New therapies for prolapse

Contributed by Dr Elena Ioannou, F2 in obstetrics and gynaecology, and Mr Alex Slack, consultant obstetrician and gynaecologist and subspecialist in urogynaecology, Pembury Hospital, Tunbridge Wells, Kent.

Section 1: Aetiology and epidemiology
The symptoms of pelvic organ prolapse can vary greatly between women and to a degree depend on the severity and site of the prolapse.
Bladder prolapse may present as a visible protrusion from the vagina

General symptoms may include a sense of fullness and/or dragging in the vagina, a visible bulge or protrusion from the vagina and sacral backache. Other symptoms can be related to bladder, bowel or sexual dysfunction.

Bowel and bladder function
In the case of an urethrocele or a cystocele, stress incontinence can occur when there is a loss of the posterior urethrovesical angle. If the angle between the bladder and urethra becomes more pronounced, there is a higher risk of incomplete emptying associated with double micturition and UTIs.

Rectocele may result in difficulty in the emptying the bowel and enterocele may present similarly. In extreme cases, a large enterocele may be associated with incarceration and obstruction of the bowel.

Uterine prolapse
Uterine prolapse may result in pressure in the vagina and in the case of second- and third-degree prolapse, the patient may experience discomfort on sitting and ulceration that can occasionally result in haemorrhage.

With such a wide range of potentially distressing symptoms the treatment of pelvic organ prolapse has received longstanding interest.

Section 2: Conservative management
Non-surgical management is largely recommended for asymptomatic/mild prolapse, women who have not completed their family, those unfit for surgery and those who prefer it.

Visualisation of the female pelvic floor muscles: improving muscle tone can reduce severity of prolapse

Pelvic floor exercise
Pelvic floor exercises can aid the management of mild degrees of prolapse and should always be encouraged postpartum as primary prevention.

There have been encouraging results to suggest that pelvic floor muscle training delivered by physiotherapists in the outpatient setting may reduce the severity of prolapse.

However, the evidence is not currently significant and larger, better designed studies are needed to quantify the actual benefit. Exercises can also be facilitated with the aid of devices such as the Colpexin sphere, which has shown positive results in recent studies.1

Pessaries
Pessaries have an established role in pelvic organ prolapse, primarily in those who are medically unfit for surgery, those awaiting surgery or those who prefer medical management. There are various types of vaginal pessary; the most commonly used are the ring and shelf varieties (see below).

In a recent study, success rates for pessary use were up to 83 per cent, with the highest rates occurring in those using systemic and local HRT.2 Ring, ring with support and Gellhorn pessaries had the highest success rates for fitting.

However, despite several other studies showing symptomatic relief and high levels of patient satisfaction, there has not been any evidence from randomised controlled trials supporting the use of pessaries for prolapse.

It must also be kept in mind that women need to have a degree of pelvic floor support to retain a pessary, and measuring and fitting need to be accurate.

Complications related to pessary use are uncommon,2 but include vaginitis and vaginal infections, erosions and ulcerations (most commonly in those with atrophic changes). In rare cases, severe complications such as erosion into the bowel or bladder may occur.

Section 3: Surgical management
For those who are candidates for surgery, the ultimate goal is to restore normal vaginal anatomy and bladder, bowel and sexual function. Both vaginal and abdominal surgical approaches can be used (see box).

The choice of surgery depends on many factors, including the nature, site and severity of the prolapse, preserving sexual function and the general health of the woman.3

Different approaches yield different success rates. For example, abdominal sacrocolpopexy has been shown to have a lower rate of recurrent vault prolapse and dyspareunia than the vaginal sacrospinous colpopexy.4

Unfortunately, evidence has demonstrated a high recurrence rate of prolapse after surgery. One study showed 29.2 per cent of patients required repeat operations within four years of the primary surgical procedure.3 Hence, improving and creating new surgical techniques has been at the forefront of pelvic organ prolapse management in recent years.

The use of grafts or meshes in combination with new techniques is rapidly gaining popularity and interest. This usually entails placing either a biological or synthetic graft between the vaginal epithelium and the underlying fascia to augment the repair.

Grafts and meshes
Biological grafts include cadaveric fascia, dermis (human/porcine) and small intestine submucosa. Advantages include in vivo tissue remodelling, histological similarity and reduced erosion rates. However, their disadvantages include restricted supply, inconsistent tissue strength and possible degradation.

The physical properties of synthetic grafts are extremely important. They can be created from absorbable or non-absorbable materials, which can be woven, knitted or non-woven/knitted.

The most important property is the size of the pores in the material. Large pores allow for tissue in-growth and passage of immune cells into the mesh to fight infection.

Type I macroporous polypropylene meshes are most commonly used. Compared with microporous meshes, they have a lower rate of mesh infections and erosions, which are significant complications.

In a recent Cochrane review, evidence suggested that use of grafts or mesh inlays at the time of vaginal wall repair might reduce the risk of recurrent cystoceles.4 In individual studies, the success rate of using synthetic meshes in anterior repairs has ranged from 42 per cent5 to 100 per cent.6

In the latter study, a 100 per cent success rate was achieved at over three years using a Marlex mesh to augment anterior colporrhaphy, with no cystoceles recurring beyond stage 2.6

In a randomised controlled trial, those who received anterior colporrhaphy plus polyglactin mesh augmentation had a success rate of 75 per cent, significantly higher than the 57 per cent success rate achieved in those receiving anterior colporrhaphy alone.7

Biological grafts have also shown promising results in anterior repairs. Porcine dermis grafts were used to augment cystocele repair with recurrence rates of 14 per cent and no serious complications at 24 months follow up.8

Data on the use of grafts in posterior repairs are also growing, despite being limited due to concerns regarding mesh erosion into the bowel and vagina. A study of 73 women achieved a 92 per cent cure rate at 12 months follow up with no serious complications when using a polyglactin mesh.7

Biological grafts have also had a degree of success in posterior repairs.

A retrospective study using dermal allograft in the augmentation of posterior repair reported a success rate of 93 per cent at over a year follow up in the 43 women who underwent surgery.9

Surgical approaches

Vaginal options include:

  • Vaginal hysterectomy
  • Anterior and posterior repair
  • Sacrospinous fixation
  • Paravaginal repair
Abdominal options include:
  • Sacrocolpopexy
  • Paravaginal repair
  • Uterosacral ligament placation

Section 4: Additional methods for improving outcomes
Studies have also assessed the use of additional methods in combination with mesh augmentation for posterior and anterior repairs, as a way of improving outcomes. More studies are needed to assess this further.

New surgical methods
An alternative to augmentation of traditional colporrhaphy is the use of a transobturator approach for treating anterior and posterior prolapse.

In the case of anterior repair, this involves complete dissection of the anterior vaginal wall and the positioning of a mesh anchored by arms that are fixed through the obturator membrane. The mesh is placed inferior to the bladder in a tension-free manner.

A similar approach has been developed for use with posterior wall prolapse. A polypropylene mesh is inserted in the posterior vaginal wall, anchored by arms placed through the sacrospinous ligament.

Anterior and posterior repairs are not the only surgical methods receiving interest.

Apical vaginal prolapse has traditionally been treated with abdominal sacrocolpopexy with success rates of 78-100 per cent over a follow up of between six months and three years.10 Mesh erosion rates of 0-13 per cent have been reported, with rates being higher in those where the mesh is introduced vaginally.

Laparoscopic sacrocolpopexy has shown encouraging results and has many advantages over open surgery.

Conclusion
Techniques for treating pelvic organ prolapse have undergone fundamental changes over the past few years. There is much interest in the use of mesh augmentation to improve the outcome of surgery and to reduce the incidence of recurrence.

There is however, very little evidence to support the use of mesh. Long-term data on outcomes and complications are not available and further work is needed to support the use of mesh in vaginal surgery.

References

1. Lukban J C, Aguirre O A, Davila G W, Sand P K. Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2006 Sep; 17(5): 449-54.

2. Hanson L A, Schulz J A, Flood C G, Cooley B, Tam F. Vaginal pessaries in managing women with pelvic organ prolapse and urinary incontinence: patient characteristics and factors contributing to success. Int Urogynecol J Pelvic Floor Dysfunct 2006 Feb; 17(2): 155-9.

3. Olsen A L, Smith V J, Bergstrom J O, Colling J C, Clark A L. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; (89): 501-6.

4. Maher C, Baessler K, Glazener C M, Adams E J, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2007; (3): CD004014.

5. Weber A M, Walters M D, Piedmonte M R, Ballard L A. Anterior colporrhaphy: a randomised control trial of three surgical techniques. Am J Obstet Gynecol 1996; 175: 10-17.

6. Flood C G, Drutz H P, Waja L. Anterior colporrhaphy reinforced with Marlex mesh for the treatment of cystoceles. Int Urogynecol J Pelvic Floor Dysfunct 1998; 9: 200-4.

7. Sand P K, Koduri S, Lobel R W et al. Prospective randomised control trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Am J Obstet Gynecol 2001; 184: 1,357-62.

8. Gomelsky A, Rudy D C, Dmochowski R R. Porcine dermis interposition graft for repair of high grade anterior compartment defects with or without concomitant pelvic organ prolapse. J Urol 2004; 171: 1,581-4.

9. Kohli N, Miklos J R. Dermal graft-augmented rectocele repair. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 146-9.

10. Nygaard I E, McCreery R, Brubaker L et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 2003; 189: 1,607-10.

For an archive of all GP clinical reviews visit www.healthcarerepublic.com/clinical/GP.

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