Management of polypropylene mesh erosion after intravaginal midurethral sling operation for female stress urinary incontinence

The intravaginal midurethral sling operations have become a trend to treat female stress urinary incontinence. Cases of complications requiring surgical revision are rarely reported. We report on seven patients with complications necessitating surgery. Six patients with vaginal erosion were treated with transvaginal excision of migrated tape and fibrotic tissues around the vaginal wall, and one patient with bladder erosion was treated with suprapubic minimal laparotomy and transvaginal partial excision of the tension-free vaginal tape (TVT). The incidence of polypropylene mesh erosion was 1.1% in this study. All patients recovered well from our surgical intervention, except the bladder erosion patient who needed anticholinergic medication to treat postoperative urgency and urge incontinence.     

Influence of TVT properties on outcomes of midurethral sling procedures: high-stiffness versus low-stiffness tape

Introduction and hypothesis

Although there is clear consensus on the use of monofilament polypropylene tapes for treating stress urinary incontinence (SUI), tapes differ in weight, stiffness, and elasticity. In this study, we compared outcomes of two tape types: high-stiffness Intramesh SOFT L.I.F.T versus low-stiffness Intramesh L.I.F.T. tape. Our null hypothesis was that in terms of performance, SOFT tape equaled L.I.F.T. tape.

Methods

Six hundred and sixty women underwent prospective transvaginal tape (TVT) surgery for SUI: 210 had the SOFT tape placed and 450 the L.I.F.T. tape. Follow-ups were scheduled at 3 and 12 months.

Results

Objective cure at 3-months’ follow-up was 87 % in the SOFT group vs 94 % in the L.I.F.T. group (p?=?0.003) and at 12 months 86 vs 96 % (p?=?0.0004), respectively. Subjective outcomes were equal. For SOFT tape, the objective failure rate at 3 months was especially pronounced in women older than 70 years: 31 vs 10 % (p?=?0.008), and subjective failure was 24 vs 7 % (p?=?0.01). At 12 months, objective failure for the SOFT tape was significantly higher in both age groups compared with L.I.F.T. [odds ratio (OR) 2.17]. Multivariate analysis showed that body mass index (BMI) ≥30 (OR 2.41), mixed incontinence (MUI) (OR 2.24), use of SOFT tape (OR 2.17), and age?≥?70 years are significant independent risk factors for surgical failure.

Conclusions

Outcomes with SOFT tape are significantly inferior than with L.I.F.T. tape, especially among elderly women. Therefore, the two variants of monofilament polypropylene tape are not interchangeable.

     

One-year outcomes of tension-free vaginal tape (TVT) mid-urethral slings in overweight and obese women

Introduction  The purpose of this study was to assess the impact of body mass index (BMI) on tension-free vaginal tape (TVT) success rates, patient satisfaction, and complications 1 year following surgery. Methods  Baseline and 1-year postsurgery outcomes were abstracted, including Urogenital Distress Inventory (UDI-6) scores, Incontinence Impact Questionnaire (IIQ-7) scores, and patient satisfaction ratings. Multivariable logistic and linear regression analyses were performed to examine relationships between outcomes and BMI. Results  Subjects (N = 195) with a mean age of 59.3 ± 12.6 were included. There was significant improvement within each group (all p values <0.01) in total UDI-6 and IIQ-7 scores from baseline to 1 year postsurgery; all groups had high patient satisfaction. No differences in improvement or complications rates were observed among the BMI cohorts (all p values >0.05). Conclusion  Differential counseling of overweight or obese women regarding outcomes of the TVT procedure is not supported by these results; longer follow-up is warranted. Poster presentation Annual Meeting of the Society of Gynecologic Surgeons, April 2009. Partially supported by the National Institute of Diabetes and Digestive and Kidney Diseases DK068389 to HER.     

Sexual function after tension-free vaginal tape (TVT) for stress incontinence: results of a mailed questionnaire

In a retrospective study we evaluated sexual function after tension-free vaginal tape (TVT) placement for urinary stress incontinence based on responses to a mailed questionnaire at least 3 months after the operation, to a maximum of 1 year. From 1999 to 2002, a sexual function questionnaire was mailed to 128 women (and their partners) who had undergone a TVT procedure for genuine urinary stress incontinence, without pelvic organ prolapse or detrusor instability. The questionnaire was returned by 96 women (75%), 69 (72%) of whom reported being sexually active. Mean frequency of intercourse did not change. Overall, 26% described improved intercourse compared to before the operation. Only one patient described worsening of intercourse after the TVT operation because of an increase in her incontinence. Overall, in this study the technique of tension-free vaginal tape as such seems to have no negative impact on sexual function. However, because of its successful outcome on incontinence, it has a positive overall effect on sexual function. The possible causes of postoperative partner discomfort require further investigation.Abbreviations AVWS Anterior vaginal wall suspension - SUI Stress urinary incontinence - TVT Tension-free vaginal tape This study was supported by the Pelvic Floor & Sexuality research group Leiden. Editorial Comment: The impact of urogynecologic surgery on sexual function is unclear. For those who are incontinent with intercourse, cure of incontinence may improve sexual activity at the price of potential damage to the vaginal anatomy. In this study sexual function following the TVT procedure was evaluated. The authors report that sexual frequency was overall unchanged, and many patients felt that intercourse improved. It appears that much of this improvement is probably related to cure of the incontinence rather than any specific features of the TVT. Although the study is flawed by its retrospective design and a long interval between the procedure and the questionnaire, the results overall are reassuring.     

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。     

经闭孔无张力阴道吊带术治疗女性压力性尿失禁(附16例报告)

目的 探讨经闭孔无张力阴道吊带术(TVT-O)治疗女性压力性尿失禁(SUI)的疗效.方法 经临床和尿动力学检查确诊16例女性SUI患者,手术自尿道外口与阴道外口之间的切口向耻骨和耻骨降支的联合处钝性分离间隙并穿过闭孔,将聚丙烯网吊带无张力置于尿道中段.结果 手术时间平均20分钟,术中出血量平均18ml,术后平均留置导尿...     

Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications

Context

Single-incision mini-slings (SIMS) have been introduced for the treatment of female stress urinary incontinence (SUI); however, concerns have been raised regarding their efficacy. No systematic reviews or meta-analyses have previously assessed these relatively new procedures.

Objective

To assess the current evidence of effectiveness and safety of SIMS compared with standard midurethral slings (SMUS) (retropubic and transobturator tension-free vaginal tapes) in the management of female SUI.

Evidence acquisition

We conducted a literature search from 1996 to January 2011. Meta-analysis of all randomised controlled trials (RCTs) comparing SIMS versus SMUS was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data were analysed using Rev-Man 5. Primary outcomes were patient-reported and objective cure rates. Secondary outcomes included perioperative complications, quality of life (QoL) changes, and costs to health services.

Evidence synthesis

A total of 758 women in nine RCTs with a mean follow-up of 9.5 mo were included. The mean age (52.3 vs 52.1 yr), body mass index (27.4 vs 27.7), and parity (2.4 and 2.4) were comparable for both groups. SIMS were associated with significantly lower patient-reported and objective cure rates at 6-12 mo compared with SMUS (risk ratio [RR]: 0.83; 95% confidence interval [CI], 0.70-0.99, and RR: 0.85; 95% CI, 0.74-0.97, respectively). SIMS were associated with significantly shorter operative time (weighed mean difference [WMD]: 8.67 min; 95% CI, 17.32 to −0.02), lower day 1 pain scores (WMD: 1.74; 95% CI, −2.58 to −0.09), and less postoperative groin pain (RR: 0.18; 95% CI, 0.04-0.72). Repeat continence surgery (RR: 6.72; 95% CI, 2.39-18.89) and de novo urgency incontinence (RR: 2.08; 95% CI, 1.01-4.28) were significantly higher in the SIMS group. There was no significant difference in the QoL scores between the groups (WMD: 33.46; 95% CI, −20.62 to 87.55). No studies compared cost to health services.

Conclusions

SIMS are associated with inferior patient-reported and objective cure rates on the short-term follow-up, as well as higher reoperation rates for SUI when compared with SMUS.     

两种微创术式治疗老年胆囊结石合并胆总管结石的临床对比

目的:比较腹腔镜胆囊切除术(LC)联合胆总管探查取石术(LCBDE)与逆行性胰胆管造影(ERCP)/经十二指肠镜Oddi括约肌切开术(EST)联合LC治疗胆囊结石合并胆总管结石老年患者的临床疗效。方法:回顾分析中日联谊医院2012年10月—2016年4月94例行微创手术治疗的胆囊结石合并胆总管结石老年患者(60岁以上)的临床资料,其中45例行LC+LCBDE(LC+LCBDE组),49例行ERCP/EST+LC(ERCP/EST+LC组),比较两组的相关临床指标。结果:LC+LCBDE组和ERCP/EST+LC组手术成功率(93.3%vs.89.8%,P=0.539)及术后并发症发生率(8.9%vs.10.2%,P=0.892)差异均无统计学差异;LC+LCBDE组住院费用明显低于ERCP/EST+LC组(37 735元vs.48 260元,P0.001);住院时间显短于ERCP/EST+LC组(11.51 d vs.13.39 d,P=0.015)。两组共81例获随访6~48个月,两组患者结石复发、胆道感染发生率无统计学差异(均P0.05),均未发生胆道狭窄、胰腺炎、胆管恶变等情况。结论:LC+LCBDE在住院费用及住院时间方面有明显优势,对胆总管结石的大小、数量无限制,且保护了Oddi括约肌功能,对于多数老年患者应作为首选,但临床工作中仍需坚持个体化原则,根据老年患者的病情及技术条件灵活选择手术方式。     

Retropubic versus transobturator tension‐free vaginal tape (TVT vs TVT‐O): Five‐year results of the Austrian randomized trial

Aims

To compare outcomes of the retropubic versus the transobturator tension‐free vaginal tape (TVT vs TVT‐O) at 5 years.

Methods

A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT‐O). Follow‐up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life. ClinicalTrials.gov (NCT 0041454).

Results

Three hundred and thirty‐one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality‐of‐life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively.

Conclusions

At 5 years, subjective and objective results after TVT and TVT‐O are stable and similar, without statistical significant differences between the procedures. Major long‐term problems appear rare.     

Result of the tension-free vaginal tape in patients with concomitant prolapse surgery: a 2-year follow-up study. An analysis from the Netherlands TVT database

This study assessed the long-term outcome of tension-free vaginal tape (TVT) in women with concomitant pelvic surgery. A prospective cohort study of 746 patients in 41 hospitals was undertaken. The Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) were used to measure the results of the TVT. Fifty-nine patients with concomitant prolapse surgery were compared with 687 women with TVT only. The decrease in IIQ/UDI mean scores were statistically significant in both groups after the TVT. The success rates of “no leakage at all” is comparable for both groups. This study, with 54 gynecologists and urologists participating, showed the long-term (2 years) success rates of TVT with concomitant prolapse surgery. It shows that the procedure in conjunction with prolapse surgery can be safely performed with good results.     

单切口经阴道可调节AjustTM吊带治疗女性压力性尿失禁16例临床分析

目的 评估AjustTM吊带系统手术治疗女性压力性尿失禁(SUI)的安全性和疗效.方法 2013年4月～2013年11月共收集SUI患者16例,应用单切口可调节AjustTM吊带系统进行治疗,记录并分析所有患者的临床资料,包括治愈率、满意度和手术并发症等.结果 16例手术均获得成功,手术时间为9～ 17min,失血量10 ～35mL,平均18±4.5mL.膀胱等盆腔脏器及尿道无损伤,围手术期无会阴血肿的发生,无切口感染发生.16例尿失禁均消失,随访半年无复发.结论 单切口A justTM吊带治疗SUI创伤小,并发症少,疗效良好.     

Use of three-dimensional ultrasound scan to assess the clinical importance of midurethral placement of the tension-free vaginal tape (TVT) for treatment of incontinence

The aim of the study is to illustrate that the midurethral positioning of the tension-free vaginal tape (TVT) may not be necessary to achieve continence. Our secondary aim is to highlight that a fair number of successfully performed TVT procedures do not result in midurethral position of the tape. A review of 31 women who underwent TVT operations and consecutively returned for their follow-up visits from July 2003 to November 2003 was conducted. Their TVT procedures were performed between March 2000 and August 2003. Transperineal three-dimensional ultrasound was used to identify and obtain objective measurements of the position of the TVT tape relative to the urethra. Any patients with significant coexisting vault or uterovaginal prolapse were surgically corrected at the same time. Their stress urinary incontinence was objectively diagnosed by performing urodynamic studies (dual-channel subtraction cystometry, erect stress test) in the outpatient urogynaecology clinic. Postoperatively, patients were reviewed at 1 month and then at 6 months followed by annual reviews subsequently. All women were reassessed at the 6-month follow-up visit with a filling and voiding cystometry to detect recurrent genuine stress incontinence and detrusor instability. Any woman complaining of stress urinary incontinence after that was reassessed with urodynamic studies as mentioned above. The majority of women (67.7%, 21 women) had the TVT tape located in the middle one-third of the urethra; 9.7% (3 women) and 22.6% (7 women) of women had the TVT tape situated in the proximal and distal one-third of the urethra, respectively. Despite this, all 31 women remained continent at their postoperative follow-up visits. The midurethral position of the TVT tape may not be essential in restoring continence. The TVT tape once inserted may not always rest in the midurethral position as described.     

Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up

The objective of the study was to obtain a prospective assessment of the efficacy and the complications associated with the use of tension-free vaginal tape (TVT) for the management of urodynamic stress incontinence at 5- and 7-year follow-up. Sixty-five female patients with stage I cystocele or less who have been operated with TVT procedure for management of urodynamic stress incontinence have been included in the study. At 5-year follow-up, the objective cure rate was 83% and failure rate 9.4%. At 7-year follow-up, the objective cure rate was 80% and the failure rate 13.5%. De novo detrusor overactivity was seen in 9.4% and 11.4% of patients at 5- and 7-year follow-up, respectively. TVT operation is an effective and safe minimally invasive procedure for the management of urodynamic stress incontinence in women without significant cystocele in the long-term follow-up. The 10- and 20-year results are awaited.     

The safety of the inside-out transobturator approach for transvaginal tape (TVT-O) treatment in stress urinary incontinence: French registry data on 984 women

This study examines the safety of the inside-out transobturator approach for transvaginal tape (TVT-O™, Gynaecare) treatment in stress urinary incontinence (SUI) in women based on a French registry of patients. A total of 984 women from 86 centres were enrolled in the study. Patients with predominant overactive bladder or significant pelvic organ prolapse were excluded from the study. Perioperative and post-operative complications were reported as well as urinary function at 4 and 12 weeks. Pain was assessed by the patients using a visual analog scale (VAS). The overall perioperative complication rate was 2.2%. The most commonly reported morbidities were vaginal wall perforation (1.3%) followed by haematoma (0.7%). Post-operative complication rate was 5.2%; the most common complication was residual pain (2.7%). The other complications of paravesical haematoma, urinary retention, vaginal erosion and re-intervention had an incidence of less than 1.0%. This study demonstrates that the transobturator transvaginal tape approach to the treatment of SUI is a safe procedure.     

Female sexual function following surgery for stress urinary incontinence: tension-free vaginal versus transobturator tape procedure

The aim of this study was to compare sexual function outcome following tension-free vaginal (TVT) versus transobturator tape (TOT) for stress urinary incontinence (SUI). All women who underwent TVT or TOT procedures for SUI with no concomitant prolapse repair between January 2002 and July 2007 were sent a retrospective pre-post questionnaire. Eighty-one and 64 women were sexually active before and after TVT and TOT procedures, respectively. Sexual function outcome did not differ pre- and postoperatively for the TVT and TOT groups, and postoperatively between the two groups. Responders reported an improvement of intercourse satisfaction in 23 (29.5%) and 21 (32.9%) cases, whereas 14 (17.3%) and eight (12.5%) complained of sexual function deterioration after TVT and TOT procedure, respectively (p = 0.43). This study suggests that anti-incontinence surgery can have a positive and negative outcome on sexual function, with no significant differences between the TVT and TOT procedures.     

The Incontinence Outcome Questionnaire: an instrument for assessing patient-reported outcomes after surgery for stress urinary incontinence

The aim of this study is to develop and psychometrically test a questionnaire (Incontinence Outcome Questionnaire, IOQ) for assessing quality of life (QOL) after surgery for stress urinary incontinence that can be used as a single measurement after the intervention. A total of 171 patients who underwent the tension-free vaginal tape (TVT/TVT-O) operation for stress urinary incontinence completed the King′s Health Questionnaire (KHQ), the Short Form-12 (SF-12) and the IOQ. The internal consistency, internal and external validity and responsiveness of the IOQ were tested. The IOQ–QOL subscale showed good internal consistency (Cronbach’s alpha = 0.83) and significant correlations with the KHQ and the SF-12 scales (r = 0.30–0.56). Partial correlations with objective parameters showed a significant relation for the IOQ–QOL subscale with objective continence/incontinence. The results of our study suggest that the IOQ is a valid and reliable instrument for assessing QOL after incontinence surgery and can be used if baseline or pre-operative data are unavailable.     

两种组合微创技术治疗胆总管结石比较的前瞻性研究

目的:比较腹腔镜胆囊切除术(LC)联合胆总管探查术(LCBDE)与内镜下乳头括约肌切开取石术(EST)+LC治疗胆总管结石的有效性、安全性及经济性。方法:采用前瞻随机对照的方法,将确诊为胆总管结石的患者按照1:1的比例随机分配为两组,分别采用LC+LCBDE与EST+LC治疗,术后随访6个月,比较两组的相关临床指标。结果:共纳入110例患者。LC+LCBDE组平均手术时间(103.9±18.0)min,平均出血量(15.3±29.5)mL,中转3例(5.5%),平均住院时间(12.02±5.8)d,平均住院费用(32 116±6 503)元,随访未发现残余结石者。EST+LC组平均手术时间(175.2±10.5)min,平均出血量(6.8±7.0)mL,中转2例(3.6%),平均住院时间(11.9±3.0)d,平均住院费用(37 571±5 017)元,术后残余结石1例(1.8%)。两组手术时间、出血量、治疗费用方面有统计学差异(均P0.05),其余指标均无统计学差异(均P0.05)。结论:两种微创治疗方案在有效性及安全性方面无明显差异,LC+LCBDE较EST+LC的治疗费用明显减少。     

A Prospective Multicenter Randomized Comparative Study Between the U- and H-type Methods of the TVT SECUR Procedure for the Treatment of Female Stress Urinary Incontinence: 1-Year Follow-Up

Background

No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure.

Objective

Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI).

Design, setting, and participants

Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study.

Intervention

Subjects were randomly allocated to either the U- or H-type method of TVT-S.

Measurements

Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients’ satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods.

Results and limitations

Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p = 0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p = 0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients’ satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods.

Conclusions

Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method.

Trial registration

The protocol of this study was not registered.     

Long-term outcomes of TVT and IVS operations for treatment of female stress urinary incontinence: monofilament vs. multifilament polypropylene tape

Introduction and hypothesis  We compared cure rates of tension-free vaginal tape (TVT) with intravaginal slingplasty (IVS) and evaluated changes in cure rates over time. Methods  One hundred three underwent TVT and 213 underwent IVS. Follow-ups were done at 3 months, 1 year, and 5 years. Results  The following results were found: objective cure for TVT 98–95–94% vs. IVS 86–86–80% (p < 0.03); subjective cure for TVT 82–79–74% vs. IVS 79–81–71% (NS). In IVS, a significant decline in subjective cure took place. Vaginal erosions were found in 11.8% of women in the IVS group and none in the TVT group. Conclusions  TVT is an effective and stable treatment, whereas IVS has a significant inferior objective cure rate, and a significant decline in subjective cure rate occurred over time. A high rate of vaginal erosions was found in the IVS group. We cannot recommend the use of multifilament polypropylene tape (IVS) for surgical treatment of stress urinary incontinence.     

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.