Surgery versus Physiotherapy for Stress Urinary Incontinence Labrie, Julien; Berghmans, Bary L.C.M; Fischer, Kathelijn ...
New England journal of medicine/The New England journal of medicine,
09/2013, Letnik:
369, Številka:
12
Journal Article
Recenzirano
Odprti dostop
In this multicenter trial comparing physiotherapy and sling surgery in women with stress urinary incontinence, the surgery group had higher rates of subjective improvement and cure at 1 year; 49% of ...the women in the physiotherapy group crossed over to surgery.
Stress urinary incontinence is a common health problem among women that negatively affects quality of life.
1
–
3
The International Consultation on Incontinence defines stress urinary incontinence as an involuntary loss of urine on physical exertion, sneezing, or coughing.
4
Pelvic-floor muscle training (physiotherapy) is generally regarded as first-line management for the condition.
5
However, physiotherapy is associated with broad variation in the rates of subjective success (53 to 97%) and objective success (5 to 49%), and more severe symptoms are associated with worse outcomes.
6
,
7
After 3 to 15 years, 25 to 50% of women initially treated with physiotherapy have proceeded to . . .
Objective
To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women.
Design
Randomised multicentre ...double‐blind placebo controlled trial.
Setting
Two Dutch teaching hospitals and one Dutch university medical centre.
Population
Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy.
Methods
Patients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores.
Main outcome measures
Primary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects.
Results
In all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3–4.4) versus placebo 5.5 (95% CI 3.9–7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410–827) versus 1126 (95% CI 671–1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) OR 4.2 (95% CI 2.1–8.3), P < 0.01.
Conclusion
Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects.
Tweetable
RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.
Tweetable
RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.
Please cite this paper as: Schuit E, Kwee A, Westerhuis M, Van Dessel H, Graziosi G, Van Lith J, Nijhuis J, Oei S, Oosterbaan H, Schuitemaker N, Wouters M, Visser G, Mol B, Moons K, Groenwold R. A ...clinical prediction model to assess the risk of operative delivery. BJOG 2012;119:915–923.
Objective To predict instrumental vaginal delivery or caesarean section for suspected fetal distress or failure to progress.
Design Secondary analysis of a randomised trial.
Setting Three academic and six non‐academic teaching hospitals in the Netherlands.
Population 5667 labouring women with a singleton term pregnancy in cephalic presentation.
Methods We developed multinomial prediction models to assess the risk of operative delivery using both antepartum (model 1) and antepartum plus intrapartum characteristics (model 2). The models were validated by bootstrapping techniques and adjusted for overfitting. Predictive performance was assessed by calibration and discrimination (area under the receiver operating characteristic), and easy‐to‐use nomograms were developed.
Main outcome measures Incidence of instrumental vaginal delivery or caesarean section for fetal distress or failure to progress with respect to a spontaneous vaginal delivery (reference).
Results 375 (6.6%) and 212 (3.6%) women had an instrumental vaginal delivery or caesarean section due to fetal distress, and 433 (7.6%) and 571 (10.1%) due to failure to progress, respectively. Predictors were age, parity, previous caesarean section, diabetes, gestational age, gender, estimated birthweight (model 1) and induction of labour, oxytocin augmentation, intrapartum fever, prolonged rupture of membranes, meconium stained amniotic fluid, epidural anaesthesia, and use of ST‐analysis (model 2). Both models showed excellent calibration and the receiver operating characteristics areas were 0.70–0.78 and 0.73–0.81, respectively.
Conclusion In Dutch women with a singleton term pregnancy in cephalic presentation, antepartum and intrapartum characteristics can assist in the prediction of the need for an instrumental vaginal delivery or caesarean section for fetal distress or failure to progress.
In this work we present the architectural and performance studies concerning a prototype of a distributed Tier2 infrastructure for HEP, instantiated between the two Italian sites of INFN-Romal and ...INFN-Napoli. The network infrastructure is based on a Layer-2 geographical link, provided by the Italian NREN (GARR), directly connecting the two remote LANs of the named sites. By exploiting the possibilities offered by the new distributed file systems, a shared storage area with synchronous copy has been set up. The computing infrastructure, based on an OpenStack facility, is using a set of distributed Hypervisors installed in both sites. The main parameter to be taken into account when managing two remote sites with a single framework is the effect of the latency, due to the distance and the end-to-end service overhead. In order to understand the capabilities and limits of our setup, the impact of latency has been investigated by means of a set of stress tests, including data I/O throughput, metadata access performance evaluation and network occupancy, during the life cycle of a Virtual Machine. A set of resilience tests has also been performed, in order to verify the stability of the system on the event of hardware or software faults. The results of this work show that the reliability and robustness of the chosen architecture are effective enough to build a production system and to provide common services. This prototype can also be extended to multiple sites with small changes of the network topology, thus creating a National Network of Cloud-based distributed services, in HA over WAN.
Abstract Introduction Recent studies have shown that CADM1/MAL-methylation testing detects high-grade CIN lesions with a high short-term progression risk for cervical cancer. Women treated for CIN2/3 ...are at risk of post-treatment disease, representing either persistent (incompletely treated) or incident (early onset) lesions. Here, we evaluated CADM1/MAL-methylation analysis as potential tool for detecting recurrent high-grade CIN lesions (rCIN2/3). Methods and materials A multicenter prospective clinical cohort study was conducted among 364 women treated for CIN2/3. Cervical scrapes were taken prior to treatment, and six and 12 months post-treatment and tested for cytology, hrHPV (plus genotype) and CADM1/MAL-methylation. When at six months either of these tests was positive, a colposcopy-directed biopsy was obtained. At 12 months, all women underwent an exit-colposcopy with biopsy. In case of rCIN2/3, re-treatment was done. Results We found 28 rCIN2 (7.7%) and 14 rCIN3 (3.8%), resulting in a total recurrence rate of 11.5%. All 14 women with rCIN3 and 15/28 (54%) with rCIN2 showed hrHPV type-persistence. Of these, 9/14 (64%) rCIN3 and 8/15 (53%) rCIN2 were CADM1/MAL-methylation positive. All incident rCIN2, characterized by hrHPV genotype-switch, were CADM1/MAL-methylation negative. All three carcinomas found after re-treatment were CADM1/MAL-methylation positive. CADM1/MAL-methylation positivity at both baseline and follow-up significantly increased the risk of ≥ rCIN3 (from 0.7% to 18.4%), and ≥ rCIN2 (from 8.2% to 36.8%), compared to a consistently CADM1/MAL-methylation negative result (p-value: < 0.001). Conclusion Post-treatment monitoring by CADM1/MAL-methylation analysis identifies women with an increased risk of rCIN2/3. Our results confirm previous data indicating that CADM1/MAL-methylation analysis provides a high reassurance against cancer.
Objective. To evaluate whether correct adherence to clinical guidelines might have led to prevention of cases with adverse neonatal outcome. Design. Secondary analysis of cases with adverse outcome ...in a multicenter randomized clinical trial. Setting. Nine Dutch hospitals. Population. Pregnant women with a term singleton fetus in cephalic position. Methods. Data were obtained from a randomized trial that compared monitoring by STAN® (index group) with cardiotocography (control group). In both trial arms, three observers independently assessed the fetal surveillance results in all cases with adverse neonatal outcome, to determine whether an indication for intervention was present, based on current clinical guidelines. Main outcome measures. Adverse neonatal outcome cases fulfilled one or more of the following criteria: (i) metabolic acidosis in umbilical cord artery (pH < 7.05 and base deficit in extracellular fluid >12 mmol/L); (ii) umbilical cord artery pH < 7.00; (iii) perinatal death; and/or (iv) signs of moderate or severe hypoxic ischemic encephalopathy. Results. We studied 5681 women, of whom 61 (1.1%) had an adverse outcome (26 index; 35 control). In these women, the number of performed operative deliveries for fetal distress was 18 (69.2%) and 16 (45.7%), respectively. Reassessment of all 61 cases showed that there was a fetal indication to intervene in 23 (88.5%) and 19 (57.6%) cases, respectively. In 13 (50.0%) vs. 11 (33.3%) cases, respectively, this indication occurred more than 20 min before the time of delivery, meaning that these adverse outcomes could possibly have been prevented. Conclusions. In our trial, more strict adherence to clinical guidelines could have led to additional identification and prevention of adverse outcome.
Please cite this paper as: Louwers J, Zaal A, Kocken M, ter Harmsel W, Graziosi G, Spruijt J, Berkhof J, Balas C, Papagiannakis E, Snijders P, Meijer C, van Kemenade F, Verheijen R. Dynamic spectral ...imaging colposcopy: higher sensitivity for detection of premalignant cervical lesions. BJOG 2011;118:309–318.
Objective To validate the dynamic spectral imaging (DSI) colposcope’s colour‐coded map in discriminating high‐ from low‐grade cervical lesions and non‐neoplastic tissue.
Design Prospective, comparative, multicentre clinical trial.
Setting The colposcopy clinics of three Dutch hospitals.
Population Women of 18 years or over with an intact cervix, referred for colposcopy.
Methods During a 3‐minute image acquisition phase, the DSI colposcope was used as a regular video colposcope: the colposcopist located and graded potential lesions based on conventional colposcopic criteria. Subsequently, a colour‐coded map was calculated and displayed, representing localisation and severity of the cervical lesion. Biopsies were collected from all atypical sites, as identified by digital mapping and/or conventional colposcopy. Furthermore, one additional biopsy was taken.
Main outcome measures Histologically confirmed high‐grade cervical disease (CIN2+).
Results In total 275 women were included in the study: 183 women were analysed in the ‘according‐to‐protocol’ (ATP) cohort and 239 women in the ‘intention‐to‐treat’ (ITT) cohort. In the ATP cohort, the sensitivity of DSI colposcopy to identify women with high‐grade (CIN2+) lesions was 79% (95% CI 70–88) and the sensitivity of conventional colposcopy was 55% (95% CI 44–65) (P = 0.0006, asymptotic McNemar test). When the DSI colour‐coded map was combined with conventional colposcopy, the sensitivity was 88% (95% CI 82–95).
Conclusions DSI colposcopy has a significantly higher sensitivity to detect cervical lesions than conventional colposcopy. If the colour‐coded map is combined with conventional colposcopic examination, the sensitivity increases further.
Please cite this paper as: Zaal A, Louwers J, Berkhof J, Kocken M, ter Harmsel W, Graziosi G, Spruijt J, Balas C, Papagiannakis E, Snijders P, Meijer C, van Kemenade F, Verheijen R. Agreement between ...colposcopic impression and histological diagnosis among human papillomavirus type 16‐positive women: a clinical trial using dynamic spectral imaging colposcopy. BJOG 2012;119:537–544.
Objective To investigate the agreement between conventional colposcopic impression, dynamic spectral imaging (DSI) colposcopy and histology, for human papillomavirus type 16‐positive (HPV16+) and non‐16 high‐risk (hr) HPV+ women.
Design Prospective, comparative, multicentre clinical trial.
Setting Three colposcopy clinics in the Netherlands.
Population Women (n = 177) aged 18 years or over with an intact cervix, referred for colposcopy.
Methods The colposcopist graded the lesion by using the DSI colposcope as a regular video colposcope. Subsequently the DSI impression was displayed and biopsies were taken from all abnormal areas as well as from a random (normal) site. A cervical smear was taken for HPV typing.
Main outcome measures Histologically confirmed high‐grade cervical intraepithelial neoplasia or cancer (CIN2+), positive for HPV16 or for any other hrHPV type.
Results The DSI colposcope identified more CIN2+ cervical lesions among HPV16+ women than in non‐16 hrHPV+ women (P = 0.032 regardless of final histology and P = 0.009 among women with CIN2+). Consequently, the sensitivity of the DSI colposcope for detecting CIN2+ lesions was higher in HPV16+ women than in non‐16 hrHPV+ women (97% versus 74%, P = 0.009). No such differences were seen for the colposcopist impression. In addition, mainly smaller cervical lesions are missed by the colposcopist.
Conclusions The sensitivity of DSI colposcopy for CIN2+ is higher in HPV16+ than in non‐16 hrHPV+ women. Furthermore, regardless of HPV16 status, the sensitivity of DSI for CIN2+ is higher than that of the colposcopist, probably because colposcopists tend to miss smaller cervical lesions.
STUDY QUESTION
Is salpingotomy cost effective compared with salpingectomy in women with tubal pregnancy and a healthy contralateral tube?
SUMMARY ANSWER
Salpingotomy is not cost effective over ...salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher.
WHAT IS KNOWN ALREADY
Women with a tubal pregnancy treated by salpingotomy or salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with salpingectomy. Both consequences imply potentially higher costs after salpingotomy.
STUDY DESIGN, SIZE, DURATION
We performed an economic evaluation of salpingotomy compared with salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively.
PARTICIPANTS/MATERIALS, SETTINGS, METHODS
We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle.
MAIN RESULTS AND THE ROLE OF CHANCE
Mean direct medical costs per woman in the salpingotomy group and in the salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval −€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative.
LIMITATIONS, REASONS FOR CAUTION
Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital.
WIDER IMPLICATIONS OF THE FINDINGS
However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child.
STUDY FUNDING/COMPETING INTEREST(S)
Netherlands Organisation for Health Research and Development, Region Västra Götaland Health & Medical Care Committee.
TRIAL REGISTRATION NUMBER
ISRCTN37002267.
PDF
