Clinical and Quality-of-life Outcomes after Autologous Fascial Sling and Tension-free Vaginal Tape: a Prospective Randomized Trial

Purpose: Evaluate the impact autologous fascial sling (AFS) and tension-free vaginal tape (TVT) procedures on quality-of-life in incontinent women. Materials and Methods: Forty-one women were randomly distributed into two groups. Group G1 (n = 21), underwent AFS and group G2 (n = 20) TVT implant. The clinical follow up was performed at 1, 6, 12 and 36 months. Results:


INTRODUCTION
Urinary incontinence (UI) can have a severe impact on quality of life (QoL).Thus, assessing the effect of interventions is of relevance.QoL is a experience of physical, emotional and social well being, as well as perceptions of health status (1).In general, UI has been shown to affect the psychologicultural values, beliefs, self concepts, goals, age and life expectancy.It is usually measured using structured

Neurourology Neurourology
There are two major types of QoL questionnaire, geforms are often used inappropriately in incontinent women (3) and it is necessary to use a disease or Sling procedures have been used for treatment of urinary incontinence in women since the beginning of the 20 th grafts include patients with a history of poor vaginal healing, pelvic bone trauma, pelvic radiation therapy, preference (6).Success rates of autologous graft used Tension-free vaginal tape (TVT) has been introduced as a minimal invasive sling procedure for treatment of stress urinary incontinence (SUI) with a high success rate (8).
The aim of this study was to evaluate the impact of autologous fascial sling (AFS) and TVT procedures on QoL in incontinent women.

MATERIALS AND METHODS
Botucatu Medical School -UNESP, with a principal complaint of stress urinary incontinence were studied in a prospective trial.These patients were randomly distributed into two groups.Group G1 (n = 21) was submitted to AFS and Group G2 (n = 20) to TVT where the procedures (TVT and Sling) were written on small pieces of paper, folded and placed into a closed box.It was opened just before the surgery when the medical team found out which procedure would be procedures were performed by the same surgeon.This Botucatu Medical School -UNESP.
Before surgery, stress urinary incontinence was in all study participants.The following parameters were max ), maximum detrusor pressure (P det.max ) and maximum urinary max ) during voiding.Valsalva leak-point pressure (VLPP) was obtained when the patient, in lithotomy position, reported the desire to void due to maximum the presence of spontaneous or provoked involuntary detrusor contractions during vesical filling phase, obstruction was considered when P det /Q max exceeded 2 max ) below 12 mL per second (10).Patients with involuntary detrusor contractions or preexisting bladder outlet obstruction during urodynamic analysis were excluded.
The clinical follow-up was performed and subjective success rate was evaluated in a transversal cut off at 1, 6, and 12 months and then annually after hospital discharge.A questionnaire was used to obtain personal data, obstetric, gynecologic, family medical reported by the patient.
erative development of symptoms of urgency, which were not present before surgery and persisted for more than 1 month.These symptoms were based on clinical evaluation.and impact on QoL were performed at 36 months after surgery.For QoL evaluation, a validated and personal interviews were conducted.The quesdomains that measure female perception of general health and the impact of urinary symptoms on life.
low women to rate the impact of urinary symptoms physical/social limitations, personal relationships, emotions and sleep and energy.The third section assesses the severity of measures associated with urinary incontinence.The fourth section consists of a separate scale for rating different urinary symptoms, including stress incontinence.Scores in each domain range between zero and 100, a higher score indicating a greater impairment of at the different dates.
Body mass index (BMI) was calculated and All patients underwent physical examination including stress test.The degree of pelvic organ prolapse was assessed and graded according to Baden et al. (13).
Basal laboratory investigations (serum creatinine, complete blood count, chemical and microscopic urinalysis, urine culture) were all routinely performed.In exceptional cases (history of lithiasis, urinary infection) renal ultrasound and plain X-ray of the kidney, ureters and bladder were carried out.
In the immediate postoperative, intravenous tramadol (10 mg/mL -1 ) was used in a patient-con--1 (administered over a period of 30 min), a continuous background i.v.infusion was -1 and a demand bolus injection was data bank.

Operative Technique
Autologous fascial sling was carried-out as A transverse suprapubic incision for withdrawal of the rectus fascia strip (10 x 2 cm) and aponeurosis closure was done with 1-vicryl thread.The strip was prepared and both its edges were tied with 0-prolene, which was left long.A Foley catheter was used to empty the bladder.A submucosal saline injection was performed on the anterior vaginal wall and a longitudinal incision was performed 2 cm from the Then the strip of rectus fascia was positioned with the aid of Stamey needle around the middle urethra maintaining the strip without tension.The wires were mucosa and the suprapubic skin incision were then submitted to autologous sling.
The TVT procedure was performed as described by Ulmsten et al., except that the operation copy was performed in all patients.
Foley catheter was left indwelling for 1 day in all patients after anti-incontinence surgery.The following parameters were postoperatively evaluated: operativeroom time, objective postoperative pain, complications, length of hospital stay, postoperative catheterization, and time to return to normal activities.
The analysis of clinical and urodynamic characteristics were performed using the Mann-Whitney the Godman test as regards the categorical ones (16).

RESULTS
demographic data and urodynamic parameters were preoperatively observed between groups (Table-1).than with AFS.There was no statistical difference between groups in bladder injuries, hospitalization time, post-operative catheterization and return to normal activities (Table-2).There was neither prolonged urine retention nor other complications in both groups.
Although 2 patients, one from each group, died from other diseases within the 36-month following interval was used for satisfaction assessment.at 36 months with no difference between groups. - The comparison between satisfaction rate and health.

COMMENTS
In our study, the initial demographic and urodynamic data demonstrated homogeneity between the groups.
In the immediate postoperative period, there were no differences between the groups, except for the TVT group.Similar outcomes were observed in  In general, cure rate may be based on a great variety of parameters, some of them seem to be very lenient whereas others are relatively subjective.Therefore, it may be more appropriate to report each selected variable separately in order to accurately convey true outcomes.In our series, cure rate was considered as complete dryness with no usage of pads, and similar results were observed in both groups.Applying the same cure criteria in observed short-term success rates with AFS and TVT this study.

Variables
Urgency incontinence is usually more bothersome for women than stress urinary incontinence.have higher BMI, and higher parity than those without has been suggested as one of the causes of de novo urgency, which could be due to extensive bladder dissection for pubovaginal sling in contrast with TVT procedure that required little dissection (20).both groups studied here.Nonetheless, given that de novo urgency is more bothersome, this fact might have similarly interfered with the quality of life of de novo detrusor overactivity with AFS and no cases

Group Satisfaction Rate Statistics
AFS 20 80 TVT with TVT implant (20).It is noteworthy that in this study the diagnosis of de novo urgency was based on clinical rather than urodynamic criteria, and this might explain the higher incidence observed.

Domain of KHQ
Long-term satisfaction rate did not statisti-higher satisfaction rate in AFS group.
In long-term evaluation of QoL no statistical difference was observed between groups.This study assessed the effect of AFS versus TVT on QoL in the surgical treatment of UI in women.The measurement incontinence, given that it is largely a symptom-de-that AFS and TVT produced similar improvements in QoL at 36-month study.Morgan et al. (21), using who had undergone AFS or TVT.
The analysis between satisfaction rate and in anti incontinence procedures.

CONCLUSION
In this study, AFS and TVT yielded similar results, except for operating time which was shorter countries where synthetic slings are often costly.
sidering AFS is associated with lower cost and rate of disease transmissions, as well as no rejections when compared with synthetic techniques.procedure for genuine stress urinary incontinence--a detrusor instability after anti-incontinence surgery: analysis of urinary incontinence severity after autologous fascia pubovaginal sling, pubovaginal sling and contrast among multinomial populations.Annals of sling vs polypropylene tape at short-term followup: of tension-free vaginal tape and fascia lata for stress had undergone the tension-free vaginal tape (TVT)

EDITORIAL COMMENT
The authors present a randomized study, with mid-term follow-up, comparing autologous versus synthetic retropubic sling to treat patients with urodynamic stress urinary incontinence.It is a very important study, since it compares the use of an autologous fascia, which has some morbidity related to the harvesting process, and a synthetic material, which may have the inconvenience of being a foreign body.The main questions regarding these two approaches are related to cure rate, morbidity, complications and costs.There is a lack of well-designed randomized series to clearly answer those questions.The use of synthetic material has great acceptance for the physicians, since it decreases the surgery time, avoids the harvesting process and seems to have similar cure rates as fascial slings.On the other hand, the fascial slings have passed the test of time and may have lower cost.The procedure cost is a very important subject.In the present article, the authors have demonstrated that both procedures have similar outcome, with cure double in the sling procedure.Thus, other similar for extra time in the operative room and the cost of using synthetic sling.
In the present study, the authors performed a good quality randomization that is illustrated by the incontinence impact on quality of life (QoL) was not evaluated pre-operatively.Since we do not have this information, it creates a bias in the results.Thus, we volume (mL) (range) of score emotions (range) 0.00 (0-100) 0.00 (0-100) Median of score sleep (range) 0.00 (0-100) Median of score severity perception of UI (range)