No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure.
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.
Subjects were randomly allocated to either the U- or H-type method of TVT-S.
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.
Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method.
The protocol of this study was not registered.
Keywords: Female stress urinary incontinence, Randomized comparative study, TVT SECUR.
Since tension-free vaginal tape (TVT) was introduced as a minimally invasive surgery for stress urinary incontinence (SUI), there has been an effort to develop a safer and less invasive procedure to avoid blind passage of the needle through the retropubic region. With this aim in mind, Delorme  described the transobturator tape (TOT). In a recent review  that compared TVT and TOT, the occurrence of bladder perforation, pelvic hematoma, and storage symptoms was significantly less common in patients treated with TOT. However, TOT carried risks of groin pain or neurovascular injury in the obturator region . Single-incision midurethral slings (MUS), the TVT SECUR (TVT-S; Gynecare, Menlo Park, CA, USA), the MiniArc (American Medical Systems, Minnetonka, MN, USA), and the Mini-Sling (ProSurg, San Jose, CA, USA), were developed to minimize those risks by the short course of the devices. The TVT-S consists of PROLENE mesh, 8 cm in length, with ends coated with an absorbable fleece material that provides fixation. The system can be fixed in a U-shaped (U) position into the connective tissue of the urogenital diaphragm or in a hammock (H) position into the obturator internus muscle.
To date, no study has been published that compares the U- and H-type methods. We conducted this study to compare the efficacy and safety of the two methods of the TVT-S in women with SUI.
2. Materials and methods
This 12-mo multicenter randomized trial involved 13 experienced surgeons (performed >15 cases of TVT-S before this trial) at 13 hospitals. Participants received detailed information about the study procedure and provided written consent before study entry. This study was performed in accordance with the principles of the Declaration of Helsinki.
Women ≥18 yr of age with urodynamic SUI or mixed urinary incontinence (MUI) with a predominance of SUI were eligible for inclusion. Women who had pelvic organ prolapse (POP) stage ≥2 on the POP quantification system , the intention to have more children, or a neurologic disease were excluded.
Consenting patients were randomly allocated to either the U- or H-type method in the operating room. Under local (and/or light sedation), spinal, or general anesthesia, surgery was performed according to the manufacturer’s instructions. For the U-type method, the inserters were introduced into the paraurethral space orienting to 45° from the sagittal midline and advanced upward until the back edge of the pubic bone was reached, creating a U-shaped sling (Fig. 1a). For the H-type method, the inserters were introduced into the obturator internus muscle parallel to the floor creating a hammock-shaped sling (Fig. 1b). An important technique was to remove the handle gently while carefully inserting the device into the connective tissue, so the ideal tension would be applied to the mesh without allowing it to loosen. Cystoscopic examination was performed in the U-type method. A urethral catheter was introduced only in the case of postoperative retention.
(a) U-shaped position and (b) hammock (H) position of the TVT SECUR system.
Baseline evaluation included each participant’s demographics, medical and surgical histories, obstetric and gynecologic histories, pelvic examination, and urodynamic study. The urodynamic study was performed according to the International Continence Society standards . At baseline and postoperative 12-mo visits, patients were assayed using the standing stress test, the Sandvik questionnaire , the Incontinence Quality of Life (I-QOL) questionnaire , the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) , the Incontinence Visual Analogue Scale (I-VAS; 0, no incontinence; 10, extremely severe incontinence) , and a 3-d voiding diary. One week after surgery, uroflowmetry and postvoid residuals were measured. Patients described urgency sensation associated with each micturition in the voiding diary using the Urinary Sensation Scale (USS; 1, no urgency, to 5, urgency incontinence) . Urgency episodes were defined as the number of micturition-associated urgencies with a USS score ≥3. We asked the patients to describe (1) if the surgery was beneficial, (2) if the surgery was satisfactory, (3) whether they would undergo the surgery again if necessary, and (4) whether they would recommend the surgery to others. Preoperative patients’ most important goal for the surgery were collated, and postoperative goal achievement (GA) was assessed using a Likert scale (0, not at all achieved; 5, completely achieved). Successful achievement was defined as a score of 4 or 5.
Operation time, estimated blood loss (EBL; calculation, total volume to volume of prefilled water in the suction chamber), immediate postoperative pain VAS (0, no pain; 10, excruciating pain), and perioperative complications were evaluated.
The primary end point was the cure rate at the 12-mo postoperative visit. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively.
2.5. Statistical methods
The center applied a stratified permuted block randomization method. Patients who had a standing stress test at baseline and the 12-mo postoperative visits consisted of the efficacy set. The safety set consisted of all participants who received the study procedure. We compared the continuous or ordinal variable between the two methods using the student t test or Mann-Whitney U test according to the normality of distribution. Comparison of nominal variables was performed using the chi-square test. Postoperative change was analyzed using the paired t test or Wilcoxon signed rank test. The Bonferroni correction was applied where necessary. SAS software v.9.1.3 (SAS Institute Inc, Cary, NC, USA) was used, and a p value <0.05 was considered statistically significant.
Of the 330 women enrolled, 285 (144 in the U group and 141 in the H group) were included in the efficacy analysis (Fig. 2). Table 1 shows the participants’ demographics. Age, menopausal status, percentage of women with detrusor overactivity (DO), and number of urgency episodes were not balanced between the groups. The mean duration of the surgery was 17.0 ± 9.7 min, and the mean duration of hospital stay was 1.0 ± 1.2 d without a significant difference between the groups. The mean EBL was 44.0 ± 80.3 ml (U, 41.8 ± 38.7 vs H, 39.0 ± 64.4; p = 0.674). The mean pain VAS was 2.4 ± 2.0 (U, 2.5 ± 2.1 vs H, 2.3 ± 1.8; p = 0.530).
|Variables||Total (n = 285)||U type (n = 144)||H type (n = 141)||p value|
|Age, yr, mean ± SD||54.2 ± 9.1 (32–85)||55.4 ± 9.1 (35–79)||53.0 ± 8.9 (32–85)||0.0136*|
|BMI, mean ± SD||24.0 ± 3.0 (17.3–39.1)||24.1 ± 3.1 (18.2–39.1)||23.9 ± 2.9 (17.3–31.7)||0.9384*|
|Parity, mean ± SD||2.6 ± 1.1 (0–9)||2.7 ± 1.2 (0–6)||2.6 ± 1.1 (1–9)||0.9900*|
|Symptom duration, yr, mean ± SD||5.8 ± 5.3 (0.3–33.0)||6.0 ± 5.6 (0.5–33.0)||5.6 ± 5.0 (0.3–30.0)||0.9801*|
|Stamey symptom grade||0.6515*|
|VLPP, cm H2O, mean ± SD||89.6 ± 25.3 (13–170)||89.8 ± 24.5 (15–170)||89.4 ± 26.2 (13–165)||1.0000*,§|
|ISD, VLPP ≤60 cm H2O||11.4%||9.8%||13.0%||0.7815†,§|
|MUCP, cm H2O, mean ± SD||46.5 ± 21.2 (11–117)||46.3 ± 21.5 (11–117)||46.8 ± 20.9 (11–114)||0.7821*|
|Voiding diary parameters|
|Frequency/24 h, mean ± SD||9.0 ± 2.8 (4–22)||9.0 ± 2.6 (4–22)||9.1 ± 2.9 (4–22)||1.0000*|
|Nocturia/24 h, mean ± SD||1.2 ± 1.1 (0–6)||1.3 ± 1.2 (0–6)||1.2 ± 1.1 (0–5)||0.8327*|
|Urgency episode/24 h, mean ± SD||2.4 ± 3.2 (0–22)||2.9 ± 3.4 (0–13)||1.9 ± 3.0 (0–22)||0.0211*|
* Mann-Whitney U test.
† Chi-square test.
§ Bonferroni correction.
BMI = body mass index; DO = detrusor overactivity; ISD = intrinsic sphincter deficiency; MUCP = maximum urethral closing pressure; VLPP = Valsalva leak point pressure.
The overall objective cure rate was 83.9% (239 of 285); 87.5% (126 of 144) for U versus 80.1% (113 of 141) for H (p = 0.091). The overall subjective cure rate was 76.4% (217 of 284); 77.1% (111 of 144) for U versus 75.7% (106 of 140) for H (p = 0.786). Table 2 summarizes the postoperative changes in the outcome measures and the comparison of the changes between groups. The improvement in all domain scores of the I-QOL questionnaire was greater in the U group. Filling, incontinence, and QOL domain scores of the ICIQ-FLUTS were significantly further improved in the U group. There was no difference in the improvement in voiding diary parameters and I-VAS between groups. Women in the U group reported higher rates of satisfaction, willingness to have surgery again, and willingness to recommend the surgery (Fig. 3). Of the 108 women who had MUI at baseline, 41.5% (U, 45.8% vs H, 37.0%; p = 0.383) reported that their urgency incontinence was cured after surgery.
Comparisons of the changes in outcome measures between the U- and H-type methods
|Variables||Total||U-type method||H-type method||p value|
|Preop||Postop||Preop||Postop||Preop||Postop||U vs H†|
|Sexual function score||1.74||0.87*||1.81||0.81*||1.66||0.94*||0.421|
|Voiding diary parameters|
|Urgency episode/24 h||2.37||1.22*||2.88||1.40*||1.86||1.04*||0.329|
* p < 0.05; comparison between pre- and postoperative, Wilcoxon signed rank test, or paired t test with Bonferroni correction.
† Comparison between U- and H-type methods, Mann-Whitney U test, or t test.
Avo/Lim = avoidance and limiting behavior; ICIQ-FLUTS = International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms; I-QOL = Incontinence Quality Of Life questionnaire; PVR = postvoid residuals; Qmax = maximum flow rate; QOL = quality of life; I-VAS = Incontinence Visual Analogue Scale.
Patients’ 12-mo perception of treatment benefit, satisfaction, willingness to have retreatment, and willingness to recommend.
Patients’ goals for the surgery consisted of five categories, and most were related to symptom relief (Table 3). After surgery, the median point of GA was 4.5 (U, 4.5 vs H, 4.0; p = 0.123). And 81% (U, 83.8% vs H, 78.2%; p = 0.546) reported that their goal was achieved successfully.
Patient-reported goals and goal achievement (n = 220)
|Category||n (%)||PGA (median, quartile)|
|Symptom relief||152 (69.1%)||4.5 (4, 5)|
|Stress incontinence||140 (63.6%)||4.5 (4, 5)|
|Frequency||6 (2.7%)||4.5 (4, 4.5)|
|Urgency||2 (0.9%)||4 (4, 4)|
|Weak stream||1 (0.5%)||2.5|
|Pelvic discomfort||2 (0.9%)||3.25 (2, 4.5)|
|Activity/exercise||47 (21.4%)||4.8 (4, 5)|
|Quality of life||12 (5%)||5 (4, 5)|
|Coping behavior||8 (4%)||4.7 (2.5, 5)|
|Sexual function||1 (0.5%)||5|
PGA = Patient-reported goal achievement.
3.2. Complications and additional procedures
Three cases of lateral vaginal wall perforation occurred during the H-type method. All cases were repaired immediately, and there were no wound complications.
A woman in the H group received 2 pt of blood due to postoperative dizziness and intraoperative bleeding (500 ml). After transfusion, her symptom was relieved, and no hematoma or intravaginal bleeding was found on physical and pelvic examination. Postoperative retention occurred in two U-group and three H-group cases. All of them recovered their normal voiding after 1 or 2 d with an indwelling urethral catheter.
De novo urgency was reported in 7.3% (U, 7.0% vs H, 7.6%; p = 0.858), and none of them reported de novo urgency incontinence. No women complained of postoperative dyspareunia.
Eleven women, six U-group and five H-group cases, received the tape plication procedure for persistent or recurrent SUI. Of those, two U-group cases had an additional H-type method of TVT-S, and three U-group cases had MUS (two TVT and one TOT). Mesh erosion and bladder or urethral injuries were not reported during the study period.
This is the first randomized study comparing the U- and H-type methods of the TVT-S. We found that cure rate was comparable between the two methods 12 mo after surgery. However, outcomes regarding QOL and satisfaction were in favor of the U-type method. We believe that the higher cure rate of the U-type method, even though it did not reach statistical significance, would affect the results.
Reported cure rates of TVT-S are similar to ours, ranging from 78% to 100% , , and . Meschia et al  in particular reported 79% and 77% success rates in the H- and U-type methods, respectively. Another single-incision sling, MiniArc, was reported as having a 69–91% cure rate  and . Our result is also comparable with those of conventional MUS whose 1-yr cure rate is 85–93%  and .
Our study population showed heterogeneous characteristics in terms of the MUI, intrinsic sphincter deficiency (ISD), and urethral hypermobility (UH). Moreover, there were unbalanced baseline characteristics regarding age, menopausal status, DO, and number of urgency episodes. Therefore, we conducted subanalysis comparing cure rates according to those variables and found that they did not change the cure rates significantly. However, according to the subanalysis by the presence of UH, the subjective cure rate was lower in the H group among women with UH (U, 86.5% vs H, 72.4%; p = 0.033). This result was different from the study conducted by Martan et al , which reported that in the group of women with larger UH it might be better to place the tape in the H position. The other results were also inconsistent with existing data in which MUI, ISD, and DO were reported as negative impact factors  and . Those disagreements might be due to the small or unbalanced sample size, especially in terms of DO. Also, mild symptom of urgency incontinence might be responsible for the similar cure rate between women with pure SUI and MUI because we included only the women with MUI with a predominance of SUI.
We explored the goal and GA of the woman with SUI. Patient-reported GA has been studied as the “fourth dimension” assessment in the study of pelvic floor disorders . A recent study demonstrated a strong correlation of GA with pelvic floor disorder–specific QOL and satisfaction . High GA in our study might result from homogeneous and realistic goals for SUI (Table 3).
Studies comparing TVT and TOT report comparable efficacy. Our study also shows similar cure rates between the U- and H-type methods. However, there is controversy in the safety profile. Porena et al  reported that TOT was as safe as TVT. In contrast, Zullo et al  reported that TOT had a lower complication rate. We had more complications in the H group. Three cases of vaginal wall perforation, one case of increased bleeding, and three cases of retention were reported in the H group. In comparison, two cases of retention were reported in the U group. Neuman  reported a 4% incidence of vaginal perforation in the first 100 cases. The TVT-S requires a wider tunnel to prevent dragging of the vaginal submucosal connective tissue when placing the end of the device into the fibrous tissue of the internal obturator muscle. Otherwise, the needle can perforate the vaginal wall. Regarding the bleeding, Masata et al  reported a case of severe bleeding from the internal obturator muscle following the H-type method. The authors suggested the scalpel-shaped tip of the inserter and the insertion technique as the possible reasons. Also, they suggested that to prevent the injury of the muscle, it is necessary not to shake or rotate the inserter during its removal . Those complications associated with the H-type method can be dealt with early in the learning curve. Therefore, a surgeon must receive adequate training before attempting this surgery.
De novo urgency is another controversial issue. Several studies reported no difference in the incidence of de novo urgency between TVT and TOT  and . In contrast, Deval et al  and Krauth et al  reported a lower rate of de novo urgency after TOT, suggesting the route of approach as a possible reason. However, David-Montefiore et al  proposed the use of nonelastic slings rather than the route of procedure as the main reason. Our study found no difference in the incidence of de novo urgency and the changes in urgency episode between methods (Table 2).
Although some unbalanced baseline characteristics were prognostic factors and appeared to have a negative effect on the U group, the U-type method showed superior outcomes. If random allocation had been balanced, and clinically significant effect size and power had been calculated, the difference in the cure rate between methods would have had statistical significance. Another limitation is that we cannot be sure of the final position of the tape. According to the published data on this issue, TOT was at a less acute angle and localized to a more distal part of the urethra than the retropubic tape, resulting in a lower rate of urethral kinking and less urethral compression . A study using perineal ultrasonography could provide some clues on this subject in the TVT-S procedure.
Both the U- and H-type methods of the TVT-S provide a comparable cure rate for female SUI. However, the U-type method shows more favorable results in terms of QOL and treatment satisfaction.
Author contributions: Jeong Zoo Lee had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Kyu-Sung Lee, Ju Tae Seo, Na, Choo, Joon Chul Kim, Jun Hyoung Seo, Yoon, Jeong Gu Lee, Duk Yoon Kim, Yoo, Min, Hong, Jeong Zoo Lee.
Acquisition of data: Kyu-Sung Lee, Ju Tae Seo, Na, Choo, Joon Chul Kim, Jun Hyoung Seo, Yoon, Jeong Gu Lee, Duk Yoon Kim, Yoo, Min, Hong, Jeong Zoo Lee.
Analysis and interpretation of data: Kyu-Sung Lee, Young-Suk Lee, Jeong Zoo Lee.
Drafting of the manuscript: Kyu-Sung Lee, Young-Suk Lee.
Critical revision of the manuscript for important intellectual content: Jeong Zoo Lee.
Statistical analysis: Kyu-Sung Lee, Young-Suk Lee.
Obtaining funding: None.
Administrative, technical, or material support: Kyu-Sung Lee.
Supervision: Jeong Zoo Lee.
Other (specify): None.
Financial disclosures: I certify that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None.
Funding/Support and role of the sponsor: None.
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a Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
b Cheil General Hospital & Women’s Healthcare Center, Kwandong University College of Medicine, Seoul, Korea
c Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
d Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
e Holy Family Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea
f CHA Medical Center, Pochon Cha University College of Medicine, Pochon, Korea
g Daehang Hospital, Seoul, Korea
h Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
i Daegu Catholic University Medical Center, Daegu Catholic University College of Medicine, Daegu, Korea
j Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea
k Paik Institute of Clinical Research, Inje University College of Medicine, Busan, Korea
l Bundang Cha Hospital, Pochon CHA University College of Medicine, Seongnam, Korea
m Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
Corresponding author. 305 Gudeok-Ro, Seo-Gu, Pusan 602-739, South Korea. Tel. +82 51 240 7350; Fax: +82 51 255 7133.
© 2010 European Association of Urology, Published by Elsevier B.V.