urinary incontinence affects up to 50% of women , resulting in a significant medical , social , and economic burden .
the annual direct costs of incontinence in the united states were estimated to be more than $ 16 billion . among women with incontinence ,
50% to 80% are identified as having stress urinary incontinence ( sui ) , or involuntary leakage of urine resulting from physical exertion or sneezing and coughing . .
similar to its frequency in western countries , about 37.8% of korean adult women suffer from sui .
although the initial treatment of stress incontinence is often nonsurgical ( behavioral therapy , pelvic - floor exercises , or incontinence devices ) , surgical treatment is considered for patients who are bothered by persistent symptoms .
an estimated 4% to 10% of women in the united states undergo surgery intended to restore continence , and this rate has increased steadily during the past 20 years . at present , one of the most successful treatments for sui is provided by surgery .
burch corposuspension was once the standard technique , but tension - free vaginal tape ( tvt ) is now the gold standard .
tvt is a minimally invasive procedure with a cure rate comparable to burch corposuspension in an appropriate randomized control study .
however , tvt has the risk of serious complications associated with the ' blind ' course of the needle through the retropubic space . therefore , bladder perforation as well as vascular and bowel injuries are occasionally reported [ 10 - 12 ] . for obviation of needle passage through the retropubic space ,
the transobturator sling procedure demonstrated a comparable cure rate but fewer complications associated with needle passage through the retropubic space .
however , the trans - obturator sling can induce entrapment of the obturator nerve , and groin and upper thigh pain occasionally occur .
therefore , further improvement of the surgical methods for the treatment of sui is needed .
the tvt - secur system was developed to reduce the invasiveness of the surgical procedures and to avoid passing the needle through the retropubic or obturator regions .
the advantages of this technique are related to the short course of the needles , which minimizes the risk of vascular , nerve , or visceral injury .
the prosthetic implant is placed under the midurethra and can be fixed in the hammock ( h ) position into the obturator internus muscle or in the u - shaped position into the connective tissue of the urogenital diaphragm behind the pubic bone .
some concerns may arise regarding the strength of the fixation point and the tensioning maneuver .
herein , we conducted a prospective , randomized , comparative study to compare effectiveness and safety between the h and u approaches of the tvt - secur procedure for the treatment of female sui .
this was a 12-month , randomized trial involving one experienced surgeon at a single medical center .
participants received detailed information about the study procedure and provided written consent before study entry .
consenting patients were randomly allocated to either the u - type or the h - type method immediately .
women who were 18 years old or older and presented with urodynamic sui for at least 3 months were selected for this study .
patients with a history of prior anti - incontinence surgery or stage 2 pelvic organ prolapse were excluded .
baseline measures included patient demographics , detailed medical and surgical history , and obstetric and gynecological history .
all women underwent a physical examination for urethral hypermobility , as measured by the q - tip test , and pelvic - organ prolapse .
preoperatively , we assayed women by a urodynamic study , sandvik questionnaire , incontinence quality of life questionnaire ( i - qol ) , bristol female lower urinary tract symptoms - scored form ( bfluts - sf ) questionnaire , incontinence visual analogue scale ( i - vas ) , 3-day voiding diary , and uroflowmetry . just after the decision of surgery ,
changes in the i - qol questionnaire , bfluts - sf questionnaire , i - vas , 3-day voiding diary , and uroflowmetry were assessed ; complications were also assessed .
patients ' perception of treatment benefit , satisfaction , and willingness to undergo retreatment or recommend treatment were also evaluated .
cure was defined as no leakage during stress after surgery at the 12-month postoperative visit .
the primary endpoint was the difference in the cure rate of sui between the h- and u - type approaches .
the secondary endpoints included differences in 1 ) postoperative changes in i - qol , bfluts - sf , i - vas , uroflowmetry , and voiding diary ; 2 ) patients ' perception of treatment benefit , satisfaction , and willingness to undergo retreatment or recommend treatment ; 3 ) perioperative parameters ( operative time , bleeding amount , and immediate postoperative pain vas ) ; and 4 ) return to normal activities . overall cure rate and complications were also evaluated .
our institutional review board approved this study , and written informed consent was obtained from all participants before enrollment .
random allocation to either the u or the h approach was performed after obtaining informed consent .
all operations were conducted at a day care surgery center by the same experienced surgeon . under a combination of local anesthesia and light sedation , patients were positioned in the dorsal lithotomy position . after infiltrating mixed normal saline with lidocaine and 1:200,000 epinephrine into the anterior vaginal wall ,
an approximately 1.5 cm midline vertical vaginal incision was made from 1 cm below the external urethral meatus , and paraurethral dissections were processed bilaterally . for the u - type procedure ,
the inserter was grasped without the protective cover and using the needle holder , and the inserter was introduced into the previously dissected paraurethral incision orienting the inserter to 45 from the sagittal midline and toward the ipsilateral shoulder .
the inserter was advanced upward until the back edge of the pubic bone was reached , keeping the inserter tip against the backside of the pubic bone .
the needle driver was disconnected from the first inserter and was connected to the second inserter after removing the protective cover .
the second inserter and device were placed in the back side of the pubic bone in the same manner . after disconnecting the needle holder from the second inserter
after the final adjustment , the release wire was pulled and the inserters were removed . for the h approach ,
dissection was made laterally , towards the ischiopubic ramus and parallel to the floor on both sides , and the inserter and device were positioned firmly into the obturator internus muscle .
urethral catheters were not used , and patients were discharged after several instances of self - voiding .
random allocation to either the u or the h approach was performed after obtaining informed consent .
all operations were conducted at a day care surgery center by the same experienced surgeon . under a combination of local anesthesia and light sedation
, patients were positioned in the dorsal lithotomy position . after infiltrating mixed normal saline with lidocaine and 1:200,000 epinephrine into the anterior vaginal wall ,
an approximately 1.5 cm midline vertical vaginal incision was made from 1 cm below the external urethral meatus , and paraurethral dissections were processed bilaterally . for the u - type procedure ,
the inserter was grasped without the protective cover and using the needle holder , and the inserter was introduced into the previously dissected paraurethral incision orienting the inserter to 45 from the sagittal midline and toward the ipsilateral shoulder .
the inserter was advanced upward until the back edge of the pubic bone was reached , keeping the inserter tip against the backside of the pubic bone .
the needle driver was disconnected from the first inserter and was connected to the second inserter after removing the protective cover .
the second inserter and device were placed in the back side of the pubic bone in the same manner . after disconnecting the needle holder from the second inserter
after the final adjustment , the release wire was pulled and the inserters were removed . for the h approach ,
dissection was made laterally , towards the ischiopubic ramus and parallel to the floor on both sides , and the inserter and device were positioned firmly into the obturator internus muscle .
urethral catheters were not used , and patients were discharged after several instances of self - voiding .
from march 2007 to july 2008 , 115 women with sui underwent the tvt - secur procedure .
of those , 53 underwent the u - type surgery , and 62 underwent the h - type surgery .
initially , 133 women were enrolled and randomly allocated to either the u - type ( n=66 ) or the h - type ( n=67 ) procedure . of those , 13 women in the u - type group and 5 women in the h - type group withdrew informed consent and did
the mean age was 55.219.34 years in those receiving the u - type surgery and 56.68.68 years in those undergoing the h - type approach ( p= 0.410 ) .
there were no significant differences in preoperative patient characteristics or perioperative parameters between the u - type and h - type approaches ( table 1 , 2 ) .
cure rates were 88.7% ( 47/53 ) for the u - type approach and 87.1% ( 54/62 ) for the h - type approach ( p=0.796 ) , with an overall cure rate of 87.8% after 12 months postoperatively .
the i - qol ( total and all subscale scores ) , filling , incontinence , sexual function , and qol sum ( bfluts - sf ) , and incontinence vas were significantly improved with both approaches , but the degree of improvement did not differ significantly between the two approaches ( table 3 ) . regarding the voiding diary , micturition episodes were reduced with both approaches , but urgency episodes decreased significantly with only the h - type approach ( table 3 ) . the maximal flow rate did not change with either approach , but post - void residuals increased in women treated with the h method ( table 3 ) .
approximately 82.9% of women treated with the u - type approach and 84.3% of those treated with the h - type method reported that they were satisfied with the surgical outcome ( p=0.858 ) . a total of 80.5% of those treated with the u - type method and 86.3% of those treated with the h - type approach reported a benefit from the surgery ( p=0.455 ) .
about 87.8% and 88.0% treated with the u - type and the h - type approaches , respectively , reported that they would recommend the surgery to others who had sui ( p=0.442 ) .
also , 87.8% and 86.3% treated with the u - type and with the h - type methods reported that they would undergo the same surgery if they had been in same condition ( p=0.800 ) . regarding intra - operative parameters ,
the mean duration of the operation was 14.86.3 min for the u - type approach and 13.45.1 min for the h - type approach ( p=0.114 ) .
the mean amount of blood loss was 56.445.3 ml for the u - type approach and 66.471.6 ml for the h - type approach ( p=0.645 ) .
immediate postoperative pain vas was 2.22.0 for the u - type approach and 2.11.8 for the h - type approach ( p=0.926 ) .
the time required for patients to return to normal activities was not significantly different between the approaches ( table 4 ) .
there were no patient complaints about dyspareunia or loss of libido after either type of procedure .
there were 3 cases of intra - operative vaginal wall perforations during the h - type approach .
all 3 cases were immediately repaired , and the wound healed without infection or erosion .
immediate postoperative retention was observed in 2 women treated with the u - type approach and in 1 woman treated with the h - type method .
one woman had tape release and additional cutting procedures for persistent and large amounts of residual urine .
overall , 4 women underwent additional midurethral sling procedures for persistent urine leakage . in detail , transobturator tape ( tot ) was applied for 3 women as an additional sling procedure and tvt was applied for 1 woman .
our study demonstrated that there was no significant difference in the cure rate between the u - type and the h - type methods of tvt - secur , with an approximately 88% overall cure rate after 1 year of follow - up , compared with previous studies reporting 1-year cure rates of 91% for tvt , 92% for tot , and 86% for tvt - obturator ( tvt - o ) procedures . to our knowledge
, no comparative studies between tvt - secur and other midurethral sling procedures such as tvt and tot have been performed . also ,
although there are some reports on tvt - secur , no prospective comparative study of the u and h methods has been carried out . in our study , both types of surgery demonstrated comparable cure rates and patient - reported outcomes at the 1-year follow - up .
our study demonstrated a comparable cure rate with the other sling methods , including tvt , the gold standard treatment for female sui .
a few studies have reported unfavorable outcomes for tvt - secur [ 19 - 21 ] . recently , however , a prospective study reported a 1-year cure rate as high as 93.5% .
in addition , miniarc , other types of midurethral slings with single - incision systems , have resulted in up to 91% 1-year cure rates .
an important point for obtaining continence is the disconnection of the inserter from the mesh .
this entails a gentle twist of the handle while gently pushing the device into the patient 's body .
this maintains the ideal tension of the mesh , which should be left abutting the urethra , forcing the periurethral tissues to protrude slightly through the mesh pores .
otherwise , the mesh will not be firmly attached to the connective tissue and will fail to provide adequate tension to the urethra .
tvt - secur is an 8 cm long polypropylene mesh with the absorbable end able to be fixed to the obturator internus internal fascia that can be inserted through a single 1.5 cm vaginal incision .
the extension of the dissection required to create a passage for the sling is very limited .
because neither sutures nor inserting needles are needed , the risk of internal injury inherent to the blind passage of inserting needles is hypothetically minimized . because mortalities have been reported after midurethral slings associated with perineal fasciitis   as well as vascular and bowl injury [ 10 - 12 ]
, safety must be considered when choosing the type of midurethral sling . in our study , 6 cases of complication were reported .
there were no cases of bladder perforation , which occurs in up to 11% of tvt procedures . nor were there any cases of vessel injury , which usually results from the blind course of the needles and occurs in up to 4.0% of those treated with tvt .
furthermore , no patient suffered from postoperative persistent groin or thigh pain due to obturator nerve entrapment by the mesh , which occurs in up to 14.3% of those treated with the transobsturator sling series .
the technique for placing the tvt - secur can be rapidly learned by the average surgeon qualified to treat sui .
however , caution is required when placing the tvt - secur extremities in the fibrous attachment of the internal obturator muscle , because this might not be quickly achieved by inexperienced surgeons .
the tvt - secur needle dimension requires a wider tunnel , and surgeons probably need some experience with the procedures to find it
. the operator must be careful to avoid vaginal perforation . in this study , there were 3 cases of intra - operative vaginal wall perforation with the h - type approach .
tvt - secur , especially the h - type , 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 .
neuman also reported a 10% incidence of vaginal tape protrusion , a 5% incidence of tape removal , a 2% incidence of bladder outlet obstruction , and a 1% incidence of paravesical hematoma .
changes in post - void residuals were significantly larger with the h - type approach than with the u - type approach .
tvt induces urethral obstruction more frequently than do trans - obturator procedures , as evidenced by ultrasonographic and urodynamic findings .
currently , it is unclear why the h - type approach resulted in significantly larger post - void residuals in our study than the u - type approach ; clinically , however , the increase is thought to be insignificant .
furthermore , of the 3 patients with immediate postoperative urinary retention , none needed additional treatment for persistent large post - void residuals or voiding symptoms after removal of the temporary urethral catheter .
generally , studies comparing tvt and tot reported no difference in de novo frequency and urgency
interestingly , midurethral sling procedures are effective in improving preexisting overactive bladder symptoms in half of the patients with mixed incontinence .
contact with urine in the proximal urethra can induce a reflex contraction of the detrusor muscle .
thus , eliminating urinary leakage may decrease this reflex after anti - incontinence surgery . at present , improvement in overactive bladder symptoms , including urgency and de novo urgency , after tvt - secur need further study .
statistically considered sample size calculation for randomized controlled trials was not applied for the design of this study . for the calculation of an optimistic sample size , the investigator must have some information on both the variability of response to therapy and the assumed degree of effectiveness of therapy .
but , because only a few reports provided information about the variability and effectiveness of each subtype of tvt - secur before our study , statistically considered sample size calculation was not applicable for this study . at baseline ,
the abdominal leak point pressure ( alpp ) of the h - type approach group was significantly higher than that of the u - type group .
but , because the absolute difference in mean value was just 7.46 cmh2o and the proportion of intrinsic sphincter deficiency ( isd , alpp<60 cmh2o ) between the u - type ( 0.37% ) and h - type ( 0.48% ) groups was not significantly different ( p=0.87 ) , the difference in alpp may be clinically insignificant .
however , this unbalanced baseline characteristic could be a prognostic factor having a negative effect on the u group .
if random allocation had been more balanced and clinically significant effect - size and power had been calculated , the surgical outcome of the u - type approach could have been superior to that of the h - type . at this time
, we can not explain the exact reasons for persistent urine leakage after tvt - secur .
all 4 women who underwent additional midurethral sling because of persistent sui after tvt - secur were cured .
therefore , one possible explanation for failure is suboptimal urethral tension of tvt - secur .
the goal of a minimally invasive surgical procedure should be to provide an acceptable cure rate that is comparable to that of standard methods as well as a relatively low incidence of complications . in the context of the acceptable cure rate and low rate of complications compared with tvt and tot
, our study demonstrates that with relatively short - term follow - up , both the u - type and the h - type approaches of the tvt - secur procedure are equally effective and safe for the treatment of female sui .
both the u - type and the h - type approaches of the tvt - secur system are effective procedures in terms of cure rate and patient - reported outcomes for the treatment of female sui with 1 year of follow - up . there were no severe complications related to either approach .
 purposewe compared outcomes of the u- and h - type approaches of the tension - free vaginal tape ( tvt)-secur procedure for the treatment of female stress urinary incontinence ( sui).materials and methodsfrom march 2007 to july 2008 , 115 women with sui underwent tvt - secur by a single surgeon . 
 patients were randomly assigned to either the u- or the h - type approach . 
 after 12 months , postoperative changes in the sandvik questionnaire , incontinence quality of life questionnaire ( i - qol ) , bristol female lower urinary tract symptoms - scored form ( bfluts - sf ) , and postoperative patient satisfaction were evaluated . 
 cure was regarded as no leakage on the sandvik questionnaire . 
 complications were also evaluated.resultsof 115 women , 53 were treated with the u approach , and 62 women were treated with the h approach . at 12 months , 
 88.7% of those treated with the u approach and 87.1% of those treated with the h approach were cured ( p=0.796 ) . 
 the i - qol and filling , incontinence , sexual function , and qol sum ( bfluts - sf ) scores were improved with both approaches , and there were no significant differences in the degree of improvement between approaches . 
 approximately 83.7% and 82.9% of the women treated with the u and h approaches , respectively , were satisfied with the outcome ( p=0.858 ) . 
 there were 3 cases of intra - operative vaginal wall perforation in the h - type group . 
 immediate postoperative retention was observed in 2 women in the u - type group and 1 woman in the h - type group . 
 one woman in the u - type group underwent tape releasing and cutting procedures for persistent large post - void residuals.conclusionsthe u- and the h - type approaches of the tvt - secur procedure provided comparable effectiveness for the treatment of female sui . 
INTRODUCTION
MATERIALS AND METHODS
1. Surgical procedure
RESULTS
DISCUSSION
CONCLUSIONS