Int Urogynecol J (2013) 24:1803–1813 DOI 10.1007/s00192-013-2171-2
POP SURGERY REVIEW
Uterine-preserving POP surgery Robert Gutman & Christopher Maher
# ICUD-EAU 2013
Abstract Introduction and hypothesis To review the safety and efficacy of uterine preservation surgery. Methods Every four years and as part of the Fifth International Collaboration on Incontinence we reviewed the Englishlanguage scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 case reports. The highest level of evidence was utilised by the committee to make evidencebased recommendations based upon the Oxford grading system. Grade A recommendation usually depends on consistent level 1 evidence. Grade B recommendation usually depends on consistent level 2 and/or 3 studies, or “majority evidence” from RCTs. Grade C recommendation usually depends on level 4 studies or “majority evidence” from level 2/3 studies or Delphi processed expert opinion. Grade D “no recommendation possible” would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi. On behalf of Committee 15 “Surgical Management of Pelvic Organ Prolapse” from the 5th International Consultation on Incontinence held in Paris, February 2012 This work has been previously published as: Maher C, Baessler K, Barber M, Cheon C, Deitz V, DeTayrac R, Gutman R, Karram M, Sentilhes L (2013) Surgical management of pelvic organ prolapse. In: Abrams, Cardozo, Khoury, Wein, (eds) 5th International Consultation on Incontinence. Health Publication Ltd, Paris, Chapter 15 and modified for publication in International Urogynaecology Journal. R. Gutman MedStar Washington Hospital Center, Washington, DC, USA C. Maher (*) University of Queensland, Royal Brisbane and Wesley Urogynaecology, 30 Chaseley Street, Auchenflower, 4067 Brisbane, Australia e-mail: [email protected]
Results A wide variety of surgical options remain for women presenting with uterine prolapse without contraindications to uterine preservation. However, long-term data are limited and the need for subsequent hysterectomy unknown (grade C). Sacrospinous hysteropexy is as effective as vaginal hysterectomy and repair in retrospective comparative studies and in a meta-analysis with reduced operating time, blood loss and recovery time. However, in a single RCT there was a higher recurrence rate associated with sacrospinous hysteropexy compared with vaginal hysterectomy (grade D). Severe prolapse increases the risk of recurrent prolapse after sacrospinous hysteropexy. In consistent level 2 evidence sacrospinous hysteropexy with mesh augmentation of the anterior compartment was as effective as hysterectomy and mesh augmentation with no significant difference in the rate of mesh exposure between the groups (grade B). Level 1 evidence from a single RCT suggests that vaginal hysterectomy and uterosacral suspension were superior to sacral hysteropexy based on reoperation rates, despite similar anatomical and symptomatic improvement (grade C). Consistent level 2 and 3 evidence suggests that sacral hysteropexy (open or laparoscopic) was as effective as sacral colpopexy and hysterectomy in anatomical outcomes; however, the sacral colpopexy and hysterectomy were associated with a five times higher rate of mesh exposure compared with sacral hysteropexy (grade B). Performing hysterectomy at sacral colpopexy was associated with a four times higher risk of mesh exposure compared with sacral colpopexy without hysterectomy (grade B). Conclusion While uterine preservation is a viable option for the surgical management of uterine prolapse the evidence on safety and efficacy is currently lacking. Keywords Uterine prolapse . Sacral hysteropexy . Sacrospinous hysteropexy Traditionally, surgical correction of uterovaginal prolapse has included a hysterectomy, despite the fact that the uterus is believed to be a passive structure in the disease process. More recently, women have opted for uterine preservation
1804
for a variety of reasons including: desire to maintain future fertility, belief that the uterus affects sexual function or sense of identity, and concern about the risks of hysterectomy. While the overall number of hysteropexy studies has increased, most are retrospective or lack a control group. Comparisons between the different hysteropexy procedures are challenging owing to the limited numbers of prospective controlled trials measuring a variety of outcomes.
Patient selection Careful patient selection is critical prior to considering uterinepreserving prolapse surgery. Table 1 lists contraindications to uterine preservation. Most studies exclude subjects with menstrual disorders and abnormal uterine or cervical pathology such as large fibroids, endometrial hyperplasia, and cervical dysplasia. A recent study by Frick illustrates the need for hysterectomy in women with postmenopausal bleeding, even with a negative work-up because of the high risk (13 %) of unanticipated endometrial cancer or hyperplasia [1]. Postmenopausal women without bleeding and premenopausal women with regular menses without abnormal uterine bleeding and a negative workup are at a low risk of unanticipated pathology.
Vaginal hysteropexy The vaginal route can be divided into repairs with and without mesh. The non-mesh repairs include Manchester repair and sacrospinous hysteropexy. The Manchester procedure The Manchester procedure is one of the oldest prolapse repairs and involves amputation of the cervix and reattachment to the cardinal ligaments. Modified Manchester procedures
Table 1 Contraindications to uterine-preserving surgery Uterine abnormalities Fibroids, adenomyosis, endometrial pathology History of current or recent cervical dysplasia Abnormal menstrual bleeding Postmenopausal bleeding Familial cancer BRAC1&2 ↑risk of ovarian cancer and theoretical risk of fallopian tube and serous endometrial cancer Hereditary non-polyposis colonic cancer 40–50 % lifetime risk of endometrial cancer Tamoxifen therapy Unable to comply with routine gynaecology surveillance
Int Urogynecol J (2013) 24:1803–1813
include plication of the uterosacral ligaments posteriorly and cardinal ligaments anteriorly for improved apical support. Nevertheless, this is primarily a procedure for cervical elongation in premenopausal women who wish to maintain fertility or older women with medical co-morbidity. There are high rates of cervical stenosis and menstrual disorders (7– 35 %) associated with cervical amputation and the use of Sturmdorf sutures [2–5]. All studies using this technique are retrospective and show relatively good anatomical and symptomatic improvement. One retrospective cohort comparing modified Manchester with total vaginal hysterectomy and uterosacral ligament suspension showed 100 % cure of the apical compartment, but a 40 % success rate based on overall stage in the Manchester group [6]. Three other retrospective cohorts comparing Manchester with vaginal hysterectomy showed no difference in anatomical or symptomatic outcomes with decreased operating time and blood loss in the Manchester group [3, 7, 8]. Despite good success rates, Kalogirou concluded, “that the Manchester procedure has a limited place in modern gynecology…” Better surgical options exist for pre-menopausal women who wish to preserve fertility including sacrospinous hysteropexy, laparoscopic uterosacral hysteropexy or laparoscopic sacral hysteropexy. For postmenopausal women with medical comorbidity that requires a minimally invasive approach, sacrospinous hysteropexy or LeFort colpocleisis would be preferable, depending on their desire to preserve vaginal function. Sacrospinous hysteropexy At sacrospinous hysteropexy, the cervix or uterosacral ligaments are transfixed to the sacrospinous ligament using permanent or delayed absorbable suture. In a recent RCT comparing sacrospinous hysteropexy (n=37) with vaginal hysterectomy and uterosacral ligament suspension (n=34), Dietz et al. reported a higher rate of apical recurrences in the hysteropexy group (21 % versus 3 % in the hysterectomy group p=0.03) [9]. Three women had stage 4 uterine prolapse preoperatively who underwent hysteropexy and all developed recurrent uterine prolapse within 1 year. Subjective outcomes improved for both groups. Hysteropexy was associated with shorter hospitalisation, quicker recovery with more rapid return to work and the total vaginal length was longer 8.8 cm versus 7.3 cm in the hysterectomy group (p
POP SURGERY REVIEW
Uterine-preserving POP surgery Robert Gutman & Christopher Maher
# ICUD-EAU 2013
Abstract Introduction and hypothesis To review the safety and efficacy of uterine preservation surgery. Methods Every four years and as part of the Fifth International Collaboration on Incontinence we reviewed the Englishlanguage scientific literature after searching PubMed, Medline, Cochrane library and Cochrane database of systematic reviews, published up to January 2012. Publications were classified as level 1 evidence (randomised controlled trials [RCT] or systematic reviews), level 2 (poor quality RCT, prospective cohort studies), level 3 (case series or retrospective studies) and level 4 case reports. The highest level of evidence was utilised by the committee to make evidencebased recommendations based upon the Oxford grading system. Grade A recommendation usually depends on consistent level 1 evidence. Grade B recommendation usually depends on consistent level 2 and/or 3 studies, or “majority evidence” from RCTs. Grade C recommendation usually depends on level 4 studies or “majority evidence” from level 2/3 studies or Delphi processed expert opinion. Grade D “no recommendation possible” would be used where the evidence is inadequate or conflicting and when expert opinion is delivered without a formal analytical process, such as by Delphi. On behalf of Committee 15 “Surgical Management of Pelvic Organ Prolapse” from the 5th International Consultation on Incontinence held in Paris, February 2012 This work has been previously published as: Maher C, Baessler K, Barber M, Cheon C, Deitz V, DeTayrac R, Gutman R, Karram M, Sentilhes L (2013) Surgical management of pelvic organ prolapse. In: Abrams, Cardozo, Khoury, Wein, (eds) 5th International Consultation on Incontinence. Health Publication Ltd, Paris, Chapter 15 and modified for publication in International Urogynaecology Journal. R. Gutman MedStar Washington Hospital Center, Washington, DC, USA C. Maher (*) University of Queensland, Royal Brisbane and Wesley Urogynaecology, 30 Chaseley Street, Auchenflower, 4067 Brisbane, Australia e-mail: [email protected]
Results A wide variety of surgical options remain for women presenting with uterine prolapse without contraindications to uterine preservation. However, long-term data are limited and the need for subsequent hysterectomy unknown (grade C). Sacrospinous hysteropexy is as effective as vaginal hysterectomy and repair in retrospective comparative studies and in a meta-analysis with reduced operating time, blood loss and recovery time. However, in a single RCT there was a higher recurrence rate associated with sacrospinous hysteropexy compared with vaginal hysterectomy (grade D). Severe prolapse increases the risk of recurrent prolapse after sacrospinous hysteropexy. In consistent level 2 evidence sacrospinous hysteropexy with mesh augmentation of the anterior compartment was as effective as hysterectomy and mesh augmentation with no significant difference in the rate of mesh exposure between the groups (grade B). Level 1 evidence from a single RCT suggests that vaginal hysterectomy and uterosacral suspension were superior to sacral hysteropexy based on reoperation rates, despite similar anatomical and symptomatic improvement (grade C). Consistent level 2 and 3 evidence suggests that sacral hysteropexy (open or laparoscopic) was as effective as sacral colpopexy and hysterectomy in anatomical outcomes; however, the sacral colpopexy and hysterectomy were associated with a five times higher rate of mesh exposure compared with sacral hysteropexy (grade B). Performing hysterectomy at sacral colpopexy was associated with a four times higher risk of mesh exposure compared with sacral colpopexy without hysterectomy (grade B). Conclusion While uterine preservation is a viable option for the surgical management of uterine prolapse the evidence on safety and efficacy is currently lacking. Keywords Uterine prolapse . Sacral hysteropexy . Sacrospinous hysteropexy Traditionally, surgical correction of uterovaginal prolapse has included a hysterectomy, despite the fact that the uterus is believed to be a passive structure in the disease process. More recently, women have opted for uterine preservation
1804
for a variety of reasons including: desire to maintain future fertility, belief that the uterus affects sexual function or sense of identity, and concern about the risks of hysterectomy. While the overall number of hysteropexy studies has increased, most are retrospective or lack a control group. Comparisons between the different hysteropexy procedures are challenging owing to the limited numbers of prospective controlled trials measuring a variety of outcomes.
Patient selection Careful patient selection is critical prior to considering uterinepreserving prolapse surgery. Table 1 lists contraindications to uterine preservation. Most studies exclude subjects with menstrual disorders and abnormal uterine or cervical pathology such as large fibroids, endometrial hyperplasia, and cervical dysplasia. A recent study by Frick illustrates the need for hysterectomy in women with postmenopausal bleeding, even with a negative work-up because of the high risk (13 %) of unanticipated endometrial cancer or hyperplasia [1]. Postmenopausal women without bleeding and premenopausal women with regular menses without abnormal uterine bleeding and a negative workup are at a low risk of unanticipated pathology.
Vaginal hysteropexy The vaginal route can be divided into repairs with and without mesh. The non-mesh repairs include Manchester repair and sacrospinous hysteropexy. The Manchester procedure The Manchester procedure is one of the oldest prolapse repairs and involves amputation of the cervix and reattachment to the cardinal ligaments. Modified Manchester procedures
Table 1 Contraindications to uterine-preserving surgery Uterine abnormalities Fibroids, adenomyosis, endometrial pathology History of current or recent cervical dysplasia Abnormal menstrual bleeding Postmenopausal bleeding Familial cancer BRAC1&2 ↑risk of ovarian cancer and theoretical risk of fallopian tube and serous endometrial cancer Hereditary non-polyposis colonic cancer 40–50 % lifetime risk of endometrial cancer Tamoxifen therapy Unable to comply with routine gynaecology surveillance
Int Urogynecol J (2013) 24:1803–1813
include plication of the uterosacral ligaments posteriorly and cardinal ligaments anteriorly for improved apical support. Nevertheless, this is primarily a procedure for cervical elongation in premenopausal women who wish to maintain fertility or older women with medical co-morbidity. There are high rates of cervical stenosis and menstrual disorders (7– 35 %) associated with cervical amputation and the use of Sturmdorf sutures [2–5]. All studies using this technique are retrospective and show relatively good anatomical and symptomatic improvement. One retrospective cohort comparing modified Manchester with total vaginal hysterectomy and uterosacral ligament suspension showed 100 % cure of the apical compartment, but a 40 % success rate based on overall stage in the Manchester group [6]. Three other retrospective cohorts comparing Manchester with vaginal hysterectomy showed no difference in anatomical or symptomatic outcomes with decreased operating time and blood loss in the Manchester group [3, 7, 8]. Despite good success rates, Kalogirou concluded, “that the Manchester procedure has a limited place in modern gynecology…” Better surgical options exist for pre-menopausal women who wish to preserve fertility including sacrospinous hysteropexy, laparoscopic uterosacral hysteropexy or laparoscopic sacral hysteropexy. For postmenopausal women with medical comorbidity that requires a minimally invasive approach, sacrospinous hysteropexy or LeFort colpocleisis would be preferable, depending on their desire to preserve vaginal function. Sacrospinous hysteropexy At sacrospinous hysteropexy, the cervix or uterosacral ligaments are transfixed to the sacrospinous ligament using permanent or delayed absorbable suture. In a recent RCT comparing sacrospinous hysteropexy (n=37) with vaginal hysterectomy and uterosacral ligament suspension (n=34), Dietz et al. reported a higher rate of apical recurrences in the hysteropexy group (21 % versus 3 % in the hysterectomy group p=0.03) [9]. Three women had stage 4 uterine prolapse preoperatively who underwent hysteropexy and all developed recurrent uterine prolapse within 1 year. Subjective outcomes improved for both groups. Hysteropexy was associated with shorter hospitalisation, quicker recovery with more rapid return to work and the total vaginal length was longer 8.8 cm versus 7.3 cm in the hysterectomy group (p
