series.

Rectovaginal fistulae (RVF) are not uncommonly seen by the colorectal surgeon and gynaecologist, often debilitating for patients and typically managed with multiple operative procedures, achieving control rather than cure. Transvaginal repair is the least common surgical approach but has clear advantages and equivalent healing rates to other approaches. Here, we describe a simple, safe and effective flapless transvaginal technique for the repair of primary and recurrent low- and mid-level RVF of varying aetiology. We report 15 cases of RVF (nine recurrent) treated by this technique at a single UK centre. The healing rate was 67%. There were no major complications. Median follow-up was 48 months.

Management of female urinary incontinence: A survey of urogynaecologists' view on the NICE guideline.

We conducted a survey to obtain the opinions of urogynaecologists regarding the National Institute for Health and Care Excellence or NICE 2013 urinary incontinence guideline and whether it would change their current practice. A closed format questionnaire was sent electronically to all members of the British Society of Urogynaecology or BSUG between January and March 2014. There were three major areas of disagreement. First, 70.2% of respondents disagreed that a multidisciplinary team review was necessary before invasive treatment for urinary incontinence. Second, 53.8% of respondents disagreed that preoperative urodynamic studies were not required in stress urinary incontinence diagnosed clinically. Third, 58.6% of respondents disagreed that oxybutynin, tolterodine and darifenacin should be used as first-line drug therapy for overactive bladder. The questionnaire demonstrates that there are significant concerns leading to more than a third of respondents not altering their current practice in line with the entire guideline.

Outcomes and follow-up after obstetric anal sphincter injuries.

INTRODUCTION AND HYPOTHESIS: To determine if the classification of obstetric anal sphincter injuries (OASIs) affected clinical and functional outcome and to assess the need for follow-up of 3a tears in secondary care METHODS: Prospective data collection in 255 patients who sustained OASIs during repair with follow-up in a specialist clinic after 6 months. RESULTS: One hundred and thirty-two patients (51.7 %) sustained 3a tears, 81 (31.7 %) 3b tears, 27 (10.6 %) 3c tears and 15 (5.8 %) had 4th degree tears. Twenty-three patients (9 %) reported symptoms at 6-month follow-up. Eight patients reported anal incontinence of liquid or solid stool. Among patients who sustained 3a tears, 8 patients were symptomatic: 7 had urgency and 1 had flatus incontinence. None of the patients who sustained 3a tears reported incontinence of solid/liquid stool. There appears to be no correlation with scan findings and symptoms at follow up. Most patients are asymptomatic. Urgency of faeces is the commonest symptom. CONCLUSIONS: The vast majority of patients are asymptomatic. The necessity of seeing all these patients in secondary care for follow-up needs to be questioned. With effective primary care follow-up, there may be a place to follow up patients with 3a tears in the community during the routine 6-week postnatal check and refer the symptomatic patients to the hospital for further review.

Super-selective angiographic embolisation of a branch of the anterior pudendal artery for the treatment of intractable post-operative bleeding.

We describe a case of post-operative bleeding after a posterior fascial defect repair. This was refractive to exploration and vaginal packing so laparotomy would have been necessary. Superselective cannulation demonstrated bleeding from a branch of the anterior pudendal artery which had crossed the midline making identification difficult during vaginal exploration. The bleeding vessel was embolised using a mixture of PVA300 and Spongistan gel foam and the bleeding ceased. The use of embolisation in the peri-operative phase is discussed.

Alport's syndrome with blue sclera.

An Indian case of Alport's syndrome who had association of keratoglobus and blue sclerae is described.

Laser palliation of esophageal carcinoma.

OBJECTIVE: Forty-five cases of advanced esophageal carcinoma were treated with Nd:YAG laser, to relieve dysphagia. METHODS: There were 36 males (80%) and nine female (20%) patients. The mean age of the patients was 55.87 years. Thirty-nine patients (86.6%) were found to have squamous cell carcinoma. Middle third growths were found to be most common (66.6%), followed by lower third (20%) and upper third (13.3%) tumours. The mean dysphagia grade at presentation was 3.33 with all 45 patients (100%) having dysphagia. RESULTS: After three months of treatment, the mean dysphagia grade improved to 1.73 with 39 patients being able to eat at least soft or solid food. Mean number of laser sessions required was 3.3. The mean weight of the patients also increased from 45.13 Kg to 47.71 Kg. Three patients developed an esophageal perforation (6.6%), out of whom two died. No other major complication was observed. CONCLUSION: Nd:YAG laser is thus an excellent means of palliation of distressful symptom of carcinoma of esophagus with expectable morbidity and mortality.

Effect of radiographic contrast material exposure on spiral CT attenuation of renal calculi.

RATIONALE AND OBJECTIVES: The authors performed this study to determine whether exposure of renal calculi to radiographic contrast material has an effect on the attenuation values at computed tomography (CT) performed with varying collimation widths. MATERIALS AND METHODS: Renal calculi (23 stones of various composition) were scanned with 1-, 3-, and 10-mm collimation. Stones were then exposed to a solution of radiographic contrast material for 5 minutes, washed with water, and rescanned 36 hours later. The reproducibility of the CT attenuation measurements on different days was evaluated by obtaining measurements in a subset of 16 renal stones on 4 different days. RESULTS: There was no statistically significant change in attenuation after contrast material exposure at narrow collimation. At wider collimation, statistically significant increases were noted in both attenuation and standard deviation. A small amount of variability between readings was noted on different days, with a minimal increase in attenuation each day. Correlation between readings remained very high. CONCLUSION: Exposure of stones to a radiographic contrast material had a statistically significant effect on CT attenuation values only at wide collimation. This may be related to technical factors including volume averaging. Absence of an effect at narrow collimation suggests that the attenuation values of renal stones do not significantly change after exposure to contrast material.

Voiding dysfunction.

Voiding dysfunction in women is common, but is frequently undiagnosed until the patient presents with symptoms. The aetiology of voiding dysfunction includes the following, any of which may lead to acute or chronic disorders: obstructive causes; postsurgical conditions; neurological disorders; overdistension; inflammatory, pharmacological, psychogenic causes and learned voiding dysfunction; detrusor myopathy and urethral sphincter hypertrophy. Clinical assessment should include history, and general, neurological and pelvic examinations. Investigations may include uroflowmetry, ultrasound for residual urine and upper urinary tract dilatation, urodynamic assessment and electromyography. New surgical techniques to identify vesical branches of the pelvic nerves intraoperatively during radical hysterectomy have been shown to help prevent voiding dysfunction postoperatively. If acute retention occurs, then bladder drainage is the most important measure. Suprapubic catheters are superior to transurethral catheters if long-term voiding difficulties are expected. Whenever possible, patients with chronic retention should be taught clean intermittent self-catheterization. Depending on the cause, other possible treatment options include urethral dilatation, insertion of an intraurethral device, and neuromodulation. Voiding dysfunction in women is still poorly understood. Prompt management of acute retention is essential, and clean intermittent self-catheterization remains the most effective therapy for chronic retention.

Anal function: effect of pregnancy and delivery.

OBJECTIVE: To investigate the effect of pregnancy and delivery on anal continence, sensation, manometry, and sphincter integrity. STUDY DESIGN: Two hundred eighty-six nulliparous women in the third trimester completed a symptom questionnaire and underwent anorectal sensation and manometric evaluations. Three months postpartum, 161 women returned and the questionnaires and investigations were repeated together with anal endosonographic examinations. RESULTS: The prevalence of fecal urgency before, during, and after pregnancy was 1%, 9.4%, and 10.5%, respectively; the prevalence of anal incontinence before, during, and after pregnancy was 1.4%, 7.0%, and 8.7%, respectively. Vaginal delivery, particularly instrumental, resulted in a decrease in anal squeeze pressures (P =.015) and resting pressures (P =.002) but had no effect on anal sensation. Postpartum anal endosonographic examination revealed sphincter disruption in 38% of women. There was no relationship between symptoms and anal manometry, sensation, or sphincter integrity. Vaginal delivery (P <.0001) and perineal trauma (P <.001) were significantly associated with sphincter defects. CONCLUSION: Vaginal delivery is associated with a decrease in anal pressures and increased anal sphincter trauma but has no effect on anal sensation. These changes were not related to anal symptoms.

Correction of helical CT attenuation values with wide beam collimation: in vitro test with urinary calculi.

RATIONALE AND OBJECTIVES: Urinary calculi are now commonly detected with helical computed tomography (CT), and it has been proposed that stone composition can be determined from CT attenuation values. However, typical scans are made with a beam collimation of 5 mm or more, resulting in volume averaging and reduction in accuracy of attenuation measurement. The authors tested a model for correction of errors in attenuation values, even at section widths larger than the width of the object. MATERIALS AND METHODS: Human urinary stones were scanned with helical CT at different beam collimation widths. A computer model was used to predict the effect of beam width and stone size on accuracy of measured attenuation. RESULTS: At 3-mm collimation, the model corrected the attenuation readings with an underestimation of 12% +/- 1 (compared with values at 1-mm collimation; 127 stones; diameters of 1.7-11.3 mm). With attenuation measured at 10-mm collimation, the model underestimated the true value by 34% +/- 3 (103 stones), with a significant negative correlation with stone diameter on magnitude of error (diameters of 3.0-11.3 mm). Correlation of data from patient scans with subsequent in vitro scanning of the same stones confirmed the validity of the model, but corrected in vivo scans consistently yielded lower values for the stones than in vitro. CONCLUSION: Volume averaging effects on attenuation in helical CT are predictable in vitro for urinary calculi--and presumably for other roughly spherical structures--as long as section width does not excessively exceed the diameter of the structure.

AIDS cholangiopathy as initial presentation of HIV infection.

AIDS related cholangiopathy is a known clinical entity, but most cases described in literature are known cases of HIV infection who have presented with pain abdomen. AIDS cholangiopathy as the initial presentation of HIV infection is very rare. Here we report such a case.

Correlation of urethral closure pressure, leak-point pressure and incontinence severity measures.

The aim of this study was to determine whether water perfusion maximum urethral closure pressure (MUCP) correlates with Valsalva leak-point pressure (LPP), and which of these best correlates with subjective and objective incontinence severity measures. Fifty-two women with previously diagnosed genuine stress incontinence (n = 46), or mixed incontinence with a minor and controlled urge component (n = 6), were assigned an incontinence status grade based on interview and diary review. These women then completed visually observed standing LPPs at 250 ml bladder capacity, supine water perfusion MUCP determinations, pad tests and quality of life questionnaires. The urodynamic and severity measures were compared with correlation analysis or analysis of variance. A modest correlation exists between LPP and MUCP (r = 0.50-0.62, P < 0.001). Both MUCP and LPP demonstrated significant decreases (P < 0.01) with increasing severity of assigned incontinence grade. A very low and insignificant correlation existed for these urodynamic parameters and pad loss or quality of life measures. MUCP and LPP correlate modestly with each other and both are comparable in predicting incontinence severity. Either can be used as the urodynamic measure to assess intrinsic sphincter deficiency.

Pregnancy and delivery: a urodynamic viewpoint.

OBJECTIVE: The aims of this study were to establish prospectively the prevalence of objective bladder dysfunction before and after delivery by means of urodynamic investigations and to assess the effect of obstetric variables on bladder function. DESIGN: Prospective longitudinal study. Twin channel subtracted cystometry was performed in the standing and sitting position, with a cough stress test at the end of filling. The investigations were repeated three months postpartum. PARTICIPANTS: Two hundred and eighty-six nulliparae with singleton pregnancies who were delivered between April 1996 and November 1997 attended for antenatal assessment after 34 weeks of gestation and 161 who returned postpartum. SETTING: Department of Obstetrics and Gynaecology in a London teaching hospital. RESULTS: The mean urodynamic values both in pregnancy and postpartum lower than values defined in a non-pregnant population. The prevalence of genuine stress incontinence and detrusor instability were antenatally 9% and 8%, respectively, and postpartum 5% and 7%, respectively. Obstetric and neonatal factors were not related to urodynamic variables. CONCLUSIONS: Despite the reported high prevalence of urinary incontinence related to pregnancy and childbirth, neither pregnancy nor delivery resulted in any consistent effects on objective bladder function. Postpartum urodynamic measurements were not related to either obstetric or neonatal variables, but were dependent on antenatal values.

Calcium stone fragility is predicted by helical CT attenuation values.

BACKGROUND AND PURPOSE: Helical CT has become the preferred method for imaging urinary calculi, and so it would be useful if data from helical CT could also be used to predict the number of shockwaves (SWs) needed to break a given stone. METHODS AND MATERIALS: We measured the number of SWs required to comminute calcium stones in vitro. RESULTS: The SW requirement correlated with stone size (volume, weight, diameter) and with helical CT attenuation values when the scans were performed at 3-mm collimation. When CT scans were performed at 1-mm collimation, the number of SWs needed for comminution did not correlate with helical CT attenuation values. This result indicates that the correlation with 3-mm scans was attributable to volume-averaging effects, in which smaller stones yield smaller attenuation values. That is, attenuation values from helical CT at larger beam collimation widths contain information about stone size that can be exploited to predict the fragility of calcium stones. We observed that for calcium stones, the number of SWs to comminution was generally less than half the stone CT attenuation value in Hounsfield units. This "half-attenuation rule" predicted the number of SWs needed to complete fragmentation for 95% of calcium stones (24/24 calcium oxalate monohydrate, 13/13 hydroxyapatite, 8/10 brushite stones). CONCLUSION: This in vitro study suggests that it may be possible to predict effective SW dose using helical CT prior to lithotripsy.

Helical CT of urinary calculi: effect of stone composition, stone size, and scan collimation.

OBJECTIVE: Helical CT has become the preferred methodology for identifying urinary calculi. However, the ability to predict stone composition, which influences patient treatment, depends on the accurate measurement of the radiographic attenuation of stones. We studied the effects of stone composition, stone size, and scan collimation width on the measurement of attenuation in vitro. MATERIALS AND METHODS: One hundred twenty-seven human urinary calculi of known composition and size were scanned at 120 kVp, 240 mA, and a 1:1 pitch at different collimations. A model, based on the physics of helical CT, was used to predict the effect of scan collimation width and stone size on measured attenuation. RESULTS: At a 1-mm collimation, stone groups could be differentiated by attenuation: the attenuation of uric acid was less than that of cystine or struvite, which overlapped; these were less than the attenuation of calcium oxalate monohydrate, which was in turn lower than that of brushite and hydroxyapatite, which overlapped and showed the highest values. At a wider collimation, attenuation was lower and the ability to differentiate stone composition was lost. Attenuation also decreased with smaller stones. At a 10-mm collimation, some uric acid stones (

Antenatal prediction of postpartum urinary and fecal incontinence.

OBJECTIVE: To investigate the effect of pregnancy and delivery on continence and to assess whether physical markers of collagen weakness can predict postpartum urinary and fecal incontinence (including incontinence of flatus). METHODS: In a prospective, longitudinal study in a London teaching hospital, 549 nulliparas were interviewed after 34 weeks' gestation and again 3 months postpartum regarding urinary and fecal symptoms before and during pregnancy and after delivery. Family histories of incontinence, prolapse, and collagen abnormalities were recorded also. Physical examination was done to assess markers of collagen weakness such as striae, hernia, varicose veins, and joint mobility. RESULTS: The prevalence of urinary incontinence before, during, and after pregnancy was 3.6%, 43.7%, and 14.6%, and rates of fecal incontinence were 0.7%, 6.0%, and 5.5%, respectively. Fecal urgency was more common in women who had spontaneous and instrument-assisted vaginal deliveries (n = 413) compared with cesareans (n = 131) (7.3% versus 3.1%; P = .046). Postnatal urinary or fecal dysfunction was not related to antenatal body mass index, smoking, race, striae, varicose veins, hemorrhoids, or family history of incontinence. Higher joint-mobility scores were associated with incontinence of flatus (P = .021) but not with other urinary or fecal symptoms. CONCLUSION: Although collagen weakness was previously implicated in the pathogenesis of incontinence, physical markers in this study could not predict postpartum urinary and fecal incontinence. Either those markers were not representative of collagen weakness, or a larger study with longer follow-up is necessary.