Severity and impact of accidental bowel leakage two decades after no, one, or two sphincter injuries.

BACKGROUND: Information about the long-term severity and subjective impact of anal incontinence in women after 1 or 2 consecutive obstetrical anal sphincter injuries is still scarce and contradictory. OBJECTIVE: This study aimed to describe the severity and impact of anal incontinence among women with 2 previous deliveries 2 decades after birth and to analyze the relative effect of 1 vs 2 obstetrical anal sphincter injuries in comparison with no obstetrical anal sphincter injuries and the possible influence of obstetrical anal sphincter injury on other pelvic floor disorders. STUDY DESIGN: We linked prospectively registered data in the Swedish Medical Birth Register with information from a postal and web-based questionnaire in 2015. Statistics Sweden identified women with 2 vaginal births from 1992 to 1998, and a simple random sample of 11,000 women was drawn from a source cohort of 64,687 women. To achieve equal-sized groups of women with 1 or 2 obstetrical anal sphincter injuries, the latter group was oversampled from 1987 to 2000. The final study cohorts consisted of 6760 women with no obstetrical anal sphincter injury, 357 women with 1 injury, and 324 women with 2 obstetrical anal sphincter injuries. Third- and fourth-degree perineal tears were grouped together for analysis. Anal incontinence was defined as either fecal or isolated gas incontinence, and fecal incontinence was defined as involuntary leakage of solid or liquid stool with or without concomitant gas. Frequencies of leakage of stool and gas were dichotomized into low frequency (less than once a month) and high frequency (several times a month or more often). Pairwise comparisons were analyzed using Fisher exact tests, Mantel-Haenszel statistics, and the Mann-Whitney U test. Trends were analyzed using Mantel-Haenszel statistics and the Spearman rank correlation test. Logistic regression models were used to obtain the age- and body-mass-index -adjusted odds ratios for outcomes. Statistical significance was set at P<.05. RESULTS: The response rate was 65.5% in the randomly selected cohort and 70.1% among women with 2 obstetrical anal sphincter injuries. Bothersome fecal incontinence occurred in 3.3% (212/6458) of women without obstetrical anal sphincter injury, in 10.4% (36/345) (adjusted odds ratio, 3.25; 95% confidence interval, 2.23-4.73) of those with 1 injury, and in 16.5% (52/315) (adjusted odds ratio, 5.16; 95% confidence interval, 3.69-7.22) of those with 2 obstetrical anal sphincter injuries (trend P<.0001). Fecal incontinence was perceived as bothersome in 28.2% (212/753) of women without an obstetrical anal sphincter injury compared with in 43.9% (36/82) and 46.0% (52/113) of those with 1 or 2 obstetrical anal sphincter injuries (trend P<.0001). Leakage of liquid stool occurred in 10.8% (724/6717) of those without injury, in 21.7% (77/355) of women with 1 injury, and 34.9% (113/324) of women with 2 obstetrical anal sphincter injuries (trend P<.0001). Incontinence affecting daily life was reported by 8.6% (577/6672) of women without injury and by 19.7% (69/351) and 29.6% (96/324) of women with 1 and 2 sphincter injuries, respectively (trend P<.0001). The mean Jorge-Wexner score was 2.44, 3.26, and 3.88 for women with no, 1, or 2 sphincter injuries (trend P<.0001). Among women with a Jorge-Wexner score of 6, >50% had bothersome anal incontinence. The adjusted odds ratio for the overall effect of 1 vs 2 obstetrical anal sphincter injuries on measures of anal incontinence was 2.19 (95% confidence interval, 1.68-2.85) and 3.91 (95% confidence interval, 3.06-5.00), respectively, when compared with no obstetrical anal sphincter injury (both P<.0001). Having 1 or 2 obstetrical anal sphincter injuries had no significant effect on other pelvic floor disorders or on lower urinary tract symptoms (P=.73 and P=.69). CONCLUSION: A consistent additive effect of 1 or 2 sphincter injuries on the severity and impact of anal incontinence was observed in women 2 decades after 2 vaginal births. This information is important for healthcare economics, clinical practice, and policy.

The influence of pregnancy, parity, and mode of delivery on urinary incontinence and prolapse surgery-a national register study.

BACKGROUND: The long-term effects of vaginal delivery, parity, and pregnancy on the pelvic floor remain uncertain and controversial issues. In comparison with studies using self-reported symptoms, surgical register data may offer a more valid means for evaluating the relative influence of these risk factors. OBJECTIVE: This study used data from 3 high-quality nationwide registers, namely the Swedish National Quality Register of Gynecological Surgery, the Swedish Medical Birth Register, and the Total Population Register, to evaluate the contribution of vaginal and cesarean delivery, parity, and factors not related to childbirth to the long-term risk for reconstructive urogenital surgery. STUDY DESIGN: This was a register-based linkage study among women aged ≥45 years who underwent urinary incontinence or prolapse surgery from 2010 to 2017. This surgical cohort was divided into nulliparous women, women with ≥1 cesarean deliveries only, those with ≥1 vaginal deliveries, and according to the number of births. A corresponding reference group was constructed based on women born in 1960 from the Total Population Register (n=2,309,765). The Swedish Medical Birth Register was used to determine the rate of women with cesarean and vaginal delivery and their respective parity. Absolute and relative risk were presented per 1000 women with 95% confidence intervals. Pairwise differences were analyzed with Fisher exact tests and the Mann-Whitney U test for dichotomous and continuous variables. The trend between ≥3 ordered categories of dichotomous variables was analyzed with Mantel-Haenszel statistics. RESULTS: A total of 39,617 women underwent prolapse surgery and 20,488 underwent incontinence surgery. Among women with prolapse surgery, 97.8% had ≥1 vaginal delivery, 0.4% had ≥1 cesarean delivery only, and 1.9% were nullipara. Corresponding figures for those with incontinence surgery were 93.1%, 2.6%, and 4.3%, respectively. Women with vaginal deliveries were overrepresented in the prolapse surgery (relative risk, 1.23; 95% confidence interval, 1.22-1.24; P<.001) and incontinence surgery groups (relative risk, 1.17; 95% confidence interval, 1.15-1.19; P<.001). Nulliparous and cesarean delivered women were underrepresented in the prolapse surgery (relative risk, 0.14; 95% confidence interval, 0.13-0.15 and relative risk 0.055; 95% confidence interval, 0.046-0.065; all P<.001) and incontinence surgery groups (relative risk, 0.31; 95% confidence interval, 0.29-0.33 and relative risk, 0.40; 95% confidence interval, 0.36-0.43). The absolute risk for prolapse surgery was lowest after cesarean delivery (0.09 per 1000 women; 95% confidence interval, 0.08-0.11) and differed by a factor of 23 (absolute risk, 2.11 per 1000 women; 95% confidence interval, 2.09-2.13) from that after vaginal birth. The absolute risk for prolapse and incontinence surgery increased consistently with parity after vaginal births. This trend was not observed after cesarean delivery, which is on par with that of nulliparous women. The first vaginal birth contributed the highest increase in the absolute risk for pelvic organ prolapse surgery (6-fold) and stress urinary incontinence surgery (3-fold). The second vaginal birth contributed the lowest increase in the absolute risk for pelvic organ prolapse surgery (∼1/3 of the first vaginal birth) and for stress urinary incontinence surgery (∼1/10 of the first vaginal birth). CONCLUSION: Surgery for urinary incontinence and prolapse was almost exclusively related to vaginal parity. The risk for prolapse surgery increased consistently with parity after vaginal births but not after cesarean delivery, whereas the risk associated with cesarean delivery was on par with that of nulliparous women. Thus, cesarean delivery seems to offer protection from the need for pelvic organ prolapse and stress urinary incontinence surgery later in life.

The influence of age and health status for outcomes after mid-urethral sling surgery-a nationwide register study.

INTRODUCTION AND HYPOTHESIS: The efficacy of mid-urethral sling (MUS) surgery in older women and women with a significant disease burden is limited. We aimed to determine the influence of chronological age and physical status (assessed by the American Society of Anesthesiologists Physical Status, ASA) classification on outcomes. METHODS: Cure rate, change in frequency of lower urinary tract symptoms, satisfaction, impact, and adverse events after MUS surgery were assessed in 5200 women aged 55-94 years with MUS surgery (2010-2017). Data were analysed by multivariate logistic regression and Mantel-Haenszel chi-square statistics. RESULTS: The cure rate was 64.2% (95% CI, 60.0-68.4) in the ≥ 75-year cohort compared to 88.5% (95% CI, 87.1-89.8) in the 55-64-year cohort (trend p < 0.0001). The estimated probability of cure, improvement, and satisfaction with the procedure decreased by aOR10yr = 0.51 for cure to aOR10yr = 0.59 for satisfaction (all p < 0.0001). Women with a significant health burden (ASA class 3-4) had lower cure rates and satisfaction than those without (65.5% vs. 83.7%, p < 0.0001 and 65.7% vs. 80.6%, p < 0.0001). Older age was more likely to be associated with de novo urgency (p = 0.0022) and nocturia ≥ 2 (p < 0.0001). Adverse events, readmission, and 30-day mortality rates were low. Women, irrespective of age, were equally satisfied if they experienced a decrease of at least one step in leakage frequency. CONCLUSIONS: Even if MUS surgery in older women and those with ASA class 3-4 was associated with a lower cure rate and less satisfactory outcome, a majority were satisfied provided they experienced a reduction of incontinence episodes.

Fecal incontinence in nonpregnant nulliparous women aged 25 to 64 years-a randomly selected national cohort prevalence study.

BACKGROUND: The extent to which fecal incontinence is associated with obstetrical history or pelvic floor injuries is still a controversial and unresolved issue. One crucial first step toward answering this question is the need to study fecal incontinence in nonpregnant, nulliparous women. OBJECTIVE: The aim of this study was to present detailed, descriptive measures of the accidental leakage of liquid or solid stool and gas in a randomly selected, large national cohort of nonpregnant, nulliparous women aged 25 to 64 years. STUDY DESIGN: The Swedish Total Population Register identified the source population. Four independent, age-stratified, simple random samples in a total of 20,000 nulliparous women aged 25 to 64 years were drawn from 625,810 eligible women. Information was collected in 2014 using postal and web-based questionnaires. The 40-item questionnaire included questions about the presence and frequency of the leakage of solid and liquid stool and gas, which provided the basis for the generic terms fecal and anal incontinence. Statistical analyses of the differences between the groups were performed using the Fisher's exact test for dichotomous variables and the Mann-Whitney U-test for continuous variables. The trend between >2 ordered categories of dichotomous variables was analyzed with Mantel-Haenszel statistics. When analyzing the trend between multiple ordered vs nonordered categorical variables, the Kruskal-Wallis test was used. The age-related probability and risk increase per 10 years for incontinence parameters was calculated from logistic regression models adjusted for body mass index. RESULTS: The study population was 9197 women, and the response rate was 52.2%, ranging from 44.7% in women aged 25 to 34 years to 62.4% among those from 55 to 64 years. All the types of incontinence, except severe isolated gas incontinence, increased with age up to 64 years. The estimated probability of fecal incontinence was 8.8% at age 25 years and 17.6% at age 64. The leakage of liquid stool was dominant, occurring in 93.1% (95% confidence interval, 91.4-94.5) of the women with fecal incontinence, whereas leakage of solid stool occurred in 33.9% (95% confidence interval, 31.1-36.7), of which approximately 80% also had concomitant leakage of liquid stool. The leakage of liquid stool increased markedly up to age 65, whereas the increase in the isolated leakage of solid stool was negligible across all ages (overall <0.4%). Liquid and solid stool, separate or in combination, co-occurred with gas in approximately 80%. The distribution pattern of the different types of leakage, single or combined, was similar in all the age groups. Both age and body mass index (kg/m2) were risk factors for fecal incontinence (P<.0001), with an interaction effect of P=.16. CONCLUSION: Abnormal stool consistency has been identified as the strongest risk factor for accidental bowel leakage. The same pattern characterized by a dominance of liquid stool and gas leakage, prevalent concomitant leakage of solid and liquid stool, and a negligible rate of isolated leakage of solid feces was observed across all ages. The low rates of isolated leakage of solid stool support the impression that dysfunction of the continence mechanism of the pelvic floor had a negligible role for bowel incontinence, which is essential information for comparison with women with birth-related injuries.

Colposcopic assessment by Swedescore, evaluation of effectiveness in the Swedish screening programme: a cross-sectional study.

OBJECTIVE: To evaluate the effectiveness and performance of Swedescore in the Swedish screening programme. DESIGN: Cross-sectional register study. SETTING AND POPULATION: All Swedish women aged over 18 years with a colposcopic assessment linked to a biopsy in the Swedish National Cervical Screening Registry, 2015-20. METHODS: Colposcopies with Swedescore were compared with the histopathological diagnosis of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). The respective influence of cytology and human papillomavirus (HPV) testing, at referral for colposcopy and concurrently with colposcopy, were investigated in regression models. MAIN OUTCOME MEASURES: CIN2+. RESULTS: A total of 11 317 colposcopic assessments with Swedescore were included. Odds ratios for CIN2+ increased for every step in the Swedescore scale. At Swedescore ≥0-1, the proportion of CIN2+ was 9.8%. At Swedescore ≥8, the specificity was 93.3% and the positive predictive value was 60.1%, Area under the receiver operating characteristics curve (AUC) was 0.71. If the smear had been abnormal at referral, a normal colposcopy (Swedescore 0-1) was still associated with a CIN2+ risk of more than 5%. In the regression model, cytology and HPV had higher odds ratio for CIN2+ than colposcopy; the combination resulted in an AUC of 0.88. CONCLUSIONS: Swedescore works well in a routine clinical setting but colposcopy assessed with Swedescore was inferior to that reported in previous clinical studies. No safe cutoff level was identified for refraining from biopsy. See-and-treat at Swedescore 8-10 is feasible only if referral cytology showed high-grade squamous intraepithelial lesion. TWEETABLE ABSTRACT: No safe cutoff level for refraining from biopsy nor for see-and-treat with Swedescore.

Detection of ectopic pregnancy and serum beta hCG levels in women undergoing very early medical abortion: a retrospective cohort study.

OBJECTIVE: To evaluate the outcome of the very early medical abortion (VEMA) protocol and whether it could increase early diagnosis and treatment of an asymptomatic ectopic pregnancy (EP). To investigate serum ß-hCG levels correlated to ultrasound findings, and decline in ß-hCG after successful VEMA. STUDY DESIGN: A retrospective case-note review. The population consisted of all women undergoing a VEMA during 2004-14 in Austria and 2012-13 in Sweden. Two cohorts identified based on sonography findings; 106 women with an empty uterine cavity were classified as a pregnancy of unknown location (PUL) and 576 women with an intrauterine sac-like structure without a yolk sac or foetal structure were classified as probable intrauterine pregnancy (probable IUP). RESULTS: Overall, 660 women (97.6%) had a successful VEMA, 94/101 women (93.1%) in the PUL group and 566/575 women (98.4%) in the probable IUP group (p < 0.001). We identified six asymptomatic EP (0.88%). A gestational sac (< 10 mm) was detected at a median/range ß-hCG level 2728 (1600-4497) IU/l. The mean decline in ß-hCG was 93%, (95% CI 91.7-94.2) 5-10 days after successful abortion. CONCLUSIONS: VEMA may be of particular clinical benefit for women. Apart from offering a possibility to start an abortion without delay as soon as the woman has sought abortion care, it may also offer an opportunity to detect and treat EP at an early gestational age. However, the rate of EP was very low.

Symptoms of fecal incontinence two decades after no, one, or two obstetrical anal sphincter injuries.

BACKGROUND: The long-term effects of 1 or 2 consecutive obstetrical anal sphincter injuries on bowel continence are still inadequately investigated, and published results remain contradictory. OBJECTIVE: This study aimed to present detailed descriptive measures of the current bowel incontinence 20 years after the first birth in women who had 2 vaginal deliveries with and without sphincter injuries. STUDY DESIGN: Birth register data were used prospectively and linked to information from a questionnaire survey about current symptoms. Women with 2 singleton vaginal births, from 1992 to 1998, and no further births were retrieved and surveyed by the Swedish Medical Birth Register and Statistics Sweden in 2015. A simple random sample of 11,000 women was drawn from a source cohort of 64,687 women. The cumulative effect was studied in all women with a repeat sphincter injury from 1987 to 2000. Postal and web-based questionnaires were used. The study population consisted of 6760 women with no sphincter injury, 357 with 1 sphincter injury, and 324 women with 2 sphincter injuries. Women with 2 deliveries without sphincter injuries aged 40 to 60 years as reference, were compared with those of women that sustained 1 or 2 consecutive sphincter injuries. Here, third- and fourth-degree perineal tears were presented as 1 group. Fecal incontinence was defined as current involuntary leakage of solid or liquid stool, with and without concomitant leakage of gas. The Fisher exact test and the Mann-Whitney U test were used to compare the results of the 2 groups. The trend was analyzed using the Mantel-Haenszel statistics. Logistic regression models obtained the estimated age-related probability of fecal incontinence components. RESULTS: The risk of sphincter injury at first delivery was 3.9%, and the risk of a repeat sphincter injury was 10.0% (odds ratio, 2.70; 95% confidence interval, 1.80-4.07). The overall prevalence of fecal incontinence in women without sphincter injuries was 11.7%, which doubled to 23.8% (odds ratio, 2.27; 95% confidence interval, 1.75-2.94) in those with 1 sphincter injury and more than tripled to 36.1% (odds ratio, 3.97; 95% confidence interval, 3.11-5.07) after 2 sphincter injuries (trend P<.0001). The proportion of women with severe fecal incontinence increased 3-fold and 5-fold from 1.8% after no obstetrical anal sphincter injury to 5.4% (95% confidence interval, 3.3-8.2) and 9.0% (95% confidence interval, 6.1-12.6) after 1 or 2 obstetrical anal sphincter injuries, respectively (trend P<.0001). In women without sphincter injuries, the estimated probability of fecal incontinence increased from 7.0% at the age of 40 years to 19.8% at the age of 60 years. In contrast, in women with 1 or 2 sphincter injuries, the estimated probability of fecal incontinence increased from 26.1% and 33.3%, respectively, at the age of 40 years to 36.8% and 48.8% at the age of 60 years. The prevalence of fecal incontinence increased after 52 years of age in women with 1 or 2 sphincter injuries. The dominant types of leakage in women with fecal incontinence were the combination of liquid stool and gas, and the triple combination consisting of solid and liquid stools and gas. The triple combination increased from 18.9% in those without sphincter injury to 28.2% in women with 2 injuries (trend P=.0204). CONCLUSION: The risk of sustaining a repeat sphincter injury at the second delivery was almost tripled compared with the risk at the first delivery. Furthermore, 1 or 2 sphincter injuries brought severe long-term consequences for bowel continence. Accidental leakage of stool and gas increased with each sphincter injury, and the effect was proportionally cumulative. After the age of 52 years, the prevalence of fecal incontinence seemed to accelerate.

Temporal trends in obstetric anal sphincter injury from the first vaginal delivery in Austria, Canada, Norway, and Sweden.

INTRODUCTION: Obstetric anal sphincter injuries (OASI) are severe complications that can cause considerable short- and long-term morbidity. Austria, Canada, Norway, and Sweden have similar socio-economic characteristics, and all four countries have access to national birth registers. In this study, we hypothesized that the incidence of OASI should be very similar for different obstetric scenarios in these four countries. Therefore, the aim was to compare the incidence of OASI in these four countries in primiparous women, with spontaneous or instrumental delivery (vacuum or forceps), and in women with a first vaginal birth after cesarean section (VBAC). MATERIAL AND METHODS: Aggregated data on 1 933 930 vaginally delivered primiparous women and women with VBAC were retrieved from the birth registers gathered in Austria, Canada, Norway, and Sweden. The annual rate of OASI (ICD-10 codes O70.2-O70.3) was presented as the percentage of women with a spontaneous delivery, vacuum or forceps delivery, and a VBAC during the period 2004-2016. RESULTS: The incidence of OASI varied considerably between countries and over time. Canada and Sweden had the highest rates, and Austria and Norway the lowest. In Norway, the rate of OASI decreased consistently for all types of deliveries after introducing a perineal protection program in 2004 (p < 0.001). During vacuum delivery, the incidence of OASI varied between countries from 4.1% to 15.5% across the study period. In Canada and Norway, the rate of OASI after a forceps delivery was similar in 2004 at ~20% and with differing trajectories to 24.3% (ß 0.49) and 6.2% (ß -1.15) (trend, all p < 0.001) in 2016. CONCLUSIONS: This comparative register study suggests that there may be considerable potential for lowering the incidence of OASI. The perineal protection program implemented by Norway has been successful. Each country should critically, without prejudice, analyze their current clinical practices and rate of OASI and consider the best preventive strategy.

Which drugs are best for overactive bladder? From patients' expectations to physicians' decisions.

AIM: In order to help physicians determine which drugs are the best for treating overactive bladder (OAB) symptoms, this review considered three questions: what are the patient's expectations? What information is generated by the Multicriteria Decision Analysis (MCDA) model? What can physicians expect from medical treatments? METHODS: A comprehensive literature search was undertaken on these three topics in order to assist physicians regarding the optimum treatment modality for OAB. RESULTS: Patients' difficulties in reporting symptoms and their expectations of treatment outcomes interfere with the success of treatment. To assist physicians in meeting patients' expectations and to choose the most appropriate treatment, a new approach, recognised by the European Medicines Agency, the MCDA model was used to compare the benefits and safety of OAB treatments. CONCLUSION: The MCDA model is useful for comparing the benefit-safety profiles of OAB drugs in order to equip clinicians with information on the drug that might best meet their patient's needs. Flexibly dosed fesoterodine appeared to be most efficacious in resolving urgency and urgency incontinence compared with other drugs, and resolution of urinary urgency appears to be associated with a reduced number of reported adverse events.

Risk of vaginal cancer among hysterectomised women with cervical intraepithelial neoplasia: a population-based national cohort study.

OBJECTIVE: To study the risk of vaginal cancer among hysterectomised women with and without cervical intraepithelial neoplasia (CIN). DESIGN: Population-based national cohort study. SETTING AND POPULATION: All Swedish women, 5 million in total, aged 20 and up, 1987-2011 using national registries. METHODS: The study cohort was subdivided into four exposure groups: hysterectomised with no previous history of CIN3 and without prevalent CIN at hysterectomy; hysterectomised with a history of CIN3/adenocarcinoma in situ (AIS); hysterectomised with prevalent CIN at hysterectomy; non-hysterectomised. MAIN OUTCOME MEASURE: Vaginal cancer. RESULTS: We identified 898 incident cases of vaginal cancer. Women with prevalent CIN at hysterectomy and those with a history of CIN3/AIS had incidence rates (IR) of vaginal cancer of 51.3 (95% CI 34.4-76.5) and 17.1 (95% CI 12.5-23.4) per 100 000, respectively. Age-adjusted IR-ratios (IRRs) compared with hysterectomised women with benign cervical history were 21.0 (95% CI 13.4-32.9) and 5.81 (95% CI 4.00-8.43), respectively. IR for non-hysterectomised women was 0.87 (95% CI 0.81-0.93) and IRR was 0.37 (95% CI 0.30-0.46). In hysterectomised women with prevalent CIN, the IR remained high after 15 years of follow up: 65.7 (95% CI 21.2-203.6). CONCLUSIONS: Our findings suggest that hysterectomised women with prevalent CIN at surgery should be offered surveillance. Hysterectomised women without the studied risk factors have a more than doubled risk of contracting vaginal cancer compared with non-hysterectomised women in the general population. Still, the incidence rate does not justify screening. TWEETABLE ABSTRACT: High risk of contracting vaginal cancer among hysterectomised women having prevalent CIN at surgery.

Smoking cessation prior to gynecological surgery-A registry-based randomized trial.

INTRODUCTION: Smoking cessation, both pre- and postoperatively, is important to reduce complications associated with surgery. Identifying feasible and effective means of alerting the patient before surgery to the importance of perioperative smoking cessation is a challenge to healthcare systems. MATERIAL AND METHODS: A randomized registry-based trial using the web-version of the Swedish national quality register for gynecological surgery, GynOp, was performed (ClinicalTrials.gov NCT03942146). Current smokers scheduled for gynecological surgery were randomly assigned before surgery to group 1 (control group, no specific information), group 2 (web-based written information), group 3 (information to doctor that the woman was a smoker and should be recommended smoking cessation or group 4 (a combination of groups 2 and 3). Perioperative smoking habits were evaluated in a postoperative questionnaire 2 months after surgery. The treatment effect was estimated to be a 15% reduction in the number of smokers at the time of surgery. Thus, 94 women in each group were required, in total 376 women, using a one-sided test with an alpha level of 0.001 and a statistical power of 80%. RESULTS: Participants (n = 1427) were recruited between 5 November 2015 and 6 December 2017. A total of 1137 smokers responded to the follow-up questionnaire (80%), with 486 women declining to participate, leaving 651 women eligible for analysis. Women who received both web-based information prior to surgery and information from a doctor, reported smoking cessation more often from 1 to 3 weeks preoperatively (Odds ratio [OR] 1.8, 95% confidence interval [CI] 1.0-3.3) and 1 to 3 weeks after surgery (OR 1.9, 95% CI 1.1-3.3) compared with the control group who received no specific information. CONCLUSIONS: A combination of written information in the health declaration and a recommendation from a doctor regarding smoking cessation may be associated with higher odds of smoking cessation at 1-3 weeks pre- and postoperatively.

Surgeon's experience and clinical outcome after retropubic tension-free vaginal tape-A case series.

INTRODUCTION: The retropubic tension-free vaginal tape procedure has been the preferred method for primary surgical treatment of stress and stress-dominant mixed urinary incontinence in women for more than 20 years. In this study, we assessed associations between surgeon's experience with the primary tension-free vaginal tape procedure and both perioperative complications and recurrence rates. MATERIAL AND METHODS: Using a consecutive case-series design, we assessed 596 patients treated with primary retropubic tension-free vaginal tape surgery performed by 18 surgeons from 1998 through 2012, with follow up through 2015 (maximum follow-up time: 10 years per patient). Data on perioperative complications and recurrence of stress urinary incontinence from medical records was transferred to a case report form. Surgeon's experience with the tension-free vaginal tape procedure was defined as number of such procedures performed as lead surgeon (1-19 ["beginners"], 20-49 and ≥50 procedures). All analyses were done with a 5% level of statistical significance. We applied the Chi-square test in the assessment of perioperative complications. The regression analyses of recurrence rate by number of tension-free vaginal tape procedures performed were restricted to the three surgeons who performed ≥50 procedures. RESULTS: We found a significantly higher rate of bladder perforations (P = .03) and a higher rate of urinary retentions among patients whose tension-free vaginal tape procedures were performed by "beginners" (P = .06). We observed a significant reduction in recurrence rates with increasing number of tension-free vaginal tape procedures for one surgeon (P = .03). CONCLUSIONS: Surgeon's experience with the tension-free vaginal tape procedure is associated with the risk of bladder perforation and urinary retention, and may be associated with the long-term effectiveness of the procedure.

The Convention on the Rights of the Child (UNCRC) and its implementation in paediatric clinical research.

The amount of research being performed in children, in particular pharmacological research, is lower than in adults, which is in direct contrast to the aims of the UN Convention on the Rights of the Child. A Pediatric Clinical Research Center (PCRC) has been established at Sahlgrenska University Hospital with the aim of supporting clinical research in children and adolescents. The number of inquiries and initiated clinical studies at PCRC has increased since the start in 2016. In addition, there is a need for regional and national infrastructures for paediatric clinical research and a national network for paediatric clinical studies. CONCLUSION: Sahlgrenska University Hospital has established an infrastructure to support paediatric research and to work with national networks and infrastructures.

The effect of childbirth on urinary incontinence: a matched cohort study in women aged 40-64 years.

BACKGROUND: The relative impact of age, pregnancy and vaginal delivery on urinary incontinence is still an unresolved issue that involves the controversial question about the protective effect of cesarean delivery. OBJECTIVE: The purpose of this study was to estimate and compare the effect size of 1 pregnancy, 1 vaginal delivery, and the derived protective effect of cesarean delivery for different aspects of urinary incontinence in women 40-64 years old, all 20 years after birth. STUDY DESIGN: This Swedish nationwide matched cohort study involved 14,335 women. Data from 3 restricted, randomly selected, source cohorts of (1) nulliparous women who were unexposed to childbirth (n=9136), (2) primiparous women who had experienced cesarean delivery and who had been exposed to 1 pregnancy (n=1412), and (3) primiparous women who had been exposed to 1 pregnancy followed by vaginal delivery (n=3787) were retrieved from The Swedish Medical Birth Register and Statistics Sweden and surveyed in 2008 and 2014, respectively. Parous women were all assessed 20 years postnatally. One-to-one matching with an interval for pairing of 3 years and 3 body mass index units was used in women 40-64 years old with information about body mass index (kilograms/square meters) and urinary incontinence. The procedure succeeded in 2630 of 2635 women (99.8%) and resulted in an adequate distribution of age and body mass index between groups. The surveys used a postal- and an internet-based questionnaire with validated questions for various aspects of urinary incontinence. Fisher's exact test and the Mann-Whitney U test were used for comparisons between matched groups; trend was analyzed with Mantel-Haenszel statistics. Predicted, age-related values of different aspects of urinary incontinence were obtained by logistic regression analysis. RESULTS: Pregnancy increased the prevalence of urinary incontinence from 20.1-30.1% (odds ratio, 1.71; 95% confidence interval, 1.43-2.05; P<.0001]. Urinary incontinence increased further after vaginal delivery to 43.0% (odds ratio, 1.75; 95% confidence interval, 1.49-2.05; P<.0001); "moderate" and "severe" urinary incontinence increased from 12.7-19.5% (odds ratio, 1.67; 95% confidence interval, 1.35-2.07; P <.0001). There was a parallel increase in urinary incontinence from 40-65 years of age in nulliparous and vaginally and cesarean delivered women. Cesarean delivery, compared with vaginal delivery, was associated with a 30.0% reduction of urinary incontinence (P<.0001) and a 35-52% reduction of more severe grades of urinary incontinence (P<.0001) and was unaffected by age. CONCLUSION: Both pregnancy and vaginal delivery incurred an increased risk of urinary incontinence in the long term. The age-related gap for urinary incontinence between nulliparous and primiparous women who were delivered by vaginal delivery or cesarean delivery was constant between parallel trajectories that spanned ages from 40-64 years. The calculated protective effect of cesarean delivery was unaltered and significant during the same age interval.

The symptom of vaginal bulging in nulliparous women aged 25-64 years: a national cohort study.

INTRODUCTION AND HYPOTHESIS: Vaginal bulging is considered the key symptom for genital organ prolapse. The aim was to investigate the age-related prevalence and frequency of symptomatic pelvic organ prolapse (sPOP) and other pelvic floor symptoms in nonpregnant nullipara aged 25-64 years. METHODS: This national postal and web-based questionnaire survey was conducted in 2014 and included four independent random samples of women aged 25-34, 35-44, 45-54, and 55-64 years. The association of sPOP with demographics and with other pelvic floor conditions and with clustering to other pelvic floor conditions, was presented in women with and without sPOP. Logistic regression was used to identify and rank variables associated with symptomatic prolapse. RESULTS: The response rate was 52% (n = 10,187) and 726 nullipara confirmed sPOP. Women with sPOP were younger (p < 0.001), shorter (p < 0.001), and more often overweight and obese (p < 0.01) compared with asymptomatic women. Previous surgery for prolapse was reported by 15 women only (0.16%). Symptomatic POP decreased from 9.8% in the youngest age group (25-34 years) to 6.1% in the oldest (55-64 years) (p < 0.0001). Symptomatic POP was more often experienced as bothersome (p = 0.012), and aggravated by straining and heavy lifting (p = 0.003), in older women. Vaginal/vulval chafing/rubbing feeling was most prevalent among the youngest 14.2%, decreasing to 7.8% among the oldest (<0.0001). This symptom occurred three to five times more often in those with sPOP (p < 0.0001). Clustering of pelvic floor symptoms was four times more prevalent in women with sPOP (23.2% versus 6.1%) (p < 0.0001). CONCLUSIONS: The high prevalence of sPOP in this study was contradictory to most earlier reports, which have shown that genital prolapse is rare in nullipara. The explanation of our results may be the low probability of the clinical condition, the dominance of weak and infrequent symptoms, and not least clustering of alternative conditions mimicking sPOP.

The retropubic tension-free vaginal tape procedure-Efficacy, risk factors for recurrence and long-term safety.

INTRODUCTION: The retropubic tension-free vaginal tape has been the preferred method for primary surgical treatment of stress urinary incontinence and stress-dominated mixed urinary incontinence in women for more than 20 years. This study presents long-term safety and efficacy data and assesses risk factors for long-term recurrence. MATERIAL AND METHODS: In a case-series design we assessed a historical cohort of primary surgeries performed with the tension-free vaginal tape procedure in 596 women from 1998 to 2012 with follow up through 2015. Information from the medical records was transferred to a case report form comprising data on early and late complications and recurrence of urinary incontinence defined as bothersome stress urinary incontinence symptoms. All analyses were performed with SPSS using Pearson chi-square, survival and Cox regression analyses. RESULTS: After a 10-year follow up, mixed urinary incontinent women (hazard ratio 2.1, 95% confidence interval [CI] 1.4-3.0) had a significantly increased risk of recurrence of stress urinary incontinence symptoms compared with women with pure stress urinary incontinence as the indication for surgery. Overall cumulative cure rates after 1, 5 and 10 years were 92% (95% CI; 90%-94%), 79% (95% CI; 75%-83%) and 69% (95% CI; 63%-75%), respectively. Recurrent surgery (0.3%) and serious tape complications needing major surgical treatment (0.3%) were rare. Six patients (1.0%) had the tape cut due to urinary retention, and nine patients (1.5%) reported urinary retention more than 3 months after surgery. CONCLUSIONS: The tension-free vaginal tape procedure has a high long-term durability. Mixed urinary incontinence as an indication for surgery predicted long-term recurrence. Long-term complications were rare.

Where Do Women With Urinary Incontinence Find Information About Absorbent Products and How Useful Do They Find It?

PURPOSE: This study aimed to determine from what sources women with urinary and dual urinary and fecal incontinence sought and received information about incontinence and absorbent products. We also evaluated source utility. DESIGN: Descriptive, embedded, mixed-methods study with qualitative interviews nested into a survey design in a modified explanatory sequence. SUBJECTS AND SETTING: The target population was community-dwelling women in Canada who used containment products to manage urinary incontinence. Three hundred fifteen women completed the online survey, and 9 participated in interviews. METHOD: Quantitative data were collected using an online survey that was advertised in multiple locations, including continence and urogynecology clinics, non-for-profit health Web sites, and social media. Descriptive statistics were used for analysis. Using initial quantitative data results, a semistructured interview guide was designed to gain further insight. Local survey participants were invited to interviews at the end of the survey. Interview transcripts were coded using content analysis. The codes were then collapsed into categories and finally themes. RESULTS: The most common sources of information (n = 284/315) were retail outlets (43%) and television/radio (42%). The greatest percentages of "useful" or "very useful" resources were healthcare professionals (83%). Content analysis identified 5 themes: (1) using existing knowledge, (2) seeking knowledge, (3) finding the right pad, (4) being safe and secure, and (5) perceptions of healthcare professionals' roles. Product choice was made through trial and error; women drew information from a variety of sources, including product labels. Perceptions of helpfulness of experiences with healthcare professionals varied. CONCLUSION: Although women used multiple sources when selecting containment products, they did not receive information in a manner that suited their needs, resulting in a trial-and-error approach to product selection. Healthcare professionals should actively give information on containment products during their assessment of continence in patient encounters.

Predicting risk of pelvic floor disorders 12 and 20 years after delivery.

BACKGROUND: Little progress has been made in the prevention of pelvic floor disorders, despite their significant health and economic impact. The identification of women who are at risk remains a key element in targeting prevention and planning health resource allocation strategies. Although events around the time of childbirth are recognized clinically as important predictors, it is difficult to counsel women and to intervene around the time of childbirth because of an inability to convey a patient's risk accurately in the presence of multiple risk factors and the long time lapse, which is often decades, between obstetric events and the onset of pelvic floor disorders later in life. Prediction models and scoring systems have been used in other areas of medicine to identify patients who are at risk for chronic diseases. Models have been developed for use before delivery that predict short-term risk of pelvic floor disorders after childbirth, but no models that predict long-term risk exist. OBJECTIVE: The purpose of this study was to use variables that are known before and during childbirth to develop and validate prognostic models that will estimate the risks of these disorders 12 and 20 years after delivery. STUDY DESIGN: Obstetric variables were collected from 2 cohorts: (1) women who gave birth in the United Kingdom and New Zealand (n=3763) and (2) women from the Swedish Medical Birth Register (n=4991). Pelvic floor disorders were self-reported 12 years after childbirth in the United Kingdom/New Zealand cohort and 20 years after childbirth in the Swedish Register. The cohorts were split so that data during the first half of the cohort's time period were used to fit prediction models, and validation was performed from the second half (temporal validation). Because there is currently no consensus on how to best define pelvic floor disorders from a patient's perspective, we chose to fit the data for each model using multiple outcome definitions for prolapse, urinary incontinence, fecal incontinence, ≥1 pelvic floor disorder, and ≥2 pelvic floor disorders. Model accuracy was measured in the following manner: (1) by ranking an individual's risk among all subjects in the cohort (discrimination) with the use of a concordance index and (2) by observing whether the predicted probability was too high or low (calibration) at a range of predicted probabilities with the use of visual plots. RESULTS: Models were able to discriminate between women who experienced bothersome symptoms or received treatment at 12 and 20 years, respectively, for pelvic organ prolapse (concordance indices, 0.570, 0.627), urinary incontinence (concordance indices, 0.653, 0.689), fecal incontinence (concordance indices, 0.618, 0.676), ≥1 pelvic floor disorders (concordance indices, 0.639, 0.675), and ≥2 pelvic floor disorders (concordance indices, 0.635, 0.619). Route of delivery and family history of each pelvic floor disorder were strong predictors in most models. Urinary incontinence before and during the index pregnancy was a strong predictor for the development of all pelvic floor disorders in most models 12 years after delivery. The 12- and 20-year bothersome symptoms or treatment for prolapse models were accurate when predictions were provided for risk from 0% to approximately 15%. The 12- and 20-year primiparous model began to over predict when risk rates reached 20%. When we predicted bothersome symptoms or treatment for urinary incontinence, the 12-year models were accurate when predictions ranged from approximately 5-60%; the 20-year primiparous models were accurate from 5% and 80%. For bothersome symptoms or treatment for fecal incontinence, the 12- and 20-year models were accurate from 1-15% risk and began to over predict at rates at >15% and 20%, respectively. CONCLUSION: Models may provide an opportunity before birth to identify women who are at low risk of the development of pelvic floor disorders and may provide institute prevention strategies such as pelvic floor muscle training, weight control, or elective cesarean section for women who are at higher risk. Models are provided at http://riskcalc.org/UR_CHOICE/.

Factors influencing the outcome of surgery for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) surgery is a common gynecological procedure. Our aim was to assess the influence of obesity and other risk factors on the outcome of anterior and posterior colporrhaphy with and without mesh. METHODS: Data were retrieved from the Swedish National Register for Gynecological Surgery on 18,554 women undergoing primary and repeat POP surgery without concomitant urinary incontinence (UI) surgery between 2006 and 2015. Multivariate logistic regression analyses were used to identify independent risk factors for a sensation of a vaginal bulge, de novo UI, and residual UI 1 year after surgery. RESULTS: The overall subjective cure rate 1 year after surgery was 80% (with mesh 86.4% vs 77.3% without mesh, p < 0.001). The complication rate was low, but was more frequent in repeat surgery that were mainly mesh related. The use of mesh was also associated with more frequent de novo UI, but patient satisfaction and cure rates were higher compared with surgery without mesh. Preoperative sensation of a vaginal bulge, severe postoperative complications, anterior colporrhaphy, prior hysterectomy, postoperative infections, local anesthesia, and body mass index (BMI) ≥30 were risk factors for sensation of a vaginal bulge 1 year postsurgery. Obesity had no effect on complication rates but was associated increased urinary incontinence (UI) after primary surgery. Obesity had no influence on cure or voiding status in women undergoing repeat surgery. CONCLUSIONS: Obesity had an impact on the sensation of a vaginal bulge and the presence of UI after primary surgery but not on complications.

Prevalence and predictors of overactive bladder in nonpregnant nulliparous women below 65 years of age.

INTRODUCTION AND HYPOTHESIS: The aetiology of the overactive bladder (OAB) symptom complex is still poorly understood. In order to obtain further insight, the prevalence and predictors of the symptoms included in OAB, that is urgency, urgency incontinence (UUI), frequency and nocturia, were investigated in a sample of nonpregnant nulliparous women. METHODS: A national, postal and web-based survey of OAB symptoms was conducted in women aged 25-64 years (n = 9,197). Crude prevalence and prevalence adjusted according to body mass index (BMI) were calculated from a logistic regression model to evaluate the prevalence of OAB. RESULTS: The response rate was 52%. The prevalence of urgency, bothersome urgency, UUI, and nocturia, but not daytime frequency, increased consistently with advancing age and increasing BMI. Urgency was associated with BMI, age ≥45 years, nocturia, and daytime frequency of eight or more micturitions. Daytime urinary micturition frequency was not affected by age either in women with OAB or in women without OAB. Bothersome OAB affected almost half of the woman in the oldest age group and was strongly associated with nocturia of two or more micturitions and OAB with UUI. CONCLUSIONS: There were contrasting changes in the prevalence of the different symptoms included in OAB. With increasing age and BMI, the prevalence of nocturia, urgency and UUI increased, while daytime frequency remained stable. These findings are of importance as the primary endpoint for the evaluation of drug therapies for OAB has often been daytime urinary frequency.