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.     

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.

     

Effects of Macroplastique® Implantation System for stress urinary incontinence and urethral hypermobility in women

A study was carried out to evaluate efficacy of Macroplastique® (MPQ) Implantation System (MIS) in women with urodynamic stress urinary incontinence (SUI) and urethral hypermobility after an unsuccessful conservative treatment. This is a prospective randomized controlled trial in women without previous incontinence surgery. Twenty-four women received MPQ. Twenty-one controls underwent a pelvic floor muscle exercises home program. Follow-up was at 3 months and the MPQ group also at 12 months. At 3 months, pad usage decreased significantly more in the MPQ group than in the control group (p?=?0.015). According to physician and patient self-assessment, respectively, 71% and 63% women in the MPQ group were considered cured or markedly improved. This was significantly higher compared to controls. There was a significant higher increase of Incontinence Quality-of-Life questionnaire score in the MPQ group compared to controls (p?=?0.017). Improvements in MPQ group at 3 months are sustained to 12 months. Adverse events were mild and transient. MIS is an acceptable option for women with SUI and urethral hypermobility.     

Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid?) for female stress and stress-predominant mixed incontinence

Introduction and hypothesis

Polyacrylamide hydrogel (PAHG, Bulkamid?) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence.

Methods

Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24?months postinjection.

Results

At 24?months, the subjective responder rate was 64?% (a statistically non-significant reduction from 67?% at 12?months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred.

Conclusions

PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.     

Dramatic increase (1997–2007) in the number of procedures for stress urinary incontinence in Belgium

Introduction and hypothesis

We wondered if the tension-free vaginal tape approach, introduced in 1998, influenced the rate of anti-incontinence surgery.

Methods

We determined the rates of anti-incontinence surgery in Belgium between 1997 and 2007, using the Belgian National Health Insurance Fund register covering the entire adult female population of nearly 4,420,000 women in Belgiun.

Results

The rate per 1,000 women of anti-incontinence surgery increased from 0.54 in 1997 to 2.03 in 2004, after which a plateau was reached (2.01 in 2007). This nearly fourfold increase coincided with the introduction in 1998 on the Belgian market of the tension-free vaginal tape (+66% more interventions between 1998 and 2001). After the introduction of the transobturator tape in 2001, the rate increased even more dramatically (+118% between 2001 and 2004).

Conclusions

Rates of anti-incontinence surgery increased by 272% in Belgium between 1997 and 2007. This increase coincided with the availability of tension-free mesh sling operations.     

Minimally invasive,non-ablative Er:YAG laser treatment of stress urinary incontinence in women—a pilot study

The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60–65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.     

A systematic review on vaginal laser therapy for treating stress urinary incontinence: Do we have enough evidence?

Introduction and hypothesis

Current treatment strategies for stress urinary incontinence (SUI) raise concerns about safety and efficacy. The purpose of this systematic review was to present available evidence related to vaginal laser therapy as a treatment option for SUI.

Methods

We searched the MEDLINE (1966–2017), Scopus (2004–2017), Clinicaltrials.gov (2008–2017) and Cochrane Central Register of Controlled Trials (CENTRAL) (1999–2017) databases for relevant studies in this field. We aimed to include all observational studies (prospective and retrospective, randomized and nonrandomized) that reported outcomes on vaginal laser therapy as a treatment option for SUI.

Results

Thirteen studies were included that recruited 818 patients who underwent laser therapy for SUI. The methodological quality of most included studies was low, as they were either individual case–control studies, case series or poor-quality cohorts (Oxford Level of Evidence 3b and 4). According to the existing evidence, laser therapy may be a useful, minimally invasive approach for treating SUI. However, the methodological limitations of included studies render them prone to significant bias, limiting their scientific integrity.

Conclusions

As the demand for minimally invasive approaches for treating SUI increases, it is expected that more patients will seek alternative treatments over current standards (midurethral slings). Given the limitations of the existing studies, it seems that conducting future trials is necessary to elucidate this field.

     

Efficacy of treatment in peri-pelvic Morel–Lavallee lesion: a systematic review of the literature

Background

Morel-Lavallee lesion (MLL) of the peri-pelvic region is less common and various treatments have been introduced to manage the lesion. No standard treatment is recommended. We performed a systematic review of literature to (1) identify the classification of peri-pelvic MLL; (2) review the treatments of the lesion and their complications; (3) define the optimal treatment of peri-pelvic MLL.

Methods

A systematic search was performed via PubMed, ISI Web of Knowledge, and Embase for English abstract articles from 1966 to 2012. We identified 21 articles detailing 153 patients with peri-pelvic MLL, most of which were level IV studies. The treatments and clinical results were reviewed.

Results

For peri-pelvic MLL patients, surgical intervention was better than conservative therapy. Sclerhodesis method is attended with good outcome in the symptomatic MLL patients without fractures. Patients with peri-pelvic fractures could be managed with local suction drainage or open debridement with dead space closure technique during fracture fixation. The delayed-diagnosis cases might be treated with mass resection when fibrosis capsule was obtained in magnetic resonance imaging.

Conclusions

Peri-pelvic MLL can be treated with various surgical methods depending on the formation of fibrosis capsule and associated injuries. Dead space closure technique is emphasized in the treatment of MLL. Higher quality of literature is required to prove this result in future research.     

Are urodynamic tests useful tools for the initial conservative management of non-neurogenic urinary incontinence? A review of the literature

OBJECTIVES: To summarise the evidence for the role of urodynamic tests in the diagnosis and classification of urinary incontinence. METHODS: Reference lists in relevant papers were reviewed and MEDLINE searches conducted. RESULTS: The mean sensitivity (specificity) of clinical history versus urodynamic tests was 0.82 (0.57) for stress incontinence, 0.69 (0.60) for urge incontinence/overactive bladder, and 0.51 (0.66) for patients with mixed incontinence. The proportion of women with a clinical diagnosis of urinary incontinence but with normal findings from urodynamic tests ranged from 3 to 8%. Overall sensitivity of urodynamic tests was about 85-90% in the diagnosis of urodynamic stress incontinence, but generally lower following diagnosis of urge and mixed incontinence. No relationship emerged between urodynamic test results and response to medical treatment. CONCLUSIONS: This literature review shows that the sensitivity of clinical history versus urodynamic tests was 0.82, 0.69 and 0.51 respectively for stress, urge and mixed urinary incontinence. It also suggests that urodynamic diagnosis does not predict response to treatment. These data add to the ongoing 'urodynamics or no urodynamics' debate in the evaluation of urinary incontinence and show that urodynamic testing may not be helpful for patients receiving initial non-invasive therapy. These data are in line with the conclusions of the 1st and 2nd International Consultations on incontinence.     

Surgery for stress urinary incontinence in Finland 1987–2009

Introduction and hypothesis

To estimate the incidence rates of stress urinary incontinence (SUI) surgery among Finnish women from 1987 to 2009 by age, and to evaluate the trends in SUI surgery.

Methods

We conducted a retrospective register-based study. All SUI procedures on adult women over age 18 years in Finland were identified from the nationwide Care Register for Health Care. Age-specific incidence rates per 1,000 women were calculated for each year. The cumulative incidence of SUI surgery was calculated.

Results

There were 38,340 procedures for SUI in 1987–2009. The overall age-adjusted incidence rate increased 2.6-fold from 0.5/1,000 women in 1987 to 1.3/1,000 in 2002, but declined thereafter by 2009 to 0.8/1,000. There was a six-fold increase in the incidence rate in the age group 60–69 years and a ten-fold increase in the age group 70–79 years from 1987 to 2002. These marked increases in operation rates coincided with the increased use of tension-free vaginal tape (TVT). In 2002, TVT accounted for 96 % of all SUI procedures. Mid-urethral slings with transobturator techniques surpassed TVT in popularity in 2007. The life-long cumulative incidence of SUI surgery was 9.9 % in 2002 and 6.3 % in 2009.

Conclusions

The incidence rates of SUI surgery increased significantly in Finland, especially among women aged 60 to 79 years. Mid-urethral slings have become the dominant procedure.

     

Do predictive parameters exist for therapy with duloxetine in women with stress urinary incontinence?

Introduction and hypothesis

To determine whether predictive parameters exist for successful duloxetine therapy in women with stress urinary incontinence (SUI).

Methods

Secondary analysis was performed of 1,714 women who received duloxetine in the Stress Urinary Incontinence Treatment (SUIT) study, a 12-month longitudinal observational study to evaluate the results and direct costs of SUI treatment. Data of 1,087 women were analyzed. Univariate and multivariate analyses (stepwise forward logistic regression) were performed to investigate factors for discontinuation of treatment.

Results

Parameters that significantly reduced the probability of treatment termination were smoking and a body mass index (BMI) <20, while obesity (BMI >30) increased the probability in the univariate analysis. In the multivariate analysis significantly reduced likelihoods of duloxetine treatment discontinuation were found for an age >65 years, country, and 7 to 13 incontinence episodes per week. Co-medication, particularly anti-cholinergics, was significantly associated with therapy termination. Previous SUI surgery had no effect.

Conclusions

Identification of predictive parameters for successful therapy with duloxetine in women with SUI is desirable, and co-medications should be critically considered.     

Is balance different in women with and without stress urinary incontinence?

AIMS: This study investigated whether there are differences in center of pressure (COP) displacement, trunk motion, and trunk muscle activity in women with and without stress urinary incontinence (SUI) during static balance tasks when the bladder is empty and moderately full. METHODS: Subjects stood on a force plate during six static balance conditions: eyes open, eyes closed, standing on foam with eyes open, standing on foam with eyes closed, tandem stance, and standing on a short base. Electromyographic activity (EMG) of the pelvic floor (PF), abdominal, and erector spinae muscles were recorded using surface electrodes. Motion of the lumbar spine, pelvis, and hips was measured with four inclinometers. Trials were performed with the bladder empty, and when the subject reported a sensation of moderate bladder fullness after drinking 250-1,000 ml of water. RESULTS: Women with SUI had greater COP displacement (range and root mean square), and increased trunk muscle EMG during static balance tests compared to continent women. When tasks were performed with the bladder moderately full, COP displacement and abdominal muscle EMG were increased in both groups. CONCLUSIONS: This study demonstrates that women with SUI have decreased balance ability compared to continent women. Increased activity of the PF and trunk muscles in women with SUI may impair balance as a result of a reduced contribution of trunk movement to postural correction or compromised proprioceptive acuity. As compromised balance has been linked to falls risk, further research into balance deficits and falls prevalence in this population is warranted.     

Medical management of stress urinary incontinence: Is there a future?

Stress urinary incontinence (SUI) is a common problem among women worldwide. Multiple treatment modalities exist, ranging from physiotherapy to surgery. Numerous reports demonstrate mixed results for efficacy and safety of several oral agents used to treat SUI. Although there are data suggesting reasonable efficacy for several medications, surgery still remains the mainstay of treatment for most women. This article reviews the available oral agents that have been studied and assesses the data supporting their use while highlighting the limitations of each.     

A systematic review of the treatment for female stress urinary incontinence by ACT® balloon placement (Uromedica,Irvine, CA,USA)

Purpose

(1) To describe the minimally invasive adjustable continence therapy (ACT)^® balloon placement surgical technique. (2) To analyse the results of ACT^® balloon in the treatment for female stress urinary incontinence (SUI).

Method

A review of the literature was performed by searching the PubMed database using the following search terms: ACT balloons, female urinary incontinence, and female continence.

Results

Eight studies were published between 2007 and 2013. The mean follow-up of these studies was 1–6 years. The mean age of the patients ranged between 62 and 73 years; 40–100 % of patients had already been treated surgically for their SUI. A significant reduction in the number of pads used per day was observed after ACT^® balloon placement, with improvement of short pad tests from 49.6 to 77.3 g preoperatively to 11.2–25.7 g after ACT^® balloon placement. Fifteen to 44 % of patients considered that their SUI had been cured and 66–78.4 % were satisfied with the result. The explantation rate ranged between 18.7 and 30.8 %. Quality of life was significantly improved, and no major complication was reported.

Conclusion

ACT^® balloons constitute a reasonable, minimally invasive alternative for the treatment for female SUI due to intrinsic sphincter disorder, especially in patients who have already experienced failure of standard surgical treatment and in clinical settings incompatible with invasive surgical placement of an artificial urinary sphincter (especially women over the age of 80 years). Long-term results are essential to evaluate the efficacy of this treatment.