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1.

INTRODUCTION

Synthetic midurethral slings are the most common operations performed for women with stress urinary incontinence (SUI). However, there is only very scarce evidence regarding the management of complications from these operations. The aim of this survey was to canvass expert opinion regarding the management of recurrent SUI and urinary retention following insertion of these slings.

METHODS

Expert urologists and urogynaecologists in the UK with an interest in SUI were identified. Three clinical scenarios on recurrent SUI and one on urinary retention following midurethral sling placements were emailed twice to the experts.

RESULTS

The majority of the experts chose a repeat synthetic midurethral retropubic transvaginal tape (TVT) as the procedure of choice for recurrent SUI in patients who had had a previous TVT or midurethral transobturator tape inserted. In patients who continued to suffer SUI after a failed second TVT, there were mixed results with experts choosing fascial slings, colposuspension and bulking agents as their preferred method of treatment. In women who develop urinary retention following a TVT, tape pull-down within two weeks was the preferred method among the experts. However, division of the tape within two to six weeks following the procedure was also popular.

CONCLUSIONS

Based on expert opinion, it is difficult to make a recommendation as to the best method of treating recurrent SUI or urinary retention following tape insertion. There is an urgent requirement for well conducted, multicentre, randomised clinical trials to look at the management of these complications and also the tools used to assess the patient before salvage surgical management.  相似文献   

2.

Introduction and hypothesis

It is unclear whether preoperative urodynamic study (UDS) values are predictive of outcomes after midurethral sling.

Materials and methods

We systematically reviewed multiple databases from January 1989 to October 2011 for English-language studies correlating UDS data with postoperative outcomes after midurethral slings. We performed random effects model meta-analyses, as indicated. Relative risk (RR) ratios for the outcome of stress urinary incontinence (SUI) cure were calculated using high maximum urethral closure pressure (MUCP) and Valsalva leak point pressure (VLPP) values as the reference group.

Results

High preoperative MUCP was associated with cure after retropubic [RR 0.67; 95% confidence interval (CI) 0.47–0.97)] and transobturator slings (RR 0.65; 95% CI 0.49–0.90). High preoperative VLPP was also associated with cure after retropubic sling (RR 0.89; 95% CI 0.82–0.96), but this relationship did not achieve statistical significance for cure after transobturator sling (RR 0.86; 95% CI 0.74–1.00).

Conclusions

Preoperative MUCP and VLPP values may add insight into postoperative outcomes after surgical treatment for SUI.  相似文献   

3.

Introduction and hypothesis

To determine the indications and risk factors for needing midurethral sling revision in a cohort of women undergoing midurethral sling placement.

Methods

This was a case–control study of all women undergoing midurethral sling placement for stress urinary incontinence (SUI) between January 2003 and December 2013. Cases were patients who underwent midurethral sling placement followed by sling revision (incision, partial or complete excision). Controls were patients who underwent sling placement only. Once all subjects had been identified, the electronic medical record was queried for demographic and perioperative and postoperative data.

Results

Of 3,307 women who underwent sling placement, 89 (2.7 %, 95 % CI 1.9 – 3.4) underwent sling revision for one or more of the following indications: urinary retention (43.8 %), voiding dysfunction (42.7 %), recurrent urinary tract infection (20.2 %), mesh erosion (21.3 %), vaginal pain/dyspareunia (7.9 %), and groin pain (3.4 %). The median time from the index to the revision surgery was 7.8 months (2.3 – 17.9 months), but was significantly shorter in patients with urinary retention. The type of sling placed (retropubic or transobturator) was not associated with indication for revision. Patients who underwent revision surgery were more likely to have had previous SUI surgery (adjusted odds ratio 4.4, 95 % CI 1.7 – 6.5) and to have undergone concomitant vaginal apical suspension (adjusted odds ratio 2.4, 95 % CI 1.4 – 4.5).

Conclusions

The rate of sling revision after midurethral sling placement was 2.7 %. Urinary retention and voiding dysfunction were the most common indications. Patients with a history of previous SUI surgery and concomitant apical suspension at the time of sling placement may be at higher risk of requiring revision surgery.
  相似文献   

4.

Context

Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results.

Objective

Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI.

Evidence acquisition

A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews.

Evidence synthesis

Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46–0.82; p = 0.00009) and objective (OR: 0.38; CI: 0.25–0.57; p < 0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09–11.68; p = 0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10–0.94; p = 0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12–0.82; p = 0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65–0.99; p = 0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75–3.57; p < 0.00001), hematoma (OR: 2.62; CI: 1.35–5.08; p = 0.005), and storage LUTS (OR: 1.35; CI: 1.05–1.72; p = 0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA).

Conclusions

Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up.  相似文献   

5.

Introduction and hypothesis

Female stress urinary incontinence is highly prevalent, and synthetic midurethral sling placement is the most common type of anti-incontinence surgery performed in the USA. We aimed to identify risk factors associated with surgery used to treated vaginal mesh exposure after midurethral sling placement for stress urinary incontinence.

Methods

We identified women who underwent anti-incontinence procedures from January 2002 through December 2012. Patients with vaginal mesh exposure undergoing surgical repair after midurethral sling placement were compared with a control group without mesh exposure in a 1:3 ratio. Patients with ObTape sling placement (Mentor Corporation) were excluded. Logistic regression models were used to evaluate associations between clinical risk factors and vaginal mesh exposure.

Results

Overall, 2,123 patients underwent primary sling placement, with 27 (1.3 %) having vaginal mesh exposure necessitating surgical repair. Patients with mesh exposure were more likely to have undergone previous bariatric surgery (P?=?0.008), hemoglobin <13 g/dL (P?=?0.006), premenopausal status (P?=?0.008), age <50 years (P?=?0.001), and the retropubic approach to sling placement (P?=?0.03). Multivariate analysis identified these risk factors: previous bariatric surgery (odds ratio [OR], 7.0; 95 % CI, 1.1–61.4), retropubic approach (OR, 5.7; 95 % CI, 1.1–107.0), preoperative hemoglobin <13 g/dL (OR, 2.8; 95 % CI, 1.1–7.5), and premenopausal status (OR, 2.6; 95 % CI, 1.0–7.3). Among postmenopausal patients, those with mesh exposure were significantly more likely to receive preoperative estrogen therapy (OR, 12.4; 95 % CI, 2.7–57.8).

Conclusions

Previous bariatric surgery, retropubic approach, premenopausal status, and lower preoperative hemoglobin were associated with a significantly increased risk of surgery for vaginal mesh exposure after midurethral sling placement. Recognizing these factors can improve preoperative patient counseling.
  相似文献   

6.

Introduction and hypothesis

Our goal was to compare outcomes of repeat vs. primary synthetic slings in patients with stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD).

Materials and methods

We reviewed patients who underwent a sling for SUI with ISD from 2003 to 2010. The patients were divided into two groups according to whether they underwent primary or repeat sling. Surgical success was defined as no incontinence and no reintervention (i.e., urethral bulking) during follow-up. Statistical analysis included the unpaired t test, Wilcoxon rank sums test, chi-squared/Fisher’s exact tests, and logistic regression to identify risk factors associated with failure.

Results

Six hundred and thirty-seven patients with ISD underwent a sling procedure at our institution; 557 (87 %) a primary sling and 80 (13 %) a repeat sling. Patient demographics were similar. Preoperatively, patients with recurrent SUI reported more subjective bother. Mean follow-up was 66.5 weeks (24–374). Success was achieved in 81 % of primary compared with 55 % of repeat slings (p?<?0.0001). Repeat patients were 3.4 times more likely to fail surgery [odds ratio (OR)?=?3.43, 95 % confidence interval (CI) 2.1–5.6]. Additionally 30 % of the repeat group underwent urethral bulking postoperatively compared with 8.6 % in the primary group (OR?=?4.4, 95 % CI 2.5–7.7). Prior incontinence procedures, a positive supine stress test, and transobturator sling were independent risk factors for failure. Among the types of slings placed (transobturator, retropubic, tensioned pubovaginal), pubovaginal slings were most successful (OR?=?2.7, 95 % CI 1.4–5.2).

Conclusion

In women with ISD, repeat slings are associated with lower success rates compared with primary slings. Pubovaginal slings resulted in the highest success rate compared with both transobturator and retropubic slings.  相似文献   

7.

Introduction and hypothesis

The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

Methods

This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

Results

Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

Conclusions

The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.
  相似文献   

8.

Introduction and hypothesis

Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up.

Methods

We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals.

Results

We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR ?5; 95% CI ?0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR ?1; 95% CI ?0.10 to 0.07). Both procedures have low complication rates.

Conclusions

At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.
  相似文献   

9.

Objectives

To evaluate the complication rates of tension-free midurethral slings compared with other surgical treatments for stress urinary incontinence, including other tension-free midurethral slings.

Methods

A systematic review of the literature using MEDLINE, EMBASE, and Web of Science was performed in January 2007. Meta-analysis was conducted by using the Review Manager software 4.2.

Results

Our search identified 33 randomized controlled trials reporting data on complication rates. Our meta-analysis showed that complication rates were similar after tension-free vaginal tape (TVT) and Burch colposuspension, with the exclusion of bladder perforation, which was more common after TVT (p = 0.0001), and reoperation rate, which was significantly higher after Burch colposuspension (p = 0.02). TVT and pubovaginal sling were followed by similar complication rates. With regards to the comparisons among retropubic tapes, TVT and intravaginal slingplasty had similar complication rates, whereas suprapubic arc sling (SPARC) was complicated by higher rates of voiding lower urinary tract symptoms (LUTS) (p = 0.02) and reoperations (p = 0.04). Comparing retropubic and transobturator tapes, the occurrence of bladder perforations (p = 0.007), pelvic haematoma (p = 0.03), and storage LUTS (p = 0.01) was significantly less common in patients treated by transobturator tapes.

Conclusions

Tension-free slings were followed by lower risk of reoperation compared with Burch colposuspension, whereas pubovaginal sling and tension-free midurethral slings had similar complication rates. With regards to different tension-free tapes, voiding LUTS and reoperations were more common after SPARC, whereas bladder perforations, pelvic haematoma, and storage LUTS were less common after transobturator tapes. The quality of many evaluated studies was limited.  相似文献   

10.

Introduction and hypothesis

To determine risk factors for sling revision after midurethral sling (MUS) placement.

Methods

This multicenter case-control study included patients who underwent MUS placement and subsequent revision secondary to voiding dysfunction from January 1999–2007 from nine Urogynecology centers across the USA. Direct logistic regression analysis was used to determine which diagnostic variables predicted sling revision.

Results

Of the patients, 197 met the study criteria. Patient demographics, urodynamic findings, and operative differences did not increase the risk for sling revision. Risk factors for sling revision did include: pre-existing voiding symptoms (OR 2.76, 95% CI 1.32–5.79; p?=?0.004) retropubic sling type (OR?=?2.28, 95% CI 1.08–4.78; p?=?0.04) and concurrent surgery (OR?=?4.88, 95% CI 2.16–11.05; p?<?0.001)

Conclusions

This study determined that pre-existing obstructive voiding symptoms, retropubic sling type, and concurrent surgery at the time of sling placement are risk factors for sling revision.  相似文献   

11.
目的 比较经耻骨后和闭孔入路经阴道尿道中段无张力悬吊术治疗女性压力性尿失禁的临床效果和并发症.方法 应用经阴道尿道中段无张力悬吊术治疗女性压力性尿失禁患者134例,根据手术入路的不同分为两组:耻骨后组(32例)和闭孔组(102例).对两组的手术时间、失血量、治愈率和有效率以及术后并发症进行比较.结果 耻骨后组和闭孔组的手术时间分别为(24±6)min和(22±5)min,术中失血量分别为(45±27)ml和(54±23)ml,治愈率分别为81.25%和78.43%,有效率分别为96.88%和98.04%,两组比较差异无统计学意义(P>0.05).两组术后并发症的发生率分别为:新发尿急6.25%和5.88%,排尿困难:3.13%和2.94%,膀胱损伤:3.13%和0%,阴道损伤:0%和2.94%,两组比较差异无统计学意义(P>0.05).术后腹股沟疼痛的发生率分别为3.13%和20.59%,两者差异有统计学意义(P<0.05).结论 耻骨后入路和闭孔入路尿道中段悬吊术均是治疗女性SUI的有效术式.  相似文献   

12.

Introduction and hypothesis

Despite established comparable efficacy between retropubic midurethral (RMUS) and transobturator slings, there are conflicting data regarding single-incision mini-slings (SIMS). This study tests the null hypothesis that the MiniArc® Single-Incision Sling is equivalent to the ALIGN® Urethral Support System for treatment of stress urinary incontinence (SUI).

Methods

Women who underwent a sling for SUI from 1 January 2008 through 31 December 2009 were identified (N?=?324). A follow-up survey was mailed. Primary outcomes were treatment failure, defined as International Consultation on Incontinence Questionnaire (ICIQ) score >0 or additional anti-incontinence procedure, and stress-specific incontinence (SSI). Secondary outcomes included Patient Global Impression of Severity and Improvement (PGI-SI), satisfaction, de novo urge, and complications.

Results

The study included 202 women who returned the survey. The SIMS group had higher body mass index (BMI) (30.7?±?6.5 vs 28.9?±?6.0 kg/m2, P?=?0.052) and shorter follow-up (18.6?±?11.5 vs 22.9?±?14.6 months, P?=?0.019). Treatment failure was higher in SIMS compared with RMUS (76.3 % vs 64.2 %) with adjusted odds ratio of 1.84 (95 % CI, 1.0, 3.5). The SIMS group was more likely to have postoperative SSI, with adjusted OR of 2.4 (95 % CI; 1.3–4.5). The RMUS group reported more improvement and satisfaction. Incidence of de novo urge and complications were similar between groups. Reoperation for mesh erosion was more likely in the RMUS group, while the SIMS had a higher reoperation rate for SUI.

Conclusions

Compared with retropubic ALIGN® Slings, MiniArc® Single-Incision Slings are less effective, with more postoperative incontinence, less patient-reported improvement, satisfaction, and higher reoperation rates for SUI.  相似文献   

13.

Introduction and hypothesis

Stress urinary incontinence is a common problem affecting 12-46 % of women. A cohort of women have a more severe form of stress urinary incontinence usually due to intrinsic urethral sphincter deficiency that has traditionally resulted in lower success rates with standard treatment modalities. We aim to address the question of whether transobturator sling insertion is more effective than retropubic sling insertion in the treatment of intrinsic sphincter deficiency-related stress urinary incontinence in women.

Methods

We searched MEDLINE, CINAHL, CENTRAL, journals, and major conferences (up to 30 June 2014). All randomised controlled trials in women with stress urinary incontinence or mixed urinary incontinence with associated intrinsic sphincter deficiency who underwent a retropubic or transobturator mid-urethral sling operation were included in this meta-analysis. The Cochrane risk of bias tool and the GRADE system were used to assess the quality of evidence.

Results

Fifty-five randomised controlled trials compared transobturator and retropubic mid-urethral slings. Twelve trials included women with intrinsic sphincter deficiency, but only 8 trials (399 women) reported data specifically for this cohort. There was a statistically significant difference in short- and medium-term (≤5 years) subjective cure rates, with the number of women reporting a cure in the transobturator group at 150 out of 199 and the retropubic group at 171 out of 200. This gives a 12 % relative risk reduction in achieving cure with the transobturator route (RR 0.88, 95 % CI 0.80 to 0.96, I2?=?0 %, moderate quality evidence [GRADE]). Objective cure was reported by five trials of 324 women and showed no statistically significant difference between the two groups, with a rate of 110 out of 159 in the transobturator group and 126 out of 165 in the retropubic group (RR 0.90, 95 % CI 0.79 to 1.03). Post-operative voiding dysfunction and de novo urgency or urgency urinary incontinence in the two treatment groups showed no significant difference. The need to undergo repeat incontinence surgery in the long term (≥5 years) was higher with the transobturator route (RR 14.4, 95 % CI 1.95 to 106, 147 women).

Conclusions

Mid-urethral slings are effective in treating women with intrinsic sphincter deficiency-associated stress urinary incontinence. The retropubic route resulted in higher subjective cure rates compared with transobturator routes. Both routes improved the overall quality of life.
  相似文献   

14.

Introduction

We present a novel outpatient transobturator autologous rectus fascia midurethral sling procedure.

Methods

A 55-year old woman presented with stress urinary incontinence (SUI) as documented by history, physical exam, and 24-h pad test. Conservative and surgical treatment options were discussed. The patient was interested only in outpatient surgical options, however, and was adamantly opposed to any mesh procedures due to concerns regarding complications. Therefore, following an in-depth discussion and informed consent, a transobturator, autologous sling procedure was performed. The vaginal dissection was performed in the standard fashion. A rectus fascial strip measuring 7?×?1 cm rectus fascia was harvested. A trocar was passed through each obturator foramen. Fascial stay sutures were retracted through the skin incisions. The sling was then appropriately tensioned and the stay sutures tied together.

Results

The patient had an uncomplicated perioperative course. She voided spontaneously with low postvoid residual. At follow-up, she had no urinary leakage.

Conclusions

The transobturator autologous midurethral sling procedure is technically feasible and, in the short term, effective. Longer follow-up and larger series are needed to validate this procedure, which, however, may become a suitable option for patients and surgeons concerned with potential mesh complications.  相似文献   

15.

Introduction and hypotheses

One of the most relevant topics in the field of pelvic floor dysfunction treatment is the long-term efficacy of surgical procedures, in particular, the use of prosthesis. Hence, a systematic review and meta-analysis was conducted to evaluate the long-term effectiveness and safety of midurethral sling (MUS) procedures for stress urinary incontinence (SUI), as reported in randomised controlled trials (RCTs) and non-randomised studies.

Methods

This systematic review is based on material searched and obtained via PubMed/Medline, Scopus, and the Cochrane Library between January 2000 and October 2016. Peer-reviewed, English-language journal articles evaluating the long-term (≥5 years) efficacy and safety of MUS in women affected by SUI were included.

Results

A total of 5,592 articles were found after the search, and excluding duplicate publications, 1,998 articles were available for the review process. Among these studies, 11 RCTs (0.6%) and 5 non-RCTs (0.3%) could be included in the qualitative and quantitative synthesis. Objective and subjective cumulative cure rates for retropubic technique (TVT) and transobturator tape (TOT; both out–in and in–out) were 61.6% (95% CI: 58.5–64.8%) and 76.5% (95% CI: 73.8–79.2%), and 64.4% (95% CI: 61.4–67.4%) and 81.3% (95% CI: 78.9–83.7%) respectively. When considering TOT using the out–in technique (TOT-OI) and TOT using the in–out technique (TVT-O) the objective and subjective cumulative cure rates were 57.2% (95% CI: 53.7–60.7%) and 81.6% (95% CI: 78.8–84.4%), and 68.8% (95% CI: 64.9–72.7%) and 81.3% (95% CI: 77.9–84.7%) respectively. Furthermore, this article demonstrates that both TVT and TOT are associated with similar long-term objectives (OR: 0.87 [95% CI: 0.49–1.53], I 2?=?67%, p?=?0.62) and subjective (OR: 0.84 [95% CI: 0.46–1.55], I 2?=?68%, p?=?0.58) cure rates. Similarly, no significant difference has been observed between TTOT-OI and TVT-O) in objective (OR: 3.03 [95% CI: 0.97–9.51], I 2?=?76%, p?=?0.06) and subjective (OR: 1.85 [95% CI: 0.40–8.48], I 2?=?88%, p?=?0.43) cure rates. In addition, this study also shows that there was no significant difference in the complication rates for all comparisons: TVT versus TOT (OR: 0.83 [95% CI: 0.54–1.28], I 2?=?0%, p?=?0.40), TOT-OI versus TVT-O (OR: 0.77 [95% CI: 0.17–3.46], I 2?=?86%, p?=?0.73).

Conclusions

Independent of the technique adopted, findings from this systematic review and meta-analysis suggest that the treatment of SUI with MUS might be similarly effective and safe at long-term follow-up.
  相似文献   

16.

Background

Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc).

Objective

To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS.

Design, setting, and participants

Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible.

Outcome measurements and statistical analysis

Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0–100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain.

Results and limitations

We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p = 0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p = 0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p < 0.01).

Conclusions

At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain.

Patient summary

This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.  相似文献   

17.

Introduction and hypothesis

De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence.

Methods

We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05.

Results

Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58).

Conclusions

Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.
  相似文献   

18.

Background and Objectives:

Five cases of pelvic nerve complications after transobturator tape (TOT) inside-out surgical procedures for stress urinary incontinence are presented.

Methods:

We conducted a chart review of patients with complications referred to our practice.

Results:

Five patients with nerve complications after TOT inside-out procedures were investigated. Pudendal neuropathy and interstitial cystitis were seen in this series of patients with several patients having myofascial pain in the lower abdominal area.

Conclusions:

Although not commonly reported, complications from needle placement and from the area of needle exit in a TOT procedure can exist, and the surgeon must be careful when placing the needle through the area of the obturator fossa.  相似文献   

19.

Background

Midurethral slings have become the most preferred surgical treatment for female urinary incontinence.

Objective

To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention.

Design, setting, and participants

Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence.

Intervention

Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure.

Outcome measurements and statistical analysis

Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires.

Results and limitations

A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups.

Conclusions

Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen.

Patient summary

Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high.

Trial registration

ClinicalTrials.gov identifier NCT00379314.  相似文献   

20.
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