VUE: Surgical Interventions for Uterine Prolapse and for Vault Prolapse

Bottom line Negative

In two parallel UK trials, uterine preservation did not differ from vaginal hysterectomy (563 women analyzed) and abdominal did not differ from vaginal vault suspension (208) in 12-month Pelvic Organ Prolapse Symptom Score or serious adverse events; abdominal repair cost £570 more.

No 12-month symptom difference in either trial; vault trial interval was wider (−2.08 to 0.86).

VUE (Vault or Uterine prolapse surgery Evaluation) was a pair of pragmatic, multicenter randomized trials at UK hospitals. In the uterine trial, 565 women with uterine prolapse were randomized to uterine preservation or vaginal hysterectomy; in the vault trial, 209 women with vault prolapse after hysterectomy were randomized to abdominal or vaginal vault suspension. At 12 months the Pelvic Organ Prolapse Symptom Score (POP-SS) did not differ in either trial (4.2 versus 4.2 in the uterine trial, 5.6 versus 5.9 in the vault trial), and serious adverse event rates were similar.^[1]

Design and population

Two parallel pragmatic multicenter randomized surgical trials (uterine and vault). Women at UK hospitals having surgery for uterine prolapse (565 randomized) or for vault prolapse after hysterectomy (209 randomized).

Arms

Uterine preservation (uterine trial) versus vaginal hysterectomy versus abdominal vault suspension (vault trial) versus vaginal vault suspension

Report and follow-up

2020 · 12 months after randomization (symptoms, quality of life) and 12 months after surgery (POP-Q examination)

Endpoint	Results	Effect	Finding
12-month Pelvic Organ Prolapse Symptom Score (0 to 28; lower is better), uterine trial; adjusted mean difference (uterine preservation minus vaginal hysterectomy)	4.2 (SD 4.9; n=230) vs 4.2 (SD 5.3; n=238)	difference -0.05; CI -0.91–0.81; P 0.91	Not met
12-month prolapse-related quality of life (0 to 10 visual analogue scale; lower is better), uterine trial; adjusted mean difference	1.7 (SD 2.5; n=237) vs 1.5 (SD 2.5; n=239)	difference 0.12; CI -0.26–0.49; P 0.54	Not met
12-month incremental NHS cost, multiply imputed base case, 2015–16 pounds sterling (uterine preservation minus vaginal hysterectomy)	Adjusted QALY difference −0.004 (95% CI −0.026 to 0.019): uterine preservation was dominated by vaginal hysterectomy, with a 15% probability of cost-effectiveness at £30,000 per QALY. With hospital tariff costing for the operation the probability was 85%.	difference 235; CI 6–464	Not met
12-month Pelvic Organ Prolapse Symptom Score (0 to 28; lower is better), vault trial; adjusted mean difference (abdominal minus vaginal)	5.6 (SD 5.4; n=88) vs 5.9 (SD 5.4; n=86)	difference -0.61; CI -2.08–0.86; P 0.42	Not met
12-month prolapse-related quality of life (0 to 10 visual analogue scale; lower is better), vault trial; adjusted mean difference	2.3 (SD 3.0; n=87) vs 2.6 (SD 2.8; n=87)	difference -0.25; CI -1.1–0.59; P 0.56	Not met
12-month incremental NHS cost, multiply imputed base case, 2015–16 pounds sterling (abdominal minus vaginal)	Adjusted QALY difference 0.004 (95% CI −0.031 to 0.041); abdominal repair had a 17% probability of cost-effectiveness at £30,000 per QALY.	difference 570; CI 459–682	Not met

Harms: Serious related adverse events, uterine trial: 14 (5.4%) vs 16 (5.9%); Serious related adverse events, vault trial: 6 (5.9%) vs 6 (6.0%); Mesh exposure requiring surgery, both trials: Two exposures among 235 mesh procedures (0.9%) in the first 12 months, both treated by surgical removal. One followed an apical procedure in the uterine trial (1 of 129 apical or concomitant mesh procedures) and one followed a concomitant tension-free vaginal tape in the vault trial (1 of 106).

ISRCTN86784244 · Report DOI

Design

Women were eligible when a gynecologist judged them to need surgery for symptomatic uterine or vault prolapse and both parties were willing to randomize. The protocol excluded women with a previous subtotal hysterectomy or cervical amputation (Manchester repair), potential future pregnancies, a comorbidity that necessitated a particular approach (fibroids, adhesions from previous abdominal surgery) or precluded randomization, obesity precluding an abdominal approach unless two vaginal approaches were feasible, and planned colpocleisis. Women were recruited between March 2013 and January 2017.^[1][2]

The protocol defined the comparisons by route. In the uterine trial, preservation was vaginal sacrospinous fixation of the uterus (sutures or mesh) or open or laparoscopic sacrohysteropexy with a mesh bridge, and vaginal hysterectomy included a prespecified vault suspension with sutures or mesh if needed. In the vault trial, the vaginal arm was sacrospinous fixation (sutures, mesh or a mesh kit) and the abdominal arm was open or laparoscopic sacrocolpopexy with a mesh bridge. Anterior or posterior repair, enterocele repair and a continence procedure were permitted. Surgeons used the techniques they knew best within these categories.^[1][2]

Allocation was by remote web-based randomization, 1:1, minimized on surgeon, age (under or over 60 years), type of planned apical repair, planned concomitant continence surgery and planned anterior or posterior repair. Randomization took place about 2 weeks before surgery in most centers. Outcome assessors were blinded to allocation, and surgeons were not.^[1]

There were three primary outcomes: the POP-SS at 12 months after randomization (seven items scored 0 to 4, total 0 to 28), prolapse-related quality of life on a 0 to 10 visual analogue scale, and incremental cost per quality-adjusted life-year (QALY) from EQ-5D-3L. Objective prolapse was a POP-Q leading edge beyond the hymen (stage 2b or more) at a clinic visit 12 months after surgery. The uterine trial was sized to detect a 2-point POP-SS difference (0.28 SD) with 90% power; the vault trial was sized for 3 points with 80% power and, after recruitment was extended, for 2.5 points. Analyses were by intention to treat among women with observed outcomes, with a linear mixed model that included surgeon as a random effect.^[1]

The uterine-trial groups were balanced for age (mean 63.4 and 63.9 years) and POP-SS (13.7 and 13.5), but apical stage 2b or more was recorded in 137 of 280 (48.9%) women assigned to preservation and 164 of 283 (58.0%) assigned to hysterectomy; the analysis adjusted for baseline values. In the vault trial all women had a previous hysterectomy (vaginal in 58 of 104 and 56 of 104), and mean age was 65.1 and 66.4 years.^[1]

Results

Uterine trial. At 12 months the adjusted POP-SS was 4.2 (SD 4.9) after uterine preservation and 4.2 (SD 5.3) after vaginal hysterectomy (mean difference −0.05, 95% CI −0.91 to 0.81; P = 0.91), so the interval excluded the 2-point difference the trial was powered to detect. Prolapse-related quality of life was 1.7 versus 1.5 (mean difference 0.12, 95% CI −0.26 to 0.49). Multiple imputation (−0.02, 95% CI −0.83 to 0.78) and a per-protocol analysis (0.19, 95% CI −0.70 to 1.08) agreed.^[1]

At 12 months after surgery, 74 of 233 (31.8%) and 78 of 229 (34.1%) women had overall stage 2b or more prolapse (odds ratio 0.85, 95% CI 0.55 to 1.32), and apical stage 2b or more was 13 of 230 (5.7%) versus 12 of 226 (5.3%). Sexual activity rose to 98 of 222 (44.1%) and 93 of 232 (40.1%), without significant differences in vaginal or sexual symptom scores. More women would recommend vaginal hysterectomy to a friend (211 of 222, 95.0%, versus 196 of 222, 88.3%; odds ratio 0.39, 95% CI 0.18 to 0.83), although the proportions reporting that prolapse was better (208 of 229, 90.8%, versus 221 of 232, 95.3%) or being satisfied (196 of 229, 85.6%, versus 211 of 233, 90.6%) did not differ significantly.^[1]

Further prolapse surgery within 12 months was reported by 15 of 244 (6.1%) after preservation and 8 of 242 (3.3%) after hysterectomy (odds ratio 2.01, 95% CI 0.81 to 4.95). The imbalance was in apical surgery (10 of 243, 4.1%, versus 3 of 242, 1.2%; odds ratio 3.43, 95% CI 0.93 to 12.64) and anterior repair (8 of 243, 3.3%, versus 1 of 242, 0.4%; odds ratio 8.10, 95% CI 1.00 to 65.57). Urgency was more frequent after preservation (32 of 230, 13.9%, versus 12 of 238, 5.0%; odds ratio 2.71, 95% CI 1.32 to 5.55), as was severe fecal incontinence (15 of 227, 6.6%, versus 7 of 235, 3.0%; odds ratio 4.64, 95% CI 1.49 to 14.42).^[1]

Vault trial. The adjusted POP-SS was 5.6 (SD 5.4) after abdominal and 5.9 (SD 5.4) after vaginal suspension (mean difference −0.61, 95% CI −2.08 to 0.86; P = 0.42), and prolapse-related quality of life was 2.3 versus 2.6 (mean difference −0.25, 95% CI −1.10 to 0.59). The imputed (−0.32, 95% CI −1.71 to 1.06) and per-protocol (−0.99, 95% CI −2.59 to 0.60) analyses did not change the conclusion.^[1]

Overall stage 2b or more prolapse was found in 28 of 86 (32.6%) after abdominal and 38 of 81 (46.9%) after vaginal repair (odds ratio 0.50, 95% CI 0.25 to 1.02). Vault stage 2b or more was 5 of 84 (6.0%) versus 7 of 78 (9.0%), and anterior stage 2b or more was 21 of 86 (24.4%) versus 33 of 81 (40.7%; odds ratio 0.38, 95% CI 0.18 to 0.79). Vaginal repair more often included a concomitant anterior or posterior repair (76.0% versus 34.7%). Further prolapse surgery within 12 months was 5 of 102 (4.9%) versus 6 of 100 (6.0%), with apical surgery in 1 of 102 (1.0%) versus 4 of 100 (4.0%).^[1]

Cost. Over 12 months from the NHS perspective, uterine preservation cost £235 more than vaginal hysterectomy (95% CI £6 to £464) with a QALY difference of −0.004 (95% CI −0.026 to 0.019); it was dominated by hysterectomy, with a 15% probability of cost-effectiveness at £30,000 per QALY, rising to 85% when hospital tariffs were used to cost the operation. Abdominal vault repair cost £570 more than vaginal repair (95% CI £459 to £682) with a QALY difference of 0.004 (95% CI −0.031 to 0.041) and a 17% probability of cost-effectiveness at £30,000 per QALY.^[1]

Surgery and treatment delivery

In the uterine trial, 215 of 280 (76.8%) women analyzed in the preservation arm received a uterine suspension (vaginal in 146, laparoscopic in 66, open in 3); 29 (10.4%) had a vaginal hysterectomy, 5 (1.8%) another apical operation and 31 (11.1%) no apical surgery. In the hysterectomy arm 254 of 283 (89.8%) had the allocated operation, 5 (1.8%) had a uterine suspension and 22 (7.8%) had no apical surgery. Synthetic non-absorbable mesh was used in the apical procedure in 81 of 249 (32.5%) women in the preservation arm and 6 of 261 (2.3%) in the hysterectomy arm. Preservation took a mean 113.7 minutes against 103.0 (adjusted difference 9.79 minutes, 95% CI 3.50 to 16.07) and blood loss was a mean 125.0 mL against 166.3 mL (adjusted difference −42.20 mL, 95% CI −62.68 to −21.73); length of stay was a mean 1.9 days in both arms. A consultant was the operating gynecologist for 225 of 280 (80.4%) women in the analyzed preservation arm and 189 of 283 (66.8%) in the hysterectomy arm.^[1]

In the vault trial, 85 of 104 (81.7%) women analyzed in the abdominal arm had an abdominal suspension (61 laparoscopic sacrocolpopexies and 24 open), 7 (6.7%) had a vaginal suspension and 11 (10.6%) had no apical surgery; 90 of 104 (86.5%) assigned to vaginal repair had sacrospinous fixation, 4 (3.8%) an abdominal suspension and 10 (9.6%) none. Apical mesh was used in 81 of 92 (88.0%) abdominal cases (synthetic non-absorbable in 71, biological in 4, a mesh kit in 6) and in 6 of 94 (6.4%) vaginal cases. The abdominal operation took a mean 145.5 minutes against 82.0 (adjusted difference 60.48 minutes, 95% CI 49.80 to 71.16); blood loss (97.7 versus 107.8 mL) and length of stay (2.1 versus 1.8 days) did not differ significantly. No concomitant surgery was recorded for 66 of 104 (63.5%) women in the analyzed abdominal arm and 21 of 104 (20.2%) in the vaginal arm.^[1]

Adverse events

In the uterine trial, serious related adverse events within 12 months of surgery occurred in 14 women (5.4%) after preservation and 16 (5.9%) after hysterectomy (N = 262 and 269; effect 0.82, 95% CI 0.38 to 1.75). Hospitalization was the most common type (10 versus 9). Excessive blood loss (over 500 mL and medically significant) was a serious intraoperative occurrence in 1 (0.4%) versus 3 (1.1%) and a serious postoperative occurrence in 1 (0.4%) versus 5 (1.9%), and urinary retention or voiding difficulty needing conservative treatment was a serious postoperative occurrence in 5 (2.0%) versus 1 (0.4%). Non-serious events were 6 (2.3%) versus 2 (0.7%).^[1]

In the vault trial, serious events occurred in 6 of 102 (5.9%) after abdominal and 6 of 100 (6.0%) after vaginal repair (odds ratio 0.97, 95% CI 0.27 to 3.44). Bladder or bowel injury at surgery was recorded in 3 (2.9%) abdominal and 1 (1.0%) vaginal case.^[1]

Across both trials two mesh exposures requiring surgical removal occurred among 235 mesh procedures (0.9%) in the first 12 months: one after an apical procedure in the uterine trial (1 of 129 apical or concomitant mesh procedures) and one after a concomitant tension-free vaginal tape in the vault trial (1 of 106).^[1]

Limitations

Surgeons could not be blinded, participants were told their allocation on request, and the clinic examiner was sometimes also the surgeon or learned the operation from the patient. Fewer than half of the women identified were randomized; in the uterine trial 774 declined, 431 (55.7%) because they preferred a specific operation and 324 (41.9%) because they preferred vaginal hysterectomy.^[1]

The preservation arm combined vaginal and laparoscopic hysteropexies with and without mesh because surgeons chose the technique they knew best, and some skilled laparoscopic surgeons did not take part. Only 215 of 280 (76.8%) analyzed in the preservation arm received a uterine suspension. The vault trial randomized 209 women, below the projected 280, and primary outcome data were available for 88 and 86 of 104 women per arm. The 12-month horizon is short for recurrence and mesh complications, and the report anticipated at least 6 years of follow-up. The participating gynecologists were experienced and self-selected, and the authors noted that their serious adverse event rates were lower than previously published rates for pelvic floor surgery.^[1]

In conversation

• Builds on PROSPECT (2016). The same group's earlier trial; its methods, outcome measures and symptom-score standard deviation informed VUE's design and sample size.
• Confirms SAVE-U (2015). Same uterine-preservation question; SAVE-U's sacrospinous hysteropexy was also noninferior to vaginal hysterectomy at 12 months.
• Confirms SUPeR (2019). Same question with a mesh hysteropexy; SUPeR also found no significant reduction in composite failure versus vaginal hysterectomy at 36 months.
• Conflicts with ASPIRe (2024). Same vault question; ASPIRe's 36-month composite failure favored sacrocolpopexy, while VUE's 12-month symptom score did not differ.

Same setting OPTIMAL (2014), SAM (2023)

VUE let surgeons choose the preservation operation (vaginal in 52.1% of the preservation arm, laparoscopic in 23.6%, with synthetic mesh in the apical procedure in 81 of 249 women who underwent apical surgery (32.5%)), whereas SAVE-U and SUPeR each tested one specified vaginal hysteropexy against vaginal hysterectomy with uterosacral ligament suspension and used composite failure endpoints rather than a symptom score. In the vault trial the abdominal arm was mostly laparoscopic sacrocolpopexy (61 of 85 abdominal suspensions), with apical mesh in 81 of 92 women who underwent apical surgery (88.0%); ASPIRe later compared sacrocolpopexy, transvaginal mesh and transvaginal native-tissue repair using a 36-month composite failure endpoint.^[4] VUE's outcome measures and sample-size assumptions came from the same group's earlier PROSPECT trial.^[1]

Guidelines and approvals

• AUGS Clinical Practice Statement (2025). Patients can be counseled that there is no difference in sexual function after uterine-preserving versus hysterectomy-based prolapse repair .^[3] The supporting text cites the VUE report among the randomized and cohort studies with 1 to 7 years of follow-up.^[3] At 12 months in the uterine trial, 98 of 222 (44.1%) and 93 of 232 (40.1%) women were sexually active, without significant differences in vaginal or sexual symptom scores.^[1]

Report history

VUE report history

Published	Report	Cutoff	Headline results	Citation
2020	12-month report (HTA monograph) · primary	—	12-month Pelvic Organ Prolapse Symptom Score (0 to 28; lower is better), uterine trial; adjusted mean difference (uterine preservation minus vaginal hysterectomy): 4.2 (SD 4.9; n=230) vs 4.2 (SD 5.3; n=238); difference -0.05; CI -0.91–0.81; P 0.91 Not met 12-month prolapse-related quality of life (0 to 10 visual analogue scale; lower is better), uterine trial; adjusted mean difference: 1.7 (SD 2.5; n=237) vs 1.5 (SD 2.5; n=239); difference 0.12; CI -0.26–0.49; P 0.54 Not met 12-month incremental NHS cost, multiply imputed base case, 2015–16 pounds sterling (uterine preservation minus vaginal hysterectomy): Adjusted QALY difference −0.004 (95% CI −0.026 to 0.019): uterine preservation was dominated by vaginal hysterectomy, with a 15% probability of cost-effectiveness at £30,000 per QALY. With hospital tariff costing for the operation the probability was 85%.; difference 235; CI 6–464 Not met POP-Q overall stage 2b or more 12 months after surgery, uterine trial; adjusted odds ratio: 74/233 (31.8%) vs 78/229 (34.1%); OR 0.85; CI 0.55–1.32; P 0.48 POP-Q apical stage 2b or more 12 months after surgery, uterine trial; adjusted odds ratio: 13/230 (5.7%) vs 12/226 (5.3%); OR 1.18; CI 0.48–2.94; P 0.72 Further prolapse surgery within 12 months of surgery, uterine trial; adjusted odds ratio: 15/244 (6.1%) vs 8/242 (3.3%); OR 2.01; CI 0.81–4.95; P 0.130 Further apical surgery within 12 months of surgery, uterine trial; adjusted odds ratio: 10/243 (4.1%) vs 3/242 (1.2%); OR 3.43; CI 0.93–12.64; P 0.064 Further anterior repair within 12 months of surgery, uterine trial; adjusted odds ratio: 8/243 (3.3%) vs 1/242 (0.4%); OR 8.1; CI 1–65.57; P 0.050 Would recommend the operation to a friend 12 months after randomization, uterine trial; adjusted odds ratio: 196/222 (88.3%) vs 211/222 (95.0%); OR 0.39; CI 0.18–0.83; P 0.01 Urgency at 12 months after randomization, uterine trial; adjusted odds ratio: 32/230 (13.9%) vs 12/238 (5.0%); OR 2.71; CI 1.32–5.55; P 0.01 Severe fecal incontinence at 12 months after randomization, uterine trial; adjusted odds ratio: 15/227 (6.6%) vs 7/235 (3.0%); OR 4.64; CI 1.49–14.42; P 0.01 12-month POP-SS, uterine trial; adjusted mean difference (uterine preservation minus vaginal hysterectomy): Multiple imputation of missing primary outcomes gave −0.02 (95% CI −0.83 to 0.78); the per-protocol analysis of women who received the allocated operation gave 0.19 (95% CI −0.70 to 1.08; P=0.68).; difference -0.02; CI -0.83–0.78; P 0.96 Women having intercourse 12 months after randomization, uterine trial: 98/222 (44.1%) vs 93/232 (40.1%); — 12-month Pelvic Organ Prolapse Symptom Score (0 to 28; lower is better), vault trial; adjusted mean difference (abdominal minus vaginal): 5.6 (SD 5.4; n=88) vs 5.9 (SD 5.4; n=86); difference -0.61; CI -2.08–0.86; P 0.42 Not met 12-month prolapse-related quality of life (0 to 10 visual analogue scale; lower is better), vault trial; adjusted mean difference: 2.3 (SD 3.0; n=87) vs 2.6 (SD 2.8; n=87); difference -0.25; CI -1.1–0.59; P 0.56 Not met 12-month incremental NHS cost, multiply imputed base case, 2015–16 pounds sterling (abdominal minus vaginal): Adjusted QALY difference 0.004 (95% CI −0.031 to 0.041); abdominal repair had a 17% probability of cost-effectiveness at £30,000 per QALY.; difference 570; CI 459–682 Not met POP-Q overall stage 2b or more 12 months after surgery, vault trial; adjusted odds ratio: 28/86 (32.6%) vs 38/81 (46.9%); OR 0.5; CI 0.25–1.02; P 0.06 POP-Q vault (apical) stage 2b or more 12 months after surgery, vault trial; adjusted odds ratio: 5/84 (6.0%) vs 7/78 (9.0%); OR 0.61; CI 0.18–2.08; P 0.43 POP-Q anterior stage 2b or more 12 months after surgery, vault trial; adjusted odds ratio: 21/86 (24.4%) vs 33/81 (40.7%); OR 0.38; CI 0.18–0.79; P 0.01 Further prolapse surgery within 12 months of surgery, vault trial; adjusted odds ratio: 5/102 (4.9%) vs 6/100 (6.0%); OR 0.79; CI 0.23–2.68; P 0.702 Further apical surgery within 12 months of surgery, vault trial; adjusted odds ratio: 1/102 (1.0%) vs 4/100 (4.0%); OR 0.23; CI 0.02–2.11; P 0.192 12-month POP-SS, vault trial; adjusted mean difference (abdominal minus vaginal): Multiple imputation of missing primary outcomes gave −0.32 (95% CI −1.71 to 1.06); the per-protocol analysis gave −0.99 (95% CI −2.59 to 0.60; P=0.22).; difference -0.32; CI -1.71–1.06; P 0.65	Hemming C, Constable L, Goulao B, et al. Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs. *Health Technol Assess.* 2020;24(13):1-220. doi:10.3310/hta24130 DOI

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References

1. Hemming C, Constable L, Goulao B, et al. "Surgical Interventions for Uterine Prolapse and for Vault Prolapse: The Two VUE RCTs." Health Technol Assess. 2020;24(13):1-220. doi:10.3310/hta24130

2. Glazener C, Constable L, Hemming C, et al. "Two Parallel, Pragmatic, UK Multicentre, Randomised Controlled Trials Comparing Surgical Options for Upper Compartment (Vault or Uterine) Pelvic Organ Prolapse (the VUE Study): Study Protocol for a Randomised Controlled Trial." Trials. 2016;17(1):441. doi:10.1186/s13063-016-1576-x

3. Chang OH, Carter Ramirez A, Edwards A, et al. "The Role of Uterine Preservation at the Time of Pelvic Organ Prolapse Surgery." Urogynecology. 2025;31(5):482-495. doi:10.1097/SPV.0000000000001667

4. Menefee SA, Richter HE, Myers D, et al. "Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial." JAMA Surg. 2024;159(8):845-855. doi:10.1001/jamasurg.2024.1206