Very Long-Term Outcomes of Robotic Mesh Sacrocolpopexy Hypothesis/Aims of Study

Trivedi H1, Christie A1, Zimmern P1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 430
On Demand Pelvic Organ Prolapse
Scientific Open Discussion Session 28
On-Demand
Pelvic Organ Prolapse Female New Instrumentation Pelvic Floor
1. U.T. Southwestern Medical Center
Presenter
Links

Abstract

Hypothesis / aims of study
Robotic mesh sacrocolpopexy has seen an increase in popularity over the past decade, particularly after the end of the transvaginal mesh placement era.  We were among the first centers adopting robotic technology for prostate cancer surgery (2004) and then pelvic floor reconstructions (2007). The early adoption of this new technology was gradual against the time-honored open repair, but our prior reports had indicated a good outcome, which then led to an increase in our surgery volume as it did in other fields of Urology1. The goal of this study is to report on our long-term data evaluating anatomic and functional outcomes after robotic mesh sacrocolpopexy (RMS) for symptomatic pelvic organ prolapse (POP) at a single tertiary-care institution.
Study design, materials and methods
Following Institutional Review Board approval, a retrospective chart review of consecutive women undergoing RMS for symptomatic POP from 2007 to 2013, with at least 5 years minimum follow-up was performed. The data originated from an existing prospectively collected database but was updated by contacting those who had not been seen in the office since 2018 by way of a structured phone interview. Data collected included baseline and follow-up physical examination, Baden-Walker or Pelvic Organ Prolapse Quantification (POP-Q) findings, and validated questionnaires including Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and global Quality of Life (QoL). Additional data was obtained on demographics, indications for surgery, peri-operative care, and any re-operation for vault prolapse, secondary compartment prolapses, secondary urinary incontinence and/or apical mesh exposure. Follow-up consisted of office visits at 6 weeks, 6 months, 12 months, and then yearly or every 2 years by FPMRS-trained examiners (MD, PA). 

RMS was performed by the same operating team throughout the study. Marlex™ mesh was used and the technique, already reported, included mesh suturing with absorbable sutures, and retroperitonealization of the mesh, with cystoscopy at the end1. The primary outcome was anatomic failure defined as vault prolapse recurrence on examination (stage 2 or greater by POP-Q or Grade 2 or greater for Baden-Walker) or re-operation for vault prolapse. Descriptive statistics were provided as medians and IQRs for continuous values, and frequencies and percentages for categorical values. Paired t-tests were used to compare pre-RMS and post-RMS POP-Q findings. All tests were performed at the 0.05 significance level using SAS 9.4 (SAS Institute Inc., Cary NC).
Results
55 women underwent RMS between 2007-2013 with 28 having clinic/telephone follow up at > 5 years. Six patients were deceased and in 2, family members reported no prolapse-related subjective issues after RMS. Twenty-one were not reachable beyond the first year after their RMS procedure.

Prior to RMS, compartment prolapse rates were as follows: 51% posterior compartment and vault prolapse, 11% anterior compartment and vault prolapse, 5% vault prolapse only, and 33% triple compartment prolapse. Nineteen patients had a prior POP repair and nearly all (53/55) were post-hysterectomy (Table 1). 

The 28 patients had a mean physical examination follow up of 47 (IQR 18-104) months. C-point went from a mean of -2 (-5.1 to 1.1) pre-RMS to -8.8 (-11.7 to -5.9) at the most recent clinic visit with a mean change of -6.9 (-7.9 to -5.8) (p<0.0001). Ap and Bp points were also improved with a mean change of -1.0 (-1.4 to -0.6) and -1.3 (-1.8 to -0.8), respectively (p<0.0001). 

Three patients had failure by physical examination without repeat operations, and one using a pessary satisfactorily. Six patients required reoperation for recurrent anterior compartment prolapse symptoms at a median of 33.5 months, with anterior colporrhaphy, anterior vaginal wall suspension, open sacrocolpopexy + posterior prolapse repair. Five of these six were asymptomatic after their repeat operations with one complaining of some residual bulge symptoms. Three patients had new POP occurrence in the anterior compartment after previous repair of posterior and vault prolapse and thus had longer median time to further treatment of 103 months. All three were treated with anterior colporrhaphy with resolution of symptoms at most recent follow-up. 

Four patients required reoperation for mesh exposure at a median of 12 months. The procedure was done vaginally with all patients asymptomatic since. 

Six patients had secondary bothersome stress urinary incontinence after RMS, three managed with injectable agents at 31, 39 and 56 months and two with slings (mid-urethral sling and a pubovaginal sling at 3 months and 35 months after RMS respectively.)

At a median follow-up time of 120 months (IQR 84-131), 16 patients had updated questionnaire outcomes with mean IIQ-7 score of 0.46 (0-21), a mean QoL score of 2 (0-10, terrible), and a mean UDI-6 score of 4 (0-18).
Interpretation of results
This report underscores favorable long-term results after RMS and, to our knowledge, this is the longest study to examine recurrence of prolapse after RMS based on physical examination findings1,2. Our reoperation rate beyond 5 years for all prolapse compartment recurrence was roughly 16%, which is consistent with previous reports on 5-year and 6-year reoperation rates at 13.3% and 10% respectively1,2. Anatomic findings remained statistically improved and subjective measures of patient satisfaction were stable. Our reoperation rate for mesh exposure was 7% with the longest time to further treatment of 33 months. 

This study is unique because all the procedures were performed by the same surgical team and follow-ups completed by FPMRS physicians or PAs. Additional follow-up was achieved with the use of a standardized phone interview. As expected in an elderly population, the lost-to-follow-up was unavoidable. Furthermore, the results of this early series were tainted by the learning curve and a tertiary care center committed to teaching. With advances in robot technology, more liberal indications for RMS, and inclusion of imaging such as MRI defecography pre-operatively, we anticipate these encouraging results to continue to grow favorably.
Concluding message
In this limited report on our very long-term experience with RMS, this procedure provided durable improvement in symptomatic POP. Mesh exposure was only noted initially. Rates of recurrence of prolapse in the same or other compartments inevitably increased as the follow-up period continued, highlighting the importance and necessity of long-term reporting.
Figure 1
References
  1. Jong K, Klein T, Zimmern PE. Long-term outcomes of robotic mesh sacrocolpopexy. J Robot Surg. 2018;12(3):455-460. doi:10.1007/s11701-017-0757-2
  2. Ou R, Xie X-J, Zimmern PE. Prolapse follow-up at 5 years or more: myth or reality? Urology. 2011;78(2):295-299. doi:10.1016/j.urology.2011.02.069
Disclosures
Funding NA Clinical Trial No Subjects None
20/11/2024 21:44:38