Risk factors for pelvic organ prolapse recurrence after sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension.

BACKGROUND: Given that the number of surgeries for pelvic organ prolapse is expected to increase worldwide, knowledge on risk factors for prolapse recurrence is of importance for developing preventive strategies and shared decision-making. OBJECTIVE: To identify risk factors for subjective and objective failure after either sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension over a period of 5 years after surgery. STUDY DESIGN: This was a secondary analysis of the 5-year follow-up of the SAVE-U trial. The SAVE-U trial was conducted in 4 Dutch hospitals. A total of 208 women with uterine prolapse stage ≥2 were randomized to sacrospinous hysteropexy or vaginal hysterectomy with uterosacral ligament suspension. For the current analysis, available annual 5-year follow-up data of 207 women were analyzed. Without missing values this analysis would have included 1035 measurements in total over the 5-year follow-up. Recurrences were analyzed as "events" using generalized linear mixed models because recurrences of anatomic failure and bothersome vaginal bulge symptoms fluctuated over time. The primary outcome was the composite outcome of failure defined as prolapse beyond the hymen, bothersome bulge symptoms, repeated surgery, or pessary use for recurrent prolapse. Secondary outcome measures were bothersome vaginal bulge symptoms, overall anatomic failure (Pelvic Organ Prolapse Quantification stage ≥2 in any compartment), apical compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2), anterior compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2), and posterior compartment recurrence (Pelvic Organ Prolapse Quantification stage ≥2). RESULTS: For the composite outcome of failure (164 events in 66 different women), statistically significant risk factors were: body mass index (odds ratio, 1.10 [per 1 kg/m2]; 95% confidence interval, 1.02-1.19; P=.02), smoking (odds ratio, 2.88; 95% confidence interval, 1.12-7.40; P=.03), and preoperative Pelvic Organ Prolapse Quantification point Ba (odds ratio, 1.23 [per 1 cm]; 95% confidence interval, 1.01-1.50; P=.04). When analyzing each surgical outcome measure separately, body mass index and Pelvic Organ Prolapse Quantification point Ba were risk factors for overall anatomic failure (462 events in 147 women; odds ratio, 1.15; 95% confidence interval, 1.07-1.25; P<.01 and odds ratio, 1.14; 95% confidence interval, 1.00-1.30; P=.05, respectively) and anterior compartment recurrence (385 events in 128 women; odds ratio, 1.11; 95% confidence interval, 1.02-1.22; P=.02 and odds ratio, 1.17; 95% confidence interval, 1.02-1.34; P=.02, respectively). Vaginal hysterectomy was a risk factor for posterior compartment recurrence when compared with sacrospinous hysteropexy (93 events in 40 women; odds ratio, 5.21; 95% confidence interval, 2.05-13.27; P<.01). Smoking was a risk factor for bothersome vaginal bulge symptoms (70 events in 41 women; odds ratio, 3.80; 95% confidence interval, 1.48-9.75; P=.01), and preoperative Pelvic Organ Prolapse Quantification stage 3 or 4 was significantly protective against bothersome bulge symptoms (odds ratio, 0.32; 95% confidence interval, 0.11-0.89; P=.03). CONCLUSION: Body mass index, smoking, and Pelvic Organ Prolapse Quantification point Ba were statistically significant risk factors for the composite outcome of failure (prolapse beyond the hymen, bothersome bulge symptoms, repeated surgery, or pessary use for recurrent prolapse) in the period of 5 years after surgery.

Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.

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.

Dutch women's attitudes towards hysterectomy and uterus preservation in surgical treatment of pelvic organ prolapse.

OBJECTIVE: To investigate Dutch women's attitudes and preferences towards hysterectomy or uterus preservation in surgical treatment of pelvic organ prolapse. STUDY DESIGN: Women's attitude was assessed by a structured questionnaire in one university hospital and one non-university teaching hospital in the Netherlands. Between December 2013 and November 2014, 102 women referred with prolapse complaints, without previous prolapse surgery, responded to the questionnaire received by mail prior to gynaecological consultation. Main outcome was the preference for uterus preserving surgery versus hysterectomy. Furthermore we studied the impact of uterus preservation and hysterectomy on body image and sexual function and the importance of treatment success, risk of urinary incontinence after surgery, complication risk, recovery time, length of hospital stay, costs and the risk of developing endometrial cancer. RESULTS: Assuming that functional and anatomical outcomes after hysterectomy and uterus preserving surgery were equal, more women expressed preference for uterus preservation (43%, 44 out of 102 women) compared to hysterectomy (27%, 27 out of 102 women). The majority of women expected a similar improvement in sexuality and body image after the two treatment modalities. Treatment success, risk for urinary incontinence after surgery and complication risk were the most important factors. Taken the future risk of endometrial cancer into account, 18% of the women preferred hysterectomy because of this risk. CONCLUSIONS: This study demonstrated that women referred with prolapse complaints have a preference for uterus preservation in case outcomes after both interventions are expected to be equal. The majority of women expected that body image and sexual function would equally improve after both interventions.

The Impact of Sacrospinous Hysteropexy and Vaginal Hysterectomy With Suspension of the Uterosacral Ligaments on Sexual Function in Women With Uterine Prolapse: A Secondary Analysis of a Randomized Comparative Study.

INTRODUCTION: Studies on pelvic organ prolapse (POP) surgery show conflicting evidence regarding the impact of uterus preservation and hysterectomy on sexual function and no large randomized trials with long-term follow-up have been published on this topic. AIMS: The aim of this secondary analysis was to evaluate and compare sexual function after sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse. METHODS: This is a secondary analysis of the SAVE U trial data, a multicenter trial in 4 nonuniversity hospitals in the Netherlands comparing sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments in primary surgery of uterine prolapse stage II or higher. Primary outcome of the original study was recurrent prolapse stage II or higher of the uterus or vaginal vault (apical compartment) evaluated by POP-Q examination in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months follow-up. Secondary outcomes were overall anatomical recurrences, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning. Data from patients who had completed the POP/urinary incontinence sexual questionnaire (PISQ-12) at baseline and 24 months after surgery were used in the present trial. Total, subscale, and individual question analyses were performed. The SAVE U trial is registered in the Dutch trial registry, number NTR1866. MAIN OUTCOME MEASURES: Differences and changes in sexual function 24 months after surgery, measured by the PISQ-12 questionnaire. RESULTS: Between November 2009 and March 2012, 208 women were randomized between sacrospinous hysteropexy (n = 103) and vaginal hysterectomy with suspension of the uterosacral ligaments (n = 105). Of these, 99 women completed questionnaires at baseline and after 24 months follow-up and were included in the present study. During a follow-up period of 24 months, no significant differences in total PISQ-12 scores were observed between the groups. After both interventions the item "avoidance of intercourse due to prolapse" significantly improved, as did the physical subscale of the PISQ-12 questionnaire. CONCLUSION: There was no statistically significant difference in overall sexual functioning (total PISQ-12 scores) between uterus-preserving sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments after a follow-up period of 24 months.

Practice pattern variation in surgical management of pelvic organ prolapse and urinary incontinence in The Netherlands.

INTRODUCTION: Practice pattern variation (PPV) is the difference in care that cannot be explained by the underlying medical condition. The aim of this study was to describe PPV among Dutch gynecologists regarding treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). MATERIALS AND METHODS: PPV was calculated from data of healthcare declaration codes of 2010. Data were provided by Vektis and Kiwa Carity. PPV for POP and UI in general was calculated per hospital and per region. Furthermore, PPV for transvaginal mesh and surgical treatment of uterine descent was assessed. RESULTS: PPV of surgical treatment for POP and UI in general was assessed for 91 hospitals. PPV for surgical treatment of uterine descent and transvaginal mesh placement was calculated for 88 hospitals. A high PPV per hospital and per region was found. In some hospitals, a hysterectomy was performed in all cases of uterovaginal prolapse, while in other hospitals, uterus-preserving techniques were mostly performed. A high PPV of transvaginal mesh placement was observed. CONCLUSION: In the small country of The Netherlands, we found a high PPV in surgical management of POP and UI with respect to the choice for surgical treatment and the type of surgery. This finding might be due to the absence of clearly defined guidelines. Studies with respect to conservative versus surgical treatment and the type of surgery are of need to establish evidence-based guidelines.

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

OBJECTIVE: To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse. DESIGN: Multicentre randomised controlled non-blinded non-inferiority trial. SETTING: 4 non-university teaching hospitals, the Netherlands. PARTICIPANTS: 208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery. INTERVENTIONS: Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments. The predefined non-inferiority margin was an increase in surgical failure rate of 7%. MAIN OUTCOME MEASURES: Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault (apical compartment) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months' follow-up. Secondary outcomes were overall anatomical recurrences, including recurrent anterior compartment (bladder) and/or posterior compartment (bowel) prolapse, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning. RESULTS: Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery (n=0, 0%) compared with vaginal hysterectomy with suspension of the uterosacral ligaments (n=4, 4.0%, difference -3.9%, 95% confidence interval for difference -8.6% to 0.7%). At 12 months, overall anatomical recurrences, functional outcome, quality of life, complications, hospital stay, measures on postoperative recovery, and sexual functioning did not differ between the two groups. Five serious adverse events were reported during hospital stay. None was considered to be related to the type of surgery. CONCLUSIONS: Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months' follow-up. TRIAL REGISTRATION: trialregister.nl NTR1866.

Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol).

BACKGROUND: Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial. METHODS: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR4029.

[Uterus preserving surgery versus vaginal hysterectomy in treatment of uterine descent: a systematic review]. / Uterussparende chirurgie versus vaginale hysterectomie als behandeling van descensus uteri.

OBJECTIVE: To compare the outcomes of uterus preserving procedures and vaginal hysterectomy in treatment of uterine prolapse. DESIGN: Systematic review. METHOD: We searched in Pubmed, Embase, the Cochrane Library and the reference lists of relevant publications for articles comparing uterus preserving procedures with vaginal hysterectomy. The following outcome measures were studied: anatomical result, subjective outcome regarding prolapse symptoms, micturition, defecation and sexual function, quality of life, duration of surgery, duration of hospital stay, amount of blood loss, complications and postoperative recovery. RESULTS: We found one systematic review, one randomised trial and five cohort studies, from which eight comparative studies were selected for review. There was no difference in subjective outcome after sacrospinous fixation, Manchester Fothergill procedure, abdominal hysteropexy and intravaginal slingplasty on comparison with vaginal hysterectomy. All procedures, except for sacrospinous ligament fixation, had similar anatomical outcomes to vaginal hysterectomy. With the exception of Manchester Fothergill procedure hospital stay was shorter after uterus preservation. The quality of most of the studies was poor, with only small numbers of patients included and short-term follow up. CONCLUSIONS: Although some uterus preserving procedures are associated with shorter operation time, shorter duration of hospital stay and less blood loss than vaginal hysterectomy, based on the current literature there is no clear preference for either uterus preserving surgery or hysterectomy in surgical treatment of uterine descent, since randomised trials of sufficient quality are lacking. Prospective clinical randomised trials with long term follow-up are needed to investigate the value of uterine preserving procedures.

One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery: a prospective randomized trial.

INTRODUCTION AND HYPOTHESIS: For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. METHODS: We conducted a prospective randomized trial in which 179 women were allocated to 1-day or 3-day suprapubic catheterization. The primary outcome was the duration of catheterization. RESULTS: Mean duration of catheterization and hospital stay was significantly shorter in the 1-day catheterization group. The number of successful voiding trials was higher in the 3-day catheterization group (90.9% versus 79.3%), but this did not reach statistical significance. The percentage of urinary tract infection did not differ significantly between the groups (4.5% versus 2.4%). CONCLUSION: Starting a voiding trial 1 day after vaginal prolapse surgery leads to shorter duration of catheterization and hospital stay.

Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial).

BACKGROUND: Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning. METHODS/DESIGN: The SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group. DISCUSSION: The SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1866.