With the increasing aging of society, 1 in 5 people are now aged 65 years or older and pelvic organ prolapse (POP) is becoming a common disease with a prevalence of approximately 30%–40% [[
The aim of an anterior TVM (A-TVM) repair is to suspend a cystocele by passing two arms of transobturator mesh into the paravesical region on each side. Two subvesical straps are inserted in the tendinous arch of the pelvic fascia from the anterior and posterior sides of the obturator foramen using TVM needles on both the left and right sides. The aim of a posterior TVM (P-TVM) repair is to correct a rectocele and/or uterine prolapse. In this procedure, one strap of mesh is passed into the pararectal space through the sacrospinous ligament from both sides. Therefore, to complete the conventional procedure of anterior and posterior TVM (AP-TVM) to treat POP, a total of 6 skin incisions (3 incisions on each side: 2 for A-TVM and 1 for P-TVM) are necessary for the TVM needle to access each of the ligaments.
The Capio SLIM device allows consistent placement of sutures in pelvic floor locations that are difficult to access [[
Seven women with POP underwent TVM surgery with the Capio device at our institution between December 2015 and April 2016. Nine women who underwent conventional TVM surgery during the same period were also selected to compare the postoperative short-term outcomes of Capio TVM surgery with those of conventional TVM surgery. All women had stage 3 prolapse according to POP-Q (Pelvic Organ Prolapse Quantification System) and underwent TVM surgery after providing written informed consent. Data were collected retrospectively from the patients’ medical records. Complaints of pain and details concerning micturition were obtained from patients by direct interview. Ethical approval for this study was obtained from the ethical committee of Shimane University Hospital (approval number: 20170224-1).
The surgery was performed under general or lumbar spinal anesthesia in a lithotomy position. The conventional TVM technique has been described previously [[
The surgical procedure used to perform a TVM repair for POP with a Capio suture capturing device (Boston Scientific) is based on that used with the Uphold™ LITE vaginal support system. In A-TVM surgery using the Capio device, after local infiltration, a longitudinal incision is made on the anterior vaginal wall and the paravesical space is opened by blunt dissection. The mesh arms are then inserted 2 cm medial to the ischial spine on the sacrospinous ligament, which allows the mesh to be inserted through the ligament by direct fixation. This operation does not require insertion via the ligament using a TVM needle or skin incisions to insert needles percutaneously. Similarly, for a P-TVM procedure, a posterior colpotomy is performed longitudinally after local infiltration and the pararectal space is opened by blunt dissection. The mesh is placed between the vaginal wall and rectum, and the mesh arms are inserted using the Capio device through the pararectal space. This procedure allows the mesh to be inserted through the ligament without a needle or skin incisions.
One patient with anterior vaginal wall prolapse underwent A-TVM, patients with both anterior and posterior vaginal wall prolapses underwent an A-TVM and P-TVM (AP-TVM) procedure, and patients without a uterus underwent total TVM (T-TVM), in which one piece of prosthetic mesh consisting of two parts connected to each other is inserted into the anterior and posterior walls.
The operating time was defined as the time from the first incision to the completion of the last suture. The urethral catheter was not removed until the second morning after surgery. Voiding volume and residual urine volume were measured at the first voiding after removal of the urethral catheter. After the first voiding, a Nelaton catheter was passed into the bladder through the urethra, and then, the volume of urine collected was measured by using a graduated cylinder. All patients were asked if they sensed the urge to urinate before their first voiding. We measured the residual urine volume after each voiding until the residual volume became less than 100 mL (per our routine practice) and calculated the number of days on which the residual urine volume needed to be measured. We defined the second day after surgery, on which the urethral catheter was removed, as day 1. Although the patients who underwent TVM surgery were scheduled to be discharged 3 days later, the length of the postoperative hospital stay was determined on the basis of each patient’s postoperative course and micturition status. The number of days to discharge was calculated from the day of surgery (defined as day 0).
Statistical analysis was performed using the unpaired Student’s t-test. P values less than 0.05 were considered significant.
An AP-TVM procedure was performed in 5 of the 7 patients in the Capio TVM group; one of the 2 remaining patients underwent an A-TVM surgery and the other underwent a T-TVM procedure. Six of the 9 patients in the conventional TVM group underwent an AP-TVM surgery, 2 underwent a T-TVM surgery, and 1 underwent an A-TVM procedure. The mean age was 72.1 ± 1.5 years in the Capio TVM group and 76.55 ± 5.6 years in the conventional TVM group. There was no significant difference in the mean operating time between the Capio TVM group and the conventional TVM group (95.28 ± 23.88 min versus 86.56 ± 23.33 min; Table 1).
Patient and surgical details.
Capio TVM Conventional TVM P Patients (n) 7 9 Age (years) 76 ± 5.6 72 ± 11.5 0.19 BMI 25.9 ± 4.0 24.8 ± 4.8 0.29 Procedures A-TVM 1 1 AP-TVM 5 6 T-TVM 1 2 Operating time (min) 95.28 ± 23.88 86.56 ± 23.33 0.25
TVM, tension-free vaginal mesh; A-TVM, anterior TVM; AP-TVM, anterior and posterior TVM; T-TVM, total TVM.
The mean urine volume that was voided under voluntary control for the first time after removal of the urethral catheter on the second morning after surgery was significantly smaller in the Capio TVM group than in the conventional TVM group (102.14 ± 80.57 mL versus 472.22 ± 459.43 mL; P<0.05, Figure 1(a)). However, the mean residual urine volume after the first voiding was significantly greater in the Capio TVM group than in the conventional TVM group (285.70 ± 2.10 mL versus 34.56 ± 73.31 mL; Figure 1(b)). Furthermore, 4 of the 7 patients in the Capio TVM group (2 AP-TVM, 1 A-TVM, and 1 T-TVM) could not sense the urge to urinate at their first urination, whereas all patients who underwent conventional TVM surgery were aware of the urge to urinate after the removal of the urethral catheter (Table 2).
Urge to urinate postoperatively.
Desire to micturate Capio TVM n=7 Conventional TVM n=9 Present 3 9 Absent 4 0
The mean number of days on which the residual urine volume needed to be measured was significantly greater in the Capio TVM group than that in the conventional TVM group (3.85 ± 2.10 days versus 1.11 ± 0.32 days), as was the mean maximal volume of residual urine on these days (355.71 ± 202.80 mL versus 35.78 ± 75.50 mL). The mean postoperative hospital stay was significantly longer in the Capio TVM group than that in the conventional TVM group (6.57 ± 1.83 days versus 3.2 ± 0.42 days; Table 3).
Postoperative course.
Capio TVM n=7 Conventional TVM n=9 P Residual urine catheterization (days) 3.85 ± 2.10 1.11 ± 0.32 <0.01 Mean maximal residual urine volume (mL) 355.71 ± 202.8 35.78 ± 74.50 <0.01 Duration of hospital stay (days) 6.57 ± 1.83 3.2 ± 0.42 <0.01
When the patients were asked at the time of discharge from hospital about the part of the body in which they felt the most intense postoperative pain, 6 patients in the Capio TVM group complained of deep-seated pain in the hip region (including some who complained of pain in the anal canal) and 1 complained of backache. In contrast, 4 patients who underwent conventional TVM surgery felt pain at the site of the skin incisions required for posterior mesh placement using TVM needles. Three patients complained of low back pain and 2 felt deep-seated pain in the hip region (Table 4).
Location of most intense pain postoperatively.
Capio TVM n=7 Conventional TVM n=9 Inner region of the hip 6 2 Skin incision for posterior mesh replacement 0 4 Low back pain 1 3
Initially used in France, TVM mesh is now widely used in POP repair in many countries. A TVM procedure does not require hysterectomy and has a good cure rate with a low rate of complications [[
We performed several TVM procedures using the Capio device because we anticipated that this new technique might be less invasive than the conventional TVM surgery. Skin incisions to guide TVM needles for ligament insertion are not necessary when performing a Capio TVM procedure. Further, avoidance of the need for TVM needles could prevent surgical complications such as injury to the bladder or rectum. Although our series is small and did not include follow-up of the long-term outcome after surgery, we did not find any merit in TVM surgery using the Capio device. Although AP-TVM takes longer time to perform than A-TVM or T-TVM surgery, the mean operating time using this device was not shorter than that required for conventional TVM surgery. In addition, the postoperative pain associated with Capio TVM surgery seems not to be less than that reported after conventional TVM surgery. Patients who underwent conventional TVM surgery complained of pain at the skin incision sites, particularly those made for posterior mesh replacement just outside and below the anus. In our Capio TVM group, there were no complaints of pain at the skin incision sites but most patients felt deep-seated pain in the hip region, which corresponded to the part of the sacrospinous ligament where the mesh arms were fixed by the Capio device. This type of pain is also observed in patients who undergo conventional TVM surgery, in which two mesh arms are passed through the sacrospinous ligament bilaterally to support the posterior mesh.
We were surprised to find that urinary function was much worse postoperatively in the patients who underwent Capio TVM surgery. After removal of the urethral catheter, more than half of the women who underwent Capio TVM surgery could not sense the urge to micturate, whereas all patients who underwent conventional surgery sensed the urge to urinate at the time of their first voiding. The volume of urine voided was decreased, and the residual urine volume was increased in the Capio TVM group. Furthermore, the requirement to measure voiding volume and the hospital stay were prolonged in this group. Similar results were reported by Rusavy et al., who showed that voiding difficulties were more frequent in patients who underwent anterior compartment repair by mesh anchored to the sacrospinous ligament using the operation kits supplied with the Capio device [[
We performed TVM surgery using the Capio device expecting that it would be less invasive in patients with POP. However, after our experience in 7 patients, we have discontinued using this device in TVM surgery. However, it remains undeniable that the more recent literature provides several articles describing the efficiency of TVM surgery using the Capio device, which typically involve less surgical dissection, shorter operating time, and low recurrence rates [[
Impact Statement. In TVM surgery using the Capio SLIM suture capturing device, the arms of the mesh can be driven through the sacrospinous ligament from both the anterior and posterior sites without the need for TVM needles or skin incisions; this surgery is thus considered to be minimally invasive. To evaluate the effectiveness of TVM surgery using the Capio device, we retrospectively compared postoperative pain, urinary function, and length of hospital stay between patients who underwent TVM surgery using the Capio device and patients who underwent conventional TVM surgery. We found that urinary function may worsen postoperatively when the Capio TVM device is used. Further studies investigating the use of the Capio device are needed.
The authors have no potential conflicts of interest to declare.
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PHOTO (COLOR): Comparison of the first voiding volume (a) and residual urine volume (b) after removal of the urethral catheter on the second postoperative day in women who underwent a TVM procedure using the Capio device or conventional TVM surgery. ∗P<0.05 and ∗∗P<0.01 versus the Capio TVM group. TVM, tension-free vaginal mesh.
By Haruhiko Kanasaki; Aki Oride; Tomomi Hara and Satoru Kyo