Sacrospinous hysteropexy versus vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: Multicentre randomized non-inferiority trial

BMJ (Online)

Volumn 351, Issue , 2015, Pages

  Detollenaere, Renée J ^a,b   Den Boon, Jan ^a   Stekelenburg, Jelle ^c   IntHout, Joanna ^d   Vierhout, Mark E ^b   Kluivers, Kirsten B ^b   Van Eijndhoven, Hugo W F ^a  

^a Department of Obstetrics and Gynaecology ^*  (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c MEDICAL CENTER LEEUWARDEN   (Netherlands)

^d RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; FEMALE; FOLLOW UP; HOSPITALIZATION; HUMAN; LIGAMENT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NETHERLANDS; ORGAN PRESERVATION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; RETROSPECTIVE STUDY; SACROSPINOUS HYSTEROPEXY; SEXUALITY; TREATMENT OUTCOME; UTEROSACRAL LIGAMENT; UTERUS PROLAPSE; UTERUS SURGERY; VAGINAL HYSTERECTOMY; BROAD LIGAMENT; CLINICAL TRIAL; COMPARATIVE STUDY; CONSERVATIVE TREATMENT; EPIDEMIOLOGY; GYNECOLOGIC SURGERY; HYSTERECTOMY; LENGTH OF STAY; MIDDLE AGED; PATHOLOGY; PROCEDURES; ROUND LIGAMENT OF UTERUS; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA; UTERINE PROLAPSE; UTERUS; WOMEN'S HEALTH;

BROAD LIGAMENT; FEMALE; GYNECOLOGIC SURGICAL PROCEDURES; HUMANS; HYSTERECTOMY; LENGTH OF STAY; MIDDLE AGED; NETHERLANDS; ORGAN SPARING TREATMENTS; QUALITY OF LIFE; RECURRENCE; ROUND LIGAMENT OF UTERUS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; UTERINE PROLAPSE; UTERUS; WOMEN'S HEALTH;

EID: 84940426500     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.h3717     Document Type: Article

References (39)

1. Slieker-ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJ, Steegers-Theunissen RP, Burger CW, Vierhout ME. The prevalence of pelvic organ prolapse symptoms and signs and their relation with bladder and bowel disorders in a general female population. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 1037-45.
2. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; 89: 501-6.
3. De Boer TA, Slieker-ten Hove MC, Burger CW, Kluivers KB, Vierhout ME. The prevalence and factors associated with previous surgery for pelvic organ prolapse and or urinary incontinence in a cross sectional study in the Netherlands. Eur J Obstet Gynecol Reprod Biol 2011; 158: 343-9.
4. Jha S, Moran P. The UK national prolapse survey: 5 years on. Int Urogynecol J 2011; 22: 517-28.
5. Vanspauwen R, Seman E, Dwyer P. Survey of current management of prolapse in Australia and New Zealand. Aust N Z J Obstet Gynaecol 2010; 50: 262-7.
6. Detollenaere RJ, den Boon J, Kluivers KB, Vierhout ME, van Eijndhoven HW. Surgical management of pelvic organ prolapse and uterine descent in the Netherlands. Int Urogynecol J 2013; 24: 781-8.
7. Korbly NB, Kassis NC, Good MM, et al. Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse. Am J Obstet Gynecol 2013; 209: 470.e1-6.
8. Frick AC, Barber MD, Paraiso MF, Ridgeway B, Jelovsek JE, Walters MD. Attitudes toward hysterectomy in women undergoing evaluation for uterovaginal prolapse. Female Pelvic Med Reconstr Surg 2013; 19: 103-9.
9. Wu MP, Long CY, Huang KH, Chu CC, Liang CC, Tang CH. Changing trends of surgical approaches for uterine prolapse: an 11-year population-based nationwide descriptive study. Int Urogynecol J 2012; 23: 865-72.
10. Maher CF, Cary MP, Slack MC, Murray CJ, Milligan M, Schluter P. Uterine preservation or hysterectomy at sacrospinous colpopexy for uterovaginal prolapse? Int Urogynecol J Pelvic Floor Dysfunct 2001; 12: 381-4.
11. Brummen HJ, van de Pol G, Aalders CIM, Heintz APM, van der Vaart. Sacrospinous hysteropexy compared to vaginal hysterectomy as primary surgical treatment for a descensus uteri: effect on urinary symptoms. Int Urogynecol J Pelvic Floor Dysfunct 2003; 14: 350-5.
12. Hefni MA, El-Toukhy TA, Bhaumik J, Katsimanis E. Sacrospinous cervicocolpopexy with uterine conservation for uterovaginal prolapse in elderly women: an evolving concept. Am J Obstet Gynecol 2003; 188: 645-50.
13. Da?llenbach P, Kaelin-Gambirasio I, Jacob S, Dubuisson JB, Boulvain M. Incidence rate and risk factors for vaginal vault prolapse repair after hysterectomy. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19: 1623-9.
14. Kantartzis KL, Turner LC, Shepherd JP, Wang L, Winger DG, Lowder JL. Apical support at the time of hysterectomy for uterovaginal prolapse. Int Urogynecol J 2015; 26: 207-12.
15. Bulletins-Gynecology ACoP. ACOG practice bulletin No 85: pelvic organ prolapse. Obstet Gynecol 2007; 110: 717-29.
16. Dietz V, van der Vaart CH, van der Graaf Y, Heintz P, Schraffordt Koops SE. One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study. Int Urogynecol J Pelvic Floor Dysfunct 2010; 2: 209-16.
17. Jeng CJ, Yang YC, Tzeng CR, Shen J, Wang LR. Sexual functioning after vaginal hysterectomy or transvaginal sacrospinous hysteropexy for uterine prolapse: a comparison. J Reprod Med 2005; 50: 669-74.
18. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013; 4: CD004014.
19. Detollenaere RJ, den Boon J, Stekelenburg J, et al. Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial). BMC Womens Health 2011; 11: 4.
20. Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009; 114: 600-9.
21. Cruikshank SH. Preventing posthysterectomy vaginal vault prolapse and enterocele during vaginal hysterectomy. Am J Obstet Gynecol 1987: 156: 1433-40.
22. Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996; 175: 10-7.
23. Ware JE, Kosinski M, Keller SD. SF-36 physical and mental component summary measures-A users' manual. 1994. New England Medical Center, The Health Institute.
24. Van der Vaart CH, de Leeuw JR, Roovers JP, Heintz AP. Measuring health-related quality of life in women with urogenital dysfunction: the urogenital distress inventory and incontinence impact questionnaire revisited. Neurourol Urodyn 2003; 22: 97-104.
25. Roovers JP, van der Bom JG, van der Vaart CH, Heintz AP. Prediction of findings at defecography in patients with genital prolapse. Br J Obstet Gynaecol 2005; 112: 1547-53.
26. Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ. Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd 2005; 149: 1574-8.
27. Schweitzer KJ, de Jong M, Milani AL. Prolaps en seks: hoe meten we de relatie? Ned Tijdschr Obst Gyn 2008; 121: 79-82.
28. Kluivers KB, Hendriks JC, Mol BW, et al. Clinimetric properties of 3 instruments measuring postoperative recovery in a gynecologic surgical population. Surgery 2008; 144: 12-21.
29. Dietz V, Schraffordt Koops SE, van der Vaart CH. Vaginal surgery for uterine descent; which options do we have? A review of the literature. Int Urogynecol J Pelvic Floor Dysfunct 2009; 20: 349-56.
30. Dietz V, Schraffordt Koops S, van der Graaf Y, Heintz P, van der Vaart C. Sacrospinous hysteropexy and vaginal hysterectomy for uterine descent: a randomized study. Int Urogynecol J 2008; 19: S1-166.
31. Agresti A, Coull B. Approximate is better than 'exact' for interval estimation of binomial proportions. Am Stat 1998; 52: 119-26.
32. Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ 1995; 310: 170.
33. Lykke R, Blaakar J, Ottesen B, Gimbel H. Pelvic organ prolapse (POP) surgery among Danish women hysterectomized for benign conditions: age at hysterectomy, age at subsequent POP operation, and risk of POP after hysterectomy. Int Urogynecol J 2015; 26: 527-32.
34. Altman D, Falconer C, Cnattinguis S, Granath F. Pelvic organ prolapse surgery following hysterectomy on benign indications. Am J Obstet Gynecol 2008; 198: 572.e1-6.
35. McCall ML. Posterior culdoplasty; surgical correction. Obstet Gynecol 1957: 10: 595.
36. Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 2014; 311: 1023-34.
37. Gutman R, Maher C. Uterine-preserving POP surgery. Int Urogynecol J 2013; 24: 1803-13.
38. Smilen SW, Saine J, Wallach SJ, Porges RF. The risk of cystocele after sacrospinous ligament fixation. Am J Obstet Gynecol 1998; 179: 1465-71.
39. Renganathan A, Edwards R, Duckett JR. Uterus conserving prolapse surgery-what is the chance of missing a malignancy? Int Urogynecol J 2010; 21: 819-21.