Uterine Sparing Robotic-Assisted Laparoscopic Sacrohysteropexy for Pelvic Organ Prolapse: Safety and Feasibility

Abstract

Background and Purpose:

The aim of this study was to describe the surgical technique and report the safety and feasibility of robotic-assisted laparoscopic sacrohysteropexy, a uterine sparing procedure to correct pelvic organ prolapse (POP). Hysterectomy at the time of POP surgery has yet to be proven to improve the durability of repair. Nevertheless, the leading indication for hysterectomy in postmenopausal women is POP.

Patients and Methods:

We reviewed the medical records of a consecutive case series of uterine sparing prolapse repair procedures from 2005 to 2011. Fifteen women were identified. Procedures utilized a type I polypropylene mesh securing the posterior uterocervical junction to the sacral promontory. This was later modified to utilize a Y-shaped strip that was inserted through the broad ligaments to include the anterior uterocervical junction.

Results:

Objective success was defined as Baden Walker grade 0 uterine prolapse and subjective success was defined as no complaint of vaginal bulge or pressure. The mean age of women was 51.8 years (28–64 years). No intraoperative complications were noted. The mean operating time was 159.4 minutes (130–201 minutes) and mean estimated blood loss was 35 mL (0–100 mL). The mean length of stay was 1.6 days (1–4 days) and mean length of follow-up was 10.8 months. Uterine prolapse improved in all 15 patients. Objective success was 93% (14/15) and subjective success was 80% (12/15).

Conclusion:

Robotic-assisted laparoscopic sacrohysteropexy was found to be a safe and feasible surgical treatment option for POP patients who desire uterine preservation.

Introduction

T he standard treatment for pelvic organ prolapse (POP) involves repair of pelvic support defects with concomitant hysterectomy. It has been commonly thought that maintenance of the uterus in situ may result in undue stress on pelvic organs and increased risk of prolapse recurrence. As a result, the leading indication for hysterectomy in postmenopausal women is POP.¹

Hysterectomy at the time of POP surgery, however, has yet to be proven to improve the durability of repair. Descent of the uterus is thought to be the result rather than the cause of POP.² Hysterectomy may, in fact, increase blood loss, operative times, and postoperative recovery times. Hysterectomy and associated pelvic floor dissection may also increase the risk of pelvic neuropathy and disrupt natural support structures, such as the uterosacral–cardinal ligament complex.³ According to studies, hysterectomy can be associated with worsening symptoms of urinary incontinence.^4,5 The uterus and cervix may also play important roles in female sexual function and orgasm, influencing female sexuality and personal identity.⁶ In a recent study, women with POP without previous hysterectomy were presented with a scenario in which the physician recommends prolapse surgery and states that the success of the procedure is similar with and without hysterectomy. Sixty percent indicated they would decline a hysterectomy. Reasons for avoiding hysterectomy included mood, relationship, quality of life, sense of femininity, body image, etc.⁷

Given these reasons, there is a growing impetus among clinicians to investigate the efficacy of uterine-sparing procedures for the treatment of POP. Although several uterine-preserving POP repair procedures have shown to be safe and feasible, the most appropriate surgical approach has yet to be determined.⁸

In this context of growing interest in uterine-sparing procedures for POP, we describe the surgical technique and report initial results of robotic-assisted laparoscopic sacrohysteropexy.

Patients and Methods

This study is a retrospective consecutive case series of 15 women with symptomatic POP who underwent robotic-assisted laparoscopic sacrohysteropexy from August 2005 to June 2011 by the same surgeon (N.R.). Patients with symptomatic uterine prolapse who failed conservative management were offered surgical intervention, including nonuterine-sparing procedures. Patients that requested uterine preservation or had reservations about prolapse repair secondary to the suggestion of hysterectomy were given the option of a robotic-assisted laparoscopic sacrohysteropexy. All patients were informed of the potential risks and benefits of uterine preservation, and the lack of long-term data to support the efficacy and durability of this procedure.

Preoperative evaluation included a thorough history and physical examination. Patients who reported a history of stress incontinence or exhibited stress incontinence with reduction of prolapse during urodynamic testing underwent a concomitant synthetic midurethral sling procedure at the time of surgery. We ensured a negative Papanicolaou test and transvaginal ultrasound on all patients to confirm the absence of cervical and other uterine pathology.

Following the procedure, patients were brought back within 2 weeks for an initial postoperative visit. Patients were then followed up at 6 weeks, 6 months, and yearly intervals. At each follow-up visit, patients were assessed for prolapse and vaginal mesh erosion.

Surgical technique

After administration of general endotracheal anesthesia, the patient is placed into a low lithotomy position. An oral gastric tube and the Foley catheter are placed and sequential compression devices are used on the lower extremities. The patient's arms are padded and tucked, and the patient is secured to the operating room table with padding and chest straps to prevent movement when maximum Trendelenburg positioning is used. A uterine manipulator (ZUMI; Cooper Surgical, Trumbull, CT) is placed vaginally. Trocar placement includes a 12 mm balloon trocar at the umbilicus for camera placement, followed by three 8 mm robotic ports and a 10/12 mm accessory port in a W-configuration. The 10/12 mm accessory port is utilized for the introduction of sutures, mesh, and suction/irrigation by the bed-side surgical assistant. The Da Vinci^® Surgical System robot (Intuitive Surgical, Sunnyvale, CA) is side docked after the patient is placed in maximal Trendelenburg.

Robotic instruments include a fenestrated bipolar forceps, ProGrasp^® forceps, monopolar scissors, and two mega needle drivers. The fourth robotic arm with an atraumatic grasper is used to retract the sigmoid colon to the left pelvic sidewall, thereby exposing the aortic bifurcation and the sacral promontory. After the colon is properly mobilized, the monopolar scissor is used to incise the peritoneum overlying the sacral promontory. The dissection is carried down to the level of anterior longitudinal ligament overlying the sacral promontory at the S1–S2 level, with care to identify and avoid injury to the middle sacral vessel(s). The peritoneal incision is continued in a caudal direction toward the cul-de-sac, which will eventually allow for extraperitonealization of the mesh at the completion of fixation.

Mesh fixation is then performed using type I polypropylene mesh. The first 11 cases utilized a single strip cut ∼4×8 cm. The uterus is retracted anteriorly using the manipulator, thereby exposing the posterior uterocervical junction. Three interrupted nonabsorbable 2-0 Ethibond^® sutures (Ethicon, Somerville, NJ) or 2-0 Gore-Tex^® sutures (WL Gore & Associates, Flagstaff, AZ) are placed into the posterior aspect of the cervix, and then sutured through the mesh. Three to four nonabsorbable sutures are placed through the mesh strip to affix the mesh to the sacral promontory under direct visualization of the sacrum. Care is taken to ensure that the strip of mesh is not placed under significant tension. The incised peritoneum is then reapproximated over the mesh using a running 2-0 Vicryl^® suture (Ethicon), thereby entirely excluding the mesh from the peritoneal cavity. At the completion of the procedure, intravenous indigo carmine is administered and cystoscopy is performed to assess ureteral patency.

Y-shaped mesh modification

Our technique for robotic-assisted laparoscopic sacrohysteropexy included one major modification during the course of the study period. Beginning February 2011, sacral fixation changed from a single posterior strip of mesh to a Y-shaped polypropylene mesh affixed both anteriorly and posteriorly as described below. This technique was used for the most recent four cases (Fig. 1).

FIG. 1.

(a) Posterior mesh suturing. (b) Passage of Y-mesh anteriorly through broad ligaments. (c) Mesh positioned anteriorly through broad ligaments. (d) Anterior mesh sutures completed. (e) Mesh fixation to sacral promontory. (f ) Extraperitonealization completed.

For the placement of the Y-shaped mesh, the uterine manipulator allows for identification of the broad ligaments. Two windows in the broad ligaments are created with monopolar current to allow the arms of the Y-shaped mesh to be brought from posterior to anterior through the opening in the broad ligaments during fixation of the mesh. The broad ligament incisions are ∼1–2 cm in diameter lateral to the cervix with care not to injure the uterine artery. Each arm of the Y-shaped mesh measures 4 cm by 8 cm, and the base portion 4 cm by 7 cm. The base portion of the mesh is first sutured posteriorly to the uterocervical junction using four interrupted nonabsorbable sutures (2-0 Gore-Tex). Subsequently, the arms of the Y-shaped mesh are brought through the broad ligaments bilaterally and sutured anteriorly on the anterior cervix. There was no peritoneal mobilization on the anterior aspect of the uterus. The sacral fixation is analogous to the aforementioned technique (see above).

Statistics

A retrospective analysis of all 15 patients was performed on electronic charts for patient demographics, physical examination, medical and surgical history, perioperative information, and outcomes after surgery. The following details of the surgery were analyzed: operative time, estimated blood loss, surgical technique (single strip or Y-shaped mesh), length of hospital stay, intraoperative complications, and early postoperative complications. Early postoperative complications were considered as occurring within 1 month of surgery. Grading of prolapse was done using the Baden-Walker classification system for all, but 2 patients who were assessed using the POP-Q system. Two POP-Q scores were converted to Baden-Walker grades for consistency.⁹ The Baden-Walker grade at the time of last known follow-up was compared to the preoperative grade for short-term anatomic results. Objective success was defined as Baden-Walker grade 0 uterine prolapse, and subjective success was defined as no complaint of vaginal bulge or pressure. The Wilcoxon signed-rank test was used to compare classifications in paired ordinal variables. The McNemar test was used to analyze categorical paired data. This study was approved by our Institutional Review Board.

Results

The mean age of this cohort was 51.8 years (range 28–64 years). Thirteen women were parous, and 8 women were postmenopausal. The mean BMI was 23.6 kg/m² (18.6–29.9 kg/m²). Uterine preservation was accomplished in all 15 patients in this cohort (Table 1). There were no conversions to open laparotomy. Five patients had concomitant transvaginal prolapse repairs: two women with anterior colporraphy, one woman with both anterior colporraphy and rectocele repair, and two women with both paravaginal and rectocele repairs. Concomitant transvaginal repairs were only performed if the surgeon felt there was prominent prolapse on examination after the apical suspension (sacrohysteropexy). Eight of the nine patients with preoperative stress urinary incontinence received concomitant anti-incontinence procedures. Seven patients received transobdurator midurethral slings, and one patient received a retropubic midurethral sling. The one patient with preoperative incontinence who did not undergo a concomitant anti-incontinence procedure was counseled about the risk of persistent stress incontinence, but elected to have a procedure at a separate setting if her incontinence was bothersome.

Table 1.

Preoperative and Postoperative Objective and Subjective Data

Variables	Preoperative	Postoperative	p
Objective (Baden-Walker)
Uterine prolapse
Grade 0	0 (0%)	14 (93%)	<0.001^a
Grade 1	0 (0%)	0 (0%)
Grade 2	4 (27%)	1 (7%)
Grade 3	7 (47%)	0 (0%)
Grade 4	4 (27%)	0 (0%)
Cystocele
Grade 0	2 (13%)	10 (67%)	<0.01^a
Grade 1	2 (13%)	1 (7%)^b
Grade 2	3 (20%)	1 (7%)^b
Grade 3	7 (47%)	3 (20%)^b
Grade 4	1 (7%)	0 (0%)
Rectocele
Grade 0	5 (33%)	12 (80%)	<0.05^a
Grade 1	1 (7%)	1 (7%)
Grade 2	5 (33%)	2 (13%)
Grade 3	3 (20%)	0 (0%)
Grade 4	1 (7%)	0 (0%)
Subjective
Subjective complaint of POP (n)	15 (100%)	3 (20%)^c	<0.001^d
Urinary incontinence (n)	9 (60%)	3 (20%)^c	<0.05^d
Voiding symptoms (n)	7 (47%)	3 (20%)^c	0.13^d
Splinting (n)	7 (47%)	0 (0%)	<0.05^d
Sexually active (n)	10 (67%)	N/A	—
Dyspareunia (n)	6 (40%)	N/A	—
Recurrent UTI (n)	3 (20%)	2 (13%)^c	1^d

Wilcoxon signed-rank test was used to compare classifications in paired ordinal variables.

All five postoperative cystoceles from single-strip cases.

All patients had symptoms before procedure.

McNemar test used to analyze categorical paired data.

POP, pelvic organ prolapse; UTI, urinary tract infection; N/A, not applicable.

The mean total operating time was 159.4 minutes (range 130–201 minutes). The difference in mean total operating time was not statistically significant between single-strip mesh (157.5 minutes) and Y-shaped mesh (162.5 minutes) cases (p-value=0.77). The total operating time includes the time spent docking and undocking the Da Vinci Surgical System robot.

The mean estimated blood loss was 35 mL (range 10–100 mL). No intraoperative complications were reported. Early postoperative complications occurred in 3 patients. Two patients suffered from port-site infections, which were successfully treated with oral antibiotics. One patient experienced nausea and vomiting immediately postoperatively that spontaneously resolved on postoperative day 3. The same patient also experienced postoperative urinary retention after catheter removal on postoperative day 1, which resolved following catheter drainage for 48 hours. The patient had received a concomitant transobdurator midurethral sling procedure.

The mean length of stay was 1.6 days (range 1–4 days). The median follow-up was 10.8 months (range 0.8–28.7 months). Uterine prolapse improved in all 15 patients. The objective success (as defined above) was 93%. There was one case of recurrent uterine prolapse (grade 2) at 4 months following this uterine-sparing procedure. This patient was not symptomatic, and did not desire any further intervention. Anterior compartment prolapse (cystocele) improved in 77% of patients (10/13) and posterior compartment prolapse (rectocele) improved in 70% (7/10). Since the conversion to the Y-shaped mesh procedure, there has been no persistence of cystocele in the four patients studied. All 15 patients presented preoperatively with complaint of vaginal protrusion and/or fullness. Twelve of the patients postoperatively no longer complained of a symptomatic vaginal bulge or pressure resulting in a subjective success rate of 80% (12/15).

Stress urinary incontinence persisted in three of the nine patients who complained of incontinence preoperatively despite concomitant anti-incontinence procedures. Lower urinary tract symptoms persisted in three of the seven patients who had these symptoms preoperatively. There were no cases of de novo urge or stress incontinence. There were no cases of mesh extrusion or erosion identified postoperatively.

Discussion

Several uterine-sparing surgeries for POP repair have been described historically. Since the concept was first introduced in 1888 with the Manchester procedure, much progress has been made. Several studies describe vaginal, abdominal, or laparoscopic approaches to uterine-sparing prolapse repairs. Nevertheless, the most efficacious and durable surgical approach has yet to be determined. Reported success rates for uterine-sparing prolapse repairs vary widely and most published studies are small and retrospective.

Success rates for abdominal uterine-sparing procedures, such as abdominal sacrohysteropexy, are variable. Barranger et al. reported a recurrence rate of 6.6% during a mean follow-up time of 44.5 months, and Roovers et al. reported a 21.9% recurrence rate with a mean follow-up time of 12 months. Reported mean operating times for abdominal uterine-sparing procedures (89–97 minutes) are shorter than our reported time of 159.4 minutes.^10,11 However, open abdominal procedures have longer hospitalizations and convalescence times and relatively higher morbidity such as hemorrhage, ileus, and wound infection. Given that the incidence of prolapse repair surgery peaks in the 6th decade, a less invasive approach for prolapse repair may be preferred.

Vaginal approaches are less invasive than open procedures, but recent concerns for morbidity related to vaginal mesh use have limited options. Furthermore, visibility is limited in vaginal repairs when compared to magnified 3D images that the robotic platform provides. Uterine-preserving vaginal repairs include uterosacral suspension and plication, sacrospinous hysteropexy, and tension-free vaginal mesh procedures. Transvaginal uterosacral plication has been reported to be associated with a high risk of ureteric injury and neurologic morbidity.^12,13 Posterior intravaginal slingplasty has shown high rates of mesh complications, including mesh erosion and infection, which can lead to significant morbidity.¹⁴ It has also been reported that ∼40% of women who undergo sacrospinous hysteropexy may develop prolapse in the anterior compartment.¹⁵

The use of vaginal mesh to correct POP gained significant popularity in the last 10–15 years until the FDA warnings reached the public in 2008 and then again in 2011. Uterine preservation using the ProLift™ system (Gynecare, Somerville, NJ) has shown success rates of 89.5% after 19 months of follow-up, but the mesh erosion rate was 12%.¹⁶ A literature review of vaginal mesh use for POP repair revealed an average mesh extrusion rate of 7.6%, varying widely from 0% to 35.7% of cases.¹⁷ Reported mesh erosion rates in abdominal sacrocolpopexy ranged from 3.6% to 10.5% depending on whether the hysterectomy was supracervical (3.6%) or total (10.5%).¹⁸ In theory, mesh extrusions, exposures, or erosion rates should be even lower in sacrohysteropexy procedures, as there is no incision for mesh to become exposed through. This is worth further investigation through a larger multicenter study with a longer follow-up and larger numbers of patients.

Minimally invasive approaches, such as laparoscopic sacrohysteropexy and laparoscopic sacrocervicopexy, have shown good results with improved quality of life and sexual activity.^19,20 Despite its advantages, the laparoscopic approach has not become a standard treatment for POP repair due to technical challenges with the need for advanced laparoscopic skills.²¹

Two European studies have described uterine-sparing robotic procedures for the repair of POP. The first study only reports outcomes of two patients making interpretation limited.²² The second is a prospective cohort study reported by Mourik et al. Fifty women with uterovaginal prolapse were treated with robotic-assisted laparoscopic sacrohysteropexy with a mean follow-up time of 16 months. Mourik et al. reported a 98% anatomic success rate, which was defined by Baden-Walker classification 0 or 1. Mourik et al. evaluated the quality of life of women following treatment through a questionnaire, and reported that 95% of the women who responded were either perfectly satisfied or had improvements in symptoms following the procedure. While Mourik et al. included all patients who had improved symptoms as being satisfied, our study had a more stringent criteria for subjective success, including only those who reported no vaginal bulge or pressure. In addition, 8 out of the 50 women in their study did not complete the questionnaire. These are potential reasons why our subjective success rates (80%) appear lower compared to the 95% reported by Mourik et al.²³

The mean estimated blood loss we report is comparable to the results found in two other robotic sacrohysteropexy studies. The mean operating time of 159.4 minutes was less than the time reported by Mourik et al. (223 minutes). This may be explained by the difference in surgical technique. While Mourik et al. report using two combined pieces of mesh fixed on the sacrum, the first mesh anteriorly placed and the second mesh posteriorly placed, our study included 11 cases with a single strip and 4 cases with a Y-shaped mesh. The mean operating times for the two cases reported by Vitobello were 120 and 135 minutes. Vitobello utilized the single-strip technique, which was similar to what was described in our study.

Conversion to laparotomy and accidental cystotomy are the most common intraoperative complications in robotic sacrocolpopexy.²⁴ Although our study had no laparotomies or any other intraoperative complications, this study was in a relatively small number of cases. Mourik et al. reported a 4% conversion rate to open in their series of sacrohysteropexy procedures. No bladder injuries were identified.

Postoperative complications described in the literature for laparoscopic or robotic-assisted sacrohysteropexy include de novo urinary incontinence, mesh extrusion, port-site infection, ileus, deep vein thrombosis, and lumbosacral osteomyelitis.^25,26 There were no patients with de novo postoperative stress incontinence in our study. The rate of port-site infections in our series (13%) is relatively high compared to other robotic studies (0%–6%)^27,28; the port-site closure technique has since been modified to try to reduce this rate.

The persistence of stress urinary incontinence in three out of the eight (37.5%) patients who received concomitant anti-incontinence procedures is higher than the reported rate of 13.4% in abdominal sacrohysteropexy reported by Elser et al.²⁹ Another recent prospective randomized study reported 76.9%–77.2% success rates of anti-incontinence procedures for women with stress urinary incontinence. However, this group included patients with very select genuine stress urinary incontinence.³⁰ Although 5/8 (62.5%) is slightly below the reported success rates in ideal settings, a relatively small number of patients received concomitant anti-incontinence procedures in this study. Mourick et al. do not perform concomitant anti-incontinent procedures during the uterine-sparing prolapse procedure. Although 8 patients (19%) had preoperative stress incontinence before surgery and reported no complaints after surgery without concomitant midurethral slings, it is not reported whether these patients received treatment for stress incontinence after the prolapse procedure.

Excessive tension on the anterior vagina mesh may increase the risk of de novo stress urinary incontinence postoperatively by excessive straightening of the urethrovesicle angle. We attempt to minimize this by ensuring that the mesh follows the curve of the sacrum into the pelvis. This may explain why there were no patients who reported de novo stress urinary incontinence in this study, as opposed to the 10% de novo stress urinary incontinence rate reported by Mourick et al.

The single-strip fixation procedure was modified to a Y-shaped mesh procedure to prevent further persistence of postoperative cystoceles. This came from the observation that by solely elevating the posterior portion of the uterus, the anterior vaginal wall was more lax and we felt this may be contributing to the appearance of recurrent cystocele postoperatively. By suturing each arm of the Y-shaped mesh on the anterior cervix, we hoped to provide better cephalad support of the anterior vaginal wall and bladder. After this modification, there were no recurrent cystoceles. This was achieved without peritoneal mobilization or dissection of the anterior aspect between the vagina and bladder. Further investigation is warranted to assess whether the anterior mesh attachment in fact reduces anterior compartment recurrences or the need for concomitant anterior repair without an unacceptable complication rate.

Limitations exist in this study. This study is a single-center, single-surgeon study. The procedure was only performed in a self-selected group of patients who requested uterine preservation, and therefore there is a small sample size. Given the design of the study, a control group is not included. However, now that we have reasonable safety data we hope to carry out large longer term prospective cohort studies or randomized trials to better assess safety and efficacy of this uterine-sparing procedure. The median follow-up period is relatively short (10.6 months) given that the first procedure was conducted in 2005. However, the majority (13/15) procedures were performed since 2009; only two procedures were performed in 2005. In addition, our institution is a tertiary referral center, and many of these patients are followed-up annually with their local gynecologist or urologist. This is a retrospective review, so there was no effort to prospectively contact the patients. Utilizing the POP-Q system would have been more helpful to see and discuss the impact of the surgical technique on the three compartments, but the POP-Q system was not yet universally used clinically until more recently. In 2006, this system was only used clinically by about 40% of members of ICS and AUGS.³¹ In addition, a validated scale was not used to measure patient satisfaction.

The strength of this study is that it reports on a minimally invasive surgical procedure, described in the context of growing impetus to investigate the efficacy of uterine-sparing reconstructive procedures for POP. Present day healthcare aims to ensure patient safety and efficacy. The decision to remove a healthy organ, such as the uterus, must be done taking into account scientific evidence as well as patient preference, needs, and values. We hope this study contributes to the growing body of literature that can help surgeons and patients make an informed decision regarding the treatment of POP.

Robotic-assisted laparoscopic sacrohysteropexy was found to be a safe and feasible surgical treatment option for POP patients who desire uterine preservation. With short-term follow-up, we found acceptable objective and subjective success rates, but long-term evaluation is needed.

Disclosure Statement

No competing financial interests exist.

Footnotes

Abbreviations Used

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