Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol).

BACKGROUND: Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial. METHODS: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR4029.

Pregnancy-related pelvic girdle pain in the Netherlands.

OBJECTIVE: In this longitudinal cohort study, we assessed the prevalence, associated delivery-related and psychosocial factors and consequences of self-reported pelvic girdle pain during and after pregnancy in the Netherlands. METHODS: A total of 412 women, expecting their first child, answered questionnaires regarding back and pelvic girdle pain, habits, and biomedical, sociodemographic and psychosocial factors, at 12 and 36 weeks gestation, and 3 and 12 months after delivery. In addition, birth records were obtained. Possible associations were studied using non-parametric tests. RESULTS: The prevalence of self-reported pelvic girdle pain was at its peak in late pregnancy (7.3%). One out of 7 women suffering from pelvic girdle pain at 36 weeks gestation, and almost half of the women suffering from pelvic girdle pain 3 months after delivery, continued to report symptoms 1 year after delivery. Women reporting pelvic girdle pain are less mobile than women without pain or women with back pain only, and more frequently have to use a wheelchair or crutches. No association was found between obstetric factors and pelvic girdle pain. Women with pelvic girdle pain report more co-morbidity and depressive symptoms. RECOMMENDATIONS: Normal obstetric procedures can be followed in women reporting pregnancy-related pelvic girdle pain. Prognosis is generally good, however, women reporting pelvic girdle pain 3 months after delivery need extra consideration. Attention needs to be given to psychosocial factors, in particular depressive symptoms.

The effect of vaginal and cesarean delivery on lower urinary tract symptoms: what makes the difference?

A prospective cohort study was undertaken to evaluate the effect of pregnancy and childbirth in nulliparous pregnant women. The focus of this paper is on the difference in the prevalences and risk factors for lower urinary tract symptoms (LUTS) between woman who delivered vaginally or by cesarean and secondly the effect of LUTS on the quality of life between these two groups was analyzed. Included were 344 nulliparous pregnant women who completed four questionnaires with the Urogenital Distress Inventory and the Incontinence Impact Questionnaire (IIQ). Two groups were formed: vaginal delivery group (VD), which included spontaneous vaginal delivery and an instrumental vaginal delivery and cesarean delivery group (CD). No statistical significant differences were found in the prevalences of LUTS during pregnancy between the two groups. Three months after childbirth, urgency and urge urinary incontinence (UUI) are less prevalent in the CD group, but no statistical difference was found 1 year postpartum. Stress incontinence was significantly more prevalent in the VD group at 3 and 12 months postpartum. The presence of stress urinary incontinence (SUI) in early pregnancy is predictive for SUI both in the VD as in CD group. A woman who underwent a CD and had SUI in early pregnancy had an 18 times higher risk of having SUI in year postpartum. Women were more embarrassed by urinary frequency after a VD. After a CD, 9% experienced urge urinary incontinence. Urge incontinence affected the emotional functioning more after a cesarean, but the domain scores on the IIQ were low, indicating a minor restriction in lifestyle. In conclusion, after childbirth, SUI was significantly more prevalent in the group who delivered vaginally. Besides a vaginal delivery, we found both in the VD and in the CD group that the presence of SUI in early pregnancy increased the risk for SUI 1 year after childbirth. Further research is necessary to evaluate the effect of SUI in early pregnancy on SUI later in life. Women were more embarrassed by urinary frequency after a vaginal delivery. UUI after a CD compared to a vaginal birth limited the women more emotionally; no difference was found for the effect of SUI on the quality of life between the two groups.

Bothersome lower urinary tract symptoms 1 year after first delivery: prevalence and the effect of childbirth.

OBJECTIVE: To assess the severity of both stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms during and after the first pregnancy, using a self-reported health-related quality-of-life questionnaire, and to assess the effect of pregnancy and childbirth on bothersome lower urinary tract symptoms (LUTS) persisting at 1 year after the first childbirth. PATIENTS AND METHODS: In a prospective cohort study, 344 women completed four self-reported questionnaires. Urogenital symptoms were assessed with the Urogenital Distress Inventory (UDI), assessing if a urogenital symptom is present and the amount of bother it causes, measured on a 4-point Likert scale, i.e. 'not at all', 'slightly', 'moderately' and 'greatly bothered'. Bothersome LUTS were defined as reporting moderate or great bother from the symptom, and as not bothersome if it was absent or present with none or only a slight degree of self-reported bother. In the analysis we used three of the five subscales from the UDI; UI, OAB and obstructive voiding, where each subscale has a range of 0 (no symptom) to 100 (all symptoms present with the highest degree of bother). RESULTS: Of the 344 women, 83 (24.2%) reported having a moderate to greatly bothersome frequency symptom at 36 weeks of gestation. After childbirth there was a statistically significant decline in the prevalence of bothersome frequency to 38 (9.6%) women (P < 0.001). Bothersome SUI was present in 53 (15.4%) women at 36 weeks of gestation, and in 36 (10.5%) at 1 year after childbirth. Fifty-eight (16.9%) women reported having moderate to greatly bothersome urge UI (UUI) and at 1 year after childbirth, 51 (14.8%) were still bothered by it. After univariate and multivariate analysis, the predictive factors for the presence of bothersome SUI were greater maternal age (32.5 vs 30.3 years old at delivery) and the presence of bothersome SUI at 12 weeks of gestation. Bothersome UUI was significantly associated with a lower educational level (odds ratio 0.08, 95% confidence interval 0.02-0.36). Women after a Caesarean delivery had more bothersome UUI and women after a spontaneous vaginal delivery developed more bothersome SUI (neither statistically significant, possibly because there were too few samples). During pregnancy, all UDI subscale scores increased significantly and after childbirth all scores decreased significantly vs 36 weeks of gestation. However, the score on the UI subscale remained significantly higher at 1 year after birth than at 12 weeks of gestation, whereas the scores on the OAB and obstructive voiding subscales were lower at 1 year after birth than at 12 weeks of gestation. Nevertheless, the scores for UI and obstructive voiding were low, indicating little bother. CONCLUSION: Most women are not bothered by their LUTS after their first delivery. As the prevalence of bothersome symptoms was highest at 36 weeks of gestation, they are probably part of a normal pregnancy. However, OAB symptoms can be perceived as bothersome. Physiotherapy and bladder training can be offered to women with bothersome LUTS. Bothersome SUI in early pregnancy and a greater maternal age were predictive of bothersome SUI at 1 year after first childbirth. A Caesarean delivery seemed to be protective for bothersome SUI at 1 year after birth, but bothersome UUI was more prevalent after a Caesarean than a vaginal delivery. More research with a larger sample is needed to allow definite statements about the effect of the mode of delivery and bothersome UI symptoms.

What is the effect of overactive bladder symptoms on woman's quality of life during and after first pregnancy?

OBJECTIVE: To evaluate the effect of overactive bladder symptoms (OAB) on women's quality of life (QoL) during and after the first pregnancy, using self-reported symptom-based QoL questionnaires. PATIENTS AND METHODS: In a prospective cohort study, 474 women were asked to complete four self-reported questionnaires. Urogenital symptoms were assessed with the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). A women was considered to experience 'dry' OAB if she replied positively to the following two questions: 'do you experience a strong feeling of urgency to empty your bladder?'; and 'do you experience frequent urination?'. A women was considered to experience 'wet' OAB if she replied positively to all of the following questions: 'do you experience a strong feeling of urgency to empty your bladder?'; 'do you experience frequent urination?'; and 'do you experience urine leakage related to the feeling of urgency?'. RESULTS: In all, 344 (72.6%) women who returned all four questionnaires were included in the analysis. After first childbirth there was a rapid decline in the prevalence of dry OAB (45.2% to 7.9%, P < 0.001). In pregnancy the prevalence of wet OAB increased significantly, but a year after childbirth the prevalence of wet OAB decreased and was similar to that at 12 weeks of gestation (P = 0.289). Women with wet OAB had higher scores on all IIQ domains than those with no OAB symptoms at 36 weeks of gestation. Women with dry or wet OAB all had higher scores on the mobility domain than those with no OAB. The scores on the physical, social and emotional functioning domains were low, suggesting a minimal restriction of lifestyle. CONCLUSION: OAB symptoms are common during pregnancy; dry OAB had no negative effect on QoL, whereas wet OAB compromised QoL both during and after pregnancy, mainly in the 'mobility' and 'embarrassment' domains. The urge urinary incontinence symptom in wet OAB seems to profoundly compromise QoL. Apparently, in young mothers with wet OAB, limitations in mobility are especially stressful and these symptoms can be embarrassing.

Defecatory symptoms during and after the first pregnancy: prevalences and associated factors.

A prospective cohort study was undertaken to evaluate the impact of pregnancy and the first delivery on the defecatory symptoms and to identify associated factors. Included were 487 nulliparous pregnant women who completed four questionnaires. Flatus and fecal incontinence, constipation, and painful defecation are already present in early pregnancy and are significantly predictive for reporting symptoms after delivery, except for fecal incontinence. A third or fourth degree sphincter tear was significantly associated with fecal incontinence 12 months postpartum and with de novo fecal incontinence, while other factors associated with de novo onset of symptoms were of borderline significance. Defecation symptoms already present in early pregnancy are highly predictive for reported symptoms at 12 months postpartum except for fecal incontinence that is mainly related to anal sphincter lesion. Therefore, investigating the effects of childbirth in general on the anorectal function is not justified without knowledge of this function during pregnancy.