TVT - SECUR
Operation in Israel and Globally
Perioperative Complications and Early Follow-up with 100
Menahem Neuman Research and Development in
Urogynecology, Shaare Zedek Medical Center, Jerusalem Israel and Urogynecology,
Assuta Medical Centers, Rishon le-Zion Israel and Tel-Aviv, Israel.
Our objective was to evaluate the complications and early follow-up of the
tension-free vaginal tape (TVT)-SECUR, a new minimally invasive
anti-incontinence operative procedure. A prospective, observational, and
consecutive patient series was conducted. Perioperative and 12-month
postoperative data were prospectively collected for the first 50 patients
against the next consecutive 50 patients, among which TVT-SECUR specific
surgical measurements were adopted (Canadian Task Force classification 2).
In private hospital operative theatres, the TVT-SECUR operation was
performed. Patients with urodynamically proved stress urinary incontinence
were enrolled in this study after detailed informed consent was given. The
TVT-SECUR, in the hammock shape to mimic the TVT-obturator placement, yet
with no skin incisions, required neither bladder catheterization nor
intraoperative diagnostic cystoscopy. The clinical and surgical data of
100 consecutive patients with TVT-SECUR were collected prospectively.
Two patients had urinary obstructions and needed surgical tape-tension
One patient had a 50 mL paravesical self-remitting hematoma. At
the first-month postoperative follow-up appointment, the objective
therapeutic failure rate for the TVT-SECUR procedure among the 50 patients
was 20.0% (10 patients).
But when the tape was placed close to the urethra with no
space allowed in between, the failure rate in the second
patient group went down to 8.0% (4 patients); yet no further
postoperative bladder outlet obstruction was diagnosed.
Four (8.0%) patients in the first group had vaginal wall penetration with
the inserters, requiring withdrawal, reinsertion, and vaginal wall repair.
This was avoided with the second patient group by facilitating the
inserters' introduction by widening the submucosal tunnel to 12 mm. Six
(12.0%) other patients in the first group needed postoperative trimming of
a vaginally extruded tape segment, performed in the office with
satisfactory results. This problem was addressed later by making the
submucosal dissection deeper to avoid intimate proximity of the tape with
the vaginal mucosa. Consequently the tape protrusion rate was reduced to
8% (4 patients).
Five (10.0%) patients in the first group had unintended tape removal at
the time of inserter removal, necessitating the use of a second TVT-SECUR.
This was addressed by meticulous detachment of the inserter before its
withdrawal, after which no further unintended tape displacements were
recorded. No clinical signs for bowel, bladder, or urethral injuries;
intraoperative bleeding; or postoperative infections were evident.
Telephone interview at the end of 12 months postoperatively was completed
with 44 (88.0%) of the first patient group and 46 (92%) of the second
patient group. In all, 39 (88.6%) and 43 (93.5%) of the
telephone-interviewed patients of the first and second groups,
respectively, reported objective urinary continence.
The TVT-SECUR, a new midurethral sling, was associated with early safety
and efficacy problems. These were identified and rectified, to make the
TVT-SECUR a safe and effective anti-incontinence procedure. Operative
complications associated with the TVT, such as bladder penetration and
postoperative outlet obstruction, and TVT-obturator complications, such as
postoperative thigh pain and bladder outlet obstruction, may be reduced
with the TVT-SECUR.
The first 100 operations' cumulative data analysis yielded some insights,
including the necessity of meticulous and proper dissection before
placement of the tape and the need for applying minimal extra tension to
the tape. However, long-term comparative data collection will be required
to draw solid conclusions regarding the appropriate position of this
operative technique within the spectrum of anti-incontinence operations.
J Minim Invasive Gynecol. 2008 Jun 6