Urethral Injection Therapy Research Articles

Which procedure for stress urinary incontinence? Injectable.

Which procedure for stress urinary incontinence? Injectable.

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

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

Patient Characteristics that May Influence the Effect of Urethral Injection Therapy for Female Stress Urinary Incontinence.

Urethral injection therapy is a well-known treatment of female stress urinary incontinence but to our knowledge the optimal group of recipients has not been established. In this study we examined which patient characteristics are associated with success after urethral injection therapy. This study is a post hoc analysis of a previously published, randomized, 33-center study of the hydrogel bulking agent Bulkamid® vs the collagen gel Contigen®. Regardless of the treatment women were considered cured if there were no stress incontinence episodes in the bladder diary and no stress incontinence symptoms on the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form), improved if there was a 50% or greater reduction in stress incontinence episodes and no effect if there was less than a 50% reduction in stress incontinence episodes 1 year after treatment. Of the 345 women who were initially randomized 291 were included in this study. A total of 191 women received hydrogel and 100 received collagen. At 1 year 74 women (25%) were cured, 164 (56%) were improved and 53 (18%) showed no effect. On multivariate logistic regression analysis age 60 years or greater and fewer than 2.5 daily stress incontinence episodes were associated with cure. In this group 90% of women experienced a treatment effect and 38% were cured compared with a 13% cure rate in those younger than 60 years with 2.5 or more daily stress incontinence episodes. Urethral injection therapy was more effective to treat stress urinary incontinence in women 60 years old or older with fewer than 2.5 daily stress incontinence episodes. It had a 90% success rate in these women.

Urethral injection therapy for urinary incontinence in women.

Urinary incontinence imposes a significant health and economic burden to society. Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used as one the surgical treatments of stress urinary incontinence (SUI) in adult women. To assess the effects of periurethral or transurethral injection therapy on the cure or improvement of urinary incontinence in women. We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 November 2010) and the reference lists of relevant articles. All randomised or quasi-randomised controlled trials of treatment for urinary incontinence in which at least one management arm involved periurethral or transurethral injection therapy. Two review authors independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently and clarification concerning possible unreported data sought directly from the investigators. Excluding duplicate reports, we identified 14 trials (excluding one that was subsequently withdrawn from publication and not included in this analysis) including 2004 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis because they all came from separate trials. Trials were small and generally of moderate quality.One trial of 45 women that compared injection therapy with conservative treatment showed early benefit for the injectable therapy with respect to continence grade (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (mean difference (MD) 0.54, 95% CI 0.16 to 0.92). Another trial, comparing Injection of autologous fat with placebo, terminated early because of safety concerns. Two trials that compared injection with surgical management found significantly better objective cure in the surgical group (RR 4.77, 95% CI 1.96 to 11.64; and RR 1.69, 95% CI 1.02 to 2.79), although the latter trial data did not reach statistical significance if an intention-to-treat analysis was used.Eight trials compared different agents and all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres and dextranomer hyaluronic acid combination gave improvements which were not shown to be more or less efficacious than collagen. Dextranomer hyaluronic acid compound treated patients appeared to have significantly higher rates of injection site complications (16% with the hyaluronic acid compound versus none with collagen; RR 37.78, 95% CI 2.34 to 610.12) and this product has now been withdrawn from the market.A comparison of periurethral and transurethral methods of injection found similar outcomes but a higher (though not statistically significant) rate of early complications in the periurethral group. One trial of 30 women showed a weak (but not clinically significant) advantage for patient satisfaction (data not suitable for analysis in RevMan) after mid-urethral injection in comparison to bladder neck injection but with no demonstrable difference in continence levels. The available evidence base remains insufficient to guide practice. In addition, the finding that placebo saline injection was followed by a similar symptomatic improvement to bulking agent injection raises questions about the mechanism of any beneficial effects. One small trial comparing silicone particles with pelvic floor muscle training was suggestive of benefit at three months but it is not known if this was sustained, and the treatment was associated with high levels of postoperative retention and dysuria. Greater symptomatic improvement was observed with surgical treatments, though the advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents, although dextranomer hyaluronic acid was associated with more local side effects and is no longer commercially available for this indication. There is insufficient evidence to show superiority of mid-urethral or bladder neck injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side effects. Also, a Brief Economic Commentary (BEC) identified three studies suggesting that urethral bulking agent might be more cost-effective compared with retropubic mid-urethral slings, transobturator or traditional sling procedure when used as an initial treatment in women without hypermobility or as a follow-up to surgery failure provided injection is kept minimal. However, urethral bulking agent might not be cost-effective when compared with traditional sling as an initial treatment of SUI when a patient is followed up for a longer period (15 months post-surgery).

A national population-based cohort study of urethral injection therapy for female stress and mixed urinary incontinence: the Danish Urogynaecological Database, 2007–2011

Urethral injection therapy (UIT) has been performed since the early 20th century and a variety of agents have been launched. In 2006, polyacrylamide hydrogel (PAGH) was introduced and is now widely used as an agent. The objective was to evaluate the efficacy of PAGH based on a national population over a 5-year period (2007-2011) and the influence of patient-related factors, surgeon experience, and department volume. A retrospective cohort study was carried out based on data from the Danish Urogynaecological Database (DugaBase). A total of 731 women were registered in the DugaBase. Cure was achieved in 75 out of 252 women (29.8%) and no leakage at all in 23 out of 252 (9.1%) at the 3-month follow-up. The mean total International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score decreased from 16 (SD 3.8) to 10.6 (SD 6.2; p < 0.001). UIT was performed at 16 departments, of which four high-volume departments performed 547 out of 814 UITs (67.2%). Women with severe UI had a decreased chance of cure (all ICIQ-SF scores), as did women on antimuscarinic drugs (adjusted OR 0.14; 95%, CI 0.04-0.41 "frequency") and (adjusted OR 0.33; 95%, CI 0.13-0.82, "amount"). Women treated by a high-volume surgeon had a higher chance of cure (OR 4.51; 95% CI, 1.21-16.82, "frequency") and a lower risk of 30-day hospital contacts (OR 0.27; 95% CI 0.09-0.76). The study represented a cure for UIT among women in an everyday life setting. A surgeon learning curve for UIT was indicated, as was assigning interventions to fewer hands to improve the surgical training value and consequently the cure rate for women with UIT.

Repeat surgery after failed midurethral slings: a nationwide cohort study, 1998-2007.

The objective was to describe the choice of subsequent surgery after failure of synthetic midurethral slings (MUS) based on a nationwide background population. We used the Danish National Patient Registry to identify women who had undergone first-time synthetic MUS from 1998 through 2007. The outcome was repeat surgery with any subsequent procedure code for urinary incontinence within a 5-year period of the first procedure. A total of 5,820 women (mean age 55.4years, ± 12.1) were registered with a synthetic MUS, and 354 (6%) underwent reoperation. The first-choice treatment for reoperation was a synthetic MUS (45.5%) followed by urethral injection therapy (36.7%) and miscellaneous operations (13.8%). Pubovaginal slings (2.8%) and Burch colposuspension (1.1%) were seldom used. At reoperation, 289 women (82%) were treated at the department where they had undergone their primary synthetic MUS. In this nationwide cohort study of synthetic MUS a repeat synthetic MUS was the first choice and urethral injection therapy a frequent second choice. The majority of reoperations (82%) took place in the same department as the primary operation.

Reoperation for urinary incontinence: a nationwide cohort study, 1998–2007

The synthetic midurethral slings were introduced in the 1990s and were rapidly replaced the Burch colposuspension as the gold standard treatment for urinary incontinence. It has been reported that the retropubic midurethral tape has an objective and subjective cure rate of 85% at 5 years of follow-up, but the rate of reoperation after retropubic midurethral tape at the long-term follow-up is less well described. Theexisting literature specifies an overall lifetime rate of reoperation of about8-9% after an initial operation for urinary incontinence. There are, however, conflicting statements about the risk of reoperation after specific surgical procedures for urinary incontinence. The objective of the study was to describe the cumulative incidence of reoperation within a 5 year period after different types ofsurgical procedures for urinary incontinence based on a nationwide population. We used the Danish National Patient Registry to identify women who had surgery for urinary incontinence from 1998 through 2007 and the outcome was a reoperation within 5 years. Kaplan-Meier curves were used to estimate the rate of reoperation for 6 types of surgery for urinary incontinence (retropubic midurethral tape, transobturator tape, urethral injection therapy, Burch colposuspension, pubovaginal slings, and miscellaneous operations). Cox proportional hazard models were used to estimate the hazard ratio (HR) with 95% confidence intervals (CIs), adjusted for factors suspected to be associated with reoperation. A total of 8671 women (mean age, 56.1 years, range 6.7-93.7 years) underwent surgical treatment for urinary incontinence. Among these women, 5820 (67%) received a synthetic midurethral sling at baseline. The cumulative incidence of reoperation after any surgical treatment for urinary incontinence was 10%. The lowest rate of reoperation was observed among women having pubovaginal slings (6%), retropubic midurethral tape (6%) and Burch colposuspension (6%) followed by transobturator tape (9%), and miscellaneous operations (12%), whereas the highest observed risk was for urethral injection therapy (44%). In a Cox proportional hazard model that adjusted for age, department volume, and calendar effect, the transobturator tape carried a 2-fold higher risk of reoperation (HR, 2.1; 95% CI, 1.5-2.9), and urethral injection therapy carried a 12 fold-higher risk (HR, 11.5; 95% CI, 9.3-14.3) compared with retropubic midurethral tape. This nationwide cohort study provides physicians with a representative evaluation of the rate of reoperations after surgical procedures for urinary incontinence. Pubovaginal slings, Burch colposuspension, and retropubic midurethral tape had a similar risk of reoperation (6%). Women who were operated with transobturator tape had a significantly higher risk of reoperation compared with retropubic midurethral tape.

Long‐term follow‐up after urethral injection with polyacrylamide hydrogel for female stress incontinence

Urethral injection therapy for treatment of stress urinary incontinence has been in use for years, but only a few long-term follow-up studies have been published. Twenty-five women, injected with polyacrylamide hydrogel 8 years earlier, were invited for follow-up. Twenty-four could be contacted; 15 had had no further treatment, seven had been re-operated with placement of mid-urethral slings, and two had been re-injected with polyacrylamide hydrogel. Eleven women attended for objective examination; all non-attenders were interviewed by telephone. Subjectively, in 44% the stress incontinence was cured or much improved, with a positive outcome according to the King's Health Questionnaire. Objectively, all patients had visible polyacrylamide hydrogel deposits on vaginal ultrasonography. No local adverse reactions were seen in the vaginal mucosa. The results of a later mid-urethral sling were unaffected by previous polyacrylamide hydrogel injection.

Urethral injection therapy: What is the mechanism of action?

The mechanism of action of injection therapy is virtually unknown. Urethral Pressure Reflectometry (UPR) is a novel technique for measuring pressure and cross-sectional area in the urethra. UPR which provides reliable physiological meaningful parameters was used to study the mechanism of urethral injection therapy. Fifteen patients with stress urinary incontinence (nine women) and mixed incontinence (six women) were investigated with UPR before and 101 days after urethral injection therapy. The patients subjectively judged if their stress and urge symptoms were cured/improved almost unchanged or worsened. Ten women were cured/improved after the injection therapy. None became worse. Six patients had urge symptoms before injection therapy which did not change after the procedure. The patients were divided into two groups based on their subjective assessments of effect. One group with effect (10 women) and 1 group without effect (5 women). The patients had significantly higher squeezing opening pressure after the treatment. The other parameters were unchanged. The mean squeezing opening pressure increased significantly (P < 0.01) more in the group of patients with effect (10.6 cmH(2)O) than in the group without effect (-1.6 cmH(2)O). Injection therapy may work by increasing the power of the urethral sphincter. The bulking material may function as additional central filler volume which increase the length of the muscle fiber and thereby the power of the sphincter.

Patient-perceived outcomes in the treatment of stress urinary incontinence: focus on urethral injection therapy

Intervention for stress urinary incontinence (SUI) is generally focused on minimizing urinary leakage. However, the overall impact of SUI therapy on patients' quality of life is, arguably, more important than leakage outcomes. We performed a literature search to investigate the effect of urethral injection therapy on quality of life. Significant quality-of-life improvements have been observed with a number of injectable agents, while there is a distinct lack of correlation between subjective and objective outcomes. Two studies comparing urethral injection therapy with surgical intervention found superior objective efficacy with surgery, but no significant differences in quality-of-life improvements. Personal goals of patients undergoing urethral injection are yet to be explored, but there may be willingness to trade a lower success rate in favor of a more minor treatment procedure. In conclusion, quality-of-life improvements after urethral injection appear significant and comparable to those obtained with surgery. Further study of patients' own perceptions, pre- and posttreatment, would be valuable.