Urethral and bladder injections for incontinence including botox.

Stress urinary incontinence (SUI) and urge incontinence (UI) are increasingly significant health concerns for millions of women. Investigation continues into the use of different types of procedures for the surgical management of UI that can be done in the ambulatory office without the use of general or regional anesthesia. Injectable treatment for SUI and UI lend themselves to the ambulatory or office setting and mimic the efficacy and safety profiles of currently available procedures.

Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status.

INTRODUCTION AND HYPOTHESIS: VENUS evaluated the efficacy of solifenacin on urgency in patients with overactive bladder (OAB). We hypothesized that solifenacin would be comparably efficacious in continent and incontinent patients. METHODS: VENUS was a 12-week, placebo-controlled trial in patients with OAB. Treatment efficacy was assessed using bladder diaries and patient-reported outcome measures. The primary endpoint was the change in daily urgency episodes. Exploratory subgroup analyses were conducted using baseline continence status. RESULTS: Solifenacin reduced urgency episodes versus placebo in continent (-3.4 vs. -2.3) and incontinent patients (-4.2 vs. -2.9) and incontinence episodes (-2.1 vs. -1.2) in that subgroup; 58% versus 42% of incontinent patients receiving solifenacin versus placebo were continent at study end. In both cohorts, solifenacin- versus placebo-treated patients showed greater improvements in perceptions of urgency severity, symptom bother, and health-related quality of life. CONCLUSION: This post hoc analysis demonstrates the efficacy of solifenacin regardless of baseline continence status.

Update of AUA guideline on the surgical management of female stress urinary incontinence.

PURPOSE: We updated the 1997 American Urological Association guideline on female stress incontinence. MATERIALS AND METHODS: MEDLINE searches of English language publications from 1994 and new searches of the literature published between December 2002 and June 2005 were performed using identified MeSH terms. Articles were selected for the index patient defined as the otherwise healthy woman who elected to undergo surgery to correct stress urinary incontinence or the otherwise healthy woman with incontinence and prolapse who elected to undergo treatment for both conditions. RESULTS: A total of 436 articles were identified as suitable for inclusion in the meta-analysis, and an additional 155 articles were suitable for complications data only due to insufficient followup of efficacy outcomes in the latter reports. Surgical efficacy was defined using outcomes pre-specified in the primary evidence articles. Urgency (resolution and de novo) was included as an efficacy outcome due to its significant impact on quality of life. The primary efficacy outcome was resolution of stress incontinence measured as completely dry (cured/dry) or improved (cured/improved). Complications were analyzed similarly to the efficacy outcomes. Subjective complications (pain, sexual dysfunction and voiding dysfunction) were also included as a separate category. CONCLUSIONS: The surgical management of stress urinary incontinence with or without combined prolapse treatment continues to evolve. New technologies have emerged which have impacted surgical treatment algorithms. Cystoscopy has been added as a standard component of the procedure during surgical implantation of slings.

Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome.

INTRODUCTION AND HYPOTHESIS: To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed. METHODS: Adults (aged > or = 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505). Endpoints examined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance. RESULTS: At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P < 0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%). CONCLUSIONS: Trospium ER was effective and well tolerated in women with OAB.

Post hoc interpretation of urodynamic evaluation is qualitatively different than interpretation at the time of urodynamic study.

OBJECTIVES: Intraobserver reliability of post hoc urodynamic interpretation is greater than interobserver reliability, attributable to interpreter bias. If post hoc interpretation is qualitatively similar to interpretation at the time of study by a urodynamicist in attendance ("live" interpretation), a similar intraobserver bias should be observed. We therefore evaluated the intra- and interobserver reliability of post hoc versus "live" interpretation. METHODS: Fifty-five consecutive urodynamic studies administered by each of two urodynamicists and interpreted at the time of study were de-identified and later re-interpreted by the same two physicians. History and exam findings, cystometric tracing, uroflow summary and radiographs were available for interpretation. Intraobserver (post hoc vs. live), interobserver (post hoc vs. live) and interobserver (post hoc vs. post hoc) reliability was assessed by correlation coefficients for quantitative data, and Cohen's kappa statistic for categorical data. RESULTS: Post hoc versus live interpretations demonstrated no superiority of intraobserver reliability. For categorical observations, intraobserver reliability was best for urodynamic observations, but worse for clinical diagnosis (kappa = 0.37) and primary treatment recommendation (kappa = 0.26). Interobserver reliabilities were similar to intraobserver. Post hoc/post hoc interobserver correlations for quantitative data were good to very good, r(2) = 0.611-0.914. CONCLUSIONS: In contrast to previously reported post hoc/post hoc comparisons, post hoc/live comparison demonstrated no superiority of intraobserver reliability. Urodynamic observations and impressions are more reliable than are clinical diagnosis and therapeutic recommendation based upon urodynamic evaluation. Unrecorded and heuristic observations at the time of study as well as interpreter judgment may thus be determinants of diagnostic interpretation of urodynamic evaluation.

Management of complications arising from transvaginal mesh kit procedures: a tertiary referral center's experience.

This case series' purpose is to review a referral center's experience with complications from mesh kits. A chart review of 12 patients who presented with complications associated with transvaginal mesh kit procedures was performed. All patients underwent complete surgical removal of the mesh to treat mesh exposure, pain, or vaginal bleeding/discharge followed by an anterior or posterior repair. The mean follow-up time after surgery was 3.4 months. Eight of 12 patients had mesh that had formed a fibrotic band. Six of 12 patients had complete resolution of pain. Of the nine patients with mesh exposure, all required significant resection of the vaginal wall. No further mesh exposure occurred. The use of transvaginal mesh kits may cause previously undescribed complications such as pelvic/vaginal pain or large extrusions requiring complete removal. Removal of all mesh except the arms may cure or significantly improve these problems.

Transurethral collagen denaturation for women with stress urinary incontinence.

Transurethral collagen denaturation was approved by the US Food and Drug Administration in 2005 for the nonsurgical treatment of stress urinary incontinence in women. In this procedure, controlled, nonablative radiofrequency energy applied through a transurethral probe produces microscopic submucosal sites of collagen denaturation, resulting in reduced tissue compliance. Treatment is administered in about 30 minutes in an outpatient setting without incisions, general anesthesia, or use of cystoscopy or other visualization. The safety and efficacy of this treatment were demonstrated in a pilot trial in 41 women and then in a subsequent 12-month sham procedure-controlled trial in more than 170 women. Ongoing clinical trials include a 3-year, open-label durability study and an evaluation of this technique in women who have failed prior surgical intervention. To date, patients who received transurethral collagen denaturation have experienced improvements in quality of life and in Valsalva leak point pressure. This procedure presents a beneficial nonsurgical treatment option for women with stress urinary incontinence.

Large urethral prolapse formation after calcium hydroxylapatite (Coaptite) injection.

A 67-year-old woman who had failed two prior anti-incontinence surgeries presented with stress urinary incontinence and intrinsic sphincteric deficiency. Calcium hydroxylapatite (Coaptite(R)) was injected cystoscopically into the bladder neck and proximal urethra and resolved her incontinence. Seven months later, she presented with difficulty in voiding and a urethral mass. Physical examination revealed a large prolapse of the urethral mucosa obstructing the external urethral meatus. Surgical exploration revealed local migration of calcium hydroxylapatite particles from the site of injection (bladder neck and proximal urethra) to the distal urethra. The prolapsed urethral mucosa was incised and marsupialized. Improper injection techniques likely contributed to urethral prolapse in this complication. Meticulous attention to injection techniques is the key to treatment success of urethral bulking agents, particularly in patients who have a scarred/fixed urethra or have multiple urethral/vaginal surgeries.

Complications of ethylene vinyl alcohol copolymer as an intraurethral bulking agent in men with stress urinary incontinence.

OBJECTIVES: To report the short-term safety and efficacy of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Inc., Covington, GA) in the off-label treatment of male stress urinary incontinence. METHODS: We reviewed the charts of all adult male patients who received EVA copolymer between 2005 and 2006 for demographics, physical examination findings, urodynamic findings, outcomes, and complications. RESULTS: A total of 17 of 18 men completed follow-up after receiving EVA during this time period. With an average of 1.4 injection sessions, 58.8% of patients experienced a complication related to the procedure, with 41.1% of these complications being urethral erosion of the material and 22% experiencing severe pain on injection. Subjective improvement of at least 50% was reported by 41.1% of patients. The mean follow-up period was 4.2 months. CONCLUSIONS: Intraurethral bulking agents are meant to be a minimally invasive procedure with lower complication rates than alternatives such as the artificial urinary sphincter and male sling. The off-label use of EVA in men in this case series resulted in a significant complication rate. Urethral erosion was the most common complication causing dysuria, precluding further bulking in others, and resulting in loss of benefit with passage of material. In addition, EVA used in men may be less efficacious than the Food and Drug Administration data reported in women, especially with prior injectable therapy. In December 2006, EVA was voluntarily taken off the marketplace by CR Bard owing to reports from clinicians.

Nocturia: etiology, diagnosis, and treatment.

Voiding at night, or nocturia, is a common reason for interrupted sleep in the adult population. The condition affects both men and women, with an incidence that increases dramatically with age. Nocturia has a negative impact on quality of life, affecting both morbidity and mortality. Effective diagnosis of the condition is dependent on a clear understanding of its underlying etiology. In general, the causes of nocturia fall into three categories: diurnal polyuria, nocturnal polyuria, and low bladder capacity. In some individuals, however, nocturnal polyuria and low bladder capacity may both contribute to the overall symptomatology of nocturia. Addressing any underlying conditions that contribute to nocturia is the first step in treating the condition. Lifestyle and behavioral changes may provide benefit in some individuals, but for many, the only option is pharmacotherapy. Antimuscarinic agents are first-line therapies for overactive bladder and are often used in the management of nocturia. Pharmacological and physicochemical differences between available antimuscarinic agents, however, translate into different safety and tolerability profiles, which may make some agents more suitable for use in certain populations, including the elderly. Careful selection of the most appropriate antimuscarinic medication is therefore central in optimizing treatment outcomes.

Does uroflow predict ISD?

AIM: The term superflow has been given to abnormally high flow rates in women, and has been thought to be indicative of intrinsic sphincteric deficiency (ISD), as ISD is associated with low urethral pressure. Pelvic organ prolapse (POP) damages the sphincteric mechanism extrinsic to the urethra. The aim of this study was to determine if ISD can be predicted from voiding flow rates in women with symptomatic POP. METHODS: The charts of 82 patients who had undergone surgery for repair of symptomatic vaginal prolapse were reviewed. Uroflow and urodynamic endpoints were compared between dry and stress incontinent patients, and correlations between abdominal leak point pressures (LPP) and pressure/flow data evaluated. RESULTS: Average maximum flow (Q(max)) at uroflow was greater than at urodynamics with no significant difference in voided volumes. Twenty eight patients were found to have urodynamic stress incontinence (SUI), and an additional 19 to have "occult" stress incontinence. Patients with SUI had higher flow rates at urodynamics than continent patients. Voiding detrusor pressures and flow rates were not different when categorized by LPP cutoffs of 100 and 60 cm/w. Abdominal leak point pressure did not significantly correlate with any uroflow or urodynamic pressure/flow parameter. CONCLUSIONS: Flow rates, whether determined by uroflow testing or at urodynamics, are not predictive of ISD as defined by a low abdominal leak point pressure, in patients with symptomatic POP. Either the effect of ISD on flow rates is a non-linear complex relationship or LPP does not adequately define ISD.

Male lower urinary tract symptoms: treatment with a-blockers, 5-a-reductase inhibitors, antimuscarinics, or a combination.

Pharmacological therapy is now considered a first-line treatment for men with moderate to severe lower urinary tract symptoms. Given the success of antimuscarinic agents, a-sympathetic blockers, and 5-a-reductase inhibitors in treating symptoms, the interest in combination therapy has grown. Despite this, large-scale trials to test the efficacy of such combination therapy are still lacking.

Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation.

Transurethral radiofrequency collagen denaturation, a nonsurgical treatment for stress urinary incontinence, reduces regional dynamic tissue compliance without causing tissue necrosis or gross tissue shrinkage, unlike transvaginal radiofrequency tissue ablation. This retrospective study evaluated long-term safety and efficacy in 21 patients from a 12-month, randomized controlled trial utilizing 3-day diaries and the Incontinence Quality of Life (I-QOL) survey. Significant increases in overall I-QOL scores 3 years or more post treatment was the primary end point. Secondary end points were reductions in frequency and severity of incontinence episodes. After 3 years, mean overall I-QOL score improvement was 12.7 (+/-26); 56% of patients achieved 50% or more reduction in frequency. No new adverse events occurred. These results indicate that radiofrequency collagen denaturation is safe and provides durable efficacy.

Treatment options for patients with suboptimal response to surgery for stress urinary incontinence.

BACKGROUND: Many women with stress urinary incontinence (SUI) undergo surgery to relieve their symptoms. Currently, tension-free vaginal tape or transobturator tape sling procedures are the surgical treatments of choice. Although these procedures are often successful, a growing number of women experience suboptimal results ranging from improvement without cure to postoperative failure. Follow-up surgery often improves residual or recurrent symptoms but generally carries lower success rates and higher complication risks. Additionally, many women with suboptimal results are reluctant to undergo further surgery. SCOPE: A PubMed literature search for studies of SUI treatment options published from 1986 to 2006 was performed. FINDINGS: The literature revealed a gap in published studies addressing non-surgical options for patients with failed SUI surgeries. Studies of non-surgical treatments for SUI often exclude women who have had prior surgeries, or do not analyze this subgroup. It is, therefore, difficult to assess non-surgical treatment options for women with failed surgeries. Women whose residual or recurring SUI is attributable to intrinsic sphincter deficiency may instead elect the injection of a bulking agent. Bulking agents are associated with a low rate of complications but frequently require several injections to be successful. Women experiencing suboptimal surgical results whose SUI is attributable to hypermobility may select a new non-surgical treatment, radiofrequency collagen denaturation. This non-invasive procedure has also demonstrated a low rate of complications. CONCLUSIONS: Considering the effect of SUI symptoms on women's quality of life, and with more women experiencing suboptimal results after surgery for SUI, it is important to assess alternatives to further surgery.

Transobturator tape, bladder perforation, and paravaginal defect: a case report.

Transobturator midurethral slings (TOT) have been shown to have less risk of vascular and visceral injury than tension-free midurethral slings. Routine cystoscopy has therefore not been felt to be necessary. A case of bladder perforation unrecognized at the time of TOT placement is presented. Findings at sling removal suggested that a clinically nonapparent paravaginal defect may have been instrumental in the injury. Consideration should be given to routine cystoscopy at the time of transobturator sling placement.

Nonsurgical transurethral radiofrequency treatment of stress urinary incontinence in women.

A transurethral radiofrequency collagen denaturation system was recently approved by the US FDA for nonsurgical, outpatient treatment of women with stress urinary incontinence associated with urethral hypermobility. Controlled radiofrequency energy applied through a transurethral probe heats submucosal tissue to produce collagen denaturation, resulting in reduced tissue compliance without necrosis, thus distinguishing this procedure from transvaginal radiofrequency tissue ablation. Treatment can be administered in 30 min under local anesthesia, without incisions, use of cystoscopy or other visualization of the treatment site. Safety and efficacy have been demonstrated in several studies, including a 12-month, multicenter, sham-procedure-controlled clinical trial in 173 women with mild-to-moderate stress urinary incontinence. In patients receiving active treatment, two of the four groups experienced significant quality-of-life changes (p = 0.004; p = 0.02), and all women exhibited significant increases in Valsalva leak point pressure (p = 0.02 vs sham group).

Current trends in the evaluation and management of female urinary incontinence.

Despite its common occurrence and often seemingly obvious causes, female urinary incontinence requires a thorough and thoughtful evaluation for its proper diagnosis and treatment. With rare exceptions, urinary incontinence is the result of failure of the sphincter mechanism to resist bladder pressures encountered during daily activities. This may be the result of sphincter failure, overactivity of the bladder detrusor muscle or both. In uncomplicated cases, the diagnosis is usually based on an evaluation in the office. Urodynamic and cystoscopic study may be helpful in complex, resistant and recurring cases of urinary incontinence of any cause. Most cases of incontinence may be classified as stress, urge or mixed urinary incontinence. Treatment of stress urinary incontinence focuses on supplementing the urethral continence mechanisms, particularly the urethral supports and periurethral striated muscle function. The current paradigm for the treatment of urge incontinence centres on pharmacologic therapy, primarily by correcting detrusor overactivity with antimuscarinic drugs. Other therapies aimed at altering sensorimotor function may be used in resistant cases. The treatment of mixed urinary incontinence requires consideration of the contribution of each of its components. With proper diagnosis, effective treatment is possible for most patients.