Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial.

Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure. Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent. Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen. Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217). Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications. Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups. Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure. Trial Registration: TrialRegister.nl Identifier: NTR 6978.

Gynecologists' perspectives on surgical treatment for apical prolapse: a qualitative study.

INTRODUCTION AND HYPOTHESIS: Vaginal sacrospinous fixation (VSF) without mesh and sacrocolpopexy (SCP) with mesh are the most frequently performed surgical procedures for apical prolapse in the Netherlands. There is no long-term evidence suggesting the optimal technique, however. The aim was to identify which factors play a role in the choice between these surgical treatment options. METHODS: A qualitative study using semi-structured interviews amongst Dutch gynecologists was carried out. An inductive content analysis was performed with Atlas.ti. RESULTS: Ten interviews were analyzed. All gynecologists performed vaginal surgeries for apical prolapse, six gynecologists perform SCP themselves. Six gynecologists would perform VSF for a primary vaginal vault prolapse (VVP); three gynecologists preferred a SCP. All participants prefer a SCP for recurrent VVP. All participants have stated that multiple comorbidities could be a reason for choosing VSF, as this procedure is considered less invasive. Most participants choose a VSF in the case of older age (6 out of 10) or higher body mass index (7 out of 10). All treat primary uterine prolapse with vaginal, uterine-preserving surgery. CONCLUSIONS: Recurrent apical prolapse is the most important factor in advising patients which treatment they should undergo for VVP or uterine descent. Also, the patient's health status and the patient's own preference are important factors. Gynecologists who do not perform the SCP in their own clinic are more likely to perform a VSF and find more reasons not to advise a SCP. All participants prefer a vaginal surgery for a primary uterine prolapse.

Location and motion of vaginal pessaries in situ in women with successful and unsuccessful pessary treatment for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective was to compare the location and motion of pessaries between women with pelvic organ prolapse (POP) with a successful (fitting) and unsuccessful (non-fitting) pessary treatment on dynamic magnetic resonance imaging (dMRI). METHODS: A cross-sectional exploratory study of 15 women who underwent a mid-sagittal dMRI of the pelvic floor at rest, during contraction and during Valsalva with three different types of pessaries. The coordinates of the pessaries cross section, inferior pubic point (IPP) and sacrococcygeal junction (SCJ) were obtained and the location (position, orientation) and the motion (translation and rotation) were calculated. Differences between the groups and between the pessaries within the groups were compared. RESULTS: Nine women with a fitting pessary and 6 women with a non-fitting pessary were selected. In the non-fitting group, the pessaries were positioned more caudally and rotated more in clockwise direction and descended more, but not significantly, during Valsalva compared with the fitting group. The Falk pessary was positioned more anteriorly in the fitting group and more cranially in the non-fitting group compared with the ring and ring with support pessary. CONCLUSIONS: A non-fitting pessary was positioned more caudally at rest; on Valsalva, it rotated more clockwise and moved more caudally, suggesting that the dynamic characteristics of the pessary might play an important role in its effectiveness. Findings of this study serve as a basis for the development of new pessary designs.

The modified Manchester Fothergill procedure compared with vaginal hysterectomy with low uterosacral ligament suspension in patients with pelvic organ prolapse: long-term outcome.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare the long-term outcome between vaginal hysterectomy with low uterosacral ligament suspension (VH) and the modified Manchester Fothergill procedure (MF) as surgical treatment in patients with pelvic organ prolapse (POP). We hypothesize that MF is non-inferior to VH in the long term. METHODS: In this single-center retrospective cohort study patients who underwent MF or VH for primary apical compartment prolapse between 2003 and 2009 were eligible for inclusion. The primary outcome was subjective recurrence of POP. Secondary outcomes included number and type of reinterventions, time to reintervention and the degree of complaints. RESULTS: One hundred sixty of 398 patients (53 MF, 107 VH) returned the questionnaires (40%). The mean follow-up was 12.97 years for MF and 13.24 years for VH (p = 0.38). There were similar rates of subjective POP recurrence (51% in both groups). The reintervention rate in the MF group was higher but reached no statistical significance [19/53 (36%) versus 29/107 (27%), p = 0.26]. Kaplan-Meier curve showed no statistically significant difference in risk of reintervention after MF at the maximum follow-up of 16.5 years [HR 1.830 (95% CI 0.934-3.586), p = 0.08]. The mean time to reintervention was 3 years shorter in the MF group (p = 0.03). CONCLUSIONS: The subjective recurrence after MF is similar to VH in treatment of POP at the long term. MF appears to be non-inferior to VH when comparing the risk of reintervention. However, the small sample size precludes a definitive conclusion of non-inferiority, and future studies are needed.

Patient's preference for sacrospinous hysteropexy or modified Manchester operation: A discrete choice experiment.

OBJECTIVE: To investigate women's preference for modified Manchester (MM) or sacrospinous hysteropexy (SH) as surgery for uterine prolapse. DESIGN: Labelled discrete choice experiment (DCE). SETTING: Eight Dutch hospitals. POPULATION: Women with uterine prolapse, eligible for primary surgery and preference for uterus preservation. METHODS: DCEs are attribute-based surveys. The two treatment options were labelled as MM and SH. Attributes in this survey were treatment success ( levels SH: 84%, 89%, 94%; levels MM: 89%, 93%, 96%), dyspareunia (levels: 0%, 5%, 10%), cervical stenosis (levels: 1%, 6%, 11%) and severe buttock pain (levels: 0%, 1%). A different combination of attribute levels was used in each choice set. Women completed nine choice sets, making a choice based on attribute levels. Data were analysed in multinomial logit models. MAIN OUTCOME MEASURES: Women's preference for MM or SH. RESULTS: 137 DCEs were completed (1233 choice sets). SH was chosen in 49% of the choice sets, MM in 51%. Of all women, 39 (28%) always chose the same surgery. After exclusion of this group, 882 choice sets were analysed, in which women preferred MM, likely associated with a labelling effect, i.e. description of the procedure, rather than the tested attributes. In that group, MM was chosen in 53% of the choice sets and SH in 47%. When choosing MM, next to the label, dyspareunia was relevant for decision-making. For SH, all attributes were relevant for decision-making. CONCLUSIONS: The preference of women for MM or SH seems almost equally divided. The variety in preference supports the importance of individualised healthcare.

Risk factors for primary pelvic organ prolapse and prolapse recurrence: an updated systematic review and meta-analysis.

OBJECTIVE: To update a previously published systematic review and perform a meta-analysis on the risk factors for primary pelvic organ prolapse and prolapse recurrence. DATA SOURCES: PubMed and Embase were systematically searched. We searched from July 1, 2014 until July 5, 2021. The previous search was from inception until August 4, 2014. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials and cross-sectional and cohort studies conducted in the Western developed countries that reported on multivariable analysis of risk factors for primary prolapse or prolapse recurrence were included. The definition of prolapse was based on anatomic references, and prolapse recurrence was defined as anatomic recurrence after native tissue repair. Studies on prolapse recurrence with a median follow-up of ≥1 year after surgery were included. METHODS: Quality assessment was performed with the Newcastle-Ottawa Scale. Data from the previous review and this review were combined into forest plots, and meta-analyses were performed where possible. If the data could not be pooled, "confirmed risk factors" were identified if ≥2 studies reported a significant association in multivariable analysis. RESULTS: After screening, 14 additional studies were selected-8 on the risk factors for primary prolapse and 6 on prolapse recurrence. Combined with the results from the previous review, 27 studies met the inclusion criteria, representing the data of 47,429 women. Not all studies could be pooled because of heterogeneity. Meta-analyses showed that birthweight (n=3, odds ratio, 1.04; 95% confidence interval, 1.02-1.06), age (n=3, odds ratio, 1.34; 95% confidence interval, 1.23-1.47), body mass index (n=2, odds ratio, 1.75; 95% confidence interval, 1.17-2.62), and levator defect (n=2, odds ratio, 3.99; 95% confidence interval, 2.57-6.18) are statistically significant risk factors, and cesarean delivery (n=2, pooled odds ratio, 0.08; 95% confidence interval, 0.03-0.20) and smoking (n=3, odds ratio, 0.59; 95% confidence interval, 0.46-0.75) are protective factors for primary prolapse. Parity, vaginal delivery, and levator hiatal area are identified as "confirmed risk factors." For prolapse recurrence, preoperative prolapse stage (n=5, odds ratio, 2.68; 95% confidence interval, 1.93-3.73) and age (n=2, odds ratio, 3.48; 95% confidence interval, 1.99-6.08) are statistically significant risk factors. CONCLUSION: Vaginal delivery, parity, birthweight, age, body mass index, levator defect, and levator hiatal area are risk factors, and cesarean delivery and smoking are protective factors for primary prolapse. Preoperative prolapse stage and younger age are risk factors for prolapse recurrence after native tissue surgery.

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.

Gynecologists' perspectives on two types of uterus-preserving surgical repair of uterine descent; sacrospinous hysteropexy versus modified Manchester.

INTRODUCTION AND HYPOTHESIS: The modified Manchester (MM) and sacrospinous hysteropexy (SSH) are the most common uterus-preserving surgical procedures for uterine descent. Little is known about gynecologists' preferences regarding the two interventions. The study's aim was to identify which factors influence Dutch (uro)gynecologists when choosing one of these techniques. METHODS: This qualitative study consists of ten semi-structured interviews with Dutch (uro)gynecologists using predetermined, open explorative questions, based on a structured topic list. An inductive content analysis was performed using Atlas.ti. RESULTS: For SSH, the majority (6/10 gynecologists) reported the more dorsal change of direction of the vaginal axis as a disadvantage and expected more cystocele recurrences (7/10). The most reported disadvantage of MM was the risk of cervical stenosis (7/10). Four gynecologists found MM not to be appropriate for patients with higher stage uterine prolapse. The quality of the uterosacral ligaments was related to the chance of recurrence according to five gynecologists. Patient counseling was biased toward one of the uterus-preserving operations (7/10). Four gynecologists stated they make the final decision while two let patient-preference lead the final decision. CONCLUSIONS: Preference for one of the uterus-preserving interventions is mainly based on the gynecologist's own experience and background. The lack of information regarding these two uterus-preserving procedures hampers evidence-based decision making, which explains the practice pattern variation. In conclusion, further research is needed to improve evidence-based counseling and shared decision making regarding the choice of procedure.

Long-term effects of motherfit group therapy in pre-(MOTHERFIT1) and post-partum women (MOTHERFIT2) with stress urinary incontinence compared to care-as-usual: study protocol of two multi-centred, randomised controlled trials.

BACKGROUND: Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training (PFMT) peri-partum has been proven effective for up to 1 year post-partum; however, its long-term effects are unknown. Group PFMT, given by a physiotherapist, has been proven to be as equally effective as individual therapy. Motherfit is a group-PFMT therapy with an emphasis on pelvic floor exercises, adherence and general fitness. Care-as-usual (CAU), if guideline driven, should, as first treatment option, consist of PFMT. Cost-effective strategies are of relevance, given the rise of health care costs. Motherfit group therapy has the potential to be cost-effective in women with urinary incontinence. Therefore, the objectives of the two current studies are: (1) to investigate whether intensive, supervised, pre-partum (MOTHERFIT1) or post-partum (MOTHERFIT2) pelvic-floor-muscle group therapy reduces 18-month post-partum severity of SUI compared to CAU and (2) whether MOTHERFIT1 OR MOTHERFIT 2 is more (cost-)effective compared to CAU. METHODS: Two multi-centred, randomised controlled trials (MOTHERFIT1, n = 150, MOTHERFIT2, n = 90) will be performed. Participants will be recruited by their midwife or gynaecologist during their routine check. Participants with SUI will receive either motherfit group therapy or CAU. Motherfit group therapy consists of eight group sessions of 60 min each, instructed and supervised by a registered pelvic physiotherapist. Motherfit group therapy includes instructions on pelvic floor anatomy and how to contract, relax and train the pelvic-floor muscles correctly and is combined with general physical exercises. Adherence during and after motherfit will be stimulated by reinforcement techniques and a mobile app. The primary outcome measure is the absence of self-reported SUI based on the severity sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) at 18 months post-partum. Secondary outcomes evaluate quality of life, subjective improvement and health care costs. DISCUSSION: The motherfit studies are, to our knowledge, the first studies that evaluate both long-term results and health care costs compared to CAU in pregnant and post-partum women with SUI. If motherfit is shown to be (cost-)effective, implementation in peri-partum care should be considered. TRIAL REGISTRATION: Netherlands Trial Register, ID: NL5816 . Registered on 18 July 2016.

Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

BACKGROUND: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. METHODS: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. TRIAL REGISTRATION: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Choice of mode of delivery in a subsequent pregnancy after OASI: a survey among Dutch gynecologists.

INTRODUCTION AND HYPOTHESIS: National and international guidelines do not provide clear recommendations on the mode of delivery in a subsequent pregnancy after obstetric anal sphincter injury (OASI). The aim of this study was to investigate the opinion of gynecologists in The Netherlands on this choice and the extent to which this choice is affected by the gynecologist's characteristics. METHODS: Of 973 gynecologists sent a questionnaire seeking their opinion on the mode of delivery in 16 different case descriptions, 234 (24%) responded. Factors influencing the opinion of the respondents on the mode of delivery, the presence of anal symptoms, the degree of OASI and the characteristics of the respondents were analyzed by univariate and multivariate logistic regression analysis. RESULTS: Recommendations on the mode of delivery in a subsequent pregnancy after OASI showed considerable variation. The recommendations depended on (previous) symptoms and the degree of OASI. For gynecologists who based their recommendations on endoanal ultrasonography outcomes (7-20% depending on the case), the degree of OASI and severity of (previous) symptoms were less important. Gynecologists basing their recommendations on endoanal ultrasonography recommended a primary cesarean section less often. Gynecologist's characteristics (including years of experience, type of hospital and subspecialty) had a small effect on their recommendations on the mode of delivery. CONCLUSIONS: Due to lack of evidence, recommendations of gynecologists in The Netherlands on the mode of delivery in a subsequent pregnancy after OASI vary widely and depend on (previous) symptoms and the degree of OASI. Gynecologists who based their recommendations on endoanal ultrasonography outcomes recommended cesarean section less often.

Diagnostic Accuracy and Clinical Implications of Translabial Ultrasound for the Assessment of Levator Ani Defects and Levator Ani Biometry in Women With Pelvic Organ Prolapse: A Systematic Review.

OBJECTIVE: The aim of this study was to assess the diagnostic accuracy and clinical implications of translabial 3-dimensional (3D) ultrasound for the assessment of levator ani defects and biometry in women with pelvic organ prolapse (POP). METHODS: We performed a systematic literature search through computerized databases including MEDLINE (via PubMed), EMBASE (via OvidSP), and the Cochrane Library using both medical subject headings and text terms from January 1, 2003, to December 25, 2015.We included articles that reported on POP status and diagnostic accuracy measurements with translabial 3D ultrasound or transperineal ultrasound for the detection of levator ani defects or for measuring pelvic floor biometry, that is, levator ani hiatus, or reported on the clinical relevance of using translabial 3D ultrasound for levator ani defects or measuring pelvic floor biometry in women with POP. RESULTS: Thirty-one articles were selected in accordance with parts of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines that can be applied to studies of diagnostic accuracy. Twenty-two articles (71%) are coauthored by 1 expert in this field. Detecting levator ani defects with translabial 3D ultrasound compared with magnetic resonance imaging showed a moderate to good agreement, whereas measuring hiatal biometry on translabial 3D ultrasound compared with magnetic resonance imaging showed a moderate to very good agreement.The interobserver agreement for diagnosing levator ani defects and measuring the levator hiatal area showed a moderate to very good agreement. Furthermore, levator ani defects increase the risk of cystocele and uterine prolapse, and levator ani defects are associated with recurrent POP.Finally, a larger hiatus was associated with POP and recurrent POP. CONCLUSIONS: Translabial 3D ultrasound is reproducible for diagnosing levator ani defects and ballooning hiatus. Both levator ani defects and a larger hiatal area are, in a selected population of patients with pelvic floor dysfunction, associated with POP and recurrent POP. More research is needed concerning external validation because most data in this article are coauthored by 1 expert in this field.

Recurrence risk is associated with preoperatively advanced prolapse stage: Is there a difference between women with stage 2 and those with stage 3 or 4 cystocele?

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) recurrence after surgery is a major problem. POP that is more advanced preoperatively is associated with a higher risk of recurrence postoperatively. We hypothesized that women with a stage 2 cystocele differ from those with a stage 3 or 4 cystocele. The aim of this study was to compare the baseline characteristics of women with mild and those with more advanced cystocele. METHODS: Patients had participated in one of two multicenter prospective cohort studies on women undergoing conventional anterior colporrhaphy without previous POP surgery. This was a secondary analysis of these data. Women with a preoperative cystocele stage 2 were compared with women with a stage 3 or 4 cystocele. Logistic regression models were employed to calculate odds ratios (OR) and 95% confidence intervals (CI). RESULTS: Two hundred and sixty-nine women were assessed, of whom 132 (49.1%) had an advanced cystocele. Only older age was significantly associated with advanced cystocele preoperatively, with an OR of 1.07 (95% CI 1.04-1.10). There were no significant differences between women with advanced or stage 2 cystocele in body mass index, vaginal deliveries, assisted delivery, positive family history of POP, concurrent rectocele, concurrent uterine of vaginal vault prolapse, major levator ani muscle defects, or levator hiatal area. CONCLUSIONS: Women with advanced cystocele were significantly older than women with stage 2 cystocele. This raises the question whether it would be favorable to perform POP surgery in an earlier stage, i.e., at a younger age, in order to prevent POP recurrence.

Obstetric anal sphincter injury: a follow-up questionnaire study on longer-term outcomes.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) contribute significantly to the development of anal incontinence (AI) in women. The aim of this study was to establish the incidence of AI after OASIS and to study the influence on the quality of life (QoL) in patients with OASIS. METHODS: This cohort study, with prospective case-control follow-up, involves women who were treated for OASIS between 2005 and 2012 in two academic medical centers in The Netherlands. Three hundred and thirteen patients and 780 controls were invited to complete a validated questionnaire (Defecation Distress Inventory, Wexner Incontinence Score, and Fecal Instrument Quality of Life) regarding symptoms and bother of AI subsequent and QoL after delivery. The main outcome measures were the presence of AI and the impact on QoL. RESULTS: The questionnaire was completed by 141 patients and 194 controls. Mean follow-up was 4 years (range 1-9 years) in both groups. In the patient group, 55 women (39 %) reported AI symptoms compared with 38 women (20 %) in the control group (odds ratio 2.7, 95 % confidence interval 1.66-4.47, p < 0.01). In women who experienced symptoms of AI as very bothersome, QoL was affected in 14 (82.0 %) patients and three (33.5 %) controls (p = 0.012). CONCLUSIONS: In this study, women with OASIS had a more than doubled risk of longer-term bothersome symptoms of AI compared with controls. Symptoms were experienced as bothersome and as having an influence on QoL.

Anatomical Cystocele Recurrence: Development and Internal Validation of a Prediction Model.

OBJECTIVE: To develop a prediction model that estimates the risk of anatomical cystocele recurrence after surgery. METHODS: The databases of two multicenter prospective cohort studies were combined, and we performed a retrospective secondary analysis of these data. Women undergoing an anterior colporrhaphy without mesh materials and without previous pelvic organ prolapse (POP) surgery filled in a questionnaire, underwent translabial three-dimensional ultrasonography, and underwent staging of POP preoperatively and postoperatively. We developed a prediction model using multivariable logistic regression and internally validated it using standard bootstrapping techniques. The performance of the prediction model was assessed by computing indices of overall performance, discriminative ability, calibration, and its clinical utility by computing test characteristics. RESULTS: Of 287 included women, 149 (51.9%) had anatomical cystocele recurrence. Factors included in the prediction model were assisted delivery, preoperative cystocele stage, number of compartments involved, major levator ani muscle defects, and levator hiatal area during Valsalva. Potential predictors that were excluded after backward elimination because of high P values were age, body mass index, number of vaginal deliveries, and family history of POP. The shrinkage factor resulting from the bootstrap procedure was 0.91. After correction for optimism, Nagelkerke's R and the Brier score were 0.15 and 0.22, respectively. This indicates satisfactory model fit. The area under the receiver operating characteristic curve of the prediction model was 71.6% (95% confidence interval 65.7-77.5). After correction for optimism, the area under the receiver operating characteristic curve was 69.7%. CONCLUSION: This prediction model, including history of assisted delivery, preoperative stage, number of compartments, levator defects, and levator hiatus, estimates the risk of anatomical cystocele recurrence.

Factors influencing postpartum women's willingness to participate in a preventive pelvic floor muscle training program: a web-based survey.

OBJECTIVE: Pregnancy and delivery are the most prominent risk factors for the onset of pelvic floor injuries and - later-on - urinary incontinence. Supervised pelvic floor muscle training during and after pregnancy is proven effective for the prevention of urinary incontinence on the short term. However, only a minority of women do participate in preventive pelvic floor muscle training programs. Our aim was to analyze willingness to participate (WTP) in an intensive preventive pelvic floor muscle training (PFMT) program and influencing factors, from the perspective of postpartum women, for participation. STUDY DESIGN: We included 169 three-month postpartum women in a web-based survey in the Netherlands. Demographic and clinical characteristics, knowledge and experience with PFMT and preconditions for actual WTP were assessed. Main outcome measures were frequencies and percentages for categorical data. Cross tabulations were used to explore the relationship between WTP and various independent categorical variables. A linear regression analysis was done to analyze which variables are associated with WTP. RESULTS: A response rate of 64% (n=169) was achieved. 31% of the women was WTP, 41% was hesitating, 12% already participated in PFMT and 15% was not interested (at all). No statistically significant association was found between WTP and risk or prognostic pelvic floor dysfunction factors. Women already having symptoms of pelvic floor dysfunction such as incontinence and pelvic organ prolapse symptoms were more WTP (p=0.010, p=0.001, respectively) as were women perceiving better general health (p<0.001). Preconditions for women to participate were program costs, and travel time not exceeding 15min. CONCLUSIONS: From the perspective of postpartum women, there is room for improvement of preventive pelvic floor management. Further research should focus on strategies to tackle major barriers and to introduce facilitators for postpartum women to participate in PFMT programs.

Risk factors for pelvic organ prolapse and its recurrence: a systematic review.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a common condition with multifactorial etiology. The purpose of this systematic review was to provide an overview of literature on risk factors for POP and POP recurrence. METHODS: PubMed and Embase were searched with "pelvic organ prolapse" combined with "recurrence" and combined with "risk factors," with Medical Subject Headings and Thesaurus terms and text words variations until 4 August 2014, without language or publication date restrictions. Only cohort or cross-sectional studies carried out in western developed countries containing multivariate analyses and with a definition of POP based on anatomical references were included. POP recurrence had to be defined as anatomical recurrence after native tissue repair without mesh. Follow-up after surgery should have been at least 1 year. Articles were excluded if POP was not a separate entity or if it was unclear whether the outcome was primary POP or recurrence. RESULTS: PubMed and Embase revealed 2,988 and 4,449 articles respectively. After preselection, 534 articles were independently evaluated by two researchers, of which 15 met the selection criteria. In 10 articles on primary POP, 30 risk factors were investigated. Parity, vaginal delivery, age, and body mass index (BMI) were significantly associated in at least two articles. In 5 articles on POP recurrence, 29 risk factors were investigated. Only preoperative stage was significantly associated in at least two articles. CONCLUSION: Parity, vaginal delivery, age, and BMI are risk factors for POP and preoperative stage is a risk factor for POP recurrence.

Translabial three-dimensional ultrasonography compared with magnetic resonance imaging in detecting levator ani defects.

OBJECTIVE: To assess the diagnostic performance of translabial three-dimensional ultrasonography in detecting major levator ani defects in women with pelvic organ prolapse compared with magnetic resonance imaging (MRI) and to assess the interobserver agreement in detecting levator ani defects with translabial three-dimensional ultrasonography. METHODS: In a multicenter cohort study, 140 women indicated for primary surgery of pelvic organ prolapse quantification stage II or more cystocele were included. Patients undergoing mesh surgery or concomitant stress incontinence surgery were excluded. All consenting patients underwent translabial three-dimensional ultrasonography and MRI of the pelvic floor before surgery. Two observers (out of a pool of four observers) assessed translabial three-dimensional ultrasound images; two other observers (out a pool of five observers) assessed MRIs for levator ani muscle damage. In case of disagreement, the images were discussed in a consensus meeting. RESULTS: Of the 135 scans, 45 major levator ani defects were detected on ultrasonogram (33.3%) and 32 were confirmed at MRI (23.7%). Of the 41 major levator ani defects detected on MRI, nine were missed at translabial three-dimensional ultrasonogram. Sensitivity was 0.78 (32 of 41) (95% confidence interval [CI] 0.65-0.91) and specificity was 0.86 (81 of 94) (95% CI 0.79-0.93) in detecting major levator ani defects with translabial three-dimensional ultrasonography compared with MRI. There was good agreement scoring levator ani defects on translabial three-dimensional ultrasonography, with a κ of 0.67 (95% CI 0.58-0.76); agreement in recognizing major levator ani defects was moderate, with a κ of 0.53 (95% CI 0.37-0.69). CONCLUSION: Translabial three-dimensional ultrasonography shows reasonable agreement with MRI in detecting major levator defects. Because of the moderate interobserver agreement, it will be difficult to implement ultrasonography in daily practice. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, www.trialregister.nl, NTR2220.

Avulsion of puborectalis muscle and other risk factors for cystocele recurrence: a 2-year follow-up study.

INTRODUCTION AND HYPOTHESIS: This study aimed to determine the relationship of recurrent cystocele with avulsion of puborectalis muscle and other risk factors. METHODS: In this prospective observational cohort study, 245 women undergoing anterior colporrhaphy were invited for a 2-year follow-up visit consisting of a questionnaire, physical examination, and translabial 3D ultrasonography. Women with and without recurrent cystocele were compared to identify recurrence risk factors. RESULTS: Of the 245 women, 156 agreed to the follow-up visit (63.7%). Objective recurrence rate was 80 of 156 (51.3%). Seventeen of the 156 (10.9%) reported subjective recurrence. Risk factors for anatomical recurrence were complete avulsion of puborectalis muscle (OR, 2.4; 95% CI, 1.3, 4.7), advanced preoperative stage (OR, 2.0; 95% CI, 1.0, 4.1), family history of prolapse (OR, 2.4; 95% CI, 1.2, 4.9), and sacrospinous fixation (OR, 6.5; 95% CI, 2.0, 21.2). CONCLUSIONS: Risk factors for anatomical cystocele recurrence after anterior colporrhaphy were complete avulsion of puborectalis muscle, advanced preoperative stage, family history of prolapse, and sacrospinous fixation.