Reproductive history of parous women and urinary incontinence in midlife: A National Birth Cohort follow-up study.

OBJECTIVE: To investigate how reproductive history was associated with urinary incontinence in midlife. DESIGN: A follow-up study. SETTING: Denmark. POPULATION: A total of 39 977 mothers who participated in the Maternal Follow up (2013-2014) in the Danish National Birth Cohort. National registries provided their reproductive history. METHODS: How parity, mode of birth and obstetric tears associated with urinary incontinence were estimated with adjusted odds ratios (OR) and 95% CI using logistic regression. MAIN OUTCOME MEASURES: Self-reported urinary incontinence including subtypes stress, urge and mixed urinary incontinence. RESULTS: At an average age of 44 years, the prevalence of any urinary incontinence was 32% (21% stress, 2% urge, and 8% mixed urinary incontinence). Women with two births more often had urinary incontinence than women with one birth (OR 1.20, 95% CI 1.10-1.31). Compared with women with only spontaneous births, a history of only caesarean sections was associated with much lower odds of urinary incontinence (OR 0.39, 95% CI 0.35-0.42) and a history of instrumental births with slightly lower odds (OR 0.92, 95% CI 0.86-0.98). Compared with no tear/first-degree tear as the largest tear, episiotomy was associated with less urinary incontinence (OR 0.91, 95% CI 0.86-0.97) whereas third/fourth-degree tears were associated with more (OR 1.14, 95% CI 1.04-1.25). Findings were mainly explained by similar associations with stress and mixed urinary incontinence. CONCLUSIONS: Vaginal birth was associated with a higher risk of long-term urinary incontinence, but our results indicate that this risk may be reduced by shortening the second stage of birth.

Urinary Incontinence in Midlife According to Weight Changes Across and After Childbearing Years.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate how weight change across and after the childbearing years was associated with urinary incontinence (UI) in midlife. METHODS: Data were obtained from 35,645 women responding to the Maternal Follow-up questionnaire in the Danish National Birth Cohort in 2013-2014. Outcome was self-reported UI and its subtypes. Exposures were changes in body mass index (BMI) across and after the childbearing years. Adjusted odds ratios were estimated using logistic regression. RESULTS: At follow-up, the mean age was 44 years and 32% experienced UI. Compared with stable weight, weight gain across the childbearing years of > 1 to 3, > 3 to 5 or > 5 BMI units increased the odds of any UI by 15%, 27%, and 41% respectively. For mixed UI, the odds increased by 23%, 41%, and 68% in these groups. Weight gain after childbearing showed the same pattern, but with a higher increase in the odds of mixed UI (25%, 60%, and 95% in the respective groups). Women with any weight loss during this period had 9% lower odds of any UI than women with a stable weight. CONCLUSIONS: Weight gain across and after childbearing increased the risk of UI in midlife, especially the subtype mixed UI. Weight loss after childbearing decreased the risk.

Urinary incontinence and work capacity.

INTRODUCTION: The purpose of this study was to explore if and how urinary incontinence affects work capacity and work-related quality of life. METHODS: This was a cross-sectional questionnaire study using a Danish validated questionnaire. The questionnaire was distributed to Danish municipal employees. RESULTS: The questionnaire was completed by 3,182 municipal workers 840 of whom experience urinary incontinence, which is equivalent to 26.4% of all participating municipal employees. Among these, 18.5% worried about their urinary incontinence at work, 14.1% reported that the condition disturbed their working life in a moderate to severe degree and 22% experienced interrupted night sleep caused by urinary incontinence. Physically demanding tasks were avoided by 4.5% of the municipal employees, whereas 1.5% reported sick leave. Finally, 0.5% planned early retirement due to their urinary incontinence. CONCLUSIONS: This study revealed a 26.4% prevalence of urinary incontinence among Danish municipal employees. We conclude that urinary incontinence affected the work-related quality of life with daily worries about accidents, odours, toilet access, fluid intake and interrupted night sleep. Furthermore, in the group reporting urinary incontinence, 1.5% had sick leave and 0.5% changed their retirement plans due to incontinence. FUNDING: This project was funded by "Satspuljemidler" allocated by the Danish Health Ministry to Kontinensforeningen. TRIAL REGISTRATION: The project is approved by the Danish Data Agency (656336).

The clinical relevance of magnetic resonance imaging of the lower back.

Magnetic resonance imaging (MRI) is commonly used in the management of low back pain (LBP). This review provides an overview of the clinical relevance of degenerative MRI findings in the lumbar spine. The association between degenerative MRI findings and LBP is relatively consistent at population level, but very little research exists on the prognostic value of MRI findings and based on the current evidence, MRI cannot be used to guide treatment. Lumbar spine MRI is only recommended for patients with progressive neurological deficits, suspicion of specific pathology or in absence of progress of conservative treatment.

Body mass index, waist circumference, and urinary incontinence in midlife: A follow-up of mothers in the Danish National Birth Cohort.

BACKGROUND: Obesity is a modifiable risk factor for urinary incontinence, yet few studies have investigated how waist circumference as compared to body mass index (BMI) influences the risk of urinary incontinence. OBJECTIVE: To estimate how BMI and waist circumference associates with risk of urinary incontinence in midlife and determine which of the two is the strongest predictor of urinary incontinence. METHODS: Cohort study among mothers in the Danish National Birth Cohort. Weight and waist circumference were self-reported 7 years after cohort entry. Symptoms of urinary incontinence in midlife were self-reported using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and analyzed continuously and as presence or absence of any, stress (SUI), urgency (UUI), and mixed (MUI) urinary incontinence. Linear and log binomial regressions were used to calculate mean differences and risk ratios (RR) with 95% confidence intervals (CI). Restricted cubic splines were generated to explore nonlinear relationships. RESULTS: Among 27 254 women at a mean age of 44.2 years, any urinary incontinence was reported by 32.1%, SUI by 20.9%, UUI by 2.4%, and MUI by 8.6%. For all outcomes, increases in risk were similar with higher BMI and waist circumference. The estimates of association were strongest for MUI (RR 1.10, 95% CI 1.08;1.12 and RR 1.12, 95% CI 1.10;1.14 for half a standard deviation increase in BMI and waist circumference, respectively). While increases in risk of the other outcomes were seen across the entire range of BMI and waist circumference, the risk of SUI rose until BMI 28 kg/m2 (waist circumference 95 cm), and then fell slightly. CONCLUSIONS: Symptoms of urinary incontinence and prevalence of any urinary incontinence, SUI, UUI, and MUI increased with higher BMI and waist circumference. Self-reported BMI and waist circumference were equally predictive of urinary incontinence.

Electrospun nanofiber mesh with connective tissue growth factor and mesenchymal stem cells for pelvic floor repair: Long-term study.

Pelvic organ prolapse (POP) affects many women, with an estimated lifetime risk of surgical intervention of 18.7%. There is a need for alternative approaches as the use of synthetic nondegradable mesh was stopped due to severe adverse events, and as current methods for pelvic floor repair have high POP recurrence rates. Thus, we hypothesized that electrospun degradable meshes with stem cells and growth factor were safe and durable for the long term in elderly rats. In an abdominal repair model, electrospun polycaprolactone (PCL) meshes coated with connective tissue growth factor (CTGF)/PEG-fibrinogen (PF) and rat mesenchymal stem cells were implanted in elderly female rats and removed after in average 53 weeks (53-week group). Collagen amount and production were quantified by qPCR and Western blotting. Moreover, histological appearance and biomechanical properties were evaluated. Results were compared with previous results of young rats with identical mesh implanted for 24 weeks (24-week group). The 53-week group differed from the 24-week group in terms of (1) reduced collagen III, (2) strong reduction in foreign body response, and (3) altered histological appearance. We found comparable biomechanical properties, aside from higher, not significant, mean tissue stiffness in the 53-week group. Lastly, we identified mesh components 53 weeks after implantation. This study provides new insights into future POP repair in postmenopausal women by showing how CTGF/PF-coated electrospun PCL meshes with stem cells exhibit sufficient support, biocompatibility, and no mesh-related complications long term in an abdominal repair model in elderly rats.

International consultation on incontinence questionnaire - Urinary incontinence short form ICIQ-UI SF: Validation of its use in a Danish speaking population of municipal employees.

INTRODUCTION: Worldwide, the estimated prevalence of urinary incontinence is 8.7%. Urinary incontinence is more frequent in women than in men. Posing the right questions is crucial, when diagnosing urinary incontinence, but also to evaluate the need of treatment and treatment effect. Therefore, reliable and validated questionnaires within this area are needed. Even though the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) has been used on a daily basis in the Danish Urogynaecological Database since 2006, it has not yet been validated in a Danish population of both men and women. OBJECTIVE: To test the reliability and validity of the Danish version of the ICIQ-UI SF in a Danish speaking population of men and women among municipal employees. METHODS: Content validity was evaluated with semi-structured interviews. A quantitative field test was performed, in which the questionnaire was distributed electronically to municipal workers by E-mail. Statistical methods included item characteristics (missings, kurtosis and skewness), internal consistency (Chronbach's alfa), test-retest (ICC), construct validity (known group validation), and floor and ceiling effect. RESULTS: A number of 1814 Danish municipal workers completed the questionnaire. Of the total number of responders, 426 were invited to complete the questionnaire twice (for test-retest) and 215 (50.5%) of these completed the questions again two weeks later. Statistical analyses of the ICIQ-UI SF demonstrated no floor and ceiling effects, skewness was zero and kurtosis 0.00-0.49. Cronbach's alfa was 0.87 and intraclass correlation coefficient 0.73. Two out of three hypotheses were accepted in the known-groups validation. CONCLUSION: This study offers an adaptation of the ICIQ-UI SF to a Danish setting. The Danish ICIQ-UI SF demonstrated acceptable reliability and validity. However, clinicians should consider the relatively high measurement error.

Treatment of apical vaginal prolapse with minimal mesh repair (Uphold): patient-reported long-term outcomes and mesh-related complications.

INTRODUCTION: To evaluate patient-reported outcomes and clinical findings after surgery for apical prolapse with the transvaginal Uphold mesh technique. Moreover, to evaluate the rate of mesh-related complications. MATERIAL AND METHODS: A historical cohort study of patients who underwent surgery from January 1, 2012 to April 30, 2019, at Aarhus University Hospital, Denmark. Pelvic examination and patient completion of questionnaires were performed in 2018-2019. Information on adverse events and reoperations was obtained from medical records. RESULTS: A total of 240 patients were operated on using the Uphold mesh, 89% due to recurrent prolapse. Follow-up was attended by 192 patients (80%). Median follow-up time was 30 months, interquartile range 19-52. During follow-up, 29 patients (15%) underwent reoperation due to prolapse and are considered failures. Among the remaining, patient satisfaction was high. Thus, average score for pelvic symptoms affecting daily life was 2, on a scale of 0-10, where 0 represents no symptoms. The Patient Global Impression of Improvement (PGI-I) had an average score of 6.4 (1: very much worse; 7 very much better). Preoperatively, 89.5% of the women had grade 2 or more apical prolapse, whereas at follow-up, this was only 6.1%. Perioperative heavy bleeding needing embolization was observed in one patient (0.5%). Two patients had serious constriction of the ureter and needed re-operation. Postoperative complications, primarily temporary voiding problems, were observed in 15 patients (8%). Complications during the follow-up period were registered in 23 patients (12%); eight of these were mesh erosions. Due to complications, 11 patients (6%) needed re-operation. CONCLUSIONS: The study confirms that the Uphold procedure in a centralized set-up is a procedure with high patient-reported satisfaction even in a population characterized by a high proportion of recurrent prolapse. Moreover, the procedure seems safe with acceptable complication rates.

The Danish Choosing Wisely concept.

Introduction Choosing Wisely has been introduced in more than 20 countries. In Denmark, the Vælg Klogt initiative was launched in the spring of 2020. The aim of Vælg Klogt is to reduce unnecessary and potentially harmful tests, treatments and procedures in healthcare. Vælg Klogt also contributes to the implementation of shared decision-making. This study explored knowledge of the Danish Vælg Klogt initiative among patient associations and scientific societies in Denmark. Methods This was a cross-sectional questionnaire study among patient associations and scientific societies. Descriptive and content analyses were used to interpret the quantitative and qualitative results, respectively. Results Both the patient associations and the scientific societies had little knowledge of Vælg Klogt; still, they agreed that overuse and waste occurs in Danish healthcare. The reasons are multifactorial, but both parties mentioned a fear of making mistakes and a lack of communication between departments. The initiative is welcomed, provided recommendations are based on evidence, integrated into clinical guidelines, well communicated and prepared in collaboration between patients and physicians. Conclusions Knowledge of the Danish Vælg Klogt initiative is scarce and implementation of Vælg Klogt must include extensive communication to patients, physicians, leaders and politicians. However, the mutual agreement between patient associations and scientific societies on the reasons for overuse promises well for the initiative. Funding none Trial registration Registered in the Central Denmark Region: 1-16-02-553-20.

Fast track sacrospinous ligament fixation: subjective and objective outcomes at 6 months.

BACKGROUND: Sacrospinous ligament fixation (SSLF) is a widely used vaginal procedure for correction of apical vaginal prolapse. The objective of this study was to evaluate subjective and objective outcomes of SSLF performed in a fast-track setting. METHODS: This was a prospective cohort study of sacrospinous ligament fixation performed using local anesthesia and light sedation in a fast-track setting at Aarhus University Hospital between April 2016 and December 2017. Objective signs of prolapse were assessed by gynecological examination preoperatively and at 6 months after the operation. Subjective symptoms were evaluated by questionnaires (the Pelvic Floor Distress Inventory (PFDI 20), and the Patient Global Impression of Improvement (PGI-I) supplemented with individual questions from the ICIQ-vaginal Symptoms (ICIQ-VS) and Sexual Questionnaire-IR (PISQ-12) questionnaires). RESULTS: One hundred and three women with a median age of 65 (36-84) years were included. Previous hysterectomy had been performed in 40% of the women, and 43% had a history of previous prolapse operations. At follow-up, 75% of the women had apical descent less than stage 2. However, 18% had anterior vaginal wall prolapse beyond the hymen, and 25% had recurrence of the apical prolapse stage 2 or more and were offered reoperation. Bladder and anal symptoms improved in most women after the operation, and the number of women reporting dyspareunia was halved. In the overall assessment by Patient Global Impression of Improvement (PGI-I) questionnaire, 76% reported improvement. No serious operative complications were reported, and 81% of the patients were discharged on the day of the surgery. CONCLUSION: In this cohort with a high rate of previous prolapse surgery, sacrospinous ligament fixation performed in a fast-track setting showed subjective and objective results comparable to the results of apical native tissue repair reported in the literature. Furthermore, the complication rate was low. Trial registration This study was notified to The Central Denmark Region Committees on Health Research Ethics on July 7, 2015, and was approved by The Danish Data Protection Agency (1-16-02-442-15). All methods were performed in accordance with the relevant guidelines and regulations. An informed consent for participation in the study and acceptance of using data for scientific purposes and publication was signed by all patients.

Overactive bladder in patients with myasthenia gravis-A cross-sectional population-based study.

BACKGROUND: In myasthenia gravis (MG), first-line treatment for MG is acetylcholinesterase inhibitors which alleviates symptoms, but concomitantly may cause autonomic adverse effects. AIMS OF THE STUDY: In this study, we evaluated if symptoms of overactive bladder (OAB) are more frequent among MG patients than healthy controls. METHODS: Eighty-three MG patients and 50 healthy sex- and age-matched controls were included and answered the questionnaire "International Consultation on Incontinence Questionnaire Overactive Bladder Module" (ICIQ-OAB), including questions about polyuria, nocturia, urgency, and stress incontinence. Clinical severity of MG was determined based on three standardized clinical evaluations. RESULTS: Compared to control subjects, MG patients had a higher total OAB score (median 5 [range 0-12] versus 3 [0; 7]) (p < 0.005) with higher scores concerning all four items. Also, MG patients had a higher bother score (10 [0-40] versus 5 [0-40]) (p < 0.05). Patients receiving a daily dose of pyridostigmine of more than 300 mg had a higher OAB score than other patients. CONCLUSIONS: Myasthenia gravis patients have more bothering symptoms of OAB than healthy controls, related to the daily dose of pyridostigmine. To minimize adverse effects in patients with symptoms of OAB, the pyridostigmine dose should be as low as possible.

MRI-based contouring of functional sub-structures of the lower urinary tract in gynaecological radiotherapy.

INTRODUCTION: Research in radiation-induced urinary morbidity is limited by lack of guidelines for contouring and dose assessment of the lower urinary tract. Based on literature regarding anatomy, physiology and imaging of the lower urinary tract, this study aimed to provide advice on contouring of relevant sub-structures, reference points and reference dimensions for gynaecological radiotherapy. MATERIAL AND METHODS: 210 MRIs for Image-Guided Adaptive Brachytherapy (IGABT) were analysed in 105 locally advanced cervical cancer patients treated with radio(chemo)therapy. Sub-structures (trigone, bladder neck and urethra) were contoured and trigone height (TH) and width (TW) were measured. Internal urethral ostium (IUO) and Posterior inferior border of pubic symphysis-urethra (PIBS-U) points were used to identify proximal and middle/low urethra, respectively. Urethra reference length (URL) was defined as IUO and PIBS-U distance. TH, TW and URL were also quantified on 54 MRIs acquired for External Beam Radiotherapy (EBRT). RESULTS: Median absolute differences in volumes and dimensions between first and second IGABT fraction were 0.7 cm3, 4.3 cm3, 0.2 cm, 0.3 cm and 0.2 cm for trigone, bladder neck, TH, TW and URL, respectively. Mean(±SD) TH and TW were 2.7(±0.4)cm and 4.4(±0.4)cm, respectively, with no significant difference (p = 0.15 and p = 0.06, respectively) between IGABT and EBRT. URL was significantly shorter in EBRT than in IGABT MRIs (p < 0.001). CONCLUSIONS: This study proposed relevant urinary sub-structures and dose points and showed that standardized contouring is reproducible. Trigone reference dimensions are robust despite different bladder filling and treatment conditions. Standardized contouring and reference points may improve understanding of urinary morbidity.

Electrospun nanofiber mesh with fibroblast growth factor and stem cells for pelvic floor repair.

Surgical outcome following pelvic organ prolapse (POP) repair needs improvement. We suggest a new approach based on a tissue-engineering strategy. In vivo, the regenerative potential of an electrospun biodegradable polycaprolactone (PCL) mesh was studied. Six different biodegradable PCL meshes were evaluated in a full-thickness abdominal wall defect model in 84 rats. The rats were assigned into three groups: (1) hollow fiber PCL meshes delivering two dosages of basic fibroblast growth factor (bFGF), (2) solid fiber PCL meshes with and without bFGF, and (3) solid fiber PCL meshes delivering connective tissue growth factor (CTGF) and rat mesenchymal stem cells (rMSC). After 8 and 24 weeks, we performed a histological evaluation, quantitative analysis of protein content, and the gene expression of collagen-I and collagen-III, and an assessment of the biomechanical properties of the explanted meshes. Multiple complications were observed except from the solid PCL-CTGF mesh delivering rMSC. Hollow PCL meshes were completely degraded after 24 weeks resulting in herniation of the mesh area, whereas the solid fiber meshes were intact and provided biomechanical reinforcement to the weakened abdominal wall. The solid PCL-CTGF mesh delivering rMSC demonstrated improved biomechanical properties after 8 and 24 weeks compared to muscle fascia. These meshes enhanced biomechanical and biochemical properties, demonstrating a great potential of combining tissue engineering with stem cells as a new therapeutic strategy for POP repair. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:48-55, 2020.

Electrospun biodegradable microfibers induce new collagen formation in a rat abdominal wall defect model: A possible treatment for pelvic floor repair?

Half of the female population over age 50 years will experience pelvic organ prolapse. We suggest a new approach based on tissue engineering principles to functionally reconstruct the anatomical structures of the pelvic floor. The aim of this study is to investigate the mechanical performance and effect on collagen and elastin production of a degradable mesh releasing basic fibroblast growth factor (bFGF). Implantation of biodegradable mesh with or without bFGF in their core has been conducted in 40 rats in an abdominal wall defect model. Samples were explanted after 4, 8, and 24 weeks, and tested for mechanical properties and the composition of connective tissue. The study showed an increase in mRNA expression for collagen-I (p = 0.0060) and collagen-III (p = 0.0086) in the 4 weeks group with bFGF. The difference was equalized at 8 and 24 weeks. No difference was found at any time for protein amount for collagen-I, collagen-III, and fibronectin. The amount of collagen decreased from 4 to 24 weeks but the fraction of collagen increased. The maximal load of the newly formed tissue showed no effect of bFGF at any time. Exclusively, histology showed a limited ingrowth of collagen fibers after 4 weeks with bFGF but signs of elastin fibers were seen at 24 weeks. The investigation showed that a biodegradable mesh promotes tissue formation with a promising strength. The mesh with bFGF did not represent any advantage on either long or short term in comparison to the mesh without bFGF. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 680-688, 2018.

Fibrogenic and angiogenic commitments of human induced pluripotent stem cells derived mesenchymal stem cells in connective tissue growth factor-delivering scaffold in an immune-deficient mice model.

Compared to terminal differentiated cells, stem cells play important roles in the maintenance and regeneration, and thus have been intensively researched as the most promising cell based therapy. In order to maximize the effectiveness of stem cell based therapies, it is essential to understand the environmental (niche) signals that regulate stem cell behavior. Recent findings suggest that fibroblasts have a mesenchymal origin and that mesenchymal stem cells (MSCs) demonstrate proangiogenic function, where both fibrogenic and angiogenic activities are associated with connective tissue growth factor (CTGF), a matricellular protein that serves as an essential mediator of skeletogenesis in development and vascular remodeling. Here, for the first time, we demonstrate that upon local delivery of CTGF from a three dimensional (3D) nanocomposite scaffold, human induced pluripotent stem cells derived MSCs can be directed to differentiate toward fibroblasts in a 3D nanocomposite scaffold in female nonobese diabetic CB-17/Icr-severe combined immunodeficient mice. The stem cell-scaffold constructs present not only intriguingly strong fibroblastic commitments but also angiogenic induction in vivo. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2266-2274, 2018.

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.

BACKGROUND: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. METHODS: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. RESULTS: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. CONCLUSIONS: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.

INTRODUCTION: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence. METHODS: Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%). RESULTS: At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen. CONCLUSIONS: Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.

Cost-effectiveness analysis of solifenacin flexible dosing in patients with overactive bladder symptoms in four Nordic countries.

OBJECTIVE: The purpose of the present analysis was to analyze and compare the cost-effectiveness of solifenacin flexible dosing (5-10 mg) with tolterodine 4 mg sustained release (SR) or placebo (assumed to be comparable to no treatment) for patients with overactive bladder (OAB) symptoms. DESIGN: A decision-analytic model was constructed. METHODS: Costs and effects were evaluated for the three treatment options in a one-year timeframe. Costs included were treatment costs, cost of pad use, and patients productivity loss based on data from the Nordic countries. SAMPLE: Results from two randomized controlled trials were used as input data in the cost-effectiveness analysis. MAIN OUTCOME MEASURES: Quality adjusted life years and incremental cost-effectiveness ratio. RESULTS: Solifenacin flexible dosing was more effective with respect to reducing OAB symptoms compared to both placebo and tolterodine 4 mg. Treatment with both solifenacin and tolterodine was more costly compared to placebo, but treatment with solifenacin was a less costly alternative compared to tolterodine 4 mg SR. Sensitivity analyses revealed that the conclusions were robust. CONCLUSION: Solifenacin flexible dosing was a cost-effective treatment alternative compared to tolterodine 4 mg SR.

Trocar-guided transvaginal mesh repair of pelvic organ prolapse.

OBJECTIVE: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. METHODS: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0-I was considered anatomic cure. RESULTS: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean+/-standard deviation age at surgery was 66.3+/-9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated. CONCLUSION: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844 LEVEL OF EVIDENCE: II.

Short-term outcome after transvaginal mesh repair of pelvic organ prolapse.

The objective of this study is to report on shortterm outcomes after pelvic organ prolapse repair using Prolift transvaginal mesh. A 3-year multicenter prospective cohort study was performed in 28 centers. Assessment preoperatively and at 2 months postoperatively included the condition-specific pelvic organ prolapse quantification system (POP-Q) and a macroscopic inflammatory scale. Subjective outcome was measured using the urogenital distress inventory (UDI) and the incontinence impact questionnaire (IIQ-7). Surgical characteristics and adverse events during follow-up were registered in a separate protocol. The evaluation is based on the interim safety analysis and includes 2-month evaluations of 123 cases. Pelvic organ perforation occurred in four cases (3.2%), three bladder injuries and one case of rectal perforation. At the 2-month follow-up, there were two cases of mesh exposure, an increase of mild-moderate granuloma formation in the operated areas (P < 0.003) but no cases of serious adverse tissue reactions related to the polypropylene mesh. Postoperative anatomical cure (defined as POP-Q stage 0-1) was 87% after anterior repair, 91% after posterior repair and 88% after total repair. All quality of life aspects measured by the IIQ-7 improved 2 months after surgery. Pelvic heaviness, vaginal bulging, and vaginal protrusion all decreased considerably (P < 0.001). There was also a significant improvement in several lower urinary tract symptoms and a decreased need for manually assisted defecation. This first report from an ongoing multicenter study suggests that transvaginal mesh surgery with the Prolift system is associated with satisfactory outcomes 2 months after surgery. There were no severe adverse events attributed to the polypropylene mesh.