Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

Unsupervised convolutional autoencoders for 4D transperineal ultrasound classification.

Purpose: 4D Transperineal ultrasound (TPUS) is used to examine female pelvic floor disorders. Muscle movement, like performing a muscle contraction or a Valsalva maneuver, can be captured on TPUS. Our work investigates the possibility for unsupervised analysis and classification of the TPUS data. Approach: An unsupervised 3D-convolutional autoencoder is trained to compress TPUS volume frames into a latent feature vector (LFV) of 128 elements. The (co)variance of the features are analyzed and statistical tests are performed to analyze how features contribute in storing contraction and Valsalva information. Further dimensionality reduction is applied (principal component analysis or a 2D-convolutional autoencoder) to the LFVs of the frames of the TPUS movie to compress the data and analyze the interframe movement. Clustering algorithms ( K -means clustering and Gaussian mixture models) are applied to this representation of the data to investigate the possibilities of unsupervised classification. Results: The majority of the features show a significant difference between contraction and Valsalva. The (co)variance of the features from the LFVs was investigated and features most prominent in capturing muscle movement were identified. Furthermore, the first principal component of the frames from a single TPUS movie can be used to identify movement between the frames. The best classification results were obtained after applying principal component analysis and Gaussian mixture models to the LFVs of the TPUS movies, yielding a 91.2% accuracy. Conclusion: Unsupervised analysis and classification of TPUS data yields relevant information about the type and amount of muscle movement present.

Effects of mesenchymal stem cells and heparan sulfate mimetics on urethral function and vaginal wall biomechanics in a simulated rat childbirth injury model.

INTRODUCTION AND HYPOTHESIS: New treatments are needed for pelvic floor disorders. ReGeneraTing Agent® (RGTA®) is a promising regenerative therapy. Therefore, the objective of this study was to compare regenerative abilities of mesenchymal stem cells (MSCs) and RGTA® on regeneration after simulated childbirth injury in rats. METHODS: Rats underwent pudendal nerve crush and vaginal distension (PNC+VD) or sham injury. Rats that underwent PNC+VD were treated intravenously with vehicle, MSCs or RGTA® 1 h, 7 days, and 14 days after surgery. Sham rats received 1 ml vehicle at all time points. After 21 days, urethral function and pudendal nerve function were tested. Vaginal tissues were harvested for biomechanical testing and histology. Biaxial testing was performed to measure tissue stiffness. RESULTS: PNC+VD decreased urethral and pudendal nerve function compared with sham. Vaginal wall stiffness was significantly decreased in longitudinal and transverse tissue axes after PNC+VD compared with sham. MSC or RGTA® did not restore urethral or pudendal nerve function. However, MSC treatment resolved loss in vaginal wall stiffness in both tissue axes and improved collagen content within the vaginal wall. RGTA® treatment increased vaginal wall anisotropy by increasing relative stiffness in the longitudinal direction. PNC+VD (with vehicle or MSCs) enhanced elastogenesis, which was not observed after RGTA® treatment. CONCLUSIONS: Treatment with MSCs facilitated recovery of vaginal wall biomechanical properties and connective tissue composition after PNC+VD, whereas treatment with RGTA® resulted in anisotropic biomechanical changes. This indicates that MSCs and RGTA® promote different aspects of vaginal tissue regeneration after simulated childbirth injury.

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial.

Importance: Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase. Objective: To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse. Design, Setting, and Participants: The PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022. Interventions: Two hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery. Main Outcomes and Measures: The primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured. Results: Among 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, -6.1% [1-sided 95% CI, -12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, -13.1% [1-sided 95% CI, -23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery. Conclusions and Relevance: Among patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery. Trial Registration: Netherlands Trial Register Identifier: NTR4883.

Transperineal ultrasound to estimate the appropriate ring pessary size for women with pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective was to predict the successful ring pessary size based on the levator hiatal area (HA). METHODS: This is a prospective case-control study. Women with symptomatic pelvic organ prolapse (POP) choosing pessary treatment were included. All women underwent an interview, clinical examination, and 3D/4D transperineal ultrasound (TPUS). The ring pessary size used in each trial and the reason for unsuccessful trials were recorded. In addition, levator hiatal area divided by ring pessary size (HARP ratio) was measured at rest, maximum contraction, and maximum Valsalva. The HARP ratios of successful and unsuccessful trials were compared, receiver operating characteristic curves in the prediction of successful trials were constructed, and the cut-off optimizing sensitivity and specificity was identified. RESULTS: A total of 162 women were assessed and 106 were included with 77 successful trials, 49 unsuccessful trials owing to dislodgment or failure to relieve POP symptoms, and 20 unsuccessful trials owing to pain/discomfort. Rest HARP ratio and Valsalva HARP ratio were significantly smaller in the successful trials versus dislodgment/failure to relieve POP symptoms trials (mean rest HARP ratio [SD]: 2.93 [0.59] vs 3.24 [0.67], p = 0.021; median Valsalva HARP ratio (IQR): 4.65 (1.56) vs 5.32 (2.08), p = 0.004). No significant difference was observed between pain/discomfort trials and successful trials. The best cut-off for the prediction of successful trials was Valsalva HARP ratio ≤ 5.00. CONCLUSIONS: Unsuccessful fitting trials due to dislodgment/failure to relieve POP symptoms are associated with a small ring pessary with respect to the levator HA. A ring pessary that produces a Valsalva HARP ratio > 5.00 has a higher risk of dislodgment/failure to relieve POP symptoms.

Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery.

BACKGROUND: Female pelvic organ prolapse (POP) has a negative effect on female sexual functioning and with an increasing life expectancy female sexual dysfunction caused by POP will be an arising global issue. AIM: Improvement in female sexual functioning, measured with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR), 24-months after pessary or surgery, for both sexually active (SA) and sexually inactive women (NSA) presenting with POP. METHODS: A multicenter prospective comparative cohort study was conducted in 22 Dutch hospitals. Women referred with moderate to severe POP symptoms and POP stage ≥ 2 were included and chose either pessary therapy or surgical intervention. The PISQ-IR was filled in at baseline and 24-months, the delta of change was calculated and compared between both groups. Multivariate linear regression was performed to adjust for potential confounding factors in the association between the summary score of the PISQ-IR and therapy. OUTCOMES: Change in PISQ-IR between pessary and surgical intervention. RESULTS: The delta of change at 24-months was calculated for 198 women in the pessary group and 129 women in the surgery group. SA women in the surgery group reported statistically significant more improvement on the condition-specific (-0.19 95%CI -0.35; -0.03, P = .02), and condition-impact (-0.48 95%CI -0.69; -0.28, P < .001) domains as well as on the summary score (-0.15 95%CI -0.23; -0.08, P < .001) as compared to the pessary group. No significant differences between pessary and surgery were found on the domains for NSA women. After controlling for potential baseline confounders, surgery still had a statistically significant effect on the summary score (B = 0.08; 95%CI interval 0.007-0.15, P = .03). Women having surgery had 2.62 times higher odds of changing from NSA to SA than pessary therapy. CLINICAL IMPLICATIONS: SA women who clearly express that POP-related symptoms limit their sexual functioning should be counseled that surgery results in a more remarkable improvement. STRENGTHS & LIMITATIONS: Our strengths include the large sample size, long-term follow-up, the use of the PISQ-IR as a validated outcome tool evaluating both SA and NSA women, and this study reflects real-life clinical practice that enhances the external validity of the findings. A limitation of our study is the considerable proportion of non-responders at 24-months follow-up. CONCLUSION: Sexual function in SA women with POP is superior in case surgery is performed as compared to pessary therapy. van der Vaart LR, Vollebregt A, Pruijssers B, et al. Female Sexual Functioning in Women With a Symptomatic Pelvic Organ Prolapse; A Multicenter Prospective Comparative Study Between Pessary and Surgery. J Sex Med 2022;19:270-279.

Transurethral versus suprapubic catheterization to test urethral function in rats.

Transurethral and suprapubic catheterization have both been used to test urethral function in rats; however, it is unknown whether these methods affect urethral function or if the order of catheterization affects the results. The aim of this cross-over designed experiment was to compare the effects of catheterization methods and order on leak point pressure (LPP) testing. LPP and simultaneous external urethral sphincter electromyography (EUS EMG) were recorded in anesthetized female virgin Sprague-Dawley rats in a cross-over design to test the effects of transurethral and suprapubic catheterization. There was no significant difference in peak bladder pressure during LPP testing whether measured with a transurethral or suprapubic catheter. There was no significant difference in peak bladder pressure between the first and second catheter insertions. However, peak EMG firing rate, as well as peak EMG amplitude and EMG amplitude difference between peak and baseline were significantly higher after the first catheter insertion compared to the second insertion, regardless of the catheter method. Our results suggest that route of catheterization does not alter urethral function, e.g. create a functional partial outlet obstruction. Either catheterization method could be used for LPP and/or EUS EMG testing in rats.

The effect of pessary treatment on puborectalis muscle function.

INTRODUCTION AND HYPOTHESIS: The objective was to assess if puborectalis muscle (PRM) function changes in women with pelvic organ prolapse (POP) undergoing pessary treatment. METHODS: This was a prospective cohort study of women with symptomatic POP choosing pessary treatment. An interview, clinical examination and 3D/4D transperineal ultrasound were performed at baseline and at 3-month follow-up. POP was assessed using the Pelvic Organ Prolapse Quantification system (POPQ). Parameters compared between baseline and follow-up were: hiatal area at rest (HArest), maximal contraction (HActx), and maximal Valsalva maneuver (HAVal), displacement in contraction (DISPL-ctx, i.e., relative difference between HArest and HActx), and displacement in Valsalva (DISPL-Val, i.e., relative difference between and HAVal and HArest). Parameters were compared in women with and those without complete avulsion. RESULTS: A total of 162 women were assessed and 34 were included. Mean age was 64 years (SD 11.4), and mean BMI 24 kg/m2 (SD 3.1). Thirty-one women had a cystocele, 8 a uterine prolapse, and 12 had a posterior compartment prolapse. Twenty-one women (61.8%) had a POP stage II, and 13 (38.2%) a POP stage III. Ring pessaries were most frequently used (97%). In the entire group a statistically significant increase in DISPL-ctx was observed (mean difference 2.1%, p = 0.017). In the no avulsion group HArest and DISPL-ctx increased significantly (mean difference 4.1%, p = 0.016 and 2.7%, p = 0.016 respectively) and the increase in DISPL-ctx was higher than in the avulsion group (mean difference 2.7% vs 0.2%, p = 0.056). CONCLUSION: Our results show that PRM function changes in women with POP undergoing pessary treatment and suggest that such change occurs mainly in the absence of complete avulsion.

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.

Multiple doses of stem cells maintain urethral function in a model of neuromuscular injury resulting in stress urinary incontinence.

Stress urinary incontinence (SUI) is more prevalent among women who deliver vaginally than women who have had a cesarean section, suggesting that tissue repair after vaginal delivery is insufficient. A single dose of mesenchymal stem cells (MSCs) has been shown to partially restore urethral function in a model of SUI. The aim of the present study was to determine if increasing the number of doses of MSCs improves urethral and pudendal nerve function and anatomy. We hypothesized that increasing the number of MSC doses would accelerate recovery from SUI compared with vehicle treatment. Rats underwent pudendal nerve crush and vaginal distension or a sham injury and were treated intravenously with vehicle or one, two, or three doses of 2 × 106 MSCs at 1 h, 7 days, and 14 days after injury. Urethral leak point pressure testing with simultaneous external urethral sphincter electromyography and pudendal nerve electroneurography were performed 21 days after injury, and the urethrovaginal complex and pudendal nerve were harvested for semiquantitative morphometry of the external urethral sphincter, urethral elastin, and pudendal nerve. Two and three doses of MSCs significantly improved peak pressure; however, a single dose of MSCs did not. Single, as well as repeated, MSC doses improved urethral integrity by restoring urethral connective tissue composition and neuromuscular structures. MSC treatment improved elastogenesis, prevented disruption of the external urethral sphincter, and enhanced pudendal nerve morphology. These results suggest that MSC therapy for postpartum incontinence and SUI can be enhanced with multiple doses.

Underestimation of pelvic organ prolapse in the supine straining position, based on magnetic resonance imaging findings.

OBJECTIVE: Pelvic organ prolapse (POP) is clinically diagnosed in the supine position, where the effect of gravity is simulated by having the patients put strain on their pelvic floor. The objective of this study was to determine the degree of POP underestimation in the supine position based on magnetic resonance imaging (MRI) findings. METHODS: This prospective study was conducted with symptomatic POP grade ≥ 2 patients. Fifteen female patients were examined with an MRI system that allows supine and upright imaging. The differences between supine and upright in distances of the bladder neck, cervix, and pouch of Douglas from the pubococcygeal line (PCL) were estimated, together with changes in the genital hiatal area. Patients were scanned at rest and during straining. All distances were compared using the Wilcoxon ranking test. RESULTS: All mean distances from the PCL increased from the supine-strain to the upright-rest and from the supine-strain to the upright-strain position. These distances were found in the supine and upright positions: the bladder descended 1.3 cm to 1.4 cm, the cervix 1.1 cm to 2.2 cm, and the pouch of Douglas 0.8 cm to 1.5 cm respectively (all p values <0.05). The hiatal area was larger in the upright-strain position (mean 42.0 cm2; SD ±14.8) than during the supine-strain position (mean 33.5 cm2; SD ±14.5), with a p value of 0.02. CONCLUSION: Upright MRI scanning of patients with POP grade ≥ 2 both at rest and during straining shows a significantly larger extent of the prolapse than that observed during supine straining.

Method and reliability of measuring midurethral area and echogenicity, and changes during and after pregnancy.

INTRODUCTION AND HYPOTHESIS: Internal closure of the urethral sphincter is one of the mechanisms in maintaining continence. Little is known about changes in the urethral sphincter during pregnancy. We designed this study to develop a reliable method to measure the area and mean echogenicity of the midurethra during and after pregnancy and to assess changes over time. METHODS: Two observers independently segmented the urethra as follows: in the sagittal plane, the urethra was positioned vertically, the marker was placed in the middle section of the lumen of the urethra, and eight tomographic US images of 2.5 -mm slices were obtained. The central image was selected, and area and mean echogenicity were calculated automatically. Intra- and interobserver reliability were determined by intraclass correlation coefficients (ICC) and their 95% confidence intervals (CI). Two hundred and eighty women underwent TPUS at 12 weeks and 36 weeks of gestation and 6 months postpartum, and 3D/4D transperineal ultrasound (TPUS) images of 40 pregnant nulliparous women were used for the reliability study. Paired t tests were used to assess changes in echogenicity and area. RESULTS: The ICC for measuring the area was substantial, at 0.77 and for measuring mean echogenicity was almost perfect, at 0.86. In the total study group (n = 280), midurethral area and mean echogenicity were significantly lower 6 months after delivery compared with 12 and 36 weeks of gestation. CONCLUSIONS: Our protocol for measuring area and mean echogenicity of the midurethra is reliable. This study indicates that structural changes in the midurethraoccur during pregnancy.

The Impact of Midurethral Sling Surgery on Sexual Activity and Function in Women With Stress Urinary Incontinence.

INTRODUCTION: Stress urinary incontinence has a negative impact on sexual function. AIM: To assess the effect of midurethral sling surgery on sexual activity and function in women with stress urinary incontinence. METHODS: This is a secondary analysis of the Value of Urodynamics Prior to Stress Incontinence Surgery (VUSIS-II) study, which assessed the value of urodynamics in women with (predominantly) stress urinary incontinence. Patients who underwent retropubic or transobturator sling surgery were included in the present study if information was available on sexual activity before and 12 months after surgery. Data were collected from a self-report validated questionnaire combined with non-validated questions. The association between midurethral sling surgery and sexual function (coital incontinence, satisfaction, and dyspareunia) was compared with McNemar χ(2) tests for nominal data and paired t-tests for ordinal data. Potentially influential factors were analyzed with univariable and multivariable logistic regression analyses. MAIN OUTCOME MEASURES: Changes in sexual activity and sexual function after midurethral sling surgery. RESULTS: Information on sexual activity was available in 293 of the 578 women (51%) included in the VUSIS-II study. At baseline, 252 of 293 patients (86%) were sexually active vs 244 of 293 (83%) after 12 months. More patients with cured stress urinary incontinence were sexually active postoperatively (213 of 247 [86%] vs 31 of 46 [67%], P < .01). There was a significant decrease in coital incontinence (120 of 236 [51%] preoperatively vs 16 of 236 [7%] postoperatively, P < .01). De novo dyspareunia was present in 21 of 238 women (9%). There was a greater improvement in coital incontinence after placement of the retropubic sling compared with the transobturator sling (odds ratio = 2.04, 95% CI = 1.10-3.80, P = .02). CONCLUSION: These data show that midurethral sling surgery has an overall positive influence on sexual function in women with stress urinary incontinence. The retropubic sling is more effective than the transobturator sling for improvement of coital incontinence. De novo dyspareunia was present in 1 of 11 women.

Association of First-Trimester Echogenicity of the Puborectalis Muscle With Mode of Delivery.

OBJECTIVE: To evaluate the association between mean echogenicity of the puborectalis muscle, measured using transperineal ultrasonography, in women during their first pregnancy and the subsequent mode of delivery. METHODS: This is a secondary analysis of a prospective observational study on the association between stress urinary incontinence and levator muscle avulsion after delivery of a first pregnancy. In this study, 280 nulliparous women with singleton pregnancies were examined with transperineal ultrasound examination at 12 and 36 weeks of gestation. Patients were recruited from an obstetrics practice associated with the university medical center in Utrecht, the Netherlands. Mean echogenicity of the puborectalis muscle values were measured at rest, in pelvic floor muscle contraction, and during the Valsalva maneuver. The subsequent mode of delivery was classified into five categories: spontaneous vaginal delivery, instrumental vaginal delivery, elective cesarean delivery, cesarean delivery resulting from nonreassuring fetal status, and cesarean delivery resulting from failure to progress. Mean echogenicity of the puborectalis muscle values according to mode of delivery were compared by analysis of variance and Tukey's post hoc test. RESULTS: Of the 254 women included, 157 had spontaneous vaginal delivery, 47 underwent cesarean delivery (11 elective, 36 emergency), and 45 had vacuum operative vaginal delivery; in five patient files, the mode of delivery was not recorded. Of the analyzed women, those who delivered by cesarean because of failure to progress had a significantly lower mean echogenicity of the puborectalis muscle in pelvic floor contraction at 12 weeks of gestation (mean echogenicity of 116±14) than women who had spontaneous vaginal delivery (132±21; Tukey's post hoc test, P=.03), instrumental vaginal delivery (138±21; P=.004), and cesarean delivery resulting from nonreassuring fetal status (139±20; P=.02). CONCLUSION: Lower mean echogenicity of the puborectalis muscle values in pelvic floor contraction during the first pregnancy at 12 weeks of gestation is associated with subsequent cesarean delivery as a result of failure to progress.

Mean echogenicity and area of puborectalis muscle in women with stress urinary incontinence during pregnancy and after delivery.

INTRODUCTION AND HYPOTHESIS: Pregnancy and childbirth are risk factors for the development of stress urinary incontinence (SUI). Urinary continence depends on normal urethral support, which is provided by normal levator ani muscle function. Our objective was to compare mean echogenicity and the area of the puborectalis muscle between women with and those without SUI during and after their first pregnancy. METHODS: We examined 280 nulliparous women at a gestational age of 12 weeks, 36 weeks, and 6 months after delivery. They filled out the validated Urogenital Distress Inventory and underwent perineal ultrasounds. SUI was considered present if the woman answered positively to the question "do you experience urine leakage related to physical activity, coughing, or sneezing?" Mean echogenicity of the puborectalis muscle (MEP) and puborectalis muscle area (PMA) were calculated. The MEP and PMA during pregnancy and after delivery in women with and without SUI were compared using independent Student's t test. RESULTS: After delivery the MEP was higher in women with SUI if the pelvic floor was at rest or in contraction, with effect sizes of 0.30 and 0.31 respectively. No difference was found in the area of the puborectalis muscle between women with and those without SUI. CONCLUSIONS: Women with SUI after delivery had a statistically significant higher mean echogenicity of the puborectalis muscle compared with non-SUI women when the pelvic floor was at rest and in contraction; the effect sizes were small. This higher MEP is indicative of a relatively higher intramuscular extracellular matrix component and could represent diminished contractile function.

Changes in the mean echogenicity and area of the puborectalis muscle during pregnancy and postpartum.

INTRODUCTION AND HYPOTHESIS: Three-dimensional (3D) and four-dimensional (4D) volume transperineal ultrasound imaging is increasingly used to assess changes in the dimensions of the pelvic floor during pregnancy and after delivery. Little is known with regard to the area of the puborectalis muscle and its structural changes. Echogenicity measurement, a parameter that provides information on the structure of muscles, is increasingly used in orthopaedics and neuromuscular disease evaluation. This study is aimed at assessing the changes in the mean echogenicity of the puborectalis muscle (MEP) and the puborectalis muscle area (PMA) during first pregnancy and after childbirth. METHODS: The MEP and PMA of 254 women during first pregnancy were measured at 12 and 36 weeks' gestation and 6 months postpartum. To determine the effect of child-birth on MEP and PMA, the results at 6 months postpartum were separately analysed for vaginal deliveries, operative vaginal deliveries (ventouse) and caesarean section deliveries. Mean differences in MEP and PMA were analysed using ANOVA statistics. RESULTS: The MEP at 6 months postpartum was, independent of manoeuvre, significantly (p < 0.001) lower than MEP values during pregnancy. After caesarean delivery, the PMA was significantly smaller at maximum pelvic floor contraction than PMA after vaginal delivery (p = 0.003) or operative vaginal delivery (p = 0.002). CONCLUSION: Our study indicates that structural changes in the puborectalis muscle during and after pregnancy, as measured by MEP, occur and can be analysed. In addition, the mode of delivery affects the area of the puborectalis during contraction after delivery. For true volume analysis, as part of an assessment of contractility of the puborectalis muscle we will need 3D volume analysis.

Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial.

OBJECTIVE: To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI). METHODS: This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications. RESULTS: The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found. CONCLUSION: An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558. LEVEL OF EVIDENCE: I.

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.).

One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study.

INTRODUCTION AND HYPOTHESIS: In a retrospective study, the sacrospinous hysteropexy was associated with a shorter recovery time compared to a vaginal hysterectomy with no differences in anatomical outcomes. No randomized trials are performed. METHODS: Sixty-six women with stage 2-4 uterine descent were randomized for vaginal hysterectomy(31) or sacrospinous hysteropexy(35). Recovery time, anatomical outcomes, functional outcomes, and quality of life were measured. RESULTS: Length of time to return to work was shorter after a sacrospinous hysteropexy (43 versus 66 days, p = 0.02). The difference in risk for recurrent prolapse stage 2 or more of the apical compartment at 1-year follow-up was 17% (95% confidence interval, 2 to 30) in favor of the vaginal hysterectomy. No differences in quality of life and urogenital symptoms were found. CONCLUSIONS: The sacrospinous hysteropexy for uterine descent is associated with an earlier recovery time, more recurrent apical prolapses but no differences in functional outcomes, and quality of life.