1. Evidence- Based Surgical Management Of POP: Traditional Repair
Diaa E.E. Rizk MSc, FRCOG, FRCS, MD
Professor and Chairman of Obstetrics and Gynaecology,
College of Medicine and Medical Sciences, Arabian Gulf University,
Manama, Bahrain.

2. DISCLOSURES Mediterranean Incontinence & Pelvic Floor Society [MIPS]
Chairman, Executive Board
International Uro-Gynecological Association [IUGA]
Member, Research and Development Committee
Editor, International Urogynecology Journal
Commercial affiliations and/or Financial relationships
None

3. The pelvis fulfils more extensive functions in the female body than in the male. In the female, it shelters the largest part of the sexual apparatus in addition to the distal end of the intestinal canal and urinary passages and thereby assumes great importance in reproduction.
Carl Litzmann (A German Anatomist); Die Foramen des Beckens, 1861.

4. Introduction
Pelvic organ prolapse [POP] is a dynamic condition which may REGRESS at the same or higher rate as incidence.
Surgically treated POP represents the severe end of the clinical spectrum.
The direct cost of POP surgery is greater than $1 billion per year.
Peri-operative death is rare (3 per 10,000 operations) although that figure underestimates mortality occurring outside of the index hospitalization for surgery.

5. Clinical Importance POP is more frequently encountered in older
women and in highly parous societies in both
Gynaecological and Urological practice.
It can also be a complication of surgical
treatment e.g. hysterectomy.
It is significant because of its increasing
prevalence and adverse effect on the quality of
life of the woman.

6. Public Health Importance
The prevalence of POP increases with age.
Therefore, the changing demographics of the
world’s population will result in more patients.
The demand for health care services related to
POP is expected to increase.

7. Did Howard A. Kelly (1858-1953) expect this?

8. Current controversies in surgical management
A. Apical vaginal prolapse (uterine and vaginal vault)
1. Abdominal sacral colpopexy versus vaginal
sacrospinous colpopexy.
2. Vaginal hysterectomy versus uterine preservation.
3. Vaginal McCall culdoplasty and uterosacral ligament
plication versus vaginal sacrospinous colpopexy and
repair.

9. Current controversies in surgical management
B. Anterior vaginal wall prolapse
1. Anterior repair versus abdominal paravaginal repair.
2. For midline cystocele defects, a traditional anterior
repair versus anterior repair with graft reinforcement.
C. Posterior vaginal wall prolapse
1. Posterior repair versus a transanal repair.
2. Posterior repair versus an abdominal posterior repair.
3. Posterior repair versus posterior repair with graft reinforcement.

10. Current controversies in surgical management
D. Any type of POP
1. Laparotomy versus laparoscopic versus robotic approach.
2. Occult stress urinary incontinence [SUI] treated at the
time of POP surgery versus left untreated.
3. Use of native tissue versus mesh or grafts.
4. One type of mesh/graft versus another type.
5. One type of suture versus another type.

11. Objectives of Operations
Relieve or improve POP symptoms and associated
lower urinary and gastrointestinal tracts symptoms.
In some women, restore normal vaginal anatomy and
maintain or improve sexual function.
In other women, an obliterative approach is more
appropriate and still achieves symptom relief.

12. Type of Procedures 1) Restorative which use the patient’s endogenous
support structures.
2) Compensatory which attempt to replace deficient
support with some type of graft.
3) Obliterative which close the vagina.

13. Use of Grafts The need to improve the outcome of traditional surgical
treatment of POP has led to increased use of grafts.
The long-term and high success rate (>80%) of mid-
urethral sling procedures using synthetic meshes for
the surgical treatment of Stress Urinary Incontinence
[SUI] had an additional influence.
There is, however, LACK of high-quality evidence
to support the ROUTINE use of synthetic meshes for
POP repairs, AS YET (NICE 2008, FDA 2011).

14. Cochrane Review 2013 (Maher et al)
40 RCT evaluating 3773 women.
Abdominal sacral colpopexy was better than vaginal
sacrospinous colpopexy for recurrent vault prolapse (RR
0.23, 95% CI ) and dyspareunia (RR 0.39, 95%
CI ).
Sacrospinous colpopexy was quicker, cheaper and
women had an earlier return to activities of daily living.

15. Cochrane Review 2013 (Maher et al)
Anterior repair was associated with more recurrent
prolapse than polyglactin (RR 1.39, 95% CI ),
porcine dermis (RR 2.72, 95% CI ),
polypropylene (RR 2.14, 95% CI ) or armed
transobturator (RR 3.55, 95% CI ) meshes.
For posterior prolapse, vaginal approach was associated
with a lower recurrent prolapse than the transanal
approach (RR 0.24, 95% CI ).
Addition of TVT to endopelvic fascia plication (RR 5.5,
95% CI ) and Burch colposuspension to sacral
colpopexy (RR 2.13, 95% CI ) were followed by
a lower risk of postoperative SUI.

16. Cochrane Review 2013 (Maher et al)
Conclusions:
Adequately powered RCT clinical trials are urgently needed.
Prospect -UK, TVM III- Sweden (in progress).

17. Review of synthetic meshes 2009 (Bako and Dar)
Anterior wall erosion rate: 2-25%. Tension-free insertion
of synthetic mesh does not appear to eliminate the risk.
Posterior wall erosion rate: 6-13%.
Apical support erosion rate: 3.5% to 12%. Increased to
16% if sutures were placed vaginally and attached to an
abdominally introduced mesh and to 40% if the
mesh was introduced vaginally. .

18. Review of synthetic meshes 2009 (Bako and Dar)
Risk factors
Age
Estrogen deficiency.
Type and pore size of synthetic mesh.
Route of placement and fixation.
Type of concomitant operations particularly hysterectomy.

19. Review of synthetic meshes 2009 (Bako and Dar)
Other complications:
Mesh-related infections ranges from 0% to 8%.
Foreign body reaction, fibrosis, fistula.
Leg Pain syndromes.
Mesh shrinkage and extensive fibrosis may lead to
dyspareunia and buttock pain.

20. Review of synthetic meshes 2009 (Bako and Dar)
Conclusions:
There is lack of strong evidence to support ROUTINE
use in anterior and posterior repairs.
There is insufficient good evidence on the long-term
safety of synthetic mesh in pelvic reconstructive surgery.
There are few RCT comparing mesh augmentation
techniques with traditional repairs for anterior and
posterior vaginal wall prolapse; most of the reported
studies are retrospective series or uncontrolled.

21. What is long-term follow up?
The efficacy and safety of surgical interventions requires
to be judged over a longer timescale than that of
non-surgical treatments.
The ICI (1999) defined durations of surgical follow up:
short term being up to 3 months, medium term from 3 to
12 months and long term over 12 months.
The consensus view is that in order to be considered
safe and efficacious in the long-term, surgical procedures
for POP require evaluation over at least 5 years.

22. Long-Term Outcomes 2013 (Funk et al)
27,809 anterior vaginal wall prolapse surgeries using
native tissue versus mesh repair.
Conclusions:
5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue repair (15.2% vs 9.8%, p<0.0001) with a 5-year risk of mesh revision/removal of 5.9%.
5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4% vs 9.3%, p=0.7).

23. Evidence-based Surgical Management
The uterus plays a PASSIVE role in prolapse, vaginal
hysterectomy ALONE does not address the underlying
problem.
The same procedures performed for vaginal suspension
can be performed with uterine conservation: uterosacral or
sacrospinous fixation by the vaginal approach or sacral
hysteropexy by the abdominal approach.
For pregnancy and delivery after prolapse repair,
decisions regarding mode of delivery should be made on a
case-by-case basis; evidence to guide such decisions is
LACKING. .

24. Evidence-based Surgical Management
Restoration of apical support is indicated once the uterus
is removed using suspension procedures to
sacrospinous ligaments, uterosacral ligaments and
iliococcygeus fascia or muscle.
Round ligament suspension is NOT effective in treating
or preventing vault prolapse.
The use of ROUTINE perineorrhaphy and levator
plication has been STOPPED because of postoperative
dyspareunia except when postoperative sexual activity is
not anticipated.

25. Evidence-based Surgical Management
There is NO CLEAR risk–benefit information for mesh
use and many are being incorporated RAPIDLY into
clinical practice despite associated serious complications.
Cadaveric fascia should not be used as graft material for
abdominal sacral colpopexy because of a higher risk of
recurrent prolapse than with synthetic mesh.
Cystoscopy should be performed intra-operatively to
assess bladder or ureteral damage after all prolapse
procedures with risk of injury to bladder or ureters
(Uterosacral ligament suspension, risk of 11% of ureteral
injury + Paravaginal repair + Sacral colpopexy).

26. Evidence-based Surgical Management
Obliterative procedures are highly successful for POP repair - approaching100% in most series.
Should be considered in the elderly and medically fragile patient who does not desire a functional vagina.
Concomitant hysterectomy appears to add morbidity.
QOL and patient symptoms generally improve (bowel, voiding function) and up to 90% of patients are satisfied with the results.

27. Evidence-based Surgical Management
Occult stress-continent women with positive stress test
are at higher risk for postoperative SUI after POP repair
alone versus with women with negative stress test.
For women with positive stress test who are having
vaginal prolapse repair, TVT or TOT reduces
postoperative SUI (RR 5.5, 95% CI ).
For stress-continent women planning sacral colpopexy,
regardless of the results of preoperative stress testing,
the addition of Burch procedure reduces the likelihood of
postoperative SUI (RR 2.13, 95% CI )- The
Colpopexy and Urinary Reduction Efforts (CARE) trial.

28. Evidence-based Surgical Management
The risk of post-operative SUI is definitely increased in
women with occult SUI but the majority of patients will NOT
develop troublesome symptoms post-operatively.
The risk reported in current studies does NOT warrant an
anti-incontinence procedure at the time of surgery for
POP in women with occult SUI (NNT= 6-10) with the
added morbidity of these procedures.
However, if performed, the risks as well as the benefits
need to be discussed with the patient very clearly.

29. Conclusions
1- Native tissue repair of POP is increasing and the results are better than previously thought with high patient satisfaction and acceptable re-operation rates. 2- Greater surgical experience is correlated with fewer trans-vaginal mesh complications. 3- Some trans-vaginal mesh complications are refractory and might not always be surgically correctable.

30. Conclusions 4- The consequences of interventions for unsuccessful
trans-vaginal mesh surgery is not usually considered
compared to the relatively treatable complications of
native tissue repair.
5- The results of the FDA’s analysis may be criticized
methodologically if applied to all patients with POP.
6- Vaginal mesh repair should be reserved for high-risk
individuals in whom the benefit of mesh placement may
justify the risk.

31. Recommendations Powered and prospective RCT comparing trans-vaginal
mesh techniques with traditional repairs for POP
are needed as most of the reported studies are small,
retrospective or uncontrolled.
The FDA is considering revising its regulatory policy about
clearance of trans-vaginal meshes for POP repair and
include clinical performance data after the 2011 Notification.
A standard protocol must be implemented for new trans-
vaginal meshes introduced to the market with continued
audit and development of a patient registry.

32. The New Government Regulations
On June 17th 2014, the Scottish Health Minister asked
for all trans-vaginal polypropylene mesh procedures to be
suspended in Scotland pending a national independent
review. This includes mesh tapes for SUI and POP.
The decision followed 18 months of campaigning by the Scottish Mesh Survivors, an advocacy group of women who suffered adverse events that has culminated in a successful parliament petition.
Currently, mesh devices are under review by European
Commission Scientific Committee on Emerging and Newly
Identified Health Risks (SCENIHR), Australian Therapeutic
Goods Administration (TGA) and UK Medicines and
Healthcare Products Regulatory Agency (MHRA).

33. The SCENIHR REPORT- December 2015
In the context of treating SUI, use of a synthetic mesh is currently considered the standard of care.
Mesh implants can be used for POP repair. Placement of mesh by vaginal route should be considered a secondary option if primary surgery has failed or exceptionally as a first option when native tissue repair is expected to fail.
It is important to consider that larger surface areas of mesh are needed for POP repair than for treating SUI.
Sufficient data are NOT available on the long-term use of non-absorbable meshes for POP repair so it is normally not recommended for young women.