Abstract
Purpose
The objective of this study is to report our initial experience about the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift™) and concomitant tension-free vaginal tape (TVT) as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI).
Materials and Methods
We reviewed the charts of patients who underwent Prolift™ and TVT between April 2009 and March 2010. All patients had a physical examination and staging of cystocele. According to the International Continence Society system 2, 5 and 3 women had stage grade II, III and IV respectively. All the patients underwent pelvic examination 1, 3, 6 month and 1 year after operation and anatomical and functional outcomes were recorded. An anatomic cure after intervention was defined as stage 0 and an improvement was defined as stage I. Anatomic failures were defined as stage II or higher on the last physical examination.
Results
The mean follow-up was 7.1 (1-11) months. Overall success rate of cystocele repair was 90%. The anatomical cure rate of cystocele was 50%. The cystocele repair improved 4 patients, but failed in 1. SUI was cured in all patients. No significant complications including bladder or vessel injury and mesh related erosion occurred. The postoperative complication was transient voiding difficulty (2 cases).
Conclusions
These preliminary results suggest that Prolift™ and TVT offer a safe and effective treatment for female anterior vaginal wall prolapse and SUI. However, a long-term follow up is necessary in order to support the good result maintenance.
Keywords: Cystocele, Stress urinary incontinence, Treatment
Introduction
Genital prolapse with or without stress urinary incontinence (SUI) is a major health care problem, and even more so with an aging population. The available surgical treatments for pelvic organ prolapse, such as colporrhaphy, have a high failure rate this treatment failure may be attributable to the use of weak native tissues. Scarring and sclerosis produced by the standard pelvic reconstructive surgical procedures can restore only 50% of the preoperative tissue strength [1].
Therefore, colpopexy using synthetic mesh over the anterior or posterior vaginal wall appears to be more reliable for the successful treatment of genital prolapse with vaginal vault prolapse. Surgery using polypropylene mesh has been widely performed because of its high success rate and low recurrence rate [2-5]. We have reported good results for cystocele repair with Gynemesh® (Ethicon, Somerville, NJ, USA) [6].
Recently, a new mesh system for the treatment of genital prolapse was introduced the Prolift™ system is now commercially available. It is a wide mesh with an anchor system that provides complete support. This system can be applied by using minimally invasive techniques. The objective of this report was to present our initial experience with transobturator tension-free vaginal mesh (Prolift™ Ethicon, Somerville, NJ, USA) and concomitant tension-free vaginal tape (TVT Ethicon) as a treatment for anterior vaginal wall prolapse associated with SUI.
Materials and methods
1. Patient Characteristics
Between April 2009 and March 2010, a total of 10 women (mean age, 60.6 years) with pelvic organ prolapse and SUI underwent surgery. All of the patients had a complete preoperative evaluation including history, physical examination, and urine culture. They had a pelvic examination with a Sims speculum in the supine and sitting positions, at rest and during a cough test and the Valsalva maneuver. Urodynamic evaluation was performed. Preoperatively, genital prolapse was quantified in the dorsal lithotomy position by use of the International Continence Society (ICS) classification: 2 patients were grade II, 5 were grade III, and 2 were grade IV. Two patients had rectocele. The detailed patient characteristics are presented in Table 1.
Table 1.
Clinical characteristics of 10 patients
2. Surgical procedure
The synthetic material used for the cystocele repair was the Prolift™ system of precut nonabsorbable monofilament soft Prolene mesh, and that used for the SUI correction was TVT mesh. The anterior part of the Prolift™ system was used for the cystocele repair. The Prolift™ procedure was performed in a manner previously described [7,8].
After correction of the cystocele, the SUI or rectocele was repaired. The SUI was corrected with TVT in all cases as previously described. After the procedure, an iodized gauze pack was left in the vagina for at least 24 h. The indwelling urinary catheter was removed on the second postoperative day.
3. Postoperative evaluation
Clinical evaluation of the anatomical results of prolapse correction and incontinence were performed at 1, 2, 3, 6, and 12 months after the surgery.
Anatomical failure was diagnosed if at least one of the compartments was classified as pelvic organ prolapse of stage IIor grater. Anatomical success was defined as an overall pelvic organ prolapse stage of 0 or I. The SUI was considered cured in cases with no urine leakage under any conditions.
Results
The mean duration of surgery for the anterior Prolift™ and TVT was 68±16 minutes. Two cases of posterior perineorrhaphy for rectocele repair and one case of hysterectomy were concomitantly performed. The mean hospital stay was 2.5±3.4 days, and the mean catheter indwelling period was 1 day.
No intraoperative complications were recorded. There were no vessel or bladder injuries. During the immediate postoperative period, two cases of urinary retention were noted. Conservative management with an alpha blocker and transient clean intermittent catheterization were provided, and the cases were completely resolved. No patient required additional surgery. There was one case of de novo urgency that resolved with anticholinergic medication. During the follow-up period, no vaginal erosion, infection, or fistulas were observed.
The mean follow-up duration was 7.1 months (range, 1-11 months). Five patients had optimal anatomical results (stage 0) and four patients had persistent, asymptomatic stage I prolapse. One patient with stage IV prolapse preoperatively had stage II at the postoperative follow-up. The overall success rate of the cystocele repair with the Prolift™ system was 90% (Table 2). Uterine prolapse and rectocele, which were repaired during the same surgery, did not recur in any of the patients, and the stress incontinence was resolved in all patients.
Table 2.
Change of Pelvic Organ Prolapse Quantification (POP-Q) stage before and after operation
Discussion
Since Julian [9] reported cystocele repair with artificial material, several materials have been widely used. Although the recurrence rate has decreased compared with the traditional colporrhaphy procedure, the technique requires a significant amount of experience.
Recently, monofilament polypropylene mesh has been reported to have low complication rates and high success rates compared with other artificial materials [2,3] and is widely used in Korea. Reports in Korea [4,5] show a 96-97% success rate with 3% vaginal erosion. In our experience, the cure rate has been 77.4% and the improvement rate 22.6% [6].
However, most of the reported results are short-term, and it is possible that the success rate might decrease with time. de Tyrac [3] reported that the success rate declined from 98% to 78% during a 5-year follow-up of polypropylene mesh. These findings suggest that the simple insertion of mesh does not prevent the effects of the weakness of the tissue, and a cystocele can develop with time.
Recently, the Prolift™ pelvic floor repair system was introduced and has shown good results. The Prolift™ procedure, using a soft Prolene mesh like Gynecare®, was designed for treating pelvic organ prolapse vaginally. It is a wide mesh with an anchor system that provides completesupport and is applied with minimally invasive techniques. The Prolift™ system incorporates the transobturator approach through the arcus tendineus fascia pelvis, as well as a transgluteal approach through the sacrospinous ligaments.
The results of this study showed a 50% cure rate and a 40% improvement rate, i.e., a 90% success rate. These findings are consistent with those of other investigators. Ignjatovic et al. [10] compared the Prolift™ system with colporrhaphy and reported a higher 1-year success rate with Prolift™ (89% vs. 48%). They also reported the results of Prolift™ and concomitant SUI correction with a 91% anatomical success rate and 87% continence success rate [11]. Altman et al. [12] reported outcomes at 2 months following individual anterior repair, individual posterior repair, and total repair with Prolift® with success rates of 87%, 91%, and 88%, respectively [3]. In Korea, Han et al. [11] reported the outcome of anterior repair at 1 year with a success rate of 100%. The results of this study showed a similar success rate but lower anatomical cure rate (stage 0) than reported in other studies. This difference may have been caused by the small number of patients, and further study with a larger number of patients and a longer follow-up period is needed.
The safety of this technique with regard to perioperative morbidity has been previously reported. A shorter-term follow-up study by Altman et al. [12] evaluated safety in a study of 248 women during a 6-month follow-up. They reported the rate of serious complications, defined as visceral injury and estimated blood loss greater than 1000 ml, as 4.4%. Minor complications, defined as urinary tract infections, urinary retention, and postoperative fever, occurred in 14.5% of patients. In the study reported by Fatton et al. [7], 110 patients were seen at 3 months. The rate of granulation tissue formation was 2.8%, and mesh exposure was 4.7%. The rate of immediate postoperative complications, including urinary tract infection, urinary retention, abscess, and hematoma formation, was 1.8%. In the present study, there was no massive bleeding, need for transfusion, or hematoma. There were two cases of transient urinary retention, and both recovered with conservative management. There was no vaginal erosion or mesh-related complications during the follow-up period.
Commonly, SUI correction is performed with a cystocele repair. When colporrhaphy or the Gynemesh procedure are performed, the transobturator method (TOT), retropubic method (TVT), or both can be used for SUI correction. However, in the case of Prolift™, the meshes cross the obturator foramen twice. In this study, TVT was used in all patients because of concern about pain or other complications.
Abou-Elela et al. [13] reported the results of Prolift™ and TVT-O in 20 patients. In that study, the patients were all cured with no complications. This suggests that the transobturator method may be safe. However, there have been no other studies to date; therefore, the safety of the SUI correction technique with Prolift™ requires further study.
The limitations of this study include the small number of patients and the short-term follow-up. Therefore, this study should be considered preliminary with regard to the success and complication rates. In addition, we did not compare the outcomes to the Gynemesh® system. Therefore, to show a higher success rate, lower recurrence rate, or lower complication rate compared with the traditional colporrhaphy or Gynemesh system®, a large, randomized prospective study and long-term follow-up are needed.
Conclusions
The Prolift™ system and concomitant TVT were evaluated in patients with anterior vaginal wall prolapse and stress incontinence. The overall success rate for cystocele repair was 90% and the SUI was cured in all patients. These preliminary results suggest that the Prolift™ system and TVT are a safe and effective treatment for anterior vaginal wall prolapse and SUI. However, long-term follow-up is necessary to confirm the good outcomes.
Footnotes
This paper was supported by Konkuk University in 2009
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