TENSION-FREE VAGINAL TAPE VERSUS

TRANSOBTURATOR TAPE FOR TREATMENT OF

STRESS URINARY INCONTINENCE: A
COMPARATIVE RANDOMIZED CLINICAL
TRIAL STUDY
Maliheh Keshvari Shirvan, Hamid Reza Rahimi, Mohammad Reza Darabi Mahboub, Zhila
Sheikhi

A Critically Appraised Topic

STEP 1
INTERNAL VALIDITY

WAS THE ASSIGNMENT OF PATIENTS TO

TREATMENTS RANDOMISED?

Ans: YES
In this prospective randomized clinical trial study
a total of 100 women with SUI who were treated
with TVT (n 50) or TOT procedure (n 50)
were included prospectively randomized by a
predetermined computer-generated
randomization code

WERE THE GROUPS SIMILAR AT THE START OF

THE TRIAL?
Ans: YES
In this prospective randomized clinical trial study
conducted at Imam Reza Academic Hospital between
March 2008 and July 2010

ASIDE FROM THE ALLOCATED TREATMENT, WERE

GROUPS TREATED EQUALLY?

Ans: Yes
The patients were followed and assessed at 1,
3, 6, 12, 18, 24, and 30 months after the
intervention. At the end of the 1st month,
complete transvaginal examination, cough test,
and upper urinary tract ultrasonography were
performed in all patients and ICIQ-UI and ICIQQOL were filled

WERE ALL PATIENTS WHO ENTERED THE TRIAL ACCOUNTED

FOR?

Ans: YES
The study population included 100 patients, 50
patients in the TVT and 50 in the TOT groups
All patients follow up data still recorded until the last
30 months follow up

WERE MEASURES OBJECTIVE OR WERE THE PATIENTS AND

CLINICIANS KEPT BLIND TO WHICH TREATMENT WAS BEING
RECEIVED?

Ans: OBJECTIVE
All patients were able to read and understand,
and willing to sign the informed consent form for
the study

STEP 2
RESULT OF THE STUDY

WHAT IS THE RESULT OF THIS STUDY?

The study population included 100 patients, 50 patients in the TVT
and 50 in the TOT groups
No significant difference was observed in the demographic
characteristics of patients
Operation time was 14.50 7.40 and 15.00 7.48 minutes (p
0.86) and hospital stay time 1.56 0.52 and 1.52 0.47 days (p
0.76) in the TVT and TOT groups, respectively.
At the 1-month follow-up, for the patients with subjective failure of
the procedure, a 1-hour pad test and ALPP determination were
performed, the results of which were positive in three and two
patients in the TVT and TOT groups respectively. In other followups, the failure rate was the same as that in the first month

 Among the patients, seven had an ALPP of less than 60 cmH2O

(4 the in TVT and 3 in the TOT group) who are considered as
ISD
It resolved with clean intermittent catheterization (CIC) within 1
week after the operation in all patients.
De novo urge incontinence occurred in six patients (3 in each
group) and anticholinergic medicationwas prescribed for 2-4
weeks after the operation.
After the procedure, results of the ICIQ questionnaires were
similar in the two groups; however, a significant difference was
observed in the ICIQ-UI and ICIQ-QOL results prior to and after
the procedure in both groups.
Our results showed similar efficacy and safety of the TVT and
TOT techniques for women with SUI. At 30 months followup,
the TVT technique was not significantly more effective than
TOT.

STEP 3
EXTERNAL VALIDITY

1. Is my patient so different to those in the study that the results cannot apply?
Ans: NO
Not different because the subject of this study are the women with stress urinary
incontinence. The subjects are asian
2. Is the treatment feasible in my setting?
Ans: YES
There is no specific instrument or medicine needed to reproduce this study that not
available in my setting.
3. Will the potential benefits of treatment outweigh the potential harms of treatment for my
patient?
Ans: YES
Our study results showed that TVT and TOT methods have similar efficacy and safety
for SUI, although the catheter indwelling time was significantly longer in the TVT group