Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study.

OBJECTIVE: To compare the 24-month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). DESIGN: Multicentre prospective comparative cohort study. SETTING: Twenty-two Dutch hospitals. POPULATION: Women referred with symptomatic POP of stage ≥2 and moderate-to-severe POP symptoms. METHODS: The primary outcome was subjective improvement at the 24-month follow-up according to the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes included improvement in prolapse-related symptoms measured with the Pelvic Floor Distress Inventory (PFDI-20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI-S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. MAIN OUTCOME MEASURE: PGI-I at 24 months. RESULTS: We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4-17.3%, P < 0.01). Seventy-nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. CONCLUSIONS: Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. TWEETABLE ABSTRACT: Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.

Risk factors for the recurrence of obstetrical anal sphincter injury and the role of a mediolateral episiotomy: an analysis of a national registry.

OBJECTIVE: The assessment of risk factors, including mediolateral episiotomy (MLE), for the recurrence of obstetric anal sphincter injury (rOASI). DESIGN: Population-based cohort study. SETTING: Data from the nationwide database of the Dutch Perinatal Registry (Perined). POPULATION: A cohort of 391 026 women at term, of whom 9943 had an OASI in their first delivery and had a second vaginal delivery of a liveborn infant in cephalic position. METHODS: Possible risk factors were tested for statistical significance using univariate and multivariate logistic regression analysis. MAIN OUTCOME MEASURES: Rate of rOASI. RESULTS: The rate of rOASI was 5.8%. Multivariate analysis identified a birthweight of ≥4000 g (adjusted OR, aOR, 2.1, 95% CI 1.6-2.6) and a duration of second stage of ≥30 minutes (aOR 1.8, 95% CI 1.4-2.3) as statistically significant risk factors for rOASI. Mediolateral episiotomy was associated with a statistically significant lower rate of rOASI in spontaneous vaginal delivery (SVD) (aOR 0.4, 95% CI 0.3-0.5) and in operative vaginal delivery (OVD) (aOR 0.2, 95% CI 0.1-0.5). CONCLUSIONS: Women with a history of OASI have a higher rate of OASI in their next delivery. Duration of the second stage of ≥30 minutes and a birthweight of ≥4000 g are significantly associated with an increased rate of rOASI. Mediolateral episiotomy is associated with a significantly lower rate of rOASI in both SVD and OVD. TWEETABLE ABSTRACT: Mediolateral episiotomy is associated with a significant lower recurrence rate of OASI in women with an OASI in their first delivery.

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.

Word catheter and marsupialisation in women with a cyst or abscess of the Bartholin gland (WoMan-trial): a randomised clinical trial.

OBJECTIVE: To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation. DESIGN: Multicentre, open-label, randomised controlled trial. SETTING: Eighteen hospitals in the Netherlands and one hospital in England. POPULATION: Women with a symptomatic cyst or abscess of the Bartholin gland. METHODS: Women were randomised to treatment with Word catheter or marsupialisation. MAIN OUTCOME MEASURES: The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10-point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention-to-treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2). RESULTS: One hundred and sixty-one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64-1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001). CONCLUSIONS: In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates. TWEETABLE ABSTRACT: Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.

Do patients prefer mesh or anterior colporrhaphy for primary correction of anterior vaginal wall prolapse: a labelled discrete choice experiment.

OBJECTIVE: We investigated patients' preferences for anterior colporrhaphy or mesh surgery as surgical correction of anterior vaginal wall prolapse. DESIGN: Labelled discrete choice experiment. SETTING: Three Dutch teaching hospitals. POPULATION: Women with anterior vaginal wall prolapse Pelvic Organ Prolapse Quantification stage 2 or more, indicated for anterior colporrhaphy (n = 100). METHODS: Discrete choice experiments are an attribute-based survey method for measuring preferences. In this experiment, women were asked to choose between two treatment scenarios, mesh surgery or anterior colporrhaphy. These surgical treatments differed in four treatment attributes: (i) recurrence rate, (ii) exposure rate, (iii) infection rate, (iv) dyspareunia. Data were analysed using a multinomial logit model. MAIN OUTCOME MEASURES: Women's preferences for anterior colporrhaphy or mesh surgery for the repair of vaginal wall prolapse. RESULTS: All treatment attributes, i.e. recurrence, exposure, infection and dyspareunia, proved to be significant in the woman's decision to choose mesh surgery (P < 0.001), while only two attributes out of three, recurrence and infection, were significant for anterior colporrhaphy (P < 0.001). The relative importance data showed that with regards to the four statistically significant attributes for mesh, dyspareunia was the most important attribute, and of the two significant attributes for anterior colporrhaphy, the risk of infection. Based on the attributes and levels in our discrete choice experiment, anterior colporrhaphy was preferred in 74% as a primary correction of anterior vaginal wall prolapse, followed by a preference for mesh in 26% of all choices. CONCLUSION: This study showed that next to the risk of recurrence, other aspects like risk of infection, dyspareunia and exposure play a role in the woman's preference for a surgical treatment. In addition, our results indicate that anterior colporrhaphy is preferred in the majority of the choices, followed by a preference for mesh surgery in a quarter of all choice sets. However, these results represent the average preference of a sample of women and cannot be taken as the preference of each individual. In the medical decision-making context, information from the current study should be personalised to fit patient's unique circumstances. For patients to construct their own, individual preferences, they should be well informed about the existence and magnitude of the potential benefits and risks related to either anterior colporrhaphy or mesh surgery.