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01-04-2012 | Original Article

Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device

Authors: T. Sayer, J. Lim, J. M. Gauld, P. Hinoul, P. Jones, N. Franco, D. Van Drie, M. Slack, for the Prosima Study Investigators

Published in: International Urogynecology Journal | Issue 4/2012

Abstract

Introduction and hypothesis

This study was designed to evaluate clinical outcomes ≥2 years following surgery with polypropylene mesh and vaginal support device (VSD) in women with vaginal prolapse, in a prospective, multi-center setting.

Methods

Patients re-consented for this extended follow-up (n = 110), with anatomic evaluation using Pelvic Organ Prolapse Quantification (POP-Q) and validated questionnaires to assess pelvic symptoms and sexual function. Complications were recorded (safety set; n = 121).

Results

Median length of follow-up was 29 months (range 24–34 months). The primary anatomic success, defined as POP-Q 0–I, was 69.1%; however, in 84.5% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms and sexual function improved significantly from baseline (p < 0.01). Mesh exposure rate was 9.1%. Five percent reported stress urinary incontinence and 3.3% required further prolapse surgery.

Conclusion

These results indicate this non-anchored mesh repair is a safe and effective treatment for women with symptomatic vaginal prolapse in the medium term.

Shah AD, Kohli N, Rajan S, Hoyte L (2008) The age distribution, rates and types of surgery for pelvic organ prolapse surgery in the USA. Int urogynaecol J 19:421–428CrossRef

Smith F, Holman C, Moorin RE, Tsoko N (2010) Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 116:1096–1100PubMedCrossRef

Nygaard I, Barber MD, Burgio KL et al (2008) Prevalence of symptomatic pelvic floor disorders in US women. JAMA 300(11):1311–1316PubMedCrossRef

Luber KM, Boero S, Choe JY (2001) The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gynecol 184:1496–1503PubMedCrossRef

Denman MA, Gregory WT, Boyles SH, Smith V, Edwards SR, Clark AL (2008) Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 198(5):555.e1–555.e5CrossRef

Withagen M, Milani AL, den Boon J, Hervest HA, Vierhout ME (2011) Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 117:242–250PubMedCrossRef

Carey M, Higgs P, Goh J et al (2009) Vaginal repair with mesh versus colporrhaphy for prolapse: a randomized controlled trial. BJOG 116(10):1380–1386PubMedCrossRef

Altman D, Vayrynen T, Ellstrom-Engh M, Axelsen S, Falconer C (2011) Anterior colporrhaphy versus transvaginal mesh for pelvic organ prolapse. NEJM 364:1826–1836PubMedCrossRef

Margulies RU, Lewicky-Gaupp C, Fenner DE, McGuire EJ, Clemens JQ, Delancey JO (2008) Complications requiring reoperation following vaginal mesh kit procedures for prolapse. Am J Obstet Gynecol 199(6):678.e1–678.e4CrossRef

10.

Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, Burr J (2008) Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. BJOG 115(11):1350–1361PubMedCrossRef

11.

Jacquetin B, Fatton B, Rosenthal C et al (2010) Total Trans-Vaginal-Mesh (TVM) technique for treatment of pelvic organ prolapse: a 3 year prospective follow up study. Int urogynaecol J 21:1455–1462CrossRef

12.

Miller D, Lucente V, Babin E, Beach P, Jones P, Robinson D (2011) Prospective clinical assessment of the trans-vaginal mesh (TVM) technique for treatment of pelvic organ prolapse—5 year results. Female Pelvic Med Reconstr Surg 17:139–143CrossRef

13.

Nieminen K, Hiltunen R, Takala T et al (2010) Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 203:235.e1–235.e8CrossRef

14.

Carey M, Slack M, Higgs P, Wynn-Williams M, Cornish A (2008) Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device. BJOG 115:391–397PubMedCrossRef

15.

Reisenauer C, Shiozawa T, Huebner M, Slack M, Carey M (2010) Anatomic study of prolapse surgery using non-anchored mesh and vaginal support device. Am J Obstet Gynecol 203:590.e1–590.e7CrossRef

16.

Zyczynski HM, Carey MP, Smith ARB, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M (2010) One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol 203:587.e1–587.e8CrossRef

17.

Bump RC, Mattiasson A, Bo K et al (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17PubMedCrossRef

18.

Barber MD, Walters MD, Bump RC (2005) Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 193(1):103–113PubMedCrossRef

19.

Wren PA, Janz NK, Brubaker L et al (2005) Reliability of health-related quality of life measures 1 year after surgical procedures for pelvic floor disorders. Am J Ob Gyn 192:780–788CrossRef

20.

Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C (2003) A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int urogynaecol J 14:164–168CrossRef

21.

Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C (2004) Erratum: a short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int urogynaecol J 15:219CrossRef

22.

Wild D, Grove A, Martin M et al (2005) Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2(8):94–104CrossRef

23.

Swift SE, Tate S, Nicholas J (2003) Correlation of symptoms with degree of pelvic organ support in a general population of women: what is pelvic organ prolapse? Am J Obstet Gynecol 189:372–379PubMedCrossRef

24.

Barber MD, Brubaker L, Nygaard I et al (2009) Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 114:600–609PubMedCrossRef

25.

Boukerrou M, Rubod C, Debet B, Boodhum R, Nayama M, Cosson M (2008) Tissue resistance of the tension-free procedure: what about healing? Int urogynaecol J 19:397–400CrossRef

26.

Handa VL, Zyczynski HM, Brubaker L et al (2007) Sexual function before and after sacrocolpopexy for pelvic organ prolapse. Am J Obst Gynecol 197:629.e1–629.e6CrossRef

27.

Blandon RE, Gebhart JB, Trabuco EC, Klingele CJ (2009) Complications from vaginally placed mesh in pelvic reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 20:523–531CrossRef

28.

Lowman JK, Jones LA, Woodman PJ et al (2008) Does the prolift system cause dyspareunia? Am J Obstet Gynecol 199:707.e1–707.e6CrossRef

29.

Iglesia CB, Solok AI, Solok ER et al (2010) Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 116:293–303PubMedCrossRef

30.

Maher CF, Feiner B, DeCuyper EM et al (2011) Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol 204(4):360.e1–360.e7CrossRef

Title: Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device
Authors: T. Sayer
J. Lim
J. M. Gauld
P. Hinoul
P. Jones
N. Franco
D. Van Drie
M. Slack
for the Prosima Study Investigators
Publication date: 01-04-2012
Publisher: Springer-Verlag
Published in: International Urogynecology Journal / Issue 4/2012
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-011-1600-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

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