Five-year follow-up study of Monarc transobturator tape for surgical treatment of primary stress urinary incontinence

Introduction and hypothesis

We hypothesized that transobturator tape (TOT) is safe and efficacious for the treatment of urodynamic stress incontinence in the long term.

Methods

We conducted a prospective study of patients with confirmed urodynamic stress incontinence (USI) who underwent a Monarc^TM TOT procedure in a tertiary center between February 2006 and March 2009 without other concurrent surgical procedures. Urodynamics were conducted at 1 and 3 years postoperatively. Subjective evaluation included Incontinence Impact Questionnaire (IIQ-7), Urinary Distress Inventory Questionnaire (UDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Objective cure was defined as no urinary leakage demonstrable on provocative filling cystometry and/ or 1-h pad test of <2 g. Subjective cure was based on a negative response to question 3 in UDI-6. Paired-samples t test, chi-square, and Fisher exact tests were applied; p?<?0.05 was considered significant. The log-rank tests were used to compare event-free survival.

Results

Sixty patients were enrolled, and 56 were evaluated at 5 years postoperatively. The majority were middle aged, postmenopausal, and overweight. Mean operating time was 31.1?±?8.9 min, intraoperative complications were minor, and median period of follow-up was 80.3?±?9.6 months. At 5 years of follow-up, objective and subjective cure rates were 89.3 % and 87.5 %, respectively. No mesh-related complications were seen. One patient needed a repeat midurethral sling procedure, and one patient each had bladder and bowel cancer.

Conclusion

Monarc TOT was safe and retained its high cure rate in the short- and long-term treatment of stress urinary incontinence.

     

Is pretreatment cystometry important in predicting response to mirabegron in women with overactive bladder symptoms?

Introduction and hypothesis

The aim of this study was to evaluate for any association between pretreatment cystometry results and outcome of treatment with mirabegron in women with overactive bladder (OAB) symptoms.

Methods

This was a prospective observational study of women with OAB symptoms that proved refractory to conservative management. All women underwent filling and voiding subtraction cystometry prior to further treatment. Women were treated with mirabegron 50 mg once daily, and outcomes were evaluated after 6 weeks’ treatment. The primary outcome measure was change in symptoms as indicated by response to the Patient Global Impression of Improvement (PGI-I) scale. The presence of detrusor overactivity (DO), the highest detrusor pressure recorded during the filling phase, the presence of urodynamic stress incontinence (USI), cystometric capacity, voided volume, maximum flow rate and detrusor pressure at maximum flow were all compared between responders and nonresponders.

Results

The study population consisted of 169 women; response rate to mirabegron was 69.8 %. There was no association between the presence of DO or maximum detrusor pressure during filling and USI, cystometric capacity, maximum flow rate and detrusor pressure at maximum flow and treatment response. In a subgroup with OAB symptoms refractory to previous treatment with antimuscarinics, there was an association between the presence of DO and a positive treatment response (p?=?0.02).

Conclusions

Overall, there is no association between urodynamic findings and response to treatment with mirabegron. This may reflect the fact that mirabegron’s mode of action mechanisms are not measurable using cystometry. In women with refractory symptoms, however, the presence of DO is associated with a positive response to treatment.

     

High urinary flow in women with stress incontinence: corrected flow–age nomogram evaluation after a transobturator tape procedure

Introduction and hypothesis

We noninvasively compared urinary flow in both pre- and post-transobturator tape (TOT) procedures in stress urinary incontinence (SUI) patients using previously reported corrected flow–age nomograms in healthy women.

Methods

This retrospective cohort study included patients who underwent a successful TOT procedure to treat SUI. Non-instrumented uroflowmetry was performed before and 3 months after surgery. Corrected maximum flow rate (cQmax) and average flow rate (cQave) were calculated using Qmax/√voided volume (VV) and Qave/√VV respectively. The ratio of corrected flow to age-adjusted corrected flow in healthy women was calculated in each patient. Each parameter was compared against pre-TOT and 3-months post-TOT values.

Results

Sixty-two patients were eligible for study inclusion. All urinary flow parameters were significantly higher pre-TOT than at 3 months post-TOT. The number of patients with cQmax and cQave over mean flow–age nomogram, compared with healthy women, before the TOT procedure decreased 3 months post-TOT; however, in many patients, cQmax and cQave were higher than in the corrected flow–age nomogram post-TOT. No significant difference in the ratio of cQmax to age-adjusted cQmax between pre- and post-TOT in the normal urinary flow group was observed, but significantly decreased in the high urinary flow group 3 months after TOT.

Conclusions

Urinary flow rates were higher in SUI patients compared with age-matched controls and successful TOT procedures normalized urinary flows in patients with high urinary flow. A simple evaluation of urinary flow using a corrected flow–age nomogram may be clinically useful in SUI patients.

     

Effects of laser procedure for female urodynamic stress incontinence on pad weight,urodynamics, and sexual function

Introduction and hypothesis

The impact of the IncontiLase^TM procedure on lower urinary tract symptoms (LUTS) remains unclear. Our aim was to evaluate the effects of the IncontiLase^TM procedure for urodynamic stress incontinence (USI).

Methods

All consecutive women with USI prospectively underwent the IncontiLase^TM procedure. Urodynamic studies, pad testing, LUTS, and sexual function questionnaires were assessed before and after treatment.

Results

Thirty-five women underwent the IncontiLase^TM procedure. Among the 28 women with baseline pad weights >1 g, 11 (39.3 %) were objectively cured and 11 (39.3 %) improved. Among the 18 women with mild USI (i.e., baseline pad weight 1–10 g), nine (50 %) were cured and five (27.8 %) improved. Among ten women with baseline pad weight >10 g, two (20 %) were cured and six (60 %) improved. Among the 32 women with complete questionnaire data at 6 months, seven (21.9 %) were subjectively cured, and four (12.5 %) improved. Regarding LUTS, the majority of domains on the King’s Health Questionnaire and female sexual desire and function exhibited significant improvements. Forty percent (12/30) of the partners of these patients felt their sexual function had improved at 6 months. Nonetheless, urodynamic values did not differ across the timeline.

Conclusions

The effect of the IncontiLase^TM procedure for mild USI was moderate at 6-month follow-up but was not effective for pad weight >10 g. Moreover, it improved LUTS, quality of life, QoL, and sexual function of both partners. Further studies should be performed to assess long-term sustained efficacy.

     

De novo overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis

Introduction and hypothesis

De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence.

Methods

We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05.

Results

Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58).

Conclusions

Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.

     

Assessment of overactive bladder symptoms among women with successful pessary placement

Introduction and hypothesis

The causal association between pelvic organ prolapse (POP) and overactive bladder (OAB) symptoms is supported by several theories. The aim of this study is to assess any changes in OAB symptoms among women with POP and OAB after successful pessary placement.

Methods

During the study period, all women with symptomatic POP stage II or greater and OAB symptoms were offered the solution of either a ring or a Gellhorn pessary. All patients were asked to complete a 3-day micturition/incontinence diary. Objective evaluation endpoints at baseline and at 6 weeks included: change in the mean number of micturitions/24 h, change in the mean volume voided per micturition/24 h, and change in the number of urinary incontinence episodes. Subjective evaluation of the urgency, frequency, and nocturia symptoms was carried out using the score change of the questions 3, 5, and 2 of the International Consultation on Incontinence Questionnaire for Evaluating Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) respectively.

Results

Seventy-four women were included in the study. A statistically significant decrease (?28.3%; p < 0.001) of the mean number of micturitions/24 h with a significant increase (37%; p < 0.001) in the mean voided volume per micturition/24 h was observed. The total urine volume/24 h remained unchanged. The number of urinary incontinence episodes was significantly increased 6 weeks after pessary placement (p < 0.001). De novo stress urinary incontinence (SUI) was reported by 16.7% of the initially stress continent women.

Conclusions

Women with coexisting POP and OAB symptoms may experience a significant improvement in micturition frequency and in urgency and frequency symptoms after successful pessary fitting.

     

Prevalence and predictors of overactive bladder in nonpregnant nulliparous women below 65 years of age

Introduction and hypothesis

The aetiology of the overactive bladder (OAB) symptom complex is still poorly understood. In order to obtain further insight, the prevalence and predictors of the symptoms included in OAB, that is urgency, urgency incontinence (UUI), frequency and nocturia, were investigated in a sample of nonpregnant nulliparous women.

Methods

A national, postal and web-based survey of OAB symptoms was conducted in women aged 25–64 years (n = 9,197). Crude prevalence and prevalence adjusted according to body mass index (BMI) were calculated from a logistic regression model to evaluate the prevalence of OAB.

Results

The response rate was 52%. The prevalence of urgency, bothersome urgency, UUI, and nocturia, but not daytime frequency, increased consistently with advancing age and increasing BMI. Urgency was associated with BMI, age ≥45 years, nocturia, and daytime frequency of eight or more micturitions. Daytime urinary micturition frequency was not affected by age either in women with OAB or in women without OAB. Bothersome OAB affected almost half of the woman in the oldest age group and was strongly associated with nocturia of two or more micturitions and OAB with UUI.

Conclusions

There were contrasting changes in the prevalence of the different symptoms included in OAB. With increasing age and BMI, the prevalence of nocturia, urgency and UUI increased, while daytime frequency remained stable. These findings are of importance as the primary endpoint for the evaluation of drug therapies for OAB has often been daytime urinary frequency.

     

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety

Introduction and hypothesis

The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

Methods

This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

Results

Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

Conclusions

The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

     

What is normal bladder neck anatomy?

Introduction and hypothesis

Functional anatomy of the bladder neck and proximal urethra has been studied extensively because of the belief that it is important for urinary continence. The aim of this study was to explore the limits of normality for pelvic floor ultrasound parameters of bladder neck and urethral mobility associated with stress urinary incontinence (SUI) and urodynamic stress incontinence (USI).

Methods

A retrospective study was conducted on 589 women seen for urodynamic testing in a tertiary urogynaecology clinic. All women were assessed following a protocol including interview, clinical examination, flowmetry, urodynamic testing and 4D pelvic floor ultrasound. Volume data sets were analysed offline to assess for bladder neck descent (BND), urethral rotation and the retrovesical angle (RVA) on maximal Valsalva.

Results

After excluding women with previous incontinence or prolapse surgery, 429 datasets were available. SI was significantly associated with the RVA (p?=?0.033) and BND (p?=?0.036); USI was associated with urethral rotation (p?=?0.021) and BND (p?<?0.001). On multivariate logistic regression analysis, controlling for confounders including age, BMI, parity, previous hysterectomy and maximal urethral pressure, the association between SUI and BND remained significant (OR [per 10 mm]?=?1.23; 95 % CI: 1.01 to 1.51; p?=?0.043), as did the association between USI and BND (OR [per 10 mm]?=?1.58; 95 % CI: 1.3 to 1.91; p?<?0.001). ROC statistics for BND suggested a cut-off of 25 mm in describing the limit of normality.

Conclusions

Measures of functional bladder neck anatomy are weakly associated with SUI and USI (with association between BND and USI being the strongest). It is suggested that a BND of 25 mm or higher be defined as abnormal (“hypermobile”) on the basis of its association with USI.

     

A blinded observational cohort study of the microbiological ecology associated with pyuria and overactive bladder symptoms

Introduction and hypothesis

This study sought to characterise the microbial ecology of the lower urinary tract in patients with symptoms of overactive bladder (OAB) using culture of the urinary urothelial cell sediment. The pathological significance of the microbiome was assessed through its relationship with known urothelial inflammatory markers and patient reported symptoms.

Methods

Adult female patients with OAB symptoms and asymptomatic controls were assessed at 12 study visits scheduled every 4 weeks. At each visit, all participants provided a clean-catch midstream urine (MSU) that was analysed to count white and uroepithelial cells, submitted to standard culture and spun urothelial-cell-sediment culture. Symptoms were assessed using validated questionnaires.

Results

This analysis shows that OAB patients differ consistently from controls, demonstrating differences in bacterial ecology (t??4.57, p?0.0001), in the microscopic pyuria count (t??6.37, p?0.0001) and presence of infected urothelial cells (t??4.21, p?0.0001). The primary outcome measure of bacterial growth [colony-forming units (CFU) ml^?1] was higher in OAB patients than in controls throughout the 12 months. Data showed a correlation between symptoms and pyuria, with notable urgency correlating with pyuria and epithelial cell shedding. The routine urine cultures (with a threshold of reporting a positive result as 10⁵ CFU/ml) were unable to distinguish OAB patients from controls. However, sediment cultures differed significantly, and there was a correlated increased immune response amongst OAB patients.

Conclusions

This study supports the need to re-examine the OAB phenotype given this association with microbial colonisation.

     

Evaluation of isolated urinary stress incontinence according to the type of levator ani muscle lesion using 3/4D transperineal ultrasound 36 months post-partum

Introduction

Vaginal delivery can lead to pelvic floor disorders. Many authors have described pelvic floor injuries that can predict future defects such as urinary incontinence and pelvic organ prolapse. We propose the assessment of urinary stress incontinence and its association with levator ani muscle (LAM) microtrauma (>20% in the levator hiatus area during Valsalva) and macrotraumas (avulsion) identified by 3/4D transperineal ultrasound (3D-TpUS) 36 months post-partum.

Materials and methods

This was a prospective observational study including 168 nulliparous women. All patients included were nulliparous with singleton gestation in cephalic presentation, at ≥37 weeks and were recruited on the first day after delivery. Thirty-six months after delivery, 3D-TpUS was carried out to identify LAM lesions (macro or micro). Clinical assessment of urinary stress incontinence (USI) was based on the ICIQ-UI-SF test; a simple stress test and urodynamic test were carried out in the same visit.

Results

A total of 105 nulliparous women were studied (51 spontaneous deliveries [SpD] and 54 vacuum-assisted deliveries [VD]). Microtraumas were identified in 35.3% of SpD and 20.4% of VD. Macrotraumas (avulsion) were identified in 9.8% of SpD and 35.2% of VD (p = 0.006). No differences were found in USI between study groups or in relation to the identification of LAM defects (19.2% in the no lesion group, 25% in the macrotrauma and 13.8% in the microtrauma groups; p = not significant). Nor were significant differences found in the results from the different study groups in the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) test (12.7±2.2 in the no lesion group, 12.5±4.2 in the macrotrauma and 13.25±4.8 in the microtrauma groups; p = NS).

Conclusion

No difference was observed in USI between patients with and without LAM lesions (microtrauma or macrotrauma) 36 months post-delivery.

     

Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial

Purpose

To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI).

Methods

A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6–IIQ7), and patient satisfaction on a scale from 0 to 10.

Results

Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan–Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference.

Conclusion

The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.

     

Bladder symptoms and urodynamic observations of patients with endometriosis confirmed by laparoscopy

Introduction and hypothesis

Patients with deep infiltrating pelvic endometriosis (DIE) often describe having lower urinary tract symptoms (LUTS). Bladder pain syndrome in women is also often associated with endometriosis. In this study, we aimed to describe the characteristics of LUTS and urodynamic observations in patients with posterior endometriosis versus those with posterior and anterior endometriosis.

Methods

This was a prospective observational study of 30 patients from two gynecologic surgical settings with experience in DIE surgery. All patients underwent preoperative standardized investigation including detailed evaluation of LUTS and urodynamic studies. During surgery, endometriosis locations were recorded and correlated to symptoms and urodynamic observations.

Results

Twenty-three patients (76.7 %) had one or more LUTS symptoms and 29 (96.7 %) had one or more abnormalities at urodynamic examination. At surgery, all patients had posterior endometriosis and ten of them also had anterior endometriosis. Patients with anterior endometriosis had increased bladder sensation (90.0 % versus 45.0 %, p?=?0.024) and painful bladder filling (70.0 % versus 30.0, p?=?0.04) compared with patients with posterior endometriosis only. Voiding symptoms (60.0 %), impairment of flowmetry (30.0 %), and increased maximum urethral closure pressure (90.0 %) were frequent and not correlated with any specific location.

Conclusions

Endometriosis infiltrating the bladder wall is associated with painful bladder symptoms. Dysfunctional voiding suggests an impairment of the inferior hypogastric plexus by posterior DIE. Clinical preoperative evaluation of bladder function should be systematic; urodynamic tests could be of interest in selected patients with DIE. Endometriosis may be a major cause of bladder pain syndrome.

     

Urinary retention in female OAB after intravesical Botox injection: who is really at risk?

Introduction and hypothesis

Intravesical onabotulinumtoxinA (Botox) injections are effective for the treatment of idiopathic overactive bladder (OAB) symptoms. The aim of our study was to assess the predisposing factors for urinary retention in women with OAB after intravesical Botox injection.

Methods

All participants were women of European descent with idiopathic OAB. OnabotulinumtoxinA (100 U) was administered in 20 intra-detrusor injections. Analysis was performed based on the results of safety assessments made during follow-up (FU) visits on weeks 2, 4 and 12, in 208 women who were treated with Botox injections for refractory OAB and who completed all FU visits.

Results

Women who required clean intermittent self-catheterisation (CISC) and those with post-void residual (PVR) greater than 200 ml were older in comparison with patients with PVR between 50 and 200 ml. Patients who required CISC were also characterised by higher parity and particularly by a higher number of vaginal deliveries. Other factors such as body mass index or comorbidities did not significantly influence PVR and the risk of CISC.

Conclusions

Elderly and/or multiparous women are at increased risk of urinary retention after intravesical 100-U Botox injections. The risk of new onset urine retention in our study has completely disappeared 2 weeks after Botox injections. Based on our results of the way in which the PVRs have changed over time, we can conclude that OAB patients should be optimally assessed during the first 2 weeks after Botox injections.

     

Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery

Introduction and hypothesis

Intravesical onabotulinumtoxinA (Botox®) is effective for idiopathic overactive bladder (OAB) symptoms. Our primary objective was to compare the efficacy of onabotulinumtoxinA for women with de novo OAB after midurethral sling (MUS) surgery and women with idiopathic OAB.

Methods

Women enrolled in this prospective study had idiopathic (n?=?53) or de novo (n?=?49) OAB symptoms after MUS, with at least one episode of urgency urine incontinence per day. OnabotulinumtoxinA (100 U) was administered in 20 intradetrusor injections. Postvoid residual volumes were checked at 2, 4 and 12 weeks. Participants completed a 3-day bladder diary and the King’s Health Questionnaire (KHQ) before and 12 weeks after treatment.

Results

After 12 weeks, 22 patients (41.5 %) in the idiopathic OAB and 19 patients (38.8 %) in the de novo OAB groups were completely dry. OnabotulinumtoxinA injections had a significant benefit within both groups (p <0.001) to decrease both the daily numbers of voids (?2.39 and ?2.0) and incontinence episodes (?1.38 and ?1.44), with no significant difference between groups. We observed an increase of mean voided volume of >90 ml in both groups. Urinary retention was observed in four patients.

Conclusions

We observed similar improvement in OAB symptoms after intravesical onabotulinumtoxinA injections within both groups. The rates of retention and requirement for catheterization even for women with a prior MUS were acceptable. These observational data provide evidence that onabotulinumtoxinA can effectively treat patients with OAB following stress urinary incontinence surgery.

     

Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?

Introduction and hypothesis

No previous studies have investigated the efficacy of mirabegron 50 mg as the first-line therapy in OAB patients. Hence, the primary objective of this study was to evaluate the efficacy of mirabegron in treatment-naive patients in comparison with those who had discontinued antimuscarinic therapy because of insufficient efficacy.

Methods

All consecutive women who had pure OAB symptoms (including urgency with or without urgency incontinence and frequency) for at least 3 months were considered for this study. Women were divided into two groups: women without any previous pharmacological treatment for OAB (group 1) and women with a previous history of failed antimuscarinics therapy (group 2).

Results

At 3-month follow-up, the objective results on the basis of the frequency–volume chart showed a significant improvement in both groups. Furthermore, a significant reduction in the Overactive Bladder Questionnaire Short Form (OABq-SF) score and in the Indevus Urgency Severity Scale (IUSS) questionnaire were reported in both groups. However, the improvement in objective and subjective outcomes was superior in group 1 to that in group 2.

Conclusions

Mirabegron is efficacious in improving OAB symptoms in both naïve patients and those who discontinued primary antimuscarinic therapy; however, its efficacy is superior when prescribed as first-line therapy.

     

The impact of urodynamics on treatment and outcomes in women with an overactive bladder: a longitudinal prospective follow-up study

Introduction and hypothesis

The aim of this study was to establish if the management of women with overactive bladder (OAB) and patient-reported outcomes differed based on the findings of urodynamics (UDS).

Methods

A prospective, longitudinal observational study conducted in urogynaecology clinics in 22 UK hospitals participating in the Diagnostic Accuracy of Bladder Ultrasound Study (BUS). A total of 687 women with OAB symptoms or urgency-predominant mixed urinary incontinence were recruited into a diagnostic study that used UDS as the reference standard. Detailed clinical history and International Consultation on Incontinence OAB Short Form (ICIQ-OAB sf) questionnaire responses were obtained before the UDS test was carried out. These questionnaires were subsequently collected at a mean of 7 and 20 months, along with patient global impression of improvement and details on medical and surgical treatments. The relationship between UDS diagnosis and treatment was examined using a multinomial regression model; logistic and repeated measures regressions were used to examine other outcomes.

Results

We recruited 687 women and the response rate was 69% at 20 months. Treatment subsequent to UDS was highly associated with diagnosis (p < 0.0001). Women who received treatment concordant with their UDS findings were more likely to report an improvement in bladder symptoms (57% vs 45%; p = 0.02) and ICIQ-OAB sf scores (0.5 points, 95%CI: 0.1 to 0.9; p = 0.02).

Conclusions

Urodynamics influenced treatment decisions made by clinicians in determining treatment pathways in women presenting with OAB. Women treated based on UDS diagnoses appear to have greater reductions in symptoms than those who do not.

     

Does the diagnosis of detrusor overactivity affect the long-term prognosis of patients treated with a retropubic midurethral sling?

Introduction and hypothesis

There are few long-term studies on the midurethral sling (MUS) procedure in patients with preoperative detrusor overactivity (DO) and there is debate regarding the usefulness of preoperative cystometry. This study was designed to provide long-term efficacy and safety data for the Advantage MUS and to compare the outcomes in patients with pure urodynamic stress incontinence (USI) with the outcomes in patients with mixed USI and DO.

Methods

This was a retrospective consecutive case series study of 100 patients with USI (USI-only group) matched to a consecutive group of a further 100 patients with preoperative USI and DO (mixed group) treated with a retropubic MUS. Outcomes were assessed using the King’s Health Questionnaire and Patient Global Impression of Improvement questionnaire.

Results

After a mean follow up of 6 years more patients in the USI-only group described themselves as “very much better” or “much better” (86 % USI-only group vs. 57 % mixed group; p?=?0.007). Quality of life was improved at 6 years from baseline in both groups. Patients in the mixed group were more likely to complain of urgency (69 % vs. 42 %; p?=?0.0007) which was more likely to be severe (34 % vs. 10 %; p?=?0.004). A repeat MUS procedure was needed in 1 % of patients and 0.6 % needed surgical removal of the MUS for persistent troublesome pain.

Conclusions

This study suggests that the preoperative diagnosis of DO affects the long-term patient-perceived outcome of the MUS procedure. However, most patients have significant long-term improvement in quality of life.

     

Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study

Introduction and hypothesis

The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI).

Methods

A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient’s life quality.

Results

Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n?=?48) and SIS groups (n?=?45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6?±?1.8 vs 3.1?±?2.1, p?<?0.001) and 12 h postoperatively (3.8?±?1.7 vs 2.1?±?1.7, p?<?0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p?=?0.399) or patient-reported success rates (91.3 % vs 93.2 %; p?=?0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life.

Conclusions

The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.

     

Bulkamid (PAHG) in mixed urinary incontinence: What is the outcome?

Introduction and hypothesis

Mixed urinary incontinence (MUI), defined as mixed symptoms of stress urinary incontinence (SUI) and overactive bladder (OAB), is a difficult entity if conservative treatment has failed. Cure rates are low compared with SUI, particularly the OAB component, may deteriorate after sling insertion. Bulking agents pose an appealing alternative for the treatment of MUI. They have shown beneficial effect in small case studies, but larger series are lacking. The aim of this prospective study was an analysis of treatment efficacy and safety profile of the bulking agent, Bulkamid, in female patients with MUI.

Methods

One hundred fifty-four women with MUI symptoms (components of SUI/OAB within the limits of 60–40% either way) received bulking therapy with polyacrylamide hydrogel (Bulkamid). Patients were followed-up 3 months postoperatively. Primary outcome was the domain Incontinence impact on the King’s Health Questionnaire (KHQ). Secondary outcomes were the other KHQ domains, visual analog scale (VAS), and International Continence Society (ICS) standardized pad weight test as objective measurement of incontinence.

Results

Statistically significant improvements were found for all KHQ domains, pad weight test, and the visual analog scale (VAS) before and after bulking. Overall complication rate was 13%.

Conclusions

This study has shown improvement in MUI after bulking therapy according to both subjective and objective outcomes. We can advocate bulking therapy for treating MUI, as it is simple and safe and shows both objective and subjective improvement and relief. Long-term results (up to 1 year) are awaited.