A 1-Year Outcome of Uphold Vaginal Mesh for Correction of Anterior Vaginal Wall Prolapse at a Single Center

Abstract

Introduction:

The Uphold^® transvaginal mesh is a lightweight mesh with only two fixation points to the sacrospinous ligaments.

Aims and Objectives:

The aim of this study was to assess the outcomes of the Uphold vaginal support system for the management of grades 3 to 4 cystocele at 1 year postoperative follow-up.

Methods:

We conducted a retrospective descriptive noncomparative study in women undergoing Uphold vaginal mesh insertion for the management of anterior vaginal wall prolapse between July 6, 2017, to April 30, 2019, at our center. The demographic, preoperative finding, intraoperative details, and postoperative complications were analyzed. Postoperative symptoms and examination findings were analyzed up to 1 year of follow-up.

Results:

A total of 183 women underwent vaginal mesh insertion during this time period. Concomitant vaginal hysterectomy was performed in 92.9%, concomitant sacrospinous ligament fixation in 71%, and concomitant midurethral sling insertion in 47% of the patients. The mean duration of surgery was 115.5 minutes and the mean blood loss was 231 mL. One hundred twenty-three patients (67.2%) attended the 1 year postoperative follow-up. At the 1 year follow-up examination, three patients (2.4%) had grade 2 cystocele and three patients had vaginal mesh erosion. All three patients with vaginal mesh extrusion were asymptomatic.

Conclusion:

Introduction

The use of transvaginal mesh for the management of pelvic organ prolapse (POP) has been the subject of much academic debate over the past 10 years in view of the risk of complications. Vaginal mesh kits were approved by the Food and Drug Administration for the repair of POP in 2001 and were introduced in the United States in 2005. The purpose of their use is to augment native tissue repair. Synthetic vaginal meshes are composed of polypropylene and are inserted between the vaginal epithelium and the underlying endopelvic fascia for support of the anterior or posterior vaginal walls.¹

Anterior colporrhaphy for the repair of cystocele has poor success rate, with recurrence rates reported to be >40%. The initial motivation for the use of vaginal meshes for the repair of POP came from the high success rates of mesh repair for abdominal hernia surgeries. Instead of delayed absorbable sutures, a permanent mesh is used, and instead of multiple sutures, a mesh fastened to pelvic support structures overlies the pelvic floor defect.^2,3

The Uphold^® mesh is a lightweight polyform mesh made from macroporous monofilament uncoated type I polypropylene. It is designed to provide level I support at the vaginal apex while also providing level II support for any accompanying cystocele. A Capio^® suture capturing device is used to connect the mesh to the sacrospinous ligament and provide apical support. Only two fixation points are used, with no fixation laterally into the levators or obturator muscles.^4,5

Aims and Objectives

The aim of this study was to assess the outcomes of the Uphold vaginal support system for the management of grades 3 to 4 cystocele at 1 year postoperative follow-up. The demographic characteristics of the patients, preoperative symptoms and examination findings, intraoperative findings, and immediate postoperative complications were also studied.

Materials and Methods

We conducted a retrospective descriptive noncomparative study in women undergoing Uphold vaginal mesh insertion for the management of anterior vaginal wall prolapse between July 6, 2017, to April 30, 2019, at KK Women's and Children's Hospital, Singapore. Inclusion criteria were patients undergoing surgery for uterovaginal/vaginal prolapse with a grade 3 or grade 4 cystocele. Exclusion criterion was previous or current pelvic organ malignancy. The Uphold vaginal support system was used in all the patients.

All surgeries were performed by the same surgeon. The Centralized Institutional Review Board approval was taken before the commencement of the study. CIRB reference no. 2019/2369.

The medical records of these patients were retrieved and their demographic data were analyzed. The preoperative findings including degree of prolapse, as assessed by the Baden–Walker classification system, were noted. The intraoperative details such as concomitant surgeries, type of anesthesia, mean duration of surgery, mean blood loss, and intraoperative complications were analyzed. Postoperative complications, duration of hospital stay, length of catheterization, readmission rate, and reason for readmission were noted.

Patients were followed up postoperatively in the urogynecology clinic at 3 days after discharge and then at 1 month, 6 months, 1, 2, 3, 4, and 5 years postoperatively. At all these visits, patients were assessed for symptoms of vaginal prolapse, urinary incontinence, voiding difficulty, vaginal pain, or dyspareunia, and a clinical examination was done.

The data were analyzed using the SPSS software with frequency, mean, and standard deviation used for quantitative variables. –χ² test was used for analyses in patients with concomitant procedures who had longer duration of surgery, more blood loss, longer duration of hospital stay, and greater recatheterization rates. The difference was considered significant at a p-value ≤0.05.

Results

A total of 183 women underwent vaginal mesh insertion for grade 3 or grade 4 cystocele between July 6, 2017, and April 30, 2019. The mean age of the patients was 64.6 years and the mean parity was 2.7. Ninety-seven percent of them had previous vaginal deliveries (Table 1). The preoperative symptoms included lump coming outside the vagina in 100% of the patients, voiding dysfunction in 14.2%, and stress urinary incontinence (SUI) in 44.3% of the patients. Eighty-seven percent of the patients had grade 3 or grade 4 cervical/vaginal vault descent on preoperative examination. Seven patients had hydronephrosis preoperatively, of whom three had grade 4 cystocele (Table 2).

Table 1.

Demographic Profile

Parameters	n = 183, n (%)
Age (years), mean ± SD (range)	64.6 ± 7.7 (39–86)
Parity, mean ± SD (range)	2.7 ± 1.3 (0–9)
Nulliparous	1 (0.5)
Vaginal delivery	178 (97.3)
LSCS only	4 (2.2)
Menopause	171 (93.4)
HRT	0
Sexual activity	43 (23.5)

HRT, hormone replacement therapy; LSCS, lower segment caesarean section; SD, standard deviation.

Table 2.

Preoperative Examination

Parameters	n = 183, n (%)
Cystourethrocele
Grade 3	127 (69.4)
Grade 4	56 (30.6)
Rectocele
Grade 0	1 (0.5)
Grade 1	2 (1.1)
Grade 2	140 (76.5)
Grade 3	28 (15.3)
Grade 4	12 (6.6)
Cervical/vaginal vault descent
Grade 0	0
Grade 1	3 (1.6)
Grade 2	24 (13.1)
Grade 3	33 (18.0)
Grade 4	123 (67.2)
Enterocele	16 (8.7)
US kidney/CT urogram	161 (88.0)
Normal	154
Hydronephrosis/hydroureteronephrosis^a	7 (4.3)

Of the seven patients with hydronephrosis, three had grade 4 cystocele.

CT, computerized tomography; US, ultrasound.

The surgery was performed under general anesthesia in 76.5% of the patients. Concomitant vaginal hysterectomy was performed in 92.9% of the patients, concomitant sacrospinous ligament fixation in 71% of the patients, and concomitant midurethral sling insertion in 47% of the patients. The mean duration of surgery was 115.5 minutes and the mean blood loss was 231 mL (Table 3). Three patients had rectal perforation intraoperatively, two of which were due to the Uphold arms perforating the rectal mucosa. The rectal injury in one of the patients was detected 2 days postoperatively and required reoperation to remove the vaginal mesh and repair of rectal injury. The rectal injury from the Uphold arm in the other patient was discovered intraoperatively and the Uphold arm was removed. The patient subsequently developed a pelvic collection at the site postoperatively that required a radiology-guided drainage. One patient had a bladder perforation from midurethral sling trocar intraoperatively. The trocar was removed and reinserted. Two patients required blood transfusion postoperatively.

Table 3.

Operative Findings

Parameters	n = 183, n (%)
Type of anesthesia
General	140 (76.5)
Regional	43 (23.5)
Patients with concomitant surgery
VH	170 (92.9)
PFR	183 (100)
SSF	130 (71.0)
MUS	86 (47.0)
Duration (minutes), mean ± SD (range)
All	115.5 ± 32.5 (49–271)
Uphold without VH	85.5 ± 19.8 (57–132)
VH ± PFR + Uphold	97.4 ± 24.8 (56–152)
VH ± PFR + SSF + Uphold	120.5 ± 28.1 (68–189)
VH ± PFR + MUS + Uphold	111.3 ± 32.2 (67–202)
VH ± PFR + MUS + SSF + Uphold	126.8 ± 35.5 (49–271)
Estimated blood loss (mL), mean ± SD (range)
All	230.9 ± 147.6 (50–1200)
Uphold without VH	161.5 ± 113.9 (50–500)
VH ± PFR + Uphold	177.2 ± 83.9 (50–400)
VH ± PFR + SSF + Uphold	257.5 ± 162.6 (50–1000)
VH ± PFR + MUS + Uphold	205.6 ± 91.2 (95–500)
VH ± PFR + MUS + SSF + Uphold	252.7 ± 169.0 (100–1200)
Complications	6 (3.3)
Rectal perforation	3
Bladder perforation	1
Need for blood transfusion	2

MUS, midurethral slings; PFR, pelvic floor repair; SSF, sacrospinous ligament fixation; VH, vaginal hysterectomy.

The mean duration of hospital stay was 3.8 days and 29% of the patients developed fever lasting up to 9 days postoperatively. Twelve patients had voiding dysfunction postoperatively. Six of these patients had concomitant midurethral sling insertion and two other patients had voiding dysfunction preoperatively. Three patients required midurethral tape loosening, one required tape division, and two required tape loosening followed by division. Eleven patients required readmission for reasons such as voiding dysfunction requiring midurethral tape division or loosening, and urinary tract infection (Table 4). Voiding dysfunction resolved in all the patients.

Table 4.

Postoperative Details

Parameters	n = 183, n (%)
Hospital stay (day), mean ± SD (range)	3.8 ± 1.6 (2–13)
Voiding dysfunction^a	12 (6.6)
Voiding dysfunction (day), mean ± SD (range)	34.0 ± 37.7 (7–127)
Excessive vaginal bleeding^b	0
Fever^c	53 (29.0)
1 Day	7
2 Days	17
3 Days	15
4 Days	8
5 Days	3
6 Days	1
8 Days	1
9 Days	1
Readmission	9 (4.9)
Revision of midurethral sling surgery	6
UTI	1
Voiding dysfunction	2
Reoperation	7 (3.8)
Tape loosening	3
Tape division and loosening	2
Tape division	1
Removal of mesh due to rectal injury	1

Voiding problem with high postvoid residual urine lasting >14 days or needing surgical intervention. Of the 12 patients with voiding dysfunction, 6 had undergone concomitant midurethral sling insertion.

Postoperative vaginal bleeding requiring medical intervention.

Temperature of >37.5°C on at least two occasions ≥4 hours apart.

UTI, urinary tract infection.

One hundred eighty-two patients (99.5%) came for 1 month postoperative follow-up, 164 (89.6%) attended the 6 months postoperative follow-up, and 123 (67.2%) attended the 1 year postoperative follow-up. At the 1 year follow-up appointment, 4.9% of the patients complained of denovo urinary urgency, 10.6% had de novo SUI, and five (4.1%) complained of dyspareunia. All the patients were satisfied with the surgery (Table 5). On examination, three (2.4%) had grade 2 cystocele and three had vaginal mesh erosion. Of the patients with vaginal mesh erosion, all three were asymptomatic (Table 6). One required excision of the exposed portion of the mesh in the clinic and the other two patients were managed conservatively with vaginal estrogens.

Table 5.

Postoperative Symptoms

	1 Month (n = 183), n (%)	6 Months (n = 183), n (%)	12 Months (n = 183), n (%)
Follow-up	182 (99.5)	164 (89.6)	123 (67.2)
Lump at introitus	0	0	0
Voiding difficulty	3 (1.6)	0	0
Denovo urgency^a	8 (4.4)	5 (3.0)	6 (4.9)
Denovo urge incontinence^a	6 (3.3)	5 (3.0)	5 (4.1)
Denovo SUI^a	4 (2.2)	14 (8.5)	13 (10.6)
Dyspareunia^a	0	6 (3.7)	5 (4.1)
Pelvic pain	0	0	0
Vaginal pain	0	0	0
Satisfaction	182 (100)	164 (100)	123 (100)
Subjective cure rate	182 (100)	164 (100)	123 (100)

Same patients.

SUI, stress urinary incontinence.

Table 6.

Postoperative Examination

	1 Month (n = 183), n (%)	6 Months (n = 183), n (%)	12 Months (n = 183), n (%)
Follow-up	182 (99.5)	164 (89.6)	123 (67.2)
Recurrent cystocele	0	0	3 (2.4)
Rectocele	0	1 (0.6)	0
Cervical descent	0	0	0
SUI	0	0	0
Extrusion	2 (1.1)^a	2 (1.2)^a	3 (2.4)^a
Objective cure rate	182 (100)	164 (100)	120 (97.6)

Same patients.

Discussion

A Cochrane review of 37 randomized controlled trials by Maher et al. concluded that use of permanent transvaginal mesh is associated with lower rates of prolapse recurrence, repeat surgery for prolapse, and prolapse on examination but higher rate of bladder injury, de novo SUI, and repeat surgery for mesh exposure.⁶ Initial studies on trocar-based vaginal mesh have reported success rates in the range of 87% to 96% (Ref.⁷). In a study by Morcos et al., it was observed that the complication rates of vaginal mesh augmented surgeries were significantly less when they were performed in centralized institutes.⁸

The vaginal mesh kits introduced first on the market involved passage of the mesh arms by trocars through the obturator membrane. It has been suggested that the biomaterials should be anchored outside the affected tissue to provide the intended pelvic floor support.⁹ More recently, single incision mesh kits that do not use trocars for mesh fixation have been introduced. Instead, the mesh arms are fixed to the sacrospinous ligament and arcus tendineus fascia pelvis using the Capio device or self- fixating tips. These newer kits include the Uphold, Pinnacle^®, and Elevate^® systems.¹⁰ The absence of lateral mesh arms penetrating through the levator muscles should help to reduce risk of vaginal and pelvic pain from the arms being inserted too tight and “banding” in the vagina.¹⁰

In a prospective case series study by Altman et al.⁴ on 207 women who underwent Uphold vaginal mesh placement for grade ≥2 apical vaginal prolapse with or without concomitant anterior vaginal wall prolapse, an optimal anatomical outcome (≤1 prolapse POP-Q) rate of 94% at the vaginal apex was reported at 1 year. The incidence of serious complications (bladder perforation, intraoperative blood loss >1000 mL, mesh removal because of pain, or mesh exposure) was 4.3% (9 out of 207 patients).⁴ Rahkola-Soisalo et al. reported a significant improvement in the quality of life of patients undergoing Uphold vaginal mesh placement in a multicenter prospective cohort study.¹¹

Four patients (2.2%) had intraoperative complications in our study. Of these, one had a bladder perforation and three had rectal perforation. Khan et al. reported 2 (1.9%) patients with intraoperative complications in their study on 106 patients who underwent Prolift mesh insertion. Both the patients had bladder perforation.¹² Bjelic-Radisic et al.¹³ in their study on 726 patients who underwent transvaginal mesh procedures with 10 different transvaginal kits reported a 6.8% rate of intra and perioperative complications. The most common complication was increased intraoperative bleeding (2.2%). Bladder and bowel perforation occurred in six (0.8%) and two (0.3%) cases, respectively.¹³

Twelve (6.6%) patients had postoperative voiding dysfunction in our study, of whom six had undergone concomitant midurethral sling insertion. The incidence of postoperative voiding dysfunction after anterior vaginal mesh repair has been reported to be between 5% and 42% in various studies.¹⁴

The incidence of concurrent SUI is reported to be ∼55% in women with stage II POP and 33% in women with stage IV POP. A cumulative SUI success rate of 61% was reported in studies employing transobturator mesh without additional continence surgery in women with SUI undergoing POP surgery. A considerable improvement in success rates (99%) was reported in such women if a midurethral sling was inserted concomitantly.¹⁴ The rate of de novo SUI at 1 year follow-up in our study was 10.6%. Stanford et al. reported a 3.9% de novo SUI rate at 1 year follow-up in their study on 128 patients who underwent Elevate transvaginal mesh insertion.¹⁵ Up to 40% resolution of preoperative bladder overactivity has been reported in women undergoing POP surgery, and de novo bladder overactivity is reported in 12% of these women.¹⁴

The recurrence of cystocele at 1 year follow-up in our study was low (2.4%). All the patients were satisfied with the surgery outcomes. In a study by Vu et al., the recurrence rate of apical–anterior prolapse was 1.89% at 2.5 years in 53 women who underwent Uphold™ insertion, and of the 47 women who underwent mesh insertion after vault prolapse, the recurrence rate was 0% in those with previous hysterectomy to 4.2% in those who underwent concomitant hysterectomy. Ninety-three percent patients were satisfied with the surgery.⁵ Letouzey et al.¹⁶ reported an anatomical success rate of 93% at 23 months in 115 patients who underwent Uphold™ insertion with a patient satisfaction rate of 95%.

Dyspareunia was reported by five (4.1%) patients at 1 year follow-up in our study. None of the patients complained of pelvic pain. Dyspareunia and pelvic pain may occur due to mesh exposure and shrinkage of fibrous tissue around the mesh. Studies have reported de novo dyspareunia rates between 3% and 10% after vaginal mesh surgery. The de novo pelvic pain rate was reported as ∼5% in previous studies.¹⁷ The risk of postoperative pelvic pain is more in patients complaining of lower abdominal or genital region pain preoperatively.

The most common complication related to the use of vaginal mesh in prolapse surgery is mesh exposure. Exposures can occur as early as 6 weeks postoperatively to as late as 4 years, but mostly occur within 1 year of the procedure.¹⁷ The vaginal mesh exposure rate in our study was low (2.4%) and only one of the patients required a mesh excision that was performed in the clinic. In the study by Letouzey et al., reoperation rate for mesh-related complications was 3.4% at 23 months.¹⁶ Synthetic nonabsorbable vaginal mesh exposure rates of 10% to 20% have been reported in the literature.¹⁸ Around 10% of women undergoing POP repair with vaginal mesh will experience vaginal mesh exposure within 10 months, according to data from 110 studies including 11,785 women.¹⁹ Risk factors for higher rates of vaginal mesh exposure include concurrent vaginal hysterectomy, experience of the surgeon, age of the patient, smoking, cystocele stage II or lower, total tension-free vaginal mesh, mesh placement over plicated fascia on the anterior vaginal wall or cellulitis or hematoma formation at the surgical site.^17,20

All the patients were satisfied with the outcomes of the surgery at 1 year follow-up in our study. Gago Ramos et al. reported a 97% satisfaction rate with surgery in their study on 49 women undergoing Pinnacle/Uphold mesh insertion.²¹

Conclusion

Our study shows a high cure rate (97.6%) for grades 3 and 4 cystocele with low rates of complications such as vaginal mesh extrusion (2.4%) and dyspareunia (4.1%) with the use of Uphold vaginal mesh at 1 year follow-up. Complications such as recurrence, mesh erosion, and pain may be delayed in onset. Hence, longer follow-up data are required.

Footnotes

Authors' Contributions

P.S. participated in data collection and article preparation. H.C.H. participated in article supervision.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this work.

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