Pessaries for pelvic organ prolapse: evaluation of vaginal discharge and pain during pessary cleaning in an outpatient setting.

INTRODUCTION AND HYPOTHESIS: Pessary treatment for pelvic organ prolapse (POP) is effective and safe, but long-term continuation is low. Pain and vaginal discharge may play a role. This study was aimed at evaluating vaginal discharge and pain during pessary cleaning in an outpatient setting and in continuous pessary use. METHODS: Women with POP who attended the outpatient clinic for pessary cleaning between January and October 2021 were included. Primary outcome was pain during removal and reinsertion of the pessary, measured by an 11-point numeric rating scale (NRS). Secondary outcome was vaginal discharge, measured by the NRS and Patient Global Impression of Change scale (PGI-C). Multiple linear regression analysis was used to identify associated variables for pain and discharge. RESULTS: A total of 150 women were included. Mean NRS during pessary removal was 4.3 (± 2.7), with 25% of women scoring a 7 or higher. Mean NRS during reinsertion was 1.8 (± 2.0). A smaller genital hiatus and presence of vaginal atrophy or vulvar skin disease were associated with pain during pessary removal. Mean NRS for vaginal discharge was 2.5 (± 2.3). Twenty-five percent of women reported that their vaginal discharge was "(very) much worse" than before they used a pessary. Presence of vaginal erosions was associated with vaginal discharge in this study population. CONCLUSIONS: Removing a pessary in an outpatient setting is a painful procedure for many women who use a pessary continuously. Moreover, 25% of these women experience an increase in vaginal discharge while using a pessary. Future research should focus on reducing these disadvantages.

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.

Fall prevention in community-dwelling adults with mild to moderate cognitive impairment: a systematic review and meta-analysis.

BACKGROUND: Cognitive impairment (CI) increases an individual's risk of falls due to the role cognition plays in gait control. Older adults with dementia fall 2-3 times more than cognitively healthy older adults and 60-80% of people with dementia fall annually. Practitioners require evidence-based fall prevention best practices to reduce the risk of falls in cognitively impaired adults living in the community. METHODS: We conducted a systematic review and meta-analysis to identify the effectiveness of primary and secondary fall prevention interventions in reducing falls and fear of falling, and improving gait, balance, and functional mobility. We searched 7 databases for fall prevention interventions involving community-dwelling adults ≥50 years with mild to moderate CI. Reviewers screened citations, extracted data, and assessed risk of bias and certainty of evidence (GRADE). We assessed statistical and methodological heterogeneity and performed a meta-analysis of studies including subgroup analysis based on intervention and risk of bias groupings. RESULTS: Five hundred nine community-dwelling adults (mean age 67.5 to 84.0 years) with mild to moderate CI from 12 randomized or clinical controlled trials (RCTs/CCTs) were included in this review. Eight studies were exercise interventions, 3 were multifactorial, and 1 provided medication treatment. Fall prevention interventions had significant effects of medium magnitude on fear of falling (standardized mean difference (SMD) -0.73 [- 1.10, - 0.36]), balance (SMD 0.66 [0.19, 1.12]), and functional mobility measured as Timed Up and Go test (SMD -0.56 [- 0.94, - 0.17]) and significant effects of small magnitude on gait control (SMD 0.26 [0.08, 0.43]) all with moderate certainty of evidence. The meta-analysis showed no significant effects for falls (number of events or falls incidence). Sub-analysis showed that exercise and low risk of bias studies remained significant for balance and perceived risk of falls. CONCLUSION: The effect of fall prevention interventions on direct outcomes, such as falls, remains unclear in cognitively impaired individuals. Exercise interventions are effective at improving fall risk factors, however, high quality studies with longer follow-up and adequate sample sizes are needed to determine their effectiveness on falls directly. There remains a gap in terms of effective fall prevention interventions for older adults with CI.

Applying the RE-AIM implementation framework to evaluate fall prevention interventions in community dwelling adults with cognitive impairment: a review and secondary analysis.

BACKGROUND: Cognitive impairment (CI) is a risk factor for falls due to environmental or living settings, balance, gait and vision impairments, as well as medications. While previous systematic reviews have focused on the effectiveness of fall prevention programs in adults with cognitive impairment, very limited information is available on their implementation. This review examines what aspects of fall prevention interventions for community-dwelling adults with CI have been reported using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to support successful implementation. METHODS: We examined the included studies from our systematic review, which searched 7 databases for primary and secondary fall prevention interventions involving community-dwelling adults ≥50 years with mild to moderate CI. Reviewers screened citations and extracted data for study characteristics and the 5 dimensions (62 criteria) of the RE-AIM framework. RESULTS: Twelve randomized or clinical controlled trials (RCTs/CCTs) consisting of 8 exercise interventions, 3 multifactorial interventions, and 1 medication treatment were included in the review. Only 4 of 62 criteria were reported by all 12 included studies and 29 criteria were not reported by any of the studies. Five of the included studies reported on 20 or more of the 62 possible RE-AIM criteria and 3 of these studies self-identified as "feasibility" studies. While Reach was the best-reported construct by the included studies, followed by Effectiveness and Implementation, the criteria within the Adoption and Maintenance constructs were rarely mentioned by these studies. In general, there was also wide variation in how each of the criteria were reported on by study authors. CONCLUSION: Based on the reporting of RE-AIM components in this review, we are unable to make connections to successful intervention components and thus practice-based recommendations for fall prevention in those with CI. The lack of detail regarding implementation approaches greatly limits the interpretation and comparisons across studies to fully inform future research efforts.

Using focus groups to explore caregiver transitions and needs after placement of family members living with dementia in 24-hour care homes.

Objectives: Family caregivers (defined broadly as family and friends) of persons with dementia are challenged to cope with myriad stressors and changes that occur along the dementia trajectory. The purpose of this study was to explore the transitions experienced by caregivers of persons with dementia after their relative relocated to a 24-hour care home.Method: Qualitative thematic and conversational analysis were used: themes were co-created and modes of speech and syntactical patterns analysed to expose discourses related to caregiving after placement in 24-hour care homes.Results: Four main themes were co-constructed from the data analysis: living with loss, relinquishing, redefining the caregiving role, and rediscovering and recreating a new self.Discussion: Caregiving continues after placement of family members with dementia in 24-hour care homes. Caregivers are at-risk group and require ongoing support throughout the caregiving journey. Study participants reported that navigation skills such as relationship building, communication, and advocacy were particularly salient to the post-placement period, when navigating the complex health care environment was a significant obstacle. Ultimately, findings from these focus groups will be used to inform an online intervention to support caregivers of a family member with dementia residing in a 24-hour care home.

Stress urinary incontinence after vaginal prolapse repair: development and internal validation of a prediction model with and without the stress test.

OBJECTIVE: To develop a prediction model for stress urinary incontinence (SUI) after vaginal prolapse repair (postoperative stress urinary incontinence [POSUI]) and assess the value of a preoperative stress test. PATIENTS AND METHODS: Secondary analysis of two trials in which women were randomised for prolapse repair with or without a midurethral sling (MUS). The trials included women with (CUPIDO-1, n = 134) and without (CUPIDO-2, n = 225) coexisting SUI. POSUI was defined as bothersome SUI one year after surgery and/or treatment of SUI in the first postoperative year. Logistic regression analysis was used to define a reference model, which was extended with the preoperative stress test. The stress test was performed with and without reduction of the prolapse. Missing values were imputed 20 times, with bootstrap resampling for internal validation of discriminatory ability. RESULTS: Three hundred fifty-six women could be included. POSUI occurred in 17% of the women (n = 61). The reference model included age (<55 years), point Ba of the pelvic organ prolapse quantification system (<-1), vaginal parity (≤3), subjective urinary incontinence, and MUS. The stress test had an odds ratio of 2.4 (95% confidence interval [CI], 1.2-4.6) in the extended model, which increased the optimism-corrected area under the receiver-operating curve from 0.74 to 0.76. The stress test was especially valuable in women with a 10% to 30% POSUI risk, where a stress test substantially impacted the POSUI risk. In more than 50% of the women, the stress test had no additional value in predicting POSUI. CONCLUSION: A preoperative stress test is not valuable for women at low risk of SUI after vaginal prolapse repair.

Should we combine vaginal prolapse surgery with continence surgery?

The risk of postoperative stress urinary incontinence (SUI) can be reduced by combining prolapse repair with continence surgery. However, more women face a serious adverse event (SAE) after vaginal prolapse surgery combined with a midurethral sling (MUS). It is difficult to predict a woman's individual postoperative SUI and SAE risk; therefore, weighing the benefits and risks of combination surgery is complex. We offer a concept that might help in considering combination surgery. According to this concept, women whose risk of needing subsequent surgery for postoperative SUI is on average 9% are likely to benefit from combination surgery.

Prolapse surgery with or without incontinence procedure: a systematic review and meta-analysis.

BACKGROUND: To reduce the risk of postoperative stress urinary incontinence (POSUI) prolapse repair might be combined with incontinence surgery. OBJECTIVES: Compare efficacy and safety of prolapse surgery with and without incontinence surgery. SEARCH STRATEGY: Including our earlier review a systematic search in PubMed, EMBASE, the Cochrane Library and the Register of Current Controlled Trials was performed from 1995 to 2017. SELECTION CRITERIA: Randomised trials comparing prolapse surgery with a midurethral sling (MUS) or Burch colposuspension. DATA COLLECTION AND ANALYSIS: Two reviewers selected eligible articles and extracted data. Stress urinary outcomes were pooled for preoperative SUI. Urgency incontinence and adverse events were pooled for incontinence procedure. MAIN RESULTS: Ten trials were included. Women with preoperative SUI symptoms or occult SUI had a lower risk to undergo subsequent incontinence surgery for POSUI after vaginal prolapse surgery with a MUS than after prolapse surgery only: 0 versus 40% [relative risk (RR) 0.0; 95% CI 0.0-0.2] and 1 versus 15% (RR 0.1; 95% CI 0.0-0.6), respectively. These differences were not significant in continent women not tested for occult SUI or without occult SUI. Serious adverse events were more frequent after vaginal prolapse repair with MUS (14 versus 8%; RR 1.7; 95% CI 1.1-2.7), but not after sacrocolpopexy with Burch colposuspension. Combination surgery did not increase the risk of overactive bladder symptoms, urgency incontinence and surgery for voiding dysfunction. CONCLUSIONS: Vaginal prolapse repair with MUS reduced the risk of postoperative SUI in women with preoperative SUI symptoms or occult SUI, but serious adverse events were more frequent. TWEETABLE ABSTRACT: Less stress incontinence after vaginal prolapse repair with sling, but more adverse events.

The predictive value of demonstrable stress incontinence during basic office evaluation and urodynamics in women without symptomatic urinary incontinence undergoing vaginal prolapse surgery.

AIMS: Women with pelvic organ prolapse without symptoms of urinary incontinence (UI) might demonstrate stress urinary incontinence (SUI) with or without prolapse reduction. We aimed to determine the value of demonstrable SUI during basic office evaluation or urodynamics in predicting SUI after vaginal prolapse repair in these women. METHODS: Women included in the CUPIDO trials without bothersome UI or UI more than once a week were eligible if they had undergone prolapse repair without incontinence surgery. The diagnostic and predictive value of demonstrable SUI was studied for postoperative SUI (POSUI). POSUI was defined as bothersome SUI at 1-year follow-up or treatment for SUI in the first postoperative year. RESULTS: In 45% (77/173) of the included women urodynamics was performed. In 19% (32/172) SUI was demonstrated with basic office evaluation, against 29% (22/77) with urodynamics. Nine percent (16/172) developed POSUI, six women underwent surgery for de novo SUI. Women with demonstrable SUI were more at risk to face POSUI: twenty-eight percent versus five percent (Diagnostic Odds Ratio: 7; 95%CI 3-22). Urodynamics predicted one more woman having POSUI, but all women who underwent treatment for de novo SUI showed SUI during basic office evaluation. Test performance did not improved with the adding of urodynamics. CONCLUSIONS: The predictive value of demonstrable SUI in symptomatically continent women undergoing vaginal prolapse repair is limited. Urodynamics added no value. The twenty-eight percent POSUI risk must be balanced against the increased complication risk if a prophylactic midurethral sling is considered.

Surgery versus physiotherapy for stress urinary incontinence.

BACKGROUND: Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. METHODS: We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. RESULTS: We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. CONCLUSIONS: For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).

MisoREST: surgical versus expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for miscarriage: a randomized controlled trial.

STUDY QUESTION: Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage? SUMMARY ANSWER: Curettage leads to a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. WHAT IS KNOWN ALREADY: In 5-50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage. STUDY DESIGN, SIZE, DURATION: From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization. MAIN RESULTS AND THE ROLE OF CHANCE: Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03-1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21-4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy. LIMITATIONS, REASONS FOR CAUTION: Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely. WIDER IMPLICATIONS OF THE FINDINGS: In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage. STUDY FUNDING/COMPETING INTERESTS: This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3310, http://www.trialregister.nl TRIAL REGISTRATION DATE: 27 February 2012. DATE OF FIRST PATIENT'S ENROLMENT: 12 June 2012.

Time efficiency of a web-based questionnaire in urogynecology: a randomized study.

INTRODUCTION AND HYPOTHESIS: Based on nationwide recommended questionnaires for women with pelvic floor dysfunction (PFD), we developed a web-based questionnaire (WBQ) that can be sent to women prior to their first visit. We hypothesized that using this WBQ would contribute to a more efficient first visit. Furthermore, we were interested in the satisfaction of patients who used the WBQ. METHODS: Women referred for PFD were randomized between WBQ and no questionnaire. Time spent per consultation was recorded in total and in split times for history taking, physical examination, counseling, and administration. Patient experience was evaluated by a standardized telephone interview. RESULTS: One hundred and twenty-eight women were randomized: 64 in the WBQ group and 64 in the control group. History taking was significantly shorter in the WBQ group [mean difference (MD) -1 m 32 s; 95 % confidence interval (CI) -2:41 to -0:23], and time for counseling was significantly longer (MD 1 m 21 s; 95 % CI 0:06-2:37). Overall time of the consultation was equal. The need for an additional visit tended to be less frequent in the WBQ group [53 % versus 64 %; relative risk (RR) 1.3, 95 % CI 0.8-2.0]. Forty-nine percent of women considered the WBQ time consuming without adding value. CONCLUSIONS: The WBQ contributed to a slightly more efficient use of the first consultation. While differences were small and patient satisfaction was low, other benefits of the WBQ should define whether the WBQ will be introduced.

Vaginal prolapse repair with or without a midurethral sling in women with genital prolapse and occult stress urinary incontinence: a randomized trial.

INTRODUCTION AND HYPOTHESIS: We compared pelvic organ prolapse (POP) repair with and without midurethral sling (MUS) in women with occult stress urinary incontinence (SUI). METHODS: This was a randomized trial conducted by a consortium of 13 teaching hospitals assessing a parallel cohort of continent women with symptomatic stage II or greater POP. Women with occult SUI were randomly assigned to vaginal prolapse repair with or without MUS. Women without occult SUI received POP surgery. Main outcomes were the absence of SUI at the 12-month follow-up based on the Urogenital Distress Inventory and the need for additional treatment for SUI. RESULTS: We evaluated 231 women, of whom 91 randomized as follows: 43 to POP surgery with and 47 without MUS. A greater number of women in the MUS group reported absence of SUI [86 % vs. 48 %; relative risk (RR) 1.79; 95 % confidence interval (CI) 1.29-2.48]. No women in the MUS group received additional treatment for postoperative SUI; six (13 %) in the control group had a secondary MUS. Women with occult SUI reported more urinary symptoms after POP surgery and more often underwent treatment for postoperative SUI than women without occult SUI. CONCLUSIONS: Women with occult SUI had a higher risk of reporting SUI after POP surgery compared with women without occult SUI. Adding a MUS to POP surgery reduced the risk of postoperative SUI and the need for its treatment in women with occult SUI. Of women with occult SUI undergoing POP-only surgery, 13 % needed additional MUS. We found no differences in global impression of improvement and quality of life.

Transvaginal prolapse repair with or without the addition of a midurethral sling in women with genital prolapse and stress urinary incontinence: a randomised trial.

OBJECTIVE: To compare transvaginal prolapse repair combined with midurethral sling (MUS) versus prolapse repair only. DESIGN: Multi-centre randomised trial. SETTING: Fourteen teaching hospitals in the Netherlands. POPULATION: Women with symptomatic stage two or greater pelvic organ prolapse (POP), and subjective or objective stress urinary incontinence (SUI) without prolapse reduction. METHODS: Women were randomly assigned to undergo vaginal prolapse repair with or without MUS. Analysis was according to intention to treat. MAIN OUTCOME MEASURES: The primary outcome at 12 months' follow-up was the absence of urinary incontinence (UI) assessed with the Urogenital Distress Inventory and treatment for SUI or overactive bladder. Secondary outcomes included complications. RESULTS: One hundred and thirty-four women were analysed at 12 months' follow-up (63 in MUS and 71 in control group). More women in the MUS group reported the absence of UI and SUI; respectively 62% versus 30% UI (relative risk [RR] 2.09; 95% confidence interval [CI] 1.39-3.15) and 78% versus 39% SUI (RR 1.97; 95% CI 1.44-2.71). Fewer women underwent treatment for postoperative SUI in the MUS group (10% versus 37%; RR 0.26; 95% CI 0.11-0.59). In the control group, 12 women (17%) underwent MUS after prolapse surgery versus none in the MUS group. Severe complications were more common in the MUS group, but the difference was not statistically significant (16% versus 6%; RR 2.82; 95% CI 0.93-8.54). CONCLUSIONS: Women with prolapse and co-existing SUI are less likely to have SUI after transvaginal prolapse repair with MUS compared with prolapse repair only. However, only 17% of the women undergoing POP surgery needed additional MUS. A well-informed decision balancing risks and benefits of both strategies should be tailored to individual women.

Prolapse surgery with or without stress incontinence surgery for pelvic organ prolapse: a systematic review and meta-analysis of randomised trials.

OBJECTIVES: The combination of prolapse surgery with an incontinence procedure can reduce the incidence of stress urinary incontinence (SUI) after surgery, but may increase adverse events. We compared the effectiveness and safety of prolapse surgery versus combined prolapse and incontinence surgery in women with pelvic organ prolapse. DESIGN AND SETTING: Pubmed, EMBASE, DARE, the Cochrane Library and the register of Current Controlled Trials were searched for randomised trials (restricted to Burch colposuspension and midurethral sling as incontinence procedure) from 1995 to 2013 limited to the English literature. METHODS: Two reviewers selected eligible articles and extracted the data. Pooling for SUI was based on three patient groups: (1) women with coexisting SUI; (2) women asymptomatic for SUI; and (3) women with occult SUI. For adverse events, pooling was based on incontinence procedure. MAIN OUTCOME MEASURES: The primary outcome was SUI. The secondary outcomes were treatment for SUI, bladder storage symptoms, obstructive voiding and adverse events. RESULTS: Seven trials were included. Pooling for women with coexisting SUI was possible for objective SUI with two studies and showed no difference. Statistical (I(2) = 95%) and clinical heterogeneity was, however, high. The largest study showed a lower incidence of persisting SUI (5% versus 23%) and treatment for this (0% versus 57%) in women who underwent prolapse repair with a midurethral sling. The second study did not find a difference in women undergoing a sacrocolpopexy with or without Burch colposuspension. In asymptomatic women, combination surgery resulted in a lower incidence of de novo subjective SUI (two studies; 24% versus 41%; relative risk [RR], 0.6; 95% confidence interval [CI], 0.3-0.9; I(2) = 36%) and the need for subsequent anti-incontinence surgery (three studies; 2% versus 7%; RR, 0.4; 95% CI, 0.2-0.8; I(2) = 13%). For the outcome objective SUI, pooling was possible for five studies, but statistical heterogeneity was high (I(2) = 82%) and the difference was not statistically significant. In the subgroup of women with occult stress incontinence, we found a lower incidence of objective SUI after combination surgery (two studies; 22% versus 52%; RR, 0.4; 95% CI, 0.3-0.8; I(2) = 32%). There were no differences in bladder storage symptoms, urgency incontinence or long-term obstructive voiding symptoms. Adverse events (two studies; 15% versus 10%; RR, 1.6; 95% CI, 1.0-2.5; I(2) = 0%) and prolonged catheterisation (three studies; 6% versus 1%; RR, 4.5; 95% CI, 1.5-13.3; I(2) = 0%) were more frequent after vaginal prolapse repair with a midurethral sling. CONCLUSIONS: Combination surgery reduces the risk of postoperative stress incontinence, but short-term voiding difficulties and adverse events were more frequent after combination surgery with a midurethral sling.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial.

BACKGROUND: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. METHODS/DESIGN: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. DISCUSSION: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. TRIAL REGISTRATION: Dutch Trial Register: NTR3110.

The Effects of a Walking Intervention on Gait Parameters in Older Adults Residing in Long-Term Care: A Randomized Controlled Trial.

OBJECTIVES: We examined the effects of a walking intervention in older adults residing in long-term care (LTC) homes on gait velocity (primary outcome), and stride length, cadence and heel-to-heel base of support (secondary outcomes) compared to those in an interpersonal interaction control group and a care-as-usual control group at 16-weeks post-intervention. METHODS: These previously unpublished gait data were collected as part of a larger prospective, randomized, three group study. One hundred and sixty-eight participants residing in 12 LTC homes were randomized into: a) a walking group (n=57) - 1:1 supervised, individualized, progressive, 30 minutes, five times a week walking program for 16 weeks; b) an interpersonal interaction group (n=55) - stationary 1:1 conversation time with research personnel; and, c) a care-as-usual control group (n=56). Gait was assessed at baseline and 16-weeks post-intervention using the GAITRite® computerized system. One-way Analysis of Covariance (ANCOVA), controlling for age, sex, cognitive status and baseline gait parameter (velocity, stride length, cadence, heel-to-heel base of support) was used to examine differences among groups for velocity, stride length, cadence, and heel-to-heel base of support at 16-weeks post-intervention. RESULTS: Ninety-one participants with available data were included in this analysis: walking group (n=31/57, mean age=82.77±6.75 years); interpersonal interaction group (n=31/55, mean age=82.74±9.27 years); care-as-usual control group (n=29/56, mean age=85.40±8.78 years). ANCOVA showed a significant difference in the mean gait velocity at 16-weeks post-intervention [F(2, 84) =6.99, p=0.0006); η2 (95%CI)=0.16 (0.02, 0.27)]. Post hoc comparisons using Sidak test showed that the estimated marginal mean (EMM) for velocity for the walking group [EMM (SE), 0.51m/s (0.03)] was significantly higher compared to the interpersonal interaction group [EMM (SE), 0.38m/s (0.03); t(83)=3.15, p=0.007] and the care-as-usual control group [EMM (SE), 0.38m/s (0.03)]; t(83)=3.32, p=0.004]. No significant difference was observed between groups for stride length, cadence or heel-to-heel base of support. CONCLUSION: LTC residents with limited physical functioning showed significant improvement in gait velocity but not in stride length, cadence or heel-to-heel base of support after a 16-week walking intervention.