Means of reaching successful antenatal transfers to level 3 hospitals in cases of threatened very preterm deliveries: a national survey.

INTRODUCTION: Centralization of very preterm deliveries to level 3 hospitals is recommended to improve infant survival and prevent brain injury. We studied the clinical practices of centralization from level 2 to level 3 hospitals in cases of threatening very preterm delivery in Finland. MATERIALS AND METHODS: Obstetricians in all 16 level 2 hospitals in Finland were invited to participate in an online survey regarding antenatal transfer to level 3 hospitals among women with threatened delivery below 32 gestational weeks. We report clinical thresholds used as indications and contraindications for antenatal transfers, and logistical factors related to transfers. RESULTS: Twelve out of 16 (75%) hospitals completed the survey. The lower gestational age threshold for antenatal transfer ranged from 22 + 0 to 23 + 0 weeks. All hospitals regarded preterm premature rupture of membranes, chorioamnionitis, and severe pre-eclampsia as indications for antenatal transfer to a level 3 hospital. Most hospitals reported transferring women in spite of regular contractions (interval over 5 min) or cervical dilatation up to 4 cm. Suspicion of placental abruption, abnormal cardiotocography tracing and poor maternal condition were the most frequently reported contraindications for antenatal transfer. The time to arrange antenatal transfer was less than 2 h in all hospitals, and overcrowding of level 3 hospitals rarely hindered antenatal transfer. CONCLUSIONS: Successful centralization of very preterm deliveries is reached in Finland by rapid and active antenatal transfers. This study identified clinical thresholds used by obstetricians in a setting of long distances and high centralization rate.

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.

INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS: Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

Reproductive factors associated with nocturia and urinary urgency in women: a population-based study in Finland.

OBJECTIVE: The objective of this study was to evaluate the association of nocturia and urinary urgency with reproductive factors, including parity, the postpartum period, the menopause, hormone replacement therapy, hysterectomy, and surgery for stress urinary incontinence (SUI). STUDY DESIGN: In 2003-2004, questionnaires eliciting urinary symptoms, reproductive factors, SUI surgery, and potential confounders were mailed to 3000 randomly selected women aged 18-79 years, identified from the Finnish Population Register. Nocturia was defined as 2 or more voids/night. Sudden compelling desire to urinate often or always (scale of never, rarely, often, always) was regarded as urgency. Pregnant and puerperal (6 weeks after delivery) women and those reporting urinary tract infection were excluded. RESULTS: Responses totaled 2002 (67%). Parity, postpartum (defined as six weeks to one year after delivery) and postmenopausal periods were associated with increased nocturia and SUI surgery with increased urgency (adjusted for age, comorbidity, medication, anthropometric, sociodemographic and lifestyle factors). Hormone therapy and hysterectomy were associated with neither symptom. CONCLUSION: Reproductive factors associated with nocturia differed from those related to urgency.

Patient-reported pelvic floor symptoms 5 years after hysterectomy with or without prolapse surgery.

OBJECTIVE: The aim of this study was to evaluate the effect of hysterectomy with or without concomitant prolapse surgery on subject-reported pelvic floor disorders (PFD) with a 5-year follow-up. STUDY DESIGN: This prospective longitudinal study was carried out in two Finnish central hospitals among 286 women who had undergone hysterectomy for benign reasons. The presence of urinary incontinence, urinary frequency, feeling of vaginal bulging, constipation and anal incontinence was evaluated at baseline, 1 and 5 years postoperatively. Analysis was performed on 256 (895%) patients who answered at least one of the follow-up questionnaires. RESULTS: Hysterectomy with concomitant native tissue prolapse surgery significantly reduced urinary incontinence, urinary frequency, constipation and the feeling of vaginal bulging, and the results were maintained over the following five years. Plain hysterectomy reduced urinary frequency and the feeling of vaginal bulging but did not relieve urinary incontinence. Hysterectomy had no effect on anal incontinence. The total subsequent prolapse and/or incontinence operation rate was 2,7%, and was higher among patients who underwent hysterectomy for pelvic organ prolapse. CONCLUSIONS: During a 5-years follow-up a hysterectomy alone or with native tissue prolapse surgery did not worsen pelvic floor disorders.

Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence. METHODS: Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory-Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded. RESULTS: Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups. CONCLUSION: The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00379314 LEVEL OF EVIDENCE: I.

Improving data collection processes for routine evaluation of treatment cost-effectiveness.

The healthcare system in Finland has begun routine collection of health-related quality of life (HRQoL) information for patients in hospitals to support more systematic cost-effectiveness analysis (CEA). This article describes the systematic collection of HRQoL survey data, and addresses challenges in the implementation of patient surveys and acquisition of cost data in the case hospital. Challenges include problems with incomplete data and undefined management processes. In order to support CEA of hospital treatments, improvements are sought from the process management literature and in the observation of healthcare professionals. The article has been written from an information system and process management perspective, concluding that process ownership, automation of data collection and better staff training are keys to generating more reliable data.

Long-term Impact of Mode of Delivery on Stress Urinary Incontinence and Urgency Urinary Incontinence: A Systematic Review and Meta-analysis.

CONTEXT: Stress urinary incontinence (SUI) and urgency urinary incontinence (UUI) are associated with physical and psychological morbidity, and large societal costs. The long-term effects of delivery modes on each kind of incontinence remain uncertain. OBJECTIVE: To investigate the long-term impact of delivery mode on SUI and UUI. EVIDENCE ACQUISITION: We searched Medline, Scopus, CINAHL, and relevant major conference abstracts up to October 31, 2014, including any observational study with adjusted analyses or any randomized trial addressing the association between delivery mode and SUI or UUI ≥1 yr after delivery. Two reviewers extracted data, including incidence/prevalence of SUI and UUI by delivery modes, and assessed risk of bias. EVIDENCE SYNTHESIS: Pooled estimates from 15 eligible studies demonstrated an increased risk of SUI after vaginal delivery versus cesarean section (adjusted odds ratio [aOR]: 1.85; 95% confidence interval [CI], 1.56-2.19; I(2)=57%; risk difference: 8.2%). Metaregression demonstrated a larger effect of vaginal delivery among younger women (p=0.005). Four studies suggested no difference in the risk of SUI between spontaneous vaginal and instrumental delivery (aOR: 1.11; 95% CI, 0.84-1.45; I(2)=50%). Eight studies suggested an elevated risk of UUI after vaginal delivery versus cesarean section (aOR: 1.30; 95% CI, 1.02-1.65; I(2)=37%; risk difference: 2.6%). CONCLUSIONS: Compared with cesarean section, vaginal delivery is associated with an almost twofold increase in the risk of long-term SUI, with an absolute increase of 8%, and an effect that is largest in younger women. There is also an increased risk of UUI, with an absolute increase of approximately 3%. PATIENT SUMMARY: In this systematic review we looked for the long-term effects of childbirth on urinary leakage. We found that vaginal delivery is associated with an almost twofold increase in the risk of developing leakage with exertion, compared with cesarean section, with a smaller effect on leakage in association with urgency.

Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence.

OBJECTIVE: To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test. METHODS: In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m(2), urethral closure pressure less than 20 cm H(2)O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score. RESULTS: When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension. CONCLUSION: Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension.

Cost effectiveness of fesoterodine and tolterodine for the treatment of overactive bladder with urge urinary incontinence in Spain and Finland.

BACKGROUND: Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. OBJECTIVE: Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with urge urinary incontinence (UUI) in Spain and Finland. METHODS: A decision-tree economic model estimated the 52-week costs and quality-adjusted life-years (QALYs) of OAB/UUI patients initiating treatment with fesoterodine 4 mg/day or tolterodine ER. Individuals were evaluated for treatment response (UUI fewer than one episode/day) and persistence at weeks 4, 12, and 24. Titration from fesoterodine 4 mg/day to 8 mg/day was permitted at week 4. At week 12, non-responders discontinued treatment permanently. Efficacy, discontinuation, and utility data were derived from four clinical trials of fesoterodine. OAB-related costs, including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections, depression, and nursing home) were also included. RESULTS: A total of 19.5 % and 18.0 % of fesoterodine and tolterodine ER patients remained on treatment until week 52, respectively. QALYs were higher with fesoterodine than tolterodine ER (0.762 vs. 0.760). In Spain, fesoterodine treatment had higher total costs than (generic) tolterodine ER (€6,697 vs. 6,597), resulting in a cost of €15,633/QALY gained. In Finland, fesoterodine was cost saving relative to (non-generic) tolterodine ER (€7,885 vs. 8,024). Sensitivity analysis confirmed that these findings were robust to the expected price decrease for generic tolterodine ER in Finland. CONCLUSION: Fesoterodine is cost effective or cost saving relative to tolterodine ER for the treatment of OAB with UUI in two European countries. Payers and prescribers should consider a broad scope of costs to make informed cost-conscious choices of antimuscarinic treatment.

Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence. OBJECTIVE: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence. INTERVENTION: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires. RESULTS AND LIMITATIONS: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups. CONCLUSIONS: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen. PATIENT SUMMARY: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00379314.

Quality of life and pelvic floor dysfunction symptoms after hysterectomy with or without pelvic organ prolapse.

OBJECTIVE: To assess the effect of hysterectomy with or without pelvic organ prolapse (POP) on health-related quality of life (HRQoL) and pelvic floor disorders. STUDY DESIGN: Prospective clinical study at two central hospitals in Finland. During one year 322 women underwent elective hysterectomy for benign conditions with or without vaginal wall repair. The study population was divided in two groups, patients with and without POP. The HRQoL questionnaires RAND-36 and 15D, and questionnaires assessing urinary and bowel dysfunction symptoms were obtained preoperatively and 12 months postoperatively. POP was defined as the descent of apical, anterior or posterior compartment of vaginal wall grade ≥2 in the Baden-Walker classification at any site. Main outcome measures were HRQoL, improvement of symptoms and de novo symptoms. RESULTS: At baseline the mean 15D score of all patients was lower than that of the age-standardized population sample (p<0.001). At one year postoperatively, the mean 15D score of the patients had improved (p=0.001), this resulting mainly on dimensions of excretion (voiding and defecation), usual activities, discomfort and symptom, distress, vitality and sexual activity. HRQoL improved especially in patients with POP. They reported improvement of symptoms in urinary incontinence, urinary frequency, constipation and sense of bulging but surgery had no effect on anal incontinence. Patients without POP reported improvement in pain dimension, urinary frequency and feeling of bulging. Urinary incontinence was the most common (15.4% and 13.8%) de novo symptom in both groups. CONCLUSIONS: Hysterectomy with or without concomitant pelvic organ prolapse surgery improves health-related quality of life and reduces pelvic floor symptoms in one-year follow-up.

A randomized trial comparing TVT with TVT-O: 12-month results.

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

Is the prevalence of overactive bladder overestimated? A population-based study in Finland.

BACKGROUND: In earlier studies, one in six adults had overactive bladder which may impair quality of life. However, earlier studies have either not been population-based or have suffered from methodological limitations. Our aim was to assess the prevalence of overactive bladder symptoms, based on a representative study population and using consistent definitions and exclusions. METHODOLOGY/PRINCIPAL FINDINGS: The aim of the study was to assess the age-standardized prevalence of overactive bladder defined as urinary urgency, with or without urgency incontinence, usually with urinary frequency and nocturia in the absence of urinary tract infection or other obvious pathology. In 2003-2004, a questionnaire was mailed to 6,000 randomly selected Finns aged 18-79 years who were identified from the Finnish Population Register Centre. Information on voiding symptoms was collected using the validated Danish Prostatic Symptom Score, with additional frequency and nocturia questions. Corrected prevalence was calculated with adjustment for selection bias due to non-response. The questionnaire also elicited co-morbidity and socio-demographic information. Of the 6,000 subjects, 62.4% participated. The prevalence of overactive bladder was 6.5% (95% CI, 5.5% to 7.6%) for men and 9.3% (CI, 7.9% to 10.6%) for women. Exclusion of men with benign prostatic hyperplasia reduced prevalence among men by approximately one percentage point (to 5.6% [CI, 4.5% to 6.6%]). Among subjects with overactive bladder, urgency incontinence, frequency, and nocturia were reported by 11%, 23%, and 56% of men and 27%, 38%, and 40% of women, respectively. However, only 31% of men and 35% of women with frequency, and 31% of subjects of both sexes with nocturia reported overactive bladder. CONCLUSIONS/SIGNIFICANCE: Our results indicate a prevalence of overactive bladder as low as 8% suggesting that, in previous studies, occurrence has been overestimated due to vague criteria and selected study populations regarding age distribution and low participation.

A cost-effectiveness analysis of tension-free vaginal tape versus laparoscopic mesh colposuspension for primary female stress incontinence.

BACKGROUND: Evaluation of cost-effectiveness of new surgical techniques is important. As the data on incontinence procedures are scarce, we evaluated the cost-effectiveness of tension-free vaginal tape procedure and laparoscopic mesh colposuspension as a primary surgical treatment for female stress urinary incontinence. METHODS: In four university teaching hospitals and two central hospitals 128 stress incontinent women were randomized to tension-free vaginal tape procedure (n=70) or laparoscopic mesh colposuspension (n=51) in order to investigate the clinical performance of these two procedures. Primary objective clinical outcome measures were: stress test and 48-h pad test. Secondary subjective outcome measures were health-related quality of life measured in terms of visual analogue scale and Urinary Incontinence Severity Score. Alongside the clinical trial, a cost-effectiveness analysis for the main outcome measures was performed. RESULTS: The changes in the 48-h pad test result did not reach statistical significance (p=0.105). When the visual analogue scale or Urinary Incontinence Severity Score are used as the outcome measure, the tension-free vaginal tape is more cost-effective than laparoscopic mesh colposuspension over a follow-up period of one year (p<0.000). CONCLUSION: The clinical and economic data of the present study suggest that over a follow-up period of one year the tension-free vaginal tape procedure is more cost-effective than laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence.

Tension-free vaginal tape procedure and laparoscopic colposuspension in the treatment of stress urinary incontinence.

PURPOSE OF REVIEW: Within the last decade we have seen substantial development in the surgical techniques used to treat female stress urinary incontinence. The laparoscopic approach became available and even less invasive methods like the tension-free vaginal tape procedure were introduced. RECENT FINDINGS: These procedures offer quicker recovery and faster return to normal activities after surgery compared with the older procedures. The tension-free vaginal tape technique has been extensively studied and clinical data from a significant number of prospective observational cohort studies have been published. The number of reports on laparoscopic incontinence surgery is more limited. Long-term follow-up results with reassuring cure rates at 5 and 7 years are available for the tension-free vaginal tape procedure. Three-year follow-up results for the laparoscopic colposuspension procedure show reasonable cure rates, though not as good as those reported for the open colposuspension, the 'gold standard'. Both of these techniques are now widely used in everyday clinical practice. Perioperative and immediate postoperative complication rates are low and acceptable. However, data are limited in terms of randomized clinical trials comparing these fairly new techniques. SUMMARY: This review attempts to highlight the recent clinical experience of these two surgical techniques, including cure rates, complications and cost-effectiveness.

Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications--a randomized clinical trial.

BACKGROUND: The purpose of the study was to evaluate the immediate outcome and complications of the tension-free vaginal tape (TVT) and laparoscopic mesh colposuspension (LC) procedures in the treatment of female stress urinary incontinence (SUI). METHODS: One hundred and twenty-eight patients suffering from urodynamically confirmed SUI were recruited to this multicenter, randomized clinical trial. After randomization there were seven drop-outs--121 patients were operated upon: 70 patients in the TVT group and 51 in the LC group. The patients were evaluated according to the study protocol before operation and 6 weeks after it. The independent sample t-test and the Mann-Whitney U-test were used to calculate statistical differences between the study groups. RESULTS: Immediate cure rates, defined as negative stress test with 300 mL saline in the bladder, were similar (92.9% in the TVT group and 88.2% in the LC group; p = ns). Return to normal voiding was faster in the TVT group (9.2 h in the TVT group vs. 24.4 h in the LC group; p = 0.004). Fewer analgesics were used in the TVT group and hospital stay was shorter in this group. Complication rates associated with the procedures were similar and the number of complications was small. CONCLUSIONS: The immediate outcome of both procedures is the same. The rates of complications were similar. However, the TVT procedure seems to be less invasive and requires fewer hospital resources than LC.