ACOG and AUGS have updated the Pelvic Organ Prolapse (POP) recommendations. Guidelines now address the FDA order for manufacturers to discontinue sale and distribution of mesh for treatment of POP in the US. The FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.
CLINICAL ACTIONS:
POP Definition and Staging
Definition
Descent of uterus or vagina which may result in organ prolapse
Pelvic organ prolapse only should be considered a problem if it is causing prolapse symptoms (ie, pressure with or without a bulge) or sexual dysfunction or if it is disrupting normal lower urinary tract or bowel function
POP-Q Staging
See below in ‘Learn More – Primary Sources’ for link to AUGS POP-Q tool
Stage 0
No prolapse
Stage 1
Criteria for stage 0 are not met
Most distal prolapse is more than 1 cm above the level of the hymen
Stage 2
Most distal prolapse is between 1 cm above and 1 cm below the hymen
Stage 3
Most distal prolapse is >1 cm below the hymen but no further than 2 cm less than the total vaginal length
Stage 4
Complete procidentia or vault eversion
History
Women presenting with POP should undergo a careful history and physical examination with attention to the degree of bother caused by the prolapse
Assess urinary incontinence and bladder emptying
Gravitational effect (increased organ displacement): Is voiding more difficult after standing?
Does manually reducing the bulge (‘splinting’) improve urinary flow?
Assess bowel function
Straining | Laxative use | Splinting to reduce rectocele and improve rectal emptying
Impact on sexual function
Dyspareunia | Coital continence
Physical
Comprehensive abdominal and physical exam
For some patients, extent of descent can be evaluated in the supine position but if unclear, having patient stand may uncover extent of prolapse
Pelvic floor tone
Ask patient to contract and relax musculature and grade on following scale
Absent | Weak | Normal | Strong
Use single blade to hold away opposite vaginal wall during visual exam of the vault and apex
Urinary symptoms
Voiding symptoms or prolapse is evident beyond hymenal ring
Perform postvoid residual volume (catheter or ultrasound)
Note: Consider urodynamics in the presence of incontinence and ≥stage II prolapse or voiding dysfunction
Urgency or other UTI symptoms
Perform urinalysis: Culture and microscopy
Assess the pelvic organs and perform a pelvic organ prolapse quantification (POP-Q)
The POP-Q system is recommended before treatment of POP to quantify the degree of prolapse
Note: If findings do not match symptoms, referral to urogynecologist “may be needed”
KEY POINTS:
Risk Factors
Increasing parity | Vaginal delivery | Age | Menopausal status | Obesity | Connective tissue disorders | Chronic constipation
Treatment
Nonsurgical
Consider nonsurgical treatment options when appropriate
Modifiable risk factors include obesity and constipation
Pelvic muscle exercises
Pessary – generally considered low-risk option and a good alternative for women who wish to maintain fertility
Follow up 3 to 4 months if patient can not replace own pessary; Otherwise annual visit sufficient
In case of erosion, remove pessary for 2 to 4 weeks and apply local estrogen therapy (may resolve without estrogen therapy) | Consider more frequent pessary removal and cleaning
Surgical Therapy for Failed/Declined Nonsurgical Treatment
Upper vaginal prolapse
Abdominal sacrocolpopexy
Uterosacral ligament suspension
Sacrospinous fixation
Anterior wall prolapse
Anterior colporrhaphy
Posterior wall prolapse
Posterior colporrhaphy
Additional Notes on Surgical Treatment
Vaginal apex suspension (uterosacral or sacrospinous ligament suspension) should be performed at the time of hysterectomy for uterine prolapse
Anterior wall prolapse is commonly associated with apical prolapse
Both should be surgically corrected if present to reduce risk of recurrent POP
Posterior wall prolapse repair is more effectively done vaginally rather than transanally
Candidates for abdominal sacrocolpopexy (mesh or biologic graft from vaginal apex to anterior longitudinal ligament of sacrum) include those at high risk for recurrence
Age <60 years
POP-Q stage 3 or 4
BMI >26
Authors of the Cochrane Review (2016) of sacrocolpopexy for apical repair concluded that mesh was not superior to native tissue repair
Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, postoperative SUI and dyspareunia than a variety of vaginal interventions
Synthetic Mesh and Biologic Graft Materials in Vaginal POP Surgery
FDA (April 2019) ordered manufacturers of synthetic mesh for POP to discontinue sale and distribution in the US
This order applies to transvaginal mesh only and not transabdominal POP or SUI
Vaginal Prolapse Repair
Both mesh or biologic grafts are associated with greater likelihood of repeat surgery for combined outcomes of prolapse, stress incontinence or mesh exposure
Data on biologic grafts (e.g. cadaver) are limited and of low quality (most no longer available for use)
Posterior Wall Prolapse
Use of synthetic mesh or biologic grafts is associated with increased complications (mesh exposure) and no improvement in outcome
Mesh or grafts should not be used routinely in the primary repair of posterior wall prolapse
Anterior Wall Prolapse
Biologic grafts show minimal/ no difference in recurrence risk vs native tissue repair
Synthetic mesh improves anatomic outcome, but is associated with
Increased risk of repeat surgery for prolapse, urinary incontinence and mesh exposure
Longer operating times and greater blood loss
11% risk of mesh erosion following anterior vaginal repair
7% of cases that will require surgical correction
Dyspareunia rate of approximately 9%
Notes:
Use of mesh or biologic grafts should only be undertaken by surgeons who have training specific for these procedures
Training should include patient selection, anatomy, intraoperative and postoperative techniques, treatment of any adverse outcomes
Routine intraoperative cystoscopy should be performed during POP surgery when there is risk to the bladder or ureter
AUGS 2013 position statement on credentialing includes the following
It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures. AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.
Mesh and Pelvic Organ Prolapse: ACOG Practice Advisory & ACOG/AUGS Recommendations
SUMMARY:
FDA (April 2019) ordered manufacturers of synthetic mesh for the treatment of Pelvic Organ Prolapse (POP) to discontinue sale and distribution in the US. ACOG responded with a Practice Advisory, which emphasizes that the FDA order applies only to mesh placed vaginally for POP and does not apply to (1) transvaginal mesh for SUI or (2) sacrocolpopexy (abdominal placement). POP is considered ‘benign’, but symptoms can seriously impact quality of life, affecting defecatory, voiding and sexual function.
Clinical Considerations
Women presenting with POP should undergo a careful history and physical examination with attention to the degree of bother caused by the prolapse
Assess urinary incontinence and bladder emptying
Assess bowel function
Carefully assess the pelvic organs and perform a pelvic organ prolapse quantification (POP-Q)
The POP-Q system is recommended before treatment of POP to quantify the degree of prolapse
Consider nonsurgical treatment options when appropriate
If surgery is necessary, the procedure should address all areas of prolapse
Vaginal apex suspension (uterosacral or sacrospinous ligament suspension) should be performed at the time of hysterectomy for uterine prolapse
Anterior wall prolapse is commonly associated with apical prolapse
Both should be surgically corrected if present to reduce risk of recurrent POP
Posterior wall prolapse repair is more effectively done vaginally rather than transanally
Synthetic Mesh and Biologic Graft Materials In Vaginal POP Surgery
Both mesh or grafts are associated with greater likelihood of repeat surgery for combined outcomes of prolapse, stress incontinence or mesh exposure
Data on biologic grafts (e.g. cadaver) is limited
Synthetic mesh has been reclassified by the FDA from a class II (moderate risk) medical device to class III (high risk)
Posterior Wall Prolapse
Use of synthetic mesh or biologic grafts is associated with increased complications (mesh exposure) and no improvement in outcome
Mesh or grafts should not be used routinely in the primary repair of posterior wall prolapse
Anterior Wall Prolapse
Biologic grafts show no difference in recurrence risk vs native tissue repair
Synthetic mesh improves anatomic outcome, but is associated with
Increased risk of repeat surgery for prolapse, urinary incontinence and mesh exposure
Longer operating times and greater blood loss
11% risk of mesh erosion following anterior vaginal repair
7% of cases that will require surgical correction
Dyspareunia rate of approximately 9%
KEY POINTS:
Use of mesh or biologic grafts should only be undertaken by surgeons who have training specific for these procedures
Training should include patient selection, anatomy, intraoperative and postoperative techniques, treatment of any adverse outcomes
Routine intraoperative cystoscopy should be performed during POP surgery when there is risk to the bladder or ureter
AUGS 2013 position statement on credentialing includes the following:
It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both/credential and audit surgeons with specific expertise, experience, training and skill to perform these procedures. AUGS has developed, and published credentialing guidelines for transvaginal mesh surgery for pelvic organ prolapse and sacrocolpopexy for the treatment of pelvic organ prolapse.
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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