Long-term efficacy and safety of a disposable vaginal device (continence guard) in the treatment of female stress incontinence

The aim of the study was to evaluate the long-term efficacy and safety of a new disposable vaginal device in the treatment of female stress incontinence. Nineteen out of 22 women with stress incontinence were subjectively and objectively cured or improved in a short-term study, and continued the treatment with the device for 1 year. All 19 completed the study: 13 (68%) were subjectively dry, 5 (26%) were improved and 1 (5%) reported unchanged incontinence. All but 1 had decreased leakage at the 24-hour pad test, and 67% a greater than 50% decrease. No significant changes were found in the other urodynamic tests. The gynecologic examination showed no signs of irritation or erosion from the device, and the subjective complaints were modest and few. It was concluded that the disposable vaginal device maintains its positive effect in alleviating the symptoms of stress incontinence in the long term, it is safe and patient compliance is good. EDITORIAL COMMENT: This is an interesting study for all clinicians who want to provide conservative treatment options for patients who are unsuitable for pelvic floor reeducation programs and surgery. Every urogynecologist sees patients who have a totally denervated pelvic floor and who are unable to contract the pelvic musculature. If these patients do not wish to be operated upon or have medical conditions that forbid elective surgery, there is still a lack of efficient and safe devices that provide relief. Unfortunately, many of the urethral devices devised to date have had major side effects that limit their use in daily practice. The authors present their extended use of an intravaginal device, the Continence Guard. Limitations to this study include the loose criteria for inclusion and the lack of strict urodynamic evaluation. In spite of these limitations, the patients experienced reasonable improvement in their incontinence with minimal side effects.     

A new colpocystourethropexy for female stress urinary incontinence

A new technique for the treatment of female stress urinary incontinence is described. It consists of colposuspension obtained by suprapubic placement of two double monofilament sutures in a spiral fashion on the lateral vaginal walls, which are fixed proximally to a Cooper's ligament and tied distally one to the other over the rectus fascia. This technique has been successfully employed in a preliminary series of 26 patients and it appears to be easy to perform and with a wide application range.     

TVT-S治疗女性压力性尿失禁的疗效和安全性分析

目的 探讨经阴道无张力尿道中段吊带术(TVT-S)治疗女性压力性尿失禁(SUI)的有效性及安全性.方法 回顾性分析2008年10月至2010年5月诊治的27例SUI患者的资料.年龄35～77(56.1±10.7)岁;单纯型20例,混合型7例;产次1～6(2.8±1.4)次;体质指数22.0～31.9(25.6±2.5);病程1～30(6.8±7.2)年.有盆腔手术史2例,均无抗尿失禁手术史,膀胱颈抬举试验均阳性;腹压漏尿点压(ALPP)27～120(60.9±27.5)cm H2O;术前ICI-Q-SF评分7～14(11.2±1.8)分.结果 27例均行TVT-S,其中行"U"术式19例,行"H"术式8例.手术时间13～19(15.3±1.4)min.术中无膀胱、尿道损伤,无闭孔血管、神经损伤,术中出血10～50 ml;术后测量最大尿流率4～50(25.4±13.1)ml,残余尿0～95(23.2±7.6)ml.术后发生轻度排尿困难3例(11.1%),出现阴道创口渗液3例(11.1%);术后随访3～21(12.6±6.7)个月,出现尿频、尿急或急迫性尿失禁10例(37.0%),无阴道侵蚀.疗效判定:治愈15例(56%),好转8例(30%),无效4例(1 5%).结论 TVT-S治疗SUI简单易行,操作安全,并发症轻微易治,但手术治愈率较低,长期疗效仍需大量临床和随访资料证明.

Abstract：

Objective To evaluate the efficacy and safety of the TVT-Secur procedure for female stress urinary incontinence (SUI). Methods Analyze retrospectively the preoperative, intraoperative and postoperative complications and follow-up data of 27 SUI patients from October 2008 to May 2010. 20 cases were simple SUI, and 7 cases were mixed SUI. The average age was 56.1 ± 10.7 years (range, 35-77), the average parity was 2.8-±- 1.4 (range, 1-6), the average body mass index was 25.6±2.5, and the average course of the disease was 6.8±7.2 yeas (range, 1-30). Two cases had past history of pelvic surgery without any anti-incontinence surgery. Mashall-marchett test was positive in all patients, with an average abdominal leak point pressure (ALPP) of 60.9±27.5 cm H2O (range, 27- 120 cm H2O). The mean International Consultation on Incontinence-Short Form (ICIQ-SF) score was 11.2 ± 1.8 (range, 7- 14) before surgery. Results 27 patients underwent TVT-Secur procedure, of which 19 cases underwent "U" procedure, and 8 cases underwent "H" procedure. The mean operation time was 15.3±1.4min (range, 13- 19 min). There were no intraoperative bladder or urethral injury, and no obturator vessel or nerve damage. The blood loss was 10 to 50 ml, and the maximum urinary flow rate was 25. 4±13. 1 ml (range, 4-50 ml). Three eases had mild dysuria(11. 1%), and 3 cases had wound effusion(11. 1%). Followed up for 12. 6 ±6. 7 months (range, 3-21 months). 10 cases complained of bladder overactivity symptoms such as frequency, urgency, and urge incontinence, and no case had vaginal erosion. Therapeutic efficacy: 15 cases were cured (56%), 8 cases were improved (30%), and 4 cases were ineffective (15%). Conclusions TVT-Secur procedure is a simple, safe and minimally invasive surgery, while the cure rate is low. The long-term efficacy needs great amount of clinical data and long-term follow-up to prove.     

A new surgical approach for the correction of female stress urinary incontinence

A new surgical approach for the correction of female urinary stress incontinence has been devised. The retropubic space is entered through a dome-shaped incision in front of the urethral meatus in the anterior vaginal vestibule. The incision does not extend beyond the lower edge of the symphysis pubis. With the tip of the hemostat or scissors the incision is opened longitudinally, and the lower legs of the incision are opened and freed up from the bulbocavernosus muscles. The bleeders are controlled. The layers of the genitourinary diaphragm are opened beginning from behind the symphysis pubis and the retropubic cavity is exposed. Then, the vesical neck and urethra are sutured to the back of the symphysis pubis in the midline. With this procedure there is no abdominal incision. The vesical neck and urethra are well exposed. The back of the symphysis pubis can be visualized with the patient in an exaggerated Trendelenburg position. All except 1 patient were cured. Hospitalization and postoperative recovery times were markedly reduced. The procedure affords easy access for drainage of the retropubic space. A new avenue is provided for insertion of an artificial sphincter to achieve urinary continence and for vesical neck colposuspension.     

Future treatment for the female stress urinary incontinence

Stress urinary incontinence (SUI) is a major urologic health problem and the number of patients with SUI will rise dramatically as the population of elderly people continues to increase in Japan. This condition causes unnecessary and detrimental psychological distress, social isolation, and public expense for care. Surgery remains the cornerstone of treatment for female SUI and also in those who have failed to improve with conservative measures. Many surgical procedures, however, have been described with varying degree of success. The ideal surgical treatment for this disease should be effective in QOL improvement, minimal invasive and durable for the long-term. Based on a new understanding of the pathophysiology of SUI as well as the development of surgical techniques and devices, mid urethral sling operations such as TVT (tension-free vaginal tape) have become widely used and they provide significant short-term and long-term cure rates. However, perioperative complications, including serious problems like bowel, vascular and bladder injuries have been reported. Most complications are related to blind trocar passage in the retropubic space. The alternative procedure transobturator procedure was developed to minimize these complications, in which tape is introduced through the obturator foramen. This technique provides high short-term cure rates, similar to those achieved with TVT, but with fewer complications. A number of injectables have been used for the treatment of SUI, including collagen, coated-beeds and Teflon. Although injectable treatment is convenient and minimally invasive, efficacy and durability are lower than other surgical procedures. Modification by tissue-engineering techniques using autologous stem cells or precursors of mature cells showed regeneration and reconstitution of urinary sphincteric function. In the future this strategy may be an attractive therapy for SUI. The choice of operation should be tailored to suit each individual case based on the clinical and urodynamic findings, as well as the age and the expectations of treatment outcome.     

新的盆底肌锻炼方式治疗女性压力性尿失禁的临床疗效分析

目的 探讨一种治疗女性压力性尿失禁(SUI)新的盆底肌锻炼方式的临床效果. 方法 采用前瞻性随机抽样的方法,选取轻、中度女性SUI患者60例,其中进行盆底肌锻炼30例(实验组),第八套广播操锻炼30例(对照组).应用国际尿失禁咨询委员会尿失禁问卷(ICI-Q-SF)、尿垫试验及尿动力学检测方法分别对两组患者锻炼前后的尿失禁程度、漏尿量、最大尿道闭合压和功能性尿道长度等指标进行测定.统计学比较组间各指标的差异. 结果 治疗前实验组尿失禁评分、漏尿量、最大尿道闭合压及功能尿道长度分别为(11.6±4.2)分、(5.9±2.2) ml、(39.4±12.5)cm H2O(1 cmH2O=0.098 kPa)和(2.5±1.2)cm,对照组分别为(10.3±2.2)分、(5.8±1.3)ml、(41.3±8.9)cm H2O和(2.1±0.5)cm,组间比较差异均无统计学意义(P＞0.05).治疗后实验组患者尿失禁评分、漏尿量及最大尿道闭合压分别为(7.7±2.7)分、(1.8±1.2)ml、(65.9±8.9)cm H2O,对照组分别为(10.1±2.1)分、(5.7±1.1)ml和(44.6±9.5)cm H2O,组间比较差异有统计学意义(P＜0.05). 结论 新的盆底肌锻炼方式能够缓解女性SUI患者的症状,推荐用于治疗轻、中度女性SUI患者的治疗.     

无张力阴道悬吊系统TVT-S治疗女性压力性尿失禁临床分析

目的 探讨第三代无张力阴道悬吊系统TVT-S治疗女性压力性尿失禁的适应证和疗效.方法 回顾性分析采用TVT-S术式治疗女性压力性尿失禁27例患者的资料.年龄25～69岁,平均51岁;病程1～20年,平均7年,既往曾行阴道前壁折叠术1例.根据美国妇产科学会POP-Q分级系统评价,Aa为-2～-1 cm,棉签试验尿道夹角＞60°,临床症状评估均为Ⅱ度.27例术前尿动力学检查膀胱顺应性正常,最大尿道闭合压(mUCP)25～60 cm H2O(1 cm H2O=0.098 kPa),平均40 cm H2O,腹压漏尿点压(VLPP)均＞60 cm H2O.混合性尿失禁1例,单纯型压力性尿失禁26例.观察指标包括手术时间、术后并发症,随访患者的疗效及生活质量.结果 局麻下手术,行U形手术4例(MUCP＜30 cm H2O),H形手术23例.手术时间6～15 min,平均8 min.术中失血量少,无尿道及膀胱损伤.术后留置尿管时间平均1 d.术后随访3～15个月,平均8.7个月,26例无需尿垫达到临床治愈,1例混合性尿失禁患者急迫性尿失禁症状改善.I-QOL问卷调查患者生活质量评价良好.25例(93%)患者对术后尿失禁症状改善表示满意,且术前尿失禁症状较重者满意度更高.结论 TVT-S是一种治疗女性压力性尿失禁安全有效且并发症低的微创术式,适合于膀胱顺应性正常、最大尿道闭合压正常、尿道移动度较大的患者,部分高龄或尿道压力较低者建议行U形TVT-S或TVT术.

Abstract：

Objective To evaluate the effectiveness and indications of a new minimally invasive surgical procedure,the tension-free vaginal tape-SECUR (TVT-S),in the treatment of female stress urinary incontinence (SUI). Methods Twenty-seven consecutive women with stress urinary incontinence underwent the procedure under local anesthesia.The mean age of the study group was 51 (range 25-69)years,average disease duration was 7 (1-20) years.In one case,repair of pelvic floor defects had been made previously.According to the pelvic organ prolapse quantitive(POP-Q) (American College of Obstetrics and Gynecology),the Aa＞-1 cm.Swab tests have shown that the angle of urethra Was greater than 60 degrees,while the evaluation of clinical symptoms were grade Ⅱ.The urodynamie test preoperatively of 27 cases display that bladder compliance was normal,mean maximum urethral closure pressure was 40cm H2O(25-60 cm H2O),and VLPP was greater than 60 cm H2O.Minimum follow up was three months (range 3-15 months).The pre-operative maximal urethral cloSHre pressure (MUCP) of all patients was above 30 cm H2O.Ninety-six percent of patients had pure USI,one patient had mixed urodynamic incontinence (MUI).Collection of the data included operative time a well as pre-and post-operative complications.Patients were post-operatively assessed by a validated urinary incontinence-specific measure of Quality of Life (QoL) questionnaire which was completed by all patients at least three months after surgery. Results All patients who underwent the procedure were under local anesthesia.Of these patients,4 cases (MUCP＜30 cm H2O) underwent TVT-S with "U" position while the other 23 underwent TVT-S with "Hammock" position.The mean operation time was 8 minutes (range 6-15 min) and blood loss during operation was about 10 ml.There were no urethral and bladder injuries during the procedure.Postoperative indwelling duration was 0-1 day.After follow-up,26 patients were cured without pad usage and 1 with mixed UI had prominent improvement in urgency incontinence symptoms.The quality of life was also improved significantly.93 % patients were satisfied with the postoperative improvement in urinary incontinence symptoms,and the more severe preoperative symptoms the higher satisfaction rate postoperatively. Conclusions TVT-S iS a safe,effective and minimally invasive procedure for SUI with less complication.The patients with normal bladder compliance and MUCP,urethral hypermobility are indicated for this surgery,some elderly patients or patients with low urethral pressure were proposed to undergo "U" position TVT-S or TVT.     

Genitourinary spheroidal membrane (GSM) for the treatment of female stress urinary incontinence

Fourteen female patients with stress urinary incontinence were implanted with the genitourinary spheroidal membrane (GSM) device (Bard), a percutaneous implantable spheroidal membrane for the treatment of urinary incontinence through localized tissue expansion. Most patients had undergone previous pelvic surgery and suffered from significant medical problems. The placement of the GSM was performed under local anesthesia, with the help of fluoroscopy, cystoscopy and digital examination. The GSM was inserted and inflated close to the posterior urethra, causing its coaptation. Mean patient follow-up is 33 months. Eight patients are now completely dry (57.1%) and 2 are significantly improved (14.3%), with a success rate of (71.4%). The remaining 4 patients (27.6%) are considered failures. Migration of the GSM into the bladder was noticed on three occasions. Two extrusions into the vaginal wall were encountered. GSM replacements were performed without ill effects. Preliminary findings suggest that the GSM prosthesis may be a simple and safe alternative for the treatment of female stress urinary incontinence. The device is still in the experimental stage and further studies in Europe have been started.     

经阴道无张力吊带术治疗女性压力性尿失禁的体会

目的探讨经阴道无张力吊带术(TVT)治疗女性压力性尿失禁(SUI)的疗效及安全性。方法对2002年5月至2004年12月施行TVT的114例女性SUI患者资料进行回顾性研究。根据Stamey尿失禁分级系统评价TVT手术的有效性。术后较术前尿失禁等级评分改善2级或2级以上为显著改善,1级为改善,无改善甚至加重为无效。术后尿失禁等级为0~1级为完全控尿,2级为有效控尿,3~4级为无效。评估术前、术后的24h尿垫试验及尿动力学检查结果。并对并发症进行统计和分析。结果随访110例(96.5%),随访时间6~30个月。24h尿垫试验术前(38.3±10.4)g,术后(8.8±7.4)g;尿失禁症状评分从术前42.3±11.4,术后20.4±9.2;尿失禁等级评分显著改善者94例(85.5%),改善者12例(10.9%),无效者4例(3.6%)。术后完全控尿者89例(80.9%),有效控尿者14例(12.7%),无效者7例(6.4%)。术中发生膀胱穿孔2例(1.8%),出血14例(12.7%)。术后1个月内有排尿不畅者9例(8.2%),尿频、尿急者12例(10.9%),尿潴留者1例(0.9%);术后6个月后有耻骨上不适者8例(7.3%),排尿不尽者2例(1.8%),尿频、尿急者3例(2.7%)。1例反复尿潴留患者经保守治疗无效,最终将吊带切断。术后未出现吊带处阴道黏膜糜烂和明显盆腔血肿。结论TVT术是目前治疗女性SUI的一种有效、安全的微创手术。     

Significant improvement in the quality of life in women treated with a novel disposable intravaginal device for stress urinary incontinence

Introduction and hypothesis  The aim of the study was to assess the quality of life (QoL) in women with stress urinary incontinence (SUI) while using a novel disposable intravaginal device. Methods  Fifty women with severe SUI who completed a 7-day control period followed by a 28-day device usage period underwent QoL assessments based on two validated questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6). Results  Mean total score for the IIQ-7 decreased from 41.8 ± 24.1 to 4.4 ± 8.7 at the pre- and poststudy visits, respectively (P < 0.001). The mean total score for the UDI-6 decreased from 48.2 ± 16.1 to 11.5 ± 11.9 at the pre- and poststudy visits, respectively (P < 0.001). Statistically significant decreases in most subscale scores were observed by the end of the study for both questionnaires (all P values <0.001). Conclusion  The novel disposable intravaginal device significantly improved QoL in women with SUI.     

Pelvic floor muscle training using an extracorporeal biofeedback device for female stress urinary incontinence

Introduction and hypothesis

Extracorporeal biofeedback was developed to reduce patient discomfort when performing strengthening exercises. The efficacy and safety of extracorporeal biofeedback combined with pelvic floor muscle training (PFMT) for the treatment of female stress urinary incontinence (SUI) were evaluated.

Methods

One hundred and six participants with SUI were enrolled in a 12-week PFMT program using extracorporeal biofeedback intervention. A standard pad test was performed, and pelvic floor muscle strength was assessed using the Oxford scale. Measurements were taken with a perineometer at baseline and at a 12-week follow-up visit. An objective cure was defined as less than 2 g of urine leakage by the standard pad test. The long-term effects of extracorporeal biofeedback and PFMT were investigated by interviewing the participants 12 months after treatment.

Results

Seventy-one participants completed the 12-week extracorporeal biofeedback intervention. The objective cure rate was 52.1 %, and there was a significant reduction in pad weight over the time period. The incontinence visual analogue scale, the Sandvik severity index, and the incontinence quality-of-life questionnaire domains were significantly improved after treatment (p?<?0.001). The strength of the PFM was significantly increased after the 12-week treatment. After PFMT, 64.3 % of 56 participants reported good treatment compliance, and 24 participants (42.9 %) had continued PFMT at home 12 months after treatment. Age and baseline pad weight were negative predictive factors for an objective cure of SUI.

Conclusions

Pelvic floor muscle training using extracorporeal biofeedback can be an effective and safe conservative treatment option for female SUI without the discomfort caused by vaginal sensors.     

Neurophysiology and therapeutic receptor targets for stress urinary incontinence

Stress urinary incontinence is the most common type of urinary incontinence in women. Stress urinary incontinence involves involuntary leakage of urine in response to abdominal pressure caused by activities, such as sneezing and coughing. The condition affects millions of women worldwide, causing physical discomfort as well as social distress and even social isolation. This type of incontinence is often seen in women after middle age and it can be caused by impaired closure mechanisms of the urethra as a result of a weak pelvic floor or poorly supported urethral sphincter (urethral hypermobility) and/or a damaged urethral sphincter system (intrinsic sphincter deficiency). Until recently, stress urinary incontinence has been approached by clinicians as a purely anatomic problem as a result of urethral hypermobility requiring behavioral or surgical therapy. However, intrinsic sphincter deficiency has been reported to be more significantly associated with stress urinary incontinence than urethral hypermobility. Extensive basic and clinical research has enhanced our understanding of the complex neural circuitry regulating normal function of the lower urinary tract, as well as the pathophysiological mechanisms that might underlie the development of stress urinary incontinence and lead to the development of potential novel strategies for pharmacotherapy of stress urinary incontinence. Therapeutic targets include adrenergic and serotonergic receptors in the spinal cord, and adrenergic receptors at the urethral sphincter, which can enhance urethral reflex activity during stress conditions and increase baseline urethral pressure, respectively. This article therefore reviews the recent advances in stress urinary incontinence research and discusses the neurophysiology of urethral continence reflexes, the etiology of stress urinary incontinence and potential targets for pharmacotherapy of stress urinary incontinence.     

Urinary proteomic pattern in female stress urinary incontinence: a pilot study

Introduction and hypothesis

Previous studies aiming to identify specific pre-defined urine protein biomarkers for stress urinary incontinence (SUI) have not identified clinically important differences. The hypothesis of our study was that the global distribution of urinary proteins, the proteome, differs between women with and those without SUI.

Methods

In this age-matched case–control study, we compared the urinary proteome of 20 women with SUI and 20 controls. Proteins were identified by applying high-performance liquid chromatography separation and tandem mass spectrometry detection. Data analysis was performed using Mascot 2.4.1 embedded in ProteinScape 3.1.

Results

We identified 828 different proteins. The concentration of six of those showed a significant difference between urine samples of SUI patients and those of controls (q value?<?0.25). Four proteins showed a higher abundance in SUI samples compared with controls: plasma serine protease inhibitor (logFC 1.11), leucine-rich alpha-2-glycoprotein (logFC 3.91), lysosomal alpha-glucosidase (logFC 1.24), and peptidyl-prolyl cis- trans isomerase A (logFC 1.96). We identified two proteins in lower abundance in SUI samples compared with controls: uromodulin (logFC ?4.87) and TALPID3 (logFC ?1.99).

Conclusions

Overexpression of plasma serine protease inhibitor, leucine-rich alpha-2-glycoprotein, lysosomal alpha-glucosidase, and peptidyl-prolyl cis- trans isomerase A, and lower expression of uromodulin and TALPID3, in urine may be associated with female SUI.

     

The YAMA UroPatch sling for treatment of female stress urinary incontinence: a pilot study

BACKGROUND AND PURPOSE: We report our initial experience using a new suburethral sling made from bovine pericardium for the treatment of urinary incontinence. To prevent rolling and curling of the sling, a unique anti-roll clip is incorporated into the UroPatch. In addition, the sling has a series of perforations that create evenly distributed tissue integration and avoid delayed seroma or hematoma formation, thereby reducing the risk of sling rejection, infection, and erosion. PATIENTS AND METHODS: Twenty-two female patients underwent suburethral sling procedures using the UroPatch. All patients demonstrated urethral hypermobility, intrinsic sphincteric deficiency, or both. Five patients had previous surgical treatment for urinary incontinence. RESULTS: All operations were completed successfully. No intraoperative or postoperative complications occurred. There was no evidence of local or systemic reaction to the UroPatch in any of the patients. With a mean follow-up of 20 months, sling rejection, erosion, or infection has not been demonstrated, and no sling required removal to date. Urinary incontinence was corrected in all but one case. CONCLUSION: The results of this pilot study suggest that the UroPatch is a promising alternative to current slings for the treatment of female urinary incontinence.     

女性压力性尿失禁的诊治（附30例报告）

目的：探讨女性压力性尿失禁（SUI）的诊治方法。方法：对30例患者的临床资料进行回顾性分析。其中行改良Stamey术17例次，Gittes术9例次，耻骨阴道吊带术7例次。结果：24例获5个月－3年随访，其中21例参加一般性体力劳动时无尿失禁现象，3例症状复发经再次手术而治愈。结论：对SUI应做尿动力学检查，治疗应根据尿失禁的程度和有无并发症而采取不同的方法，提倡超声导向经皮穿刺膀胱颈悬吊术治疗该病。