Objective
The purpose of this study was to evaluate outcomes after standardized transvaginal prolapse repair with nonanchored mesh and a vaginal support device.
Study Design
Postoperative vaginal support was assessed by pelvic organ prolapse quantitative examination after repair of symptomatic stage II/III prolapse. Validated questionnaires assessed pelvic symptoms and sexual function. Visual analog scales quantified experience with the vaginal support device.
Results
One hundred thirty-six women received the planned surgery; 95.6% of the women returned for the 1-year assessment: 76.9% of the cases were stage 0/I; however, in 86.9% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms, quality of life, and sexual function improved significantly from baseline ( P < .05). Median visual analog scale scores for vaginal support device awareness and discomfort were 2.6 and 1.2, respectively (0 = none; 10 = worst possible).
Conclusion
Vaginal support, pelvic symptoms, and sexual function improved at 1 year, compared with baseline, after trocar-free prolapse repair with nonanchored mesh and a vaginal support device.
Annually, >200,000 women undergo surgery for pelvic organ prolapse (POP) in the United States, most of which are vaginal procedures. Treatment of vaginal prolapse is associated with high recurrence rates. One community-based prospective study determined a 17% risk for surgical reintervention within 10 years of prolapse or incontinence surgery. This rate has led to an increasing use of implants to obtain more durable results. However, the introduction of vaginal graft augmentation with the use of trocars has introduced new complications that are not associated with traditional repairs, such as extra-pelvic infections and mesh contraction, which cause pelvic and vaginal pain that often require further surgery. To reduce these complications, new materials and mesh delivery techniques have been developed. A lack of safety data and clinical outcomes for these new devices continues to cause controversy.
This study describes a new surgical system that has been developed to treat prolapse transvaginally without trocars. This system is based on the finding that nonanchored mesh that is positioned deep to the full-thickness of the vaginal walls and extends over the obturator internus muscles and arcus tendineus fasciae pelvis anteriorly; and the sacrospinous ligaments posteriorly, will provide durable anatomic support when it is stabilized with a vaginal support device (VSD) during initial tissue in-growth. The prototype procedure was modified to enhance standardization and safety for general use. The aim of this study was to report 1-year anatomic and functional outcomes in a multicenter, international setting.
Materials and Methods
This prospective cohort study of the Gynecare Prosima Pelvic Floor Repair System (Ethicon, Somerville, NJ) was conducted in 11 sites in the United States, United Kingdom, Germany, and Australia in 2007 after approval from the various institutional review boards or ethics committees. Women with symptomatic stage II or II prolapse by the Pelvic Organ Prolapse Quantification (POPQ) exam who were planning augmented vaginal prolapse repair in anterior, posterior, or both compartments were invited to participate. Concomitant vaginal hysterectomy, midurethral sling, and perineorrhaphy were permitted. Exclusion criteria included additional prolapse procedures, previous prolapse mesh repair, hysterectomy within 6 months of index surgery, diseases known to affect bladder or bowel function, and an inability to complete the study.
Investigator surgeons were proficient in vaginal prolapse surgery with and without mesh, including colporrhaphy and sacrospinous ligament fixation. Two investigators had extensive experience with the prototype device (M.S.; M.C.). Central training comprised review of the manufacturer’s instructions for use, cadaveric dissection with device placements, and observation of live surgery. To enhance generalizability, recruitment was limited to 20 subjects per site. Data were maintained and analyzed by the research team of the manufacturer. Investigators who were unfamiliar with the device performed at least 1 anterior and posterior procedure under the observation of a development team member.
The system comprises precut, macroporous polypropylene mesh implants (Gynecare Gynemesh PS Nonabsorbable Prolene Soft Mesh; Ethicon), a VSD, anterior and/or posterior inserters, and a 60-mL syringe ( Figures 1 and 2 ) . Surgeons placed the grafts according to the manufacturer’s instructions for use. After hydrodissection, a sagittal incision was made, and the respective anatomic plane was developed with sharp and blunt dissection to the apex. For anterior compartment repair, the graft was placed flat in vesicovaginal plane with arms extending through channels that were directed anterior and superior to the ischial spine to rest across the arcus tendineus and in contact with the parietal fascia of the obturator internus muscle. Posteriorly, the graft was positioned over the rectovaginal plane with the extension arms placed through 2 channels at the lateral fornices and positioned across each sacrospinous ligament. Plication of attenuated prevesical tissue, an enterocele, or the central portion of attenuated prerectal tissue was permitted to enable the graft to lay flat. The protocol mandated antibiotic and deep venous thrombosis prophylaxis, cystoscopy after anterior repairs, digital rectal examination after posterior repairs, and a 2-layer closure of the vaginal fibromuscular layer and superficial squamous epithelial layer. The trapezium-shaped VSD has trimmable sections to conform to the upper two-thirds of the vagina. It is postulated to buttress the vagina from increased intraabdominal pressures and to inhibit wound and mesh contraction. The recommended duration of VSD wear (3-4 weeks after surgery) is supported by preclinical testing that established that polypropylene mesh reaches a steady-state of tissue integration at 28 days. The integrated, inflatable balloon that replaces traditional gauze packing for 24 hours after surgery is removed without dislodging the VSD. Full details of the surgical procedure are reported elsewhere.
The primary objective was to evaluate anatomic outcome. Success was defined as POPQ stage 0 or I at 1 year in the treated compartment, without further surgical intervention. An alternate definition of success was the leading edge of vaginal walls above the hymen (ie, <0 cm) in the treated compartment at 1 year, without surgical retreatment. Medical history, POPQ examination, symptom, and quality of life (QoL) measures were collected before the operation and at 6 and 12 months after surgery. Approximately 130 women were to be enrolled to ensure that at least 118 subjects could be evaluated at 1 year. This would allow for up to 15 failures to meet the 97.6% lower confidence interval and to fall to ≤80% success with the use of exact binomial confidence limits.
Answers to the Patient Global Impression of Change (PGI-C) inventory assessed the women’s perception of improvement of their prolapse condition at 1 year with the use of a 5-point Likert scale from “much worse” to “much better.” Short-form versions of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) were used to measure the degree of symptom improvement and impact of prolapse on QoL, respectively. Both questionnaires have domains that evaluate prolapse, urinary, and colorectal symptoms. For sexually active women, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function questionnaire (PISQ-12) was administered to evaluate sexual function. Dyspareunia was ascertained with a response of “always” or “usually” on question 5 of the PISQ-12: “Do you feel pain during sexual intercourse?” For all instruments, the validated US-English version was used at the United States, United Kingdom, and Australian sites. All instruments that were used in Germany underwent translation and cultural adaptation in accordance with international guidelines. Postoperative pain was evaluated with a visual analog scale (VAS) at 24 hours after surgery and again 3-4 weeks later. By marking a series of 10-cm VASs, patients reported their discomfort during balloon removal and their awareness of and discomfort with the device as well as the acceptability of vaginal discharge that was associated with the VSD. For each VAS, 0 was considered to be none, and 10 was considered to the worst possible.
Results were summarized as mean ± SD or median (range), when appropriate. All patients who underwent surgical retreatment for prolapse were considered failed cases. Discrete data were summarized as frequency and percent, with 95% confidence intervals calculated, when applicable. A t test was used to calculate probability values, when appropriate, for change from baseline to 1 year. Exploratory analyses evaluated the impact of duration of VSD wear on anatomic support, with a 2-sided Fisher’s exact test. All analyses were performed with statistical software (SAS EG 4.1 with SAS version 9.1.3; SAS Institute Inc, Cary, NC).
Results
One hundred thirty-six women received their study surgery; 130 women (95.6%) attended their 1-year visit. Additionally, there were 12 device run-in cases and 2 women in whom the mesh was not placed because of cystotomy; these 14 women are included in safety analyses only. Baseline characteristics are detailed in Table 1 . Perioperative details that were inclusive of the final VSD size that was placed by the surgeons and the subjects’ experience with the VSD are reported in Table 2 .
| Characteristic | Measure (n = 136) |
|---|---|
| Age, y a | 64.3 ± 10.5 |
| Body mass index, kg/m 2 a | 28.4 ± 5.0 |
| <30, n (%) | 88 (64.7) |
| 30-40, n (%) | 43 (31.6) |
| >40, n (%) | 5 (3.7) |
| Parity, n b | 3 (0–12) |
| Topical estrogen, n (%) | 27 (19.9) |
| Smoking status, n (%) | |
| Current | 8 (6.1) |
| Former | 35 (26.7) |
| Previous hysterectomy, n (%) | 76 (55.9) |
| Previous prolapse surgery, n (%) | 35 (25.7) |
| Previous anti-incontinence surgery, n (%) | 19 (14.0) |
| ICS POPQ, n (%) | |
| Stage II | 73 (53.7) |
| Stage III | 63 (46.3) |
a Data are expressed as mean ± SD;
| Variable | All (n = 136) | Anterior (n = 31) | Posterior (n = 33) | Combined (n = 72) |
|---|---|---|---|---|
| Operating time, min a , b | 69.2 ± 31.8 | 54.8 ± 28.1 | 57.1 ± 38.9 | 80.8 ± 24.7 |
| Operating time excluding concurrent surgery, min a , b | 54.6 ± 24.0 | 36.3 ± 11.5 | 35.0 ± 7.3 | 74.6 ± 17.4 |
| Concurrent surgery, n (%) | 96 (70.6) | |||
| Vaginal hysterectomy, n (%) | 23 (16.9) | 1 (3.2) | 1 (3.0) | 21 (29.2) |
| Midurethral sling, n (%) | 45 (33.1) | 16 (51.6) | 12 (36.4) | 17 (23.6) |
| Perineal repair | 58 (42.6) | 6 (19.4) | 14 (42.4) | 38 (52.8) |
| VSD size, n (%) | ||||
| Small | 57 (41.9) | |||
| Medium | 44 (32.4) | |||
| Large | 35 (25.7) | |||
| Visual analog scale results for balloon and VSD b | ||||
| Discomfort on balloon removal c , d | 0.4 (0.0–6.8) | |||
| Pain at 24 hr after surgery c , e | 1.1 (0.0–8.4) | |||
| Pain at 3-4 wk after surgery c , e | 0.1 (0.0–8.9) | |||
| Awareness of VSD at 3-4 wk c , f | 2.6 (0.0–10.0) | |||
| Discomfort of VSD at 3-4 wk c , d | 1.2 (0.0–10.0) | |||
| Patients with vaginal discharge, n (%) | 117 (86.7) | |||
| Acceptability of vaginal discharge c , g | 0.9 (0.0–10.0) |
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