Body mass index influences the risk of reoperation after first-time surgery for pelvic organ prolapse. A Danish cohort study, 2010-2016.

INTRODUCTION AND HYPOTHESIS: The aims of this study were to evaluate the impact of body mass index (BMI) on the risk of reoperation for pelvic organ prolapse (POP) up to 5 years after first-time surgery. MATERIALS AND METHODS: This nationwide register-based study includes first-time POP surgery in 2010 through 2016. The cumulative incidence proportions of reoperation were analyzed in a Cox regression model and described using Kaplan-Meier plots stratified in BMI categories. RESULTS: A total of 28,533 first-time procedures were performed in 22,624 women; 76.6% had single-compartment repair. The 1- and 5-year reoperation rate within the same compartment was 2.6% and 6.1% respectively for women with BMI < 25, and for women with BMI > 35 it was 3.7% and 11.2 respectively. In the anterior compartment there was a significantly increased adjusted hazard ratio for reoperation in the same compartment with increasing BMI (reference group BMI < 25), BMI 30-34.9 with an aHR = 1.34 (CI 95% 1.04-1.71) and BMI ≥ 35 aHR = 1.77 (CI 95% 1.17-2.67). The 1- and 5-year reoperation rate in an adjacent compartment was 0.6% and 1.6% respectively for women with BMI < 25, and for women with BMI > 35 it was 1.0% and 4.4 respectively. For reoperation in an adjacent compartment the adjusted results were BMI 30-34.9 aHR = 1.64 (95% CI 1.05-2.56) and BMI > 35 aHR = 2.64 (95% CI 1.36-5.14) when the first-time operation was in the anterior compartment. CONCLUSIONS: If the woman had BMI > 35 and first-time surgery was in the anterior compartment, she had an almost doubled risk of reoperation within 5 years both in the same compartment and in an adjacent compartment compared to women with BMI < 35. In the apical and posterior compartment there was a trend towards increasing risk of reoperation with increasing BMI, although with a broad confidence interval.

Surgical repair of vaginal vault prolapse; a comparison between ipsilateral uterosacral ligament suspension and sacrospinous ligament fixation-a nationwide cohort study.

INTRODUCTION AND HYPOTHESIS: Hysterectomy is frequently performed and associated with increased risk of subsequent genital prolapse including vaginal vault prolapse. Ipsilateral uterosacral ligament suspension (IUSLS) and sacrospinous ligament fixation (SSLF) are two commonly performed surgical techniques to treat vaginal vault prolapse. There is no consensus on the ideal operation technique. The aim of this study was to compare IUSLS and SSLF to treat vaginal vault prolapse based on the number of repeat surgeries. METHODS: Previously hysterectomized patients operated on with IUSLS or SSLF in Denmark in 2010-2016 were included in this nationwide register-based cohort study and followed until June 2017. Data were obtained from Danish National Databases, to which reporting is mandatory by law, entailing high validity and completeness of data. Data were analyzed using Cox proportional hazard regression analysis adjusted for age, preoperative prolapse stage, smoking, BMI, and previous prolapse surgery. RESULTS: In total, 744 patients were included; 384 underwent IUSLS while 360 underwent SSLF. After 5 years, 6.5% of patients operated on with IUSLS and 21.8% operated on with SSLF had a repeat surgery in the apical compartment and 12.4% and 30.6% in any compartment, respectively. The risk of repeat surgery was 4.8 times higher after SSLF compared to IUSLS [confidence interval (CI): 2.7-8.4] in the apical compartment and 2.4 times higher (CI: 1.2-5.1) in the anterior compartment. No difference was seen in the posterior compartment. CONCLUSIONS: This study finds significantly higher numbers of repeat surgeries after SSLF compared to after IUSLS in a Danish nationwide cohort.

A structured review on the female urethral anatomy and innervation with an emphasis on the role of the urethral longitudinal smooth muscle.

A damaged sphincteric unit or support system, unstable urethral deformability or damaged sensory innervation are all potential causes of a dysfunctional urethral sphincter. With the current improvement in pharmacological targets and urodynamic understanding, studies have begun quantifying individual structures and their importance in closure pressure and consequently urethral continence. However, when it comes to the function of the longitudinal urethral smooth muscle layer, there is currently no consensus. The intent of this structured review is to critically examine literature regarding the female urethral anatomy and closure mechanism. We hypothesized that the longitudinal smooth muscle is a prerequisite for sufficient urethral closure and not merely involved during micturition. Overall opinions on a dysfunctional closure mechanism are controversial. Nonetheless, basic mechanics may be applied to understand simple urodynamics. With the assumption of longitudinal muscles forming a plug when contracted, this could have a substantial effect on the continence mechanism.

De novo urinary incontinence after pelvic organ prolapse surgery-a national database study.

INTRODUCTION AND HYPOTHESIS: To investigate the prevalence and risk factors of de novo urinary incontinence (UI) after pelvic organ prolapse (POP) surgery. METHODS: Data from 2013 to 2016 were collected from the Danish Urogynecological Database, where registration for any urogynecological procedure performed in Denmark is mandatory. Inclusion criteria were urinary continent women who underwent POP surgery. A woman was urinary continent if her total score on the International Consultation on Incontinence Questionnaire-Urinary Incontinence-short form (ICIQ-UI-sf) was 0 and she answered 'never' to 'When does urine leak?' Postoperatively, the women were categorized as continent or women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI), mixed urinary incontinence (MUI) or undefined UI. We performed multivariate logistic regression analyses. The included parameters were preoperative POP stage (POP-Q), compartment, BMI and age. P values < 0.05 were considered statistically significant. RESULTS: We included 1198 women. The risk of de novo UI was 15%; 45% had SUI, 30% had UUI, 16% had MUI, and 10% had undefined UI. BMI was highly associated with de novo UI; the risk was 12% for women with BMI < 25, 16% for women with BMI 25 - < 30 and 23% for women with BMI ≥ 30. Age, compartment and POP stage were not associated with de novo UI. CONCLUSIONS: The prevalence of de novo UI is the same regardless of the involved compartment/s and POP stage. BMI is significantly associated with de novo UI; twice as many women with BMI ≥ 30 had de novo UI compared with women with BMI < 25.

Trends in apical prolapse surgery between 2010 and 2016 in Denmark.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common diagnosis. Today there is no consensus on the ideal operation technique for apical prolapse. Vaginal hysterectomy with suspension of the vaginal cuff is the most frequently used, but the popularity of uterus-preserving techniques is increasing. The aim of this study was to describe trends in surgical techniques used to treat primary apical prolapse in Danish hospitals. METHODS: Data were obtained from the Danish Urogynecological Database and included women with primary prolapse surgery in the apical compartment operated in Denmark 2010-2016. Public hospital departments were divided into three categories according to degree of urogynecological specialization: high level, moderate level, and no specialization. RESULTS: The number of vaginal hysterectomies decreased and the number of uterus-preserving operations increased from 2010 to 2016. The proportion of uterus-preserving techniques versus vaginal hysterectomy differed substantially between different hospital types. At departments with high and moderate levels of specialization, uterus-preserving techniques increased during the period, accounting for nearly 90% and 40%, respectively, in 2016, while decreasing to < 35% for departments with no specialization. Three of the four departments with high-level specialization preferred the Manchester-Fothergill procedure, while one preferred sacrospinous hysteropexy. Only 2.3% of all procedures were performed at private hospitals. CONCLUSIONS: The proportion of uterus-preserving techniques to treat apical prolapse increased from 2010 to 2016. However, there is a wide variation in practice at the different hospitals. An agreement on uterus-preserving techniques has not been reached.

A nationwide cohort study of hospital contacts after surgical treatment for urinary incontinence.

AIMS: The aim was to assess complications of urinary incontinence (UI) for women who had a hospital contact within 30 days and to evaluate the conventional method of classifying complications vs grading complications into the Clavien-Dindo classification (CDC) system. METHODS: A historical cohort study based on a nationwide population of women who had hospital contact within 30 days of surgical treatment for UI during a 5-year period. RESULTS: There were 874 (16.2%) hospital contacts to the Department of Obstetrics and Gynecology, among 5393 procedures. For retropubic midurethral sling (RPMUS) and transobturator midurethral sling (TOMUS), the most common reasons for hospital contacts were voiding dysfunction, self-reported pain within 14 days and acute cystitis and for urethral injection therapy (UIT) persisting UI, acute cystitis, and voiding dysfunction. Voiding dysfunction requiring surgery, use of catheter or both, occurred more frequently in women who had RPMUS as compared with TOMUS (30.5% vs 21.7%; P = .01). Women, who received RPMUS and TOMUS, had surgical complications classified as up to CD IIIb, whereas women who had UIT were classified as up to CD II. CONCLUSIONS: Sixteen percent of the women had a hospital contact within 30 days. A more obstructive character of RPMUS than for TOMUS was indicated, as more women with voiding dysfunction required surgery or catheter following RPMUS. The CDC system in its current form does not improve the overall characterization of complications in terms of type and severity following synthetic midurethral sling and UIT treatment.

Surgical treatment of primary uterine prolapse: a comparison of vaginal native tissue surgical techniques.

INTRODUCTION AND HYPOTHESIS: Uterine prolapse is a common diagnosis. Today no consensus exists on which operation technique is ideal to treat apical prolapse. Vaginal hysterectomy (VH) with suspension of the vaginal cuff is the most frequently used. The popularity of uterus-preserving techniques is increasing. The aim of this study was to compare the efficiency of vaginal native tissue operations to treat primary apical prolapse, evaluated on risk of relapse surgery. METHODS: Data were obtained from the Danish National Patient Registry (NPR), which contains all operations performed in Denmark. Patients operated on for primary apical prolapse in Denmark 2010-2016 were included and followed until 2017. Clinical data were obtained from the Danish Urogynecological Database. Patients who were previously hysterectomized or operated on for prolapse in the apical compartment were excluded. Data were analyzed using Cox proportional hazard regression analysis and adjusted for age, BMI, smoking, preoperative prolapse stage and previous POP operations. RESULTS: In total, 7247 operations were included. The hazard ratio (HR) for relapse operation in the apical compartment was significantly higher after sacrospinous hysteropexy (SH) compared with the Manchester-Fothergill procedure (MP) [40.2 confidence interval (CI) 21.6-74.7] and VH (8.5 CI: 6.0-12.1). Likewise, the HR was higher in the anterior compartment after SH compared with MP (4.3 CI: 2.9-6.4) and VH (2.8 CI: 2.0-4.0). No convincing difference was found in the posterior compartment. The 5-year reoperation rates were 30%, 7% and 11% after SH, MP, and VH, respectively. CONCLUSIONS: Sacrospinous hysteropexy has exceedingly high numbers of reoperations due to prolapse recurrence.

Prolapse reduction deteriorates the urethral closure mechanism.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) reduction is often performed in the preoperative assessment of women before POP surgery. Using urethral pressure reflectometry (UPR), we sought to investigate how POP reduction affects the urethral closure mechanism. METHODS: Women with anterior or posterior vaginal wall prolapse stage ≥II with and without POP reduction were examined with a speculum. We performed prolapse staging according to the Pelvic Organ Prolapse Quantification system, UPR measurements at rest and during squeezing, and standardized stress tests with 300 ml saline. All examinations were repeated after insertion of a speculum. RESULTS: We included 38 women: 22 with anterior and 16 with posterior vaginal wall prolapse POP-Q stage ≥II. During POP reduction, resting and squeezing urethral pressures decreased by 2.5 cmH2O (p = 0.007) and 5.1 cmH2O (p < 0.0001), respectively, in all women. During POP reduction, the number of positive stress tests increased from four (18%) to eight (36%) in women with anterior vaginal wall prolapse and from one (6%) to nine (56%) in women with posterior vaginal wall prolapse. CONCLUSIONS: POP reduction decreases urethral pressure, especially during squeezing, and consequently increases the number of positive stress tests. The test itself artificially deteriorates the urethral closure mechanism.

Perioperative cardiovascular complications following urogynecological operations.

INTRODUCTION: The risk of perioperative cardiovascular complications following operations for urinary incontinence and pelvic organ prolapse (POP) must be taken into consideration during surgical planning. The literature on the cardiovascular risk following urinary incontinence and POP operations shows conflicting results. Our aims were to provide an estimate of the mortality and the risk of cardiovascular complications following urinary incontinence and POP operations considering women's preoperative cardiovascular comorbidity. MATERIAL AND METHODS: This nationwide register-based study includes a total of 13 992 operations for urinary incontinence and 35 765 for POP from 2007 to 2017. The risk was estimated as an incidence/rate ratio for women with and without former cardiovascular comorbidity adjusted for relevant confounders by using a case-crossover study design. RESULTS: A total of 7677 patients were at high risk, with a cardiovascular comorbidity prior to the operation, and 42 076 patients were at low risk, with no cardiovascular comorbidity. Overall, 11 patients died within 30 days following an operation, of whom five were in the high-risk group and six in the low-risk group. Of the women at high risk, 0.59% had cardiovascular complications from 0 to 6 days following an operation, corresponding to an incidence/rate ratio of 3.64 (95% CI; 2.67-4.97), compared with women at low risk where no complications were registered in the first week. CONCLUSIONS: We found an increased risk of cardiovascular complications following urogynecological operations in women with preoperative cardiovascular comorbidity, and no increased risk in women without prior cardiovascular comorbidity. In general, the risk of cardiovascular complications was lower than that found in previous studies.

Pelvic floor muscle training with and without supplementary KAATSU for women with stress urinary incontinence - a randomized controlled pilot study.

AIMS: To explore if adding occlusion training of a thigh (KAATSU) to low-intensity pelvic floor muscle training (PFMT) could increase effect of PFMT in women with stress urinary incontinence (SUI). METHODS: Single-blinded randomized controlled pilot study. Women with SUI and an ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Short form) score of ≥12 were randomized to a low-intensity PFMT program followed by KAATSU (KAATSU + PFMT) or to a low-intensity PFMT program without KAATSU (PFMT group), both performed four times a week for 12 weeks. PRIMARY OUTCOME: Change in the ICIQ-UI-SF score at a 12-week follow-up. SECONDARY OUTCOMES: a 3-day leakage diary, the PGI-I (Patient Global Index of Improvement scale), bother with KAATSU in a numeric rank scale and change in urethral opening pressure (UOP) measured with urethral pressure reflectometry (UPR) at rest, contraction and straining at the 12-week follow-up. RESULTS: Forty-one women with SUI and an ICIQ-UI-SF of 13 (range 12-16) were included. Fourteen in the KAATSU + PFMT and 17 in the PFMT group completed the study. Both groups had a significant and clinically relevant improvement of the ICIQ-UI-SF score and decrease in number of incontinence episodes with no significant between group differences. UOP did not increase significantly in either group. Bother with KAATSU was low but seven of 14 women expressed dislike with KAATSU. CONCLUSIONS: The added KAATSU protocol did not increase the effect of low-intensity PFMT and it was not well tolerated. While subjective effect was significant in both intervention groups this was not reflected in the UPR measures.

A Danish national population-based cohort study of synthetic midurethral slings, 2007-2011.

INTRODUCTION AND HYPOTHESIS: Synthetic midurethral slings (MUSs) have shown similar cure rates in several short- and medium-term follow-up studies. Recently, long-term follow-up studies have indicated that the cure rate is higher following the retropubic midurethral sling (RPMUS) compared with the transobturator midurethral sling (TOMUS) procedure. The aim was to evaluate the efficacy of synthetic MUSs and to examine the influence of department and surgeon volume and patient-related factors on the cure rate of synthetic MUSs. METHODS: A retrospective cohort study based on a national population over a 5-year period (2007-2011) using data from the Danish Urogynaecological Database (DugaBase). RESULTS: A total of 4519 women with first-time MUS were registered in the DugaBase. Cure was achieved in 1242/1639 (75.78%) at a 3-month follow-up. RPMUSs were more frequently in use in high-volume departments compared with the other departments and more often implanted by high- than low-volume surgeons. Women treated by a medium- (adjusted OR 1.82; 95% CI 1.01-3.28, "frequency") or high-volume surgeon (1.98; 1.18-3.32, "frequency") had an increased probability of cure compared with women treated by a low-volume surgeon. The difference was only significant for women who received a TOMUS. CONCLUSIONS: This national population-based cohort study confirmed a high cure rate of synthetic MUSs at short-term follow-up. It is the largest study to indicate a learning curve for TOMUS. Patients were not actively involved in which synthetic MUS was to be performed as the choice of surgical option was made at the departmental level.

Influence of body mass index on short-term subjective improvement and risk of reoperation after mid-urethral sling surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the impact of body mass index (BMI) on the subjective improvement and risk of reoperation after first-time mid-urethral sling surgery. METHODS: Data were retrieved from the national Danish Urogynaecological Database, including women with first-time surgery with mid-urethral polypropylene slings from 2011 to 2016. The subjective improvement was assessed by the difference in symptoms based on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) completed pre- and 3 months postoperatively. A reoperation was defined as any new surgical procedure for stress urinary incontinence performed within the study period. RESULTS: During the study period, 6,414 mid-urethral sling procedures were performed; 80.0% of these women filled out both pre- and post-surgical International Consultation on Incontinence Questionnaire (ICI-Q) forms. 42.4% had a BMI < 25, 34.6% had BMI 25-30, 16.9% had BMI 30-35, and 6.0% BMI >35. The subjective improvement after surgery was high in all BMI categories and there were no differences between the categories. The overall cumulative hazard proportion at 2 years of follow-up was 1.9% (CI 95%: 1.6-2.3) and after 5 years 2.4% (CI 95%: 2.0-2.9). Adjusted for age, smoking, and use of alcohol, the cumulative hazard proportion after 2 years of follow-up was 3.2% (CI 95%: 1.6-6.2) for women with BMI >35 and after 5 years 4.0% (CI 95%: 2.0-7.7), which was the highest proportion of reoperation in the study. The crude hazard ratio was 1.84 (CI 95%: 0.89-3.83) women with BMI >35 and the adjusted hazard ratio was 1.94 (CI 95%: 0.92-4.09). CONCLUSIONS: We found high subjective improvement after the first-time surgery unrelated to BMI. Women with a BMI over 35 had the highest proportion of reoperations, although this was not statistically significant.

Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: an activity-based costing analysis.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a common diagnosis that imposes high and ever-growing costs to the healthcare economy. Numerous surgical techniques for the treatment of POP exist, but there is no consensus about which is the ideal technique for treating apical prolapse. The aim of this study was to estimate hospital costs for the most frequently performed operation, vaginal hysterectomy with uterosacral ligament suspension (VH) and the uterus-preserving Manchester-Fothergill procedure (MP), when including costs of postoperative activities. METHODS: The study was based on a historical matched cohort including 590 patients (295 pairs) who underwent VH or MP during 2010-2014 owing to apical prolapse. The patients were matched according to age and preoperative prolapse stage and followed for a minimum of 20 months. Data were collected from four national registries and electronic medical records. Unit costs were obtained from relevant departments, hospital administration, calculated, or estimated by experts. The hospital perspective was applied for costing the resource use. RESULTS: Total costs for the first 20 months after operation were 3,514 € per VH patient versus 2,318 € per MP patient. The cost difference between the techniques was 898 € (95% confidence interval [CI]: 818-982) per patient when analyzing the primary operation only and 1,196 € (CI: 927-1,465) when including subsequent activities within 20 months (p < 0.0001). CONCLUSIONS: The MP is substantially less expensive than the commonly used VH from a 20-month time perspective. Healthcare costs can be reduced by one third if MP is preferred over VH in the treatment of apical prolapse.

The effect of single oral doses of duloxetine, reboxetine, and midodrine on the urethral pressure in healthy female subjects, using urethral pressure reflectometry.

AIMS: To evaluate the effect on urethral pressure of reference drugs known to reduce stress urinary incontinence symptoms by different effect size and mechanisms of action on urethral musculature under four test conditions in healthy female subjects using urethral pressure reflectometry. METHODS: Healthy females aged 18-55 years were recruited by advertising for this phase 1, single site, placebo-controlled, randomized, four-period, crossover study. The interventions were single oral doses of 10 mg Midodrine, 80 mg Duloxetine, 12 mg Reboxetine, and placebo. The endpoints were the opening urethral pressure measured in each period at four time points (predose and 2, 5.5, and 9 h after dosing). RESULTS: Twenty-nine females were enrolled; 25 randomized and 24 completed the study. The opening urethral pressure was higher in all measurements with filled bladder compared with empty bladder, and during squeezing compared to the resting condition. All three drugs increased the opening urethral pressure during all four conditions with a ranking of their effect on urethral pressure matching their reported clinical effect (difference vs. placebo at their reported time of peak plasma concentrations [Tmax ] during resting with filled bladder: Midodrine 9.3 cmH2 O [95%CI 3.0, 15.5], Duloxetine 24.2 cmH2 O [95%CI 17.9, 30.5], and Reboxetine 44.9 cmH2 O [95% CI 40.2, 52.8] cmH2 O). CONCLUSIONS: Urethral pressure reflectometry is capable of detecting drug-induced changes in urethral tone in various conditions. The magnitude of drug-induced changes by the test drugs seems to match their clinical profile and differences in mode of action.

Predictors and reasons for help-seeking behavior among women with urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to evaluate the predictors and reasons for help-seeking behavior among women with urinary incontinence (UI) in Germany and Denmark. METHODS: This international postal survey was conducted in 2014. In each country, 4,000 women of at least 18 years of age were randomly selected. The questionnaires included validated items regarding help-seeking behavior and the ICIQ-UI SF. UI was defined as any involuntary loss of urine. Binary logistic regression analysis was used to assess factors predicting help-seeking behavior. Reasons for seeking or not seeking help were evaluated in terms of the severity of UI and as the most frequently reported. RESULTS: Of 1,063 Danish women with UI, 25.3% had consulted a physician compared with 31.4% of 786 German women with UI (p = 0.004). The severity and duration of UI, and actively seeking information regarding UI, were significant independent predictors of help-seeking behavior. Women with slight/moderate UI did not seek help because they did not consider UI as a problem, whereas of women with severe/very severe UI, German women reported that other illnesses were more important and Danish women reported that they did not have enough resources to consult a physician. CONCLUSIONS: Only a small proportion of women with UI had consulted a physician, and the driving forces for help-seeking behavior were severity and duration of UI and actively seeking information regarding UI. Public information campaigns might enhance consultation rates providing that passively receiving and actively seeking information have the same effects on help-seeking behavior. We show for the first time that reasons for not consulting a physician for UI vary depending on the severity of the UI.

The Manchester-Fothergill procedure versus vaginal hysterectomy with uterosacral ligament suspension: a matched historical cohort study.

INTRODUCTION AND HYPOTHESIS: This study compares vaginal hysterectomy with uterosacral ligament suspension (VH) with the Manchester-Fothergill procedure (MP) for treating pelvic organ prolapse (POP) in the apical compartment. METHODS: Our matched historical cohort study is based on data from four Danish databases and the corresponding electronic medical records. Patients with POP surgically treated with VH (n = 295) or the MP (n = 295) in between 2010 and 2014 were matched for age and preoperative POP stage in the apical compartment. The main outcome was recurrent or de novo POP in any compartment. Secondary outcomes were recurrent or de novo POP in each compartment and complications. RESULTS: The risk of recurrent or de novo POP in any compartment was higher after VH (18.3%) compared with the MP (7.8%) (Hazard ratio, HR = 2.5, 95% confidence interval (CI): 1.3-4.8). Recurrence in the apical compartment occurred in 5.1% after VH vs. 0.3% after the MP (hazard ratio (HR) = 10.0, 95% confidence interval (CI) 1.3-78.1). In the anterior compartment, rates of recurrent or de novo POP were 11.2% after VH vs. 4.1% after the MP (HR = 3.5, 95% CI 1.4-8.7) and in the posterior compartment 12.9% vs. 4.7% (HR = 2.6, 95% CI 1.3-5.4), respectively. There were more perioperative complications (2.7 vs. 0%, p = 0.007) and postoperative intra-abdominal bleeding (2 vs. 0%, p = 0.03) after VH. CONCLUSIONS: This study shows that the MP is superior to VH; if there is no other indication for hysterectomy, the MP should be preferred to VH for surgical treatment of POP in the apical compartment.