Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial

Abstract Objective To evaluate the effectiveness and success of uterus preserving sacrospinous hysteropexy as an alternative to vaginal hysterectomy with uterosacral ligament suspension in the surgical treatment of uterine prolapse five years after surgery. Design Observational follow-up of SAVE U (sacrospinous fixation versus vaginal hysterectomy in treatment of uterine prolapse ≥2) randomised controlled trial. Setting Four non-university teaching hospitals, the Netherlands. Participants 204 of 208 healthy women in the initial trial (2009-12) with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery who had been randomised to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. The women were followed annually for five years after surgery. This extended trial reports the results at five years. Main outcome measures Prespecified primary outcome evaluated at five year follow-up was recurrent prolapse of the uterus or vaginal vault (apical compartment) stage 2 or higher evaluated by pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes were overall anatomical failure (recurrent prolapse stage 2 or higher in apical, anterior, or posterior compartment), composite outcome of success (defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pessary use for recurrent prolapse), functional outcome, quality of life, repeat surgery, and sexual functioning. Results At five years, surgical failure of the apical compartment with bothersome bulge symptoms or repeat surgery occurred in one woman (1%) after sacrospinous hysteropexy compared with eight women (7.8%) after vaginal hysterectomy with uterosacral ligament suspension (difference−6.7%, 95% confidence interval −12.8% to−0.7%). A statistically significant difference was found in composite outcome of success between sacrospinous hysteropexy and vaginal hysterectomy (89/102 (87%) v 77/102 (76%). The other secondary outcomes did not differ. Time-to-event analysis at five years showed no differences between the interventions. Conclusions At five year follow-up significantly less anatomical recurrences of the apical compartment with bothersome bulge symptoms or repeat surgery were found after sacrospinous hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension. After hysteropexy a higher proportion of women had a composite outcome of success. Time-to-event analysis showed no differences in outcomes between the procedures. Trial registration trialregister.nl NTR1866.

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Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial

JAMA ◽

10.1001/jama.2018.2827 ◽

2018 ◽

Vol 319 (15) ◽

pp. 1554 ◽

Cited By ~ 53

Author(s):

J. Eric Jelovsek ◽

Matthew D. Barber ◽

Linda Brubaker ◽

Peggy Norton ◽

Marie Gantz ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Surgical Outcomes ◽

Behavioral Therapy ◽

Pelvic Organ ◽

Uterosacral Ligament ◽

Uterosacral Ligament Suspension ◽

Sacrospinous Ligament ◽

Sacrospinous Ligament Fixation ◽

Prolapse Symptoms

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Re: Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation with or without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial

The Journal of Urology ◽

10.1016/j.juro.2018.07.033 ◽

2018 ◽

Vol 200 (4) ◽

pp. 704-705

Author(s):

Alan J. Wein

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Surgical Outcomes ◽

Behavioral Therapy ◽

Pelvic Organ ◽

Uterosacral Ligament ◽

Uterosacral Ligament Suspension ◽

Sacrospinous Ligament ◽

Sacrospinous Ligament Fixation ◽

Prolapse Symptoms

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Efficacy of Quercus infectoria Oliv. Galls in the Management of Uterovaginal Prolapse: A Randomized Clinical Trial

International Journal of Science and Research (IJSR) ◽

10.21275/art20175709 ◽

2017 ◽

Vol 6 (7) ◽

pp. 1690-1694

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Uterovaginal Prolapse ◽

Quercus Infectoria

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To Compare the Effectiveness of Vaginal High Uterosacral Ligament Suspension and McCall's Culdoplasty during Vaginal Hysterectomy for Pelvic Organ Prolapse

The Journal of South Asian Federation of Menopause Societies ◽

10.5005/jp-journals-10032-1112 ◽

2017 ◽

Vol 5 (2) ◽

pp. 81-86

Author(s):

Krutika Bhalerao ◽

Anuja V Bhalerao ◽

Richa Garg

Keyword(s):

Pelvic Organ Prolapse ◽

Coming Out ◽

Vaginal Hysterectomy ◽

Pelvic Organ ◽

Uterosacral Ligament ◽

Vaginal Vault ◽

Care Hospital ◽

Uterosacral Ligament Suspension ◽

Vaginal Length ◽

Vault Suspension

ABSTRACT Introduction Vaginal vault prolapse can be prevented by supporting the vaginal cuff, which is an essential part of hysterectomy, whether done abdominally or vaginally. The American Association of Gynecologic Laparoscopists (AAGL) has recommended for future research, specifically, a randomized trial comparing McCall's culdoplasty (with uterosacral ligament plication) with vaginal high uterosacral ligament suspension (HUSLS) (without plication), since both procedures are accessible to gynecological surgeons without urologic background. Hence, this study was carried out. Aim To compare both anatomic and functional outcomes of patients undergoing vaginal HUSLS or McCall's culdoplasty at the time of vaginal hysterectomy. Materials and methods This hospital-based prospective comparative study was carried out at a tertiary care hospital from January 1, 2013 to December 31, 2015 over a period of 3 years after obtaining Ethical Committee approval. All women attending gynecological outpatient department having symptom of mass coming out of vagina were subjected to detailed history, examination, and later underwent either HUSLS (43) or McCall's culdoplasty (42), for vault suspension with concomitant hysterectomy. The effectiveness of both the procedures was assessed by preoperative and postoperative pelvic organ prolapse quantification (POP-Q) and both were compared. Observations There was statistically significant improvement in all the sites of POP-Q points by HUSLS and McCall's culdoplasty as a method of vault suspension except in total vaginal length (TVL). Vault suspension by HUSLS is better than McCall's culdoplasty. All the points of POP-Q showed better results but the point C was significantly placed at a higher level by HUSLS (p = 0.000) as compared with McCall's culdoplasty. The time required for HUSLS was statistically more as compared with repair by McCall's culdoplasty (81.55/74.53 minutes, T: 1.981, p: 0.05). Complications, such as hemorrhage and ureteric injuries were more in HUSLS (2/43, 4.8%) as compared with McCall's culdoplasty (0/42); this is statistically significant. Conclusion High uterosacral ligament suspension provides excellent suspensory support to vaginal vault. Vagina is suspended over the levator ani with normal axis toward sacrum. By doing HUSLS, the vagina is symmetrically supported directed toward the hollow of sacrum. High uterosacral ligament suspension is highly recommended for young women with POP as vaginal length is not altered at all and so is the quality of life. How to cite this article Bhalerao AV, Bhalerao K, Garg R. To Compare the Effectiveness of Vaginal High Uterosacral Ligament Suspension and McCall's Culdoplasty during Vaginal Hysterectomy for Pelvic Organ Prolapse. J South Asian Feder Menopause Soc 2017;5(2):81-86.

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