How common are tape erosions? A comparison of two versions of the transobturator tension‐free vaginal tape procedure

OBJECTIVE: To compare two transobturator suburethral tapes (Obtape, Mentor-Porges and TVT-O, Gynaecare, Johnson and Johnson) used in the management of urodynamic stress incontinence (USI), for tape erosion (vaginal/urethral) rates, clinical presentation, management and outcome. PATIENTS AND METHODS: We retrospectively studied women who underwent a transobturator suburethral tension-free vaginal tape (TVT) procedure for managing USI in a tertiary referral centre in the West of Scotland over a 36-month period. In our department, the transobturator approach has been the first-choice approach for TVTs since July 2003. Two types of tapes were mainly used, Obtape and TVT-O, and the choice of tape was primarily decided by the surgeons' preference. RESULTS: In all, 316 women had a transobturator tape procedure, of which 96 were associated with another procedure; 112 women had TVT-O using the 'inside-out' technique and 204 had the 'outside-in' technique. Of the latter, 192 had Obtape, four had Obtryx (Boston Scientific) and eight had Monarc (American Medical Systems Inc.) tapes. Sixteen women developed vaginal tape erosion, and significantly more were in the Obtape group than in the TVT-O group (7.29% vs 1.78%, P = 0.038). The patients' age, body mass index, previous vaginal surgery and concomitant vaginal surgery were not significant risk factors for erosions. The time between surgery and diagnosis of erosion was 1-45 weeks, with only one patient being asymptomatic; all others presented with clinical symptoms such as vaginal bleeding, discharge and dyspareunia. Thirteen patients were continent at presentation and 10 of these remained continent after surgical management. In the TVT-O group the erosions were in the lateral vaginal wall, while in the Obtape group the erosions were in the form of central tape extrusion secondary to defective vaginal wall healing. CONCLUSION: There were significantly more vaginal tape erosions in the Obtape group than in the TVT-O group. No cases of urethral erosions were identified.     

Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial

Introduction and hypothesis

The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust?) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up.

Methods

This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O).

Results

The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p?=?76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p?=?1.0, OR 1.22, 95 % CI 0.24 – 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p?=?0.76, OR 0.77, 95 % CI 0.17 – 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse.

Conclusions

After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.

     

Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence

Introduction and hypothesis

The minimally invasive tension-free vaginal tape (TVT) operation has become the “gold standard” of incontinence surgery. The aim of the present study was to evaluate the long-term effect of the tape material and to assess the continence status 17 years after surgery

Methods

A cohort of 90 women operated upon with the TVT procedure at three Nordic centers has been prospectively followed for 17 years. All of the women alive according to national registries were contacted and invited to visit the clinics for evaluation. Pelvic examination was performed to reveal any adverse effects of the tape material. Objective and subjective continence status were assessed by a cough stress test and the patients’ global impression of improvement as well as by condition-specific quality of life questionnaires.

Results

Seventy-eight percent of the potentially assessable women were evaluated either by a clinic visit or by a telephone interview. One case of a minimal, symptom-free tape extrusion was seen. No other tape complications occurred. Over 90 % of the women were objectively continent. Eighty-seven per cent were subjectively cured or significantly improved.

Conclusion

The TVT operation is durable for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects     

Does age affect the outcome of suburethral tape surgery? The importance of national registries in answering bigger questions

Introduction and hypothesis

The objective of this article was to use the British Society of Urogynaecology (BSUG) database to assess the impact of age on success rates and insertion complications of suburethral tapes for primary procedures using the Patient Global Impression of Improvement (PGII) as the primary endpoint.

Methods

We carried out a retrospective analysis of data at a national level (BSUG database) using PGII as the primary outcome measure. Secondary outcomes included improvement in stress incontinence and complications from surgery. All episodes of suburethral tapes on the database were extracted and analysis was by decade of life.

Results

A total of 7,600 cases were identified on the database, of which 757 were in women over 70 years of age, with 119 in women over 80. Just over 80 % of the cases on the database involved retropubic and just under 20 % transobturator tapes. Short-term follow-up was available for 54 % of the cases. The PGII remained high in all age groups, but did decrease slightly with age, with more than 90 % of women under 50 scoring highly, which reduced to 70 % in those over 80. Improvement in stress incontinence was globally high, with 98 % scoring highly in the women aged under 50 and 85 % in the 80+ group. This suggests that the suburethral tapes worked well in treating stress incontinence. Reassuringly, complications did not increase with age, although short-term voiding difficulties were higher with increasing age.

Conclusion

Contributing to national databases gives useful information that may be difficult to ascertain from RCTs. Suburethral tapes appear to have good efficacy and low complications with increasing age.

     

Are there any factors predicting the cure and complication rates of tension-free vaginal tape?

Predictive factors that could possibly affect the cure and complication rates of tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence (SUI) were investigated. Seventy-five consecutive patients with urodynamically proven SUI and who had undergone a TVT operation were evaluated according to a follow-up protocol. Median age was 51.2 (33–69). Thirteen (17%) of the patients had had previous anti-incontinence surgery. Sixteen (21%) patients had complained of pure stress and 59 (79%) of mixed incontinence. Valsalva leak point pressure (VLPP) values had been found to be below 60 cmH₂O in 36 (48%) and over 60 cmH₂O in 39 (52%) patients, while detrusor overactivity (DO) had been detected in six (8%) patients during urodynamic evaluation. Local, general, and epidural anesthesia had been performed in 43 (57%), 29 (39%), and three (4%) patients, respectively. Univariate analyses were done using Fishers exact and Chi-square tests. Multivariate analyses were done using logistic regression test to determine predictive factors affecting cure and complication rates. Mean surgical and hospitalization times were 34.7 min (20–70) and 1.2 days (1–5), respectively. Mean follow-up was 21.6 months (6–38). Cure and improvement rates were 89 and 8%, respectively. Thirty-one complications were observed in 27 (36%) patients. Intraoperative bladder perforation and bleeding occurred in three (4%) and two (3%) patients, respectively. Sixty-six (88%) patients voided spontaneously after TVT while nine (12%) performed clean intermittent catheterization (CIC) for a period of time. Seven of nine patients regained the spontaneous voiding ability within 1 month. The tape was cut in two of these retentive patients and one with severe storage lower urinary tract symptoms (LUTS) either unilaterally or bilaterally. On univariate (Fishers exact test, p =0.018), and multivariate (Logistic regression, p =0.013) analyses, patient age was the only statistically significant parameter affecting the cure rate, which was significantly lower particularly over 55 years of age. No significant factor predicting the complications was detected. TVT is an effective and safe surgical procedure in the treatment of SUI. In this study age was the only significant predictive factor affecting the cure rate while no significant factor predicting the complications was detected. Cure rate was significantly lower in patients over 55 years of age. Editorial Comment: This review of the TVT experience in the authors institution again reports a fairly high success rate with this procedure. Contrary to some other articles, the type of anesthesia did not appear to affect cure rate, but the patients age did. In addition, prior incontinence surgery, and whether the procedure was performed by attending or resident, did not affect the most common complication, which was intraoperative bladder perforation. Interestingly, the authors report that most of the bladder perforations were not obvious on cystoscopy, but were found when urine extruded from the suprapubic incisions. A note of caution to all surgeons.     

Suburethral tape via the obturator route: is the TOT a simplification of the TVT?

Suburethral meshes can be implanted via the classic retropubic route (TVT) or by a new insertion technique that passes the tape into the obturator foramen (TOT). In a retrospective study we compared one 18-month period of 94 TOT (tension-free obturator tape) and one 18-month period of 99 TVT (tension-free vaginal tape), which preceded the change in the approach route. All operations were performed by the same surgeon using the same Prolene mesh and withno other surgical procedure associated. These two series were similar in terms of patient age, previous surgical history, degree of incontinence and preoperative urethral closure pressure. The analysis shows morehemorrhagic complications in the TVT group (10%) than in the TOT group (2%), but the difference was not significant. Bladder injuries were more frequent in the TVT group (10%) than in the TOT group (0%), but there was one urethral injury in the TOT group. The mean follow-up was 29.5 months in the TVT group and 12.8 months in the TOT group. The urinary results were the same, with 90% and 95% cured, respectively. In conclusion, the obturator approach shows identical urinary results to the classic retropubic approach. Because of the nature of the procedure, major hemorrhage and bowel perforation are excluded in the TOT procedure. Thus simplicity, safety and continence result mean that the obturator approach represents the best method of suburethral tape insertion for the treatment of urinary stress incontinence.Abbreviations TOT Tension-free obturator tape - TVT Tension-free vaginal tapeEditorial Comment: These authors describe a comparison between tension-free vaginal tape and a new transobturator midurethral sling procedure. Although the study is significantly limited because of its non-concurrent, non-randomized design, and by the fact that follow-up was done via telephone with only 75% of patients, the authors do show that there are early data to suggest that the transobturator technique may have similar efficacy and fewer side effects than the tension-free vaginal tape technique.     

Seven years of objective and subjective outcomes of transobturator (TVT-O) vaginal tape: Why do tapes fail?

Introduction and hypothesis

This study reports long-term outcomes of the transvaginal tension-free vaginal tape–obturator (TVT-O) procedure for treating stress urinary incontinence (SUI), including possible risk factors for failure.

Methods

This was a retrospective study of women who underwent TVT-O with or without concomitant prolapse surgery. Procedures were performed at a tertiary referral urogynecology unit. Participants presented with SUI and had urodynamic stress incontinence (USI). Women with a history of previous anti-incontinence procedures, radical pelvic surgery, and detrusor overactivity (DO) were excluded. Objective cure was defined as absence of urine leakage during a cough stress test (CST). Subjective outcome was based on the International Consultation on Incontinence Questionnaire for Evaluating Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Quality of life was assessed using the King’s Health Questionnaire (KHQ). Univariate and multivariate analyses were used to identify risk factors for subjective failure.

Results

One hundred twenty-four consecutive women were assessed, with a median follow-up of 90.3 (range 80–103) months. Overall objective and subjective cure rates were 81.5 % (101/124) and 83.5 % (103/124), respectively. A significant improvement was observed in all KHQ domains. Concomitant vaginal hysterectomy [odds ratio (OR)?=?2.98, 95 % confidence interval (CI)?1.10–8.05, p?=?0.03] and increasing point C (OR?=?1.17, 95 % CI 1.05–1.30, p?=?0.006] were associated with a higher risk for subjective failure. De novo urgency rate was 7 %.

Conclusions

The TVT-O procedure provides high objective and subjective long-term efficacy, a clinically meaningful improvement in patient quality of life, and an excellent safety profile. Concomitant vaginal hysterectomy and apical compartment prolapse were associated with a higher risk for objective and subjective failure.     

Injury of the corona mortis during vaginal tape insertion (TVT-Secur? using the U-Approach)

Introduction and hypothesis  

We report a serious bleeding complication due to injury of the corona mortis following insertion of a transvaginal tape, TVT-Secur™ (Ethicon Women's Health, Sommerville, NJ, USA).     

Surgical therapy of female stress incontinence 2001. TVT (tension-free vaginal tape)--what else?

Ohne Zusammenfassung     

Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling

Introduction and hypothesis

Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust? SIMS and the Align? transobturator tape sling.

Methods

We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported.

Results

We randomized 30 women to the Ajust? group and 28 to the Align? group. At 1 year the cure/improvement rates were 93.3% in the Ajust? group and 96.4% in the Align? group. The rate difference for cure/improvement was of ?3.1% (95% CI ?14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust? SIMS under the pre-established criteria. Three women in the Ajust? group reported persistent thigh pain 1 year after surgery, but none in the Align? group reported pain.

Conclusions

At 1 year, the Ajust? SIMS showed non-inferior effectiveness compared with the Align? transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust? group.

     

Are the outcomes of transobturator tape procedure for female stress urinary incontinence durable in long-term follow-up?

Purpose

To evaluate long-term cure rates and late complication rates after treatment for female stress urinary incontinence (SUI) with transobturator tape (TOT) procedure and to compare the outcomes of 1st year versus 5th year.

Methods

We analyzed 138 women who underwent TOT procedure for pure SUI and mixed urinary incontinence in two institutions during the time period of June 2005–May 2008 retrospectively. We used two kinds of polypropylene monofilament tapes (Heine Medizin^®urethral support system, Germany and I-STOP^®CL Medical, France) for the standard outside-in TOT in similar numbers. All patients were evaluated with pelvic examination including cough stress test and International Consultation on Incontinence Questionnaire-Short Form at 3 and 12 months and annually. Our primary outcome measures were rates of objective cure, subjective cure, patient satisfaction and failure for long-term follow-up.

Results

The objective cure, subjective cure and patient satisfaction rates of the 126 women at 1 year were 89.6, 86.5 and 92 % respectively. During 5-year follow-up, objective cure rate was stable with 87.3 % rate (p = 0.554), whereas subjective cure and patient satisfaction rates were decreased to 65.9 and 73 %, respectively (p = 0.001). Complications are reported according to the Clavien–Dindo classification with Gr I 14.3 %, Gr II 64.3 %, Gr IIIa 7.1 % and Gr IIIb 14.3 %.

Conclusions

TOT procedure is an effective minimal invasive procedure with satisfactory results for female SUI in short term. Although recovery in SUI symptoms was stable during 5-year follow-up, subjective cure and patient satisfaction rates decreased significantly due to urge urinary incontinence symptoms.     

„Tethered tape“ oder der 4. Faktor

Background

This is the first report of a newly identified cause of recurrent stress urinary incontinence (SUI) after midurethral tape insertion.

Patients and methods

This article reports a series of cases with primary or secondary tape failure including clinical presentation and findings, the results of pelvic floor (PF) ultrasound, and the (surgical) correction of malpositioned vaginal tapes.

Results

A vaginal tape for treating SUI must be accurately placed under the mid-third of the urethra and at a distance of 3–5 mm from the urethra. Alignment parallel to the urethra in the urethrovaginal septum is also essential for adequate function. A tethered tape refers to the adhesion of a tape edge to the anterior vaginal wall either during primary wound closure or due to secondary ingrowths and is typically associated with recurrent SUI during activities or changes in posture. Less common is SUI through an increase in pressure from cranially, which occurs when coughing or laughing. “Vaginal polyps” may point to imminent vaginal erosion of the tape. In the sagittal plane, the PF examination will identify an oblique orientation of the tape at rest, an abnormal closeness of the tape to the transducer, and changes in tape shape upon manipulation of the vaginal probe. Once the diagnosis has been established, a tethered tape is easy to correct by realignment or tightening to accomplish correct positioning parallel to the urethra. This measure restores tape function and continence.

Conclusion

Primary or secondary failure of a tension-free vaginal tape may be caused by a tethered tape. This complication can be diagnosed on the basis of characteristic findings at PF ultrasound. In most women, the tape position can be corrected and there is no need for tape removal.     

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women—2-year follow-up

Introduction and hypothesis

The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI).

Methods

This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked “Never”/“Urine does not leak” in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented.

Results

One hundred ninety-seven women with proven SUI were randomized into three groups—TVT-O (n?=?68), TVT-S H (n?=?64), and TVT-S U (n?=?65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2?years (SD, 0.8; range, 0.1 to 3.8?years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p?<?0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p?=?0.02).

Conclusions

Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.     

Does concomitant vaginal prolapse repair affect the outcomes of the transobturator tape procedure in the long term?

Introduction and hypothesis

Little information is available on the effects of concomitant vaginal prolapse repair on the outcomes of the transobturator tape (TOT) procedure. The purpose of this study is to assess the results and complications of TOT when combined with vaginal prolapse repair with a long-term follow-up.

Methods

We conducted a retrospective cohort study of 232 female patients who underwent the TOT procedure at two institutions. There were two groups: group 1 consisted of patients who had undergone TOT alone and group 2 consisted of patients who had undergone concomitant vaginal prolapse repair. The outcomes were analyzed considering four postoperative parameters: objective cure, subjective cure, resolution of urgency urinary incontinence (UUI), and patient satisfaction. The mean follow-up was 66.3 months (range 60–85).

Results

A total of 117 patients in group 1 and 104 patients in group 2 were documented in this study. The subjective and objective cure rates were 87.17 %, 64.95 % in group 1 and 89.42 %, 68.26 % in group 2. Patient satisfaction rates (visual analog scale [VAS] score ≥80) were 71.79 and 83.65 % in groups 1 and 2 respectively (p?=?0.035). Complications were reported according to the Clavien–Dindo classification with grade I 7.7 %, grade II 69.2 %, grade IIIa 7.7 %, and grade IIIb 15.4 %, and grade I 9.5 %, grade II 47.6 %, grade IIIa 42.8 %, and grade IIIb 0 % in groups 1 and 2 respectively.

Conclusions

Concomitant vaginal prolapse repair with TOT does not have any negative effects on continence outcomes; on the contrary, it increases patient satisfaction.