SAVE-U: Sacrospinous Hysteropexy versus Vaginal Hysterectomy for Uterine Prolapse
SAVE-U was a multicenter, non-blinded noninferiority randomized trial in 208 women with POP-Q stage 2 or higher uterine prolapse that compared vaginal sacrospinous hysteropexy with vaginal hysterectomy with uterosacral ligament suspension. Apical failure (stage 2 or higher apical prolapse with bothersome bulge symptoms, or repeat apical surgery) at 12 months occurred in 0/102 women after hysteropexy and 4/100 after hysterectomy (difference −3.9 percentage points, 95% CI −8.6 to 0.7), within the 7-point noninferiority margin.[1]
- Design and population
- Multicenter, non-blinded noninferiority randomized trial. 208 women with POP-Q stage 2 or higher uterine prolapse needing surgery and no previous pelvic floor surgery, in four Dutch non-university teaching hospitals.
- Arms
- Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension
- Report and follow-up
- 2015 · 12 months; independent examiner not involved in treatment
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 12-month apical-compartment surgical failure (POP-Q stage 2 or higher of uterus or vault with bothersome bulge symptoms, or repeat surgery for apical prolapse); intention to treat with last observation carried forward; risk difference in percentage points (hysteropexy minus hysterectomy) | 0/102 (0%) vs 4/100 (4.0%) | difference -3.9; CI -8.6–0.7 | Met |
Harms: Buttock pain during hospital stay: 9/103 (9%) vs 0/105 (0%); Urinary retention (more than 150 mL after catheter removal): 15/103 (15%) vs 12/105 (11%); Serious adverse events during hospital stay: 3/103 vs 2/105
Netherlands Trial Register NTR1866 · Report DOI
Design
Four Dutch non-university teaching hospitals enrolled women between November 27, 2009 and March 12, 2012. Eligible women had uterine prolapse of 1 cm above the hymen or beyond (stage 2 or higher) and needed surgery. Exclusions were previous pelvic floor or prolapse surgery, known malignancy or an abnormal cervical smear, a wish to preserve fertility, abnormal uterine ultrasound findings or abnormal uterine bleeding, and immunological or hematological disorders that interfere with recovery. Coexisting anterior or posterior wall prolapse and cervical elongation did not exclude women, and concomitant colporrhaphy and anti-incontinence surgery were allowed.[1]
Each hospital offered both operations in a standardized manner, and every gynecologist had performed at least 20 procedures of each type before the trial. Residents could operate under direct supervision. Allocation was 1:1 in blocks of four, stratified by hospital and prolapse stage. Surgeons and women were not blinded; an independent doctor not involved in treatment did the 12-month examination.[1]
The primary outcome was changed during enrolment, before data analysis and with ethics approval, from overall anatomical failure to a composite apical outcome: POP-Q stage 2 or higher of the uterus or vaginal vault with bothersome bulge symptoms, or repeat surgery for recurrent apical prolapse, at 12 months. Bothersome bulge was a positive answer to either of two Urogenital Distress Inventory bulge questions together with a bother response of "somewhat" to "very much." Overall anatomical failure became a secondary outcome, alongside a composite success (no prolapse beyond the hymen, no bothersome bulge, no repeat surgery or pessary for recurrence). The 7-point noninferiority margin assumed a 3% apical failure rate with hysterectomy; with 80% power and an allowance for 10% loss to follow-up, the target was 208 women (104 per arm). The main analysis was intention to treat with last observation carried forward, checked with conservative imputation (failure for missing data) and a per-protocol analysis. Women consented to annual follow-up to 60 months.[1]
Results
In total, 103 women were randomized to hysteropexy and 105 to hysterectomy. The groups were similar at baseline (median age 62.7 versus 61.9 years; uterine prolapse stage 2 in 65% and 63%, stage 3 in 28% and 28%, stage 4 in 8% and 10%; bothersome bulge in 93% and 95%). At 12 months, apical failure occurred in 0/102 (0%) versus 4/100 (4.0%) in the intention-to-treat analysis with last observation carried forward (difference −3.9 percentage points, 95% CI −8.6 to 0.7), so hysteropexy met the noninferiority criterion. The upper confidence limit also stayed below the 7-point margin with conservative imputation (6/103, 6%, versus 10/105, 10%; difference −3.6, 95% CI −11.2 to 3.9) and in the per-protocol analysis (0/98 versus 3/90, 3%; difference −3.3, 95% CI −8.0 to 1.3).[1]
Composite success was 91/102 (89%) after hysteropexy and 83/100 (83%) after hysterectomy (difference 6.1, 95% CI −3.6 to 15.8). Overall anatomical failure, the original primary outcome, was 51/101 (50%) versus 44/100 (44%) (difference 6.4, 95% CI −7.4 to 20.1). By compartment, anterior failure was 47/101 (47%) versus 33/99 (33%) (difference 12.9, 95% CI −0.5 to 26.4), and posterior failure was 4/101 (4%) versus 14/99 (14%) (difference −10.0, 95% CI −18.2 to −1.8). Repeat surgery for recurrent prolapse in any compartment occurred in 1/102 (1%) versus 4/102 (4%). Urogenital Distress Inventory, Defecatory Distress Inventory, SF-36 and recovery-index scores did not differ; PISQ-12 total scores at 12 months were 37 in both groups.[1]
The prespecified 5-year follow-up was published as an observational follow-up of the trial; POP-Q scores were available for 168 of the 208 randomized women (81%). Apical failure occurred in 1/102 (1%) after hysteropexy and 8/102 (7.8%) after hysterectomy (difference −6.7 percentage points, 95% CI −12.8 to −0.7), a confidence interval that excludes zero. With missing data counted as failure, apical failure was 16/103 (16%) versus 27/105 (26%) (difference −9.8, 95% CI −20.9 to 1.2). In the time-to-event analysis it was 4/102 (4%) versus 9/102 (9%) (difference −4.7, 95% CI −11.4 to 2.0).[2]
Five-year composite success was 89/102 (87%) after hysteropexy and 77/102 (76%) after hysterectomy (difference 11.5, 95% CI 0.8 to 22.2); in the time-to-event analysis it was 70% versus 64% (difference 5.3, 95% CI −7.9 to 18.5). Overall anatomical failure was 46/102 (45%) versus 51/102 (50%), anterior failure 41/102 (40%) versus 36/101 (36%), and posterior failure 5/102 (5%) versus 18/101 (18%) (difference −12.7, 95% CI −21.5 to −3.9). Repeat surgery for recurrent prolapse in any compartment occurred in 3/102 (3%) versus 7/102 (7%). Functional outcome, quality of life and sexual function did not differ between the groups.[2]
At 10 years, apical failure occurred in 3/44 women (7%) after hysteropexy and 7/49 (14%) after hysterectomy (difference −6.6 percentage points, 95% CI −19.9 to 6.7); only 44 and 49 women contributed the primary outcome. Posterior-compartment failure among women with evaluable POP-Q data was 5/43 (11.6%) versus 24/46 (52.2%) (difference −37.1, 95% CI −54.3 to −19.9). Obstructive micturition scores were higher after hysteropexy despite a median of 0 in both groups (interquartile range 0 to 33.3 versus 0 to 0; P = 0.01). Other secondary outcomes did not differ significantly.[3]
Surgery and treatment delivery
Hysteropexy was performed through a posterior vaginal wall incision, with access to the right sacrospinous ligament through the pararectal space. Two permanent sutures (Prolene 1.0) were placed under direct vision through the ligament at least 2 cm from the ischial spine, passed through the posterior cervix and tied to suspend the uterus; the posterior wall was closed with absorbable suture. Vaginal hysterectomy followed a standard sequence of circumcision, bladder and bowel dissection, peritoneal entry and stepwise release with clamps and sutures, with the uterosacral ligaments ligated and transected. They were then attached to the vaginal vault with two delayed absorbable sutures, placed as high as possible on the visible ligament, generally caudal to the ischial spine. Concomitant colporrhaphy and anti-incontinence surgery were done afterward if indicated.[1][2]
Mean operating time was 59 minutes (SD 13) for hysteropexy and 72 minutes (SD 21) for hysterectomy (mean difference −13.5 minutes, 95% CI −18.5 to −8.6). Mean estimated blood loss was 202 versus 209 mL, and mean hospital stay was 3 days in both groups. Posterior colporrhaphy accompanied 30/103 (29%) of hysteropexies and 52/105 (50%) of hysterectomies; anterior colporrhaphy accompanied 100/103 (97%) and 104/105 (99%), and anti-incontinence surgery 4/103 (4%) and 4/105 (4%). Residents performed 3 hysteropexies (3%) and 19 hysterectomies (18%); overall surgical failure did not differ between gynecologist-performed and resident-performed procedures (91/180 versus 9/19; P = 0.81).[1]
There were 14 protocol deviations. Two women allocated to hysterectomy received hysteropexy because of technical difficulty, and one had an abdominal hysterectomy because of adhesions. McCall culdoplasty replaced uterosacral suspension in 6 of 102 women in the hysterectomy group (6%). All women were analyzed as randomized.[1]
Adverse events
During the hospital stay, buttock pain occurred in 9/103 women (9%) after hysteropexy and 0/105 after hysterectomy. It resolved spontaneously within 6 weeks (visual analogue score below 2) in 8 of the 9; the ninth had suture cutting and vaginal hysterectomy 4 months after surgery for persistent pain at the suture site. Urinary retention of more than 150 mL after catheter removal occurred in 15/103 (15%) versus 12/105 (11%); all affected women voided spontaneously after a median of 5 days of catheterization (range 1 to 40). Infection requiring antibiotics occurred in 3/103 (3%) versus 0/105.[1]
Three serious adverse events occurred after hysteropexy (stroke with full recovery, postoperative pneumonia, anaphylaxis to prophylactic antibiotics) and two after hysterectomy (atrial fibrillation requiring cardioversion, and a death from paralytic ileus, aspiration pneumonia and multi-organ failure). None was judged related to the type of surgery. One hysterectomy-group woman had a reoperation for bleeding.[1]
By 5 years, 2/102 women (2%) had undergone hysterectomy after hysteropexy: one for stage 1 endometrial carcinoma and one for persistent buttock pain. Surgery for stress urinary incontinence was needed in 2/102 (2%) versus 6/102 (6%). All serious adverse events potentially related to surgery occurred in the first 12 months.[2]
Limitations
Surgeons and women could not be blinded, and the 5-year examiners could not be blinded because the cervix is present or absent on POP-Q examination. The primary outcome was redefined during enrolment, before data analysis. The groups differed in concomitant posterior repair (29% versus 50%), in resident involvement (3% versus 18%) and in suture material, permanent for hysteropexy and delayed absorbable for uterosacral suspension, so the comparison is of each operation as practiced at these centers.[1][2]
At 5 years, 5 of 9 women with apical failure had withdrawn before the last visit, so the last-observation-carried-forward analysis may be biased; the time-to-event analysis was added to address this, and it showed no difference between arms. Ten-year data were available for 93 of the 208 randomized women, and the authors state that the reduced sample may limit detection of differences. Enrollment required no previous prolapse surgery and excluded women wishing to preserve fertility.[1][2][3]
In conversation
- Built on by SAM (2023). SAM took SAVE-U's lower 5-year anatomic recurrence after hysteropexy as rationale; it compared hysteropexy with the Manchester procedure instead of hysterectomy.
- Confirmed by VUE (2020). Same uterine-preservation question; SAVE-U's sacrospinous hysteropexy was also noninferior to vaginal hysterectomy at 12 months.
- Parallel to SUPeR (2019). US trial using the same hysterectomy with uterosacral suspension control against a mesh-augmented sacrospinous hysteropexy.
- Parallel to SUPeR (2019). Same comparator, vaginal hysterectomy with uterosacral suspension; SAVE-U tested suture sacrospinous hysteropexy, SUPeR tested mesh hysteropexy.
An earlier small randomized trial by Dietz and colleagues, whose primary outcome was recovery time, found more apical recurrence after sacrospinous hysteropexy at 12 months. It defined recurrence as POP-Q stage 2 or higher of the uterus or vault alone, whereas SAVE-U required bothersome bulge or repeat surgery; SAVE-U also reported the hymen-based and composite definitions so that later trials can compare against it.[1] SUPeR tested a mesh-augmented hysteropexy against the same hysterectomy-with-uterosacral-suspension control, and SAM compared sacrospinous hysteropexy with the Manchester procedure.
Guidelines and approvals
The AUGS 2025 clinical practice statement on uterine preservation, which cites the SAVE-U 12-month and 5-year reports, states that in the absence of previous or current uterine or cervical pathology all patients with a uterus should be offered uterine-preserving prolapse surgery . It also states that patients can be counseled that there is no difference in sexual function after uterine-preserving versus hysterectomy-based prolapse repair .[4]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2015-07-23 | 12-month randomized report · primary | — | 12-month apical-compartment surgical failure (POP-Q stage 2 or higher of uterus or vault with bothersome bulge symptoms, or repeat surgery for apical prolapse); intention to treat with last observation carried forward; risk difference in percentage points (hysteropexy minus hysterectomy): 0/102 (0%) vs 4/100 (4.0%); difference -3.9; CI -8.6–0.7 Met 12-month apical-compartment surgical failure, intention to treat with missing data imputed as failure; risk difference in percentage points (hysteropexy minus hysterectomy): 6/103 (6%) vs 10/105 (10%); difference -3.6; CI -11.2–3.9 12-month apical-compartment surgical failure, per-protocol population; risk difference in percentage points (hysteropexy minus hysterectomy): 0/98 (0%) vs 3/90 (3%); difference -3.3; CI -8–1.3 12-month composite success (no prolapse beyond the hymen, no bothersome bulge symptoms, no repeat surgery or pessary for recurrence), intention to treat with last observation carried forward; risk difference in percentage points (hysteropexy minus hysterectomy): 91/102 (89%) vs 83/100 (83%); difference 6.1; CI -3.6–15.8 12-month POP-Q stage 2 or higher in any compartment (the original primary outcome); risk difference in percentage points (hysteropexy minus hysterectomy): 51/101 (50%) vs 44/100 (44%); difference 6.4; CI -7.4–20.1 12-month anterior-compartment POP-Q stage 2 or higher; risk difference in percentage points (hysteropexy minus hysterectomy): 47/101 (47%) vs 33/99 (33%); difference 12.9; CI -0.5–26.4 12-month posterior-compartment POP-Q stage 2 or higher; risk difference in percentage points (hysteropexy minus hysterectomy): 4/101 (4%) vs 14/99 (14%); difference -10; CI -18.2–-1.8 Repeat surgery for recurrent prolapse in any compartment by 12 months; risk difference in percentage points (hysteropexy minus hysterectomy): 1/102 (1%) vs 4/102 (4%); difference -2.9; CI -7.8–2 PISQ-12 total score at 12 months, mean (SD): 37 (5), n=49 vs 37 (4), n=56; P 0.62 | Detollenaere RJ, den Boon J, Stekelenburg J, et al. 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. *BMJ.* 2015;351:h3717. doi:10.1136/bmj.h3717 DOI |
| 2019-09-10 | 5-year observational follow-up · updated | — | 5-year apical-compartment surgical failure (POP-Q stage 2 or higher with bothersome bulge symptoms, or repeat surgery for apical prolapse); intention to treat with last observation carried forward; risk difference in percentage points (hysteropexy minus hysterectomy): 1/102 (1%) vs 8/102 (7.8%); difference -6.7; CI -12.8–-0.7 Met 5-year apical-compartment surgical failure, missing data imputed as failure; risk difference in percentage points (hysteropexy minus hysterectomy): 16/103 (16%) vs 27/105 (26%); difference -9.8; CI -20.9–1.2 5-year cumulative incidence of apical-compartment surgical failure (Kaplan-Meier); risk difference in percentage points (hysteropexy minus hysterectomy): 4/102 (4%) vs 9/102 (9%); difference -4.7; CI -11.4–2 5-year composite success (no prolapse beyond the hymen, no bothersome bulge symptoms, no repeat surgery or pessary for recurrence), last observation carried forward; risk difference in percentage points (hysteropexy minus hysterectomy): 89/102 (87%) vs 77/102 (76%); difference 11.5; CI 0.8–22.2 5-year POP-Q stage 2 or higher in any compartment; risk difference in percentage points (hysteropexy minus hysterectomy): 46/102 (45%) vs 51/102 (50%); difference -4.8; CI -18.5–8.9 5-year anterior-compartment POP-Q stage 2 or higher; risk difference in percentage points (hysteropexy minus hysterectomy): 41/102 (40%) vs 36/101 (36%); difference 4.5; CI -8.9–17.8 5-year posterior-compartment POP-Q stage 2 or higher; risk difference in percentage points (hysteropexy minus hysterectomy): 5/102 (5%) vs 18/101 (18%); difference -12.7; CI -21.5–-3.9 Repeat surgery for recurrent prolapse in any compartment by 5 years; risk difference in percentage points (hysteropexy minus hysterectomy): 3/102 (3%) vs 7/102 (7%); difference -3.8; CI -10.2–2.5 | Schulten SFM, Detollenaere RJ, Stekelenburg J, et al. 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. *BMJ.* 2019;366:l5149. doi:10.1136/bmj.l5149 DOI |
| 2026-08-13 | 10-year follow-up · updated | — | 10-year apical-compartment surgical failure (stage 2 or higher of uterus or vault with bothersome bulge symptoms, or repeat surgery for apical prolapse); risk difference in percentage points (hysteropexy minus hysterectomy): 3/44 (7%) vs 7/49 (14%); difference -6.6; CI -19.9–6.7 10-year posterior-compartment anatomical failure among women with available POP-Q data; risk difference in percentage points (hysteropexy minus hysterectomy): 5/43 (11.6%) vs 24/46 (52.2%); difference -37.1; CI -54.3–-19.9 Obstructive micturition score at 10 years, median (IQR): 0 (0 to 33.3) vs 0 (0 to 0); P 0.01 | Oegema K, Schulten SFM, Stekelenburg J, et al. Sacrospinous hysteropexy versus vaginal hysterectomy in women with uterine prolapse: 10-year follow-up of a randomised controlled trial. *Int Urogynecol J.* Published online August 13, 2026. doi:10.1007/s00192-026-06822-1 DOI |
References
1. Detollenaere RJ, den Boon J, Stekelenburg J, et al. "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." BMJ. 2015;351:h3717. doi:10.1136/bmj.h3717
2. Schulten SFM, Detollenaere RJ, Stekelenburg J, et al. "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." BMJ. 2019;366:l5149. doi:10.1136/bmj.l5149
3. Oegema K, Schulten SFM, Stekelenburg J, et al. "Sacrospinous hysteropexy versus vaginal hysterectomy in women with uterine prolapse: 10-year follow-up of a randomised controlled trial." Int Urogynecol J. Published online August 13, 2026. doi:10.1007/s00192-026-06822-1
4. Chang OH, Ramirez AC, 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