SAM: Manchester Procedure versus Sacrospinous Hysteropexy for Uterine Descent
SAM (SAcrospinous hysteropexy versus the Manchester procedure) was a multicenter, unblinded noninferiority randomized trial in 26 Dutch hospitals that compared sacrospinous hysteropexy with the Manchester procedure as a first uterus-preserving operation in 434 women with uterine descent at POP-Q point D at or proximal to −1 cm, with a composite of anatomic, symptomatic and retreatment success at 2 years as the primary outcome. Sacrospinous hysteropexy did not meet the 9% noninferiority margin: composite success was 77.0% versus 87.3%.[1]
- Design and population
- Multicenter, unblinded noninferiority randomized trial in 26 Dutch hospitals. Adults undergoing a first operation for symptomatic prolapse with uterine descent at POP-Q point D at or proximal to −1 cm, without prior pelvic floor surgery or a need for concomitant anti-incontinence surgery.
- Arms
- Sacrospinous hysteropexy versus Manchester procedure
- Report and follow-up
- 2023 · 2 years; primary outcome complete in 393 of 430 analyzed participants (196 and 197)
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 2-year composite success, as-randomized analysis; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure) | 151/196 (77.0%) vs 172/197 (87.3%) | difference -10.3; CI -17.8–-2.8; P 0.007 | Not met |
| 2-year composite success, per-protocol analysis; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure) | 145/187 (77.5%) vs 171/195 (87.7%) | difference -10.2; CI -17.7–-2.6; P 0.008 | Not met |
Harms: Participants with a serious adverse event: 9/207 vs 11/213; Death: 1/207 (0.5%) vs 5/213 (2.3%); Urinary retention following treatment: 37/203 (18.2%) vs 25/204 (12.3%)
Netherlands Trial Register NTR 6978 · Report DOI
Design
Women aged 18 years or older planning a first operation for symptomatic prolapse of any stage were eligible if they had uterine descent with POP-Q point D at or proximal to −1 cm. The investigators chose point D to separate presumed failure of the uterine suspensory ligaments from cervical elongation. Exclusions were previous pelvic floor surgery, a need for concomitant anti-incontinence surgery, a preference for hysterectomy, a contraindication to uterine preservation (abnormal bleeding, premalignancy or malignancy), insufficient Dutch fluency and a wish for future childbearing. The authors estimate that about 90% of women having a first prolapse operation would have met the point D criterion.[1]
Recruitment ran from July 3, 2018 to February 18, 2020 in 26 hospitals (4 academic, 20 teaching, 2 nonteaching), and the last follow-up visit took place on September 19, 2022. After two exclusions per group, 215 women remained in each arm; at baseline the median age was 61 and 63 years, overall POP-Q stage 3 was present in 59.5% and 50.2%, and prolapse extended beyond the hymen in the anterior compartment in 58.1% and 59.5% (sacrospinous hysteropexy and Manchester procedure, respectively).[1]
Seventy-two gynecologic surgeons took part; each had performed at least 20 of both procedures, with at least 10 of each in the 2 years before the study, and all agreed on standardized techniques before enrollment. A research nurse randomized participants on site through a web-based interface in a 1:1 ratio with dynamic blocks of 2, 4 and 6. The trial was not blinded. Prolapse quantification took place before surgery and at 6 weeks, 1 year and 2 years, and the postoperative examination was done by a trained professional who had not been the participant's surgeon; questionnaires were completed at 3, 6, 9, 12 and 24 months.[1]
The primary outcome required all three of: no vaginal prolapse beyond the hymen in any compartment, no bothersome bulge symptoms (a negative answer to PFDI-20 POPDI-6 item 3, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?") and no retreatment with a pessary or surgery within 2 years. The sample size assumed 89% success in both arms and a noninferiority margin of 9 percentage points, chosen to align with earlier prolapse trials that used margins of 7% and 10%. With 80% power and a significance level of α = 0.025, 193 women per group were needed, and 430 were planned to allow for 10% loss to follow-up. Sacrospinous hysteropexy was tested against the Manchester procedure with the Farrington-Manning test, and noninferiority had to hold in both the as-randomized and the per-protocol populations. The as-randomized analysis included every participant with complete primary-outcome data, regardless of the operation received, and used complete cases; two Manchester participants lost to follow-up after retreatment were analyzed as not meeting the composite.[1]
Results
At 2 years, composite success was 151/196 (77.0%) after sacrospinous hysteropexy and 172/197 (87.3%) after the Manchester procedure (difference −10.3 percentage points, 95% CI −17.8 to −2.8; P = 0.007). The lower confidence limit fell below the −9-point margin, so noninferiority was not met (P = 0.65 in the Results text; the abstract gives 0.63). The per-protocol result was the same: 145/187 (77.5%) versus 171/195 (87.7%), difference −10.2 points (95% CI −17.7 to −2.6; noninferiority P = 0.62).[1]
Only the anatomic component of the composite differed significantly:[1]
| Component, as randomized | Sacrospinous hysteropexy | Manchester procedure | Difference, points (95% CI) |
|---|---|---|---|
| No prolapse beyond the hymen | 170/196 (86.7%) | 187/195 (95.9%) | −9.2 (−14.7 to −3.7) |
| No bothersome bulge symptoms | 179/200 (89.5%) | 183/201 (91.0%) | −1.5 (−7.3 to 4.3) |
| No reintervention | 187/199 (94.0%) | 195/201 (97.0%) | −3.0 (−7.1 to 1.0) |
Anatomic failures were distributed differently by compartment. Prolapse beyond the hymen in the anterior compartment was present in 20/196 (10.2%) after sacrospinous hysteropexy and 5/195 (2.6%) after the Manchester procedure; apical prolapse beyond the hymen in 2/196 (1.0%) and 0/195, and posterior prolapse beyond the hymen in 4/196 (2.0%) and 3/195 (1.5%). Counting milder descent, anterior-compartment POP-Q stage 2 or higher was more frequent after hysteropexy (124/196, 63.3%, versus 87/195, 44.6%) and posterior-compartment stage 2 or higher was more frequent after the Manchester procedure (22/196, 11.2%, versus 54/195, 27.7%); both P < 0.001.[1]
Reoperation for recurrence in a previously operated compartment occurred in 9/207 (4.3%) after sacrospinous hysteropexy and in none after the Manchester procedure. Of the 7 apical reoperations after hysteropexy, 1 was a cervical amputation, 3 were modified Manchester procedures and 3 were robot-assisted sacropexies. Pessary use in the first postoperative year was 8/200 (4.0%) versus 5/201 (2.5%). Bothersome bulge symptoms were reported by 21/200 (10.5%) and 18/201 (9.0%), and 156/195 (80.0%) versus 160/195 (82.1%) reported being much or very much improved. The report found no significant group differences in other patient-reported outcomes or in POP-Q measurements.[1]
A prospective economic evaluation alongside the trial, with 2-year follow-up (multiple-imputation base case, 2019 euros) found mean societal costs of €9,869 after sacrospinous hysteropexy and €8,410 after the Manchester procedure, a difference of −€1,458 (95% CI −€2,746 to −€171) with the Manchester procedure. Direct healthcare costs were €4,737 versus €4,426 (difference −€311, 95% CI −€767 to €145), and the societal gap arose mainly from productivity costs. Quality-adjusted life years over 2 years were 1.67 versus 1.68 (P = 0.346).[2]
A planned analysis of sexual function at 24 months used an equivalence design with a margin of ±0.31 points on the PISQ-IR. Among sexually active women (101 Manchester, 99 sacrospinous hysteropexy), scores improved by 0.27 points (95% CI 0.19–0.34) after the Manchester procedure and 0.20 points (95% CI 0.11–0.29) after hysteropexy; the difference of 0.09 (95% CI 0.01–0.17) lay within the margin. De novo dyspareunia was reported by 5% after the Manchester procedure and 13% after hysteropexy among women sexually active at baseline, and by 6% (n = 7) and 11% (n = 12) after counting women who became sexually inactive.[3]
Surgery and treatment delivery
In sacrospinous hysteropexy the posterior cervix was fixed unilaterally to the right sacrospinous ligament with two nonabsorbable sutures. The Manchester procedure combined extraperitoneal plication of the uterosacral ligaments at the posterior side of the uterus, cervical amputation and plication of the cardinal ligaments on the anterior side of the cervix. A suture-capturing device was used in 114/200 (57.0%) of hysteropexies.[2] Median operating time was 63 minutes (IQR 48–81) with hysteropexy and 62 minutes (IQR 48–80) with the Manchester procedure, and median estimated blood loss was 50 mL (IQR 50–100) versus 100 mL (IQR 50–137.5).[1][2]
Twelve participants had major protocol violations: 2 women randomized to the Manchester procedure received hysteropexy and 5 randomized to hysteropexy received a Manchester procedure; 4 received a nonstudy procedure instead of hysteropexy (1 vaginal hysterectomy and 3 colporrhaphies without apical reconstruction), and 1 had a concomitant sphincter ani repair. These participants stayed in the as-randomized analysis and were excluded from the per-protocol analysis. Of the amputated cervices, 164 (80.4%) were examined histologically; 4 showed abnormal findings, including one CIN2 in a patient who had no preoperative Papanicolaou test. No gynecologic malignancy was detected during follow-up.[1]
Adverse events
Serious adverse events occurred in 9/207 sacrospinous hysteropexy participants and 11/213 Manchester participants. Six women died during the study, 1 after hysteropexy (0.5%) and 5 after the Manchester procedure (2.3%); one Manchester participant died 5 weeks after surgery of a suspected massive pulmonary embolism that was plausibly related to the operation, and the remaining deaths were judged unlikely to be study related. Urinary retention after treatment was more frequent after hysteropexy (37/203, 18.2%, versus 25/204, 12.3%), whereas urinary tract infection within 6 weeks was less frequent (16/205, 7.8%, versus 24/209, 11.5%). Blood loss above 500 mL occurred in 3/203 (1.5%) and 1/213 (0.5%), with no transfusions or injuries to adjacent organs in either group.[1]
Complications specific to each operation differed. Buttock pain requiring extra visits or treatment occurred only after hysteropexy (5/207; 4/207, 1.9%, with treatment). It was severe in 1 woman and persistent for at least 2 months in 3. Three of them had the suture removed (at 2 days, 4 months and 6 months) and underwent another prolapse operation, and three received a local nerve block. Cervical stenosis occurred only after the Manchester procedure (2/212, 0.9%), presenting with postmenopausal bleeding in one woman and dysmenorrhea with hematometra in the other. Reoperation for a reason other than prolapse was recorded in 4/207 (1.9%) versus 2/212 (0.9%), and rehospitalization in 7/207 (3.4%) versus 4/212 (1.9%).[1]
Limitations
The trial was not blinded, and the primary outcome included a patient-reported bulge component. The results apply to uterine descent with POP-Q point D at or proximal to −1 cm, so women with more advanced uterine descent were excluded; point D is among the least reliable POP-Q measurements, and cervical elongation, the usual indication for the Manchester procedure, was not the selection criterion. The trial studied the posterior approach to sacrospinous hysteropexy and a Manchester procedure with posterior uterosacral and anterior cardinal plication, so it does not address the anterior approach or other Manchester modifications. All hospitals were Dutch, and no screening log of eligible patients was kept. Follow-up was 2 years, with extended follow-up still being collected.[1][2]
In conversation
- Builds on SAVE-U (2015). SAM took SAVE-U's lower 5-year anatomic recurrence after hysteropexy as rationale; it compared hysteropexy with the Manchester procedure instead of hysterectomy.
SAM compared two uterus-preserving operations, whereas SAVE-U compared sacrospinous hysteropexy with vaginal hysterectomy and uterosacral suspension. The two trials also define failure differently: SAVE-U used anatomic failure within a single vaginal compartment with a 7% margin, and SAM used a composite of anatomy, symptoms and retreatment with a 9% margin.[1]
Guidelines and approvals
- AUGS (2025 clinical practice statement on uterine preservation at prolapse surgery). Cites 4/164 (2.4%) Manchester specimens with abnormal cervical histology in SAM, which it describes as cervical intraepithelial neoplasia, in the text supporting its advice that women who keep the uterus continue cervical cancer screening and be offered a workup for abnormal uterine bleeding .[4]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2023-08-15 | Two-year randomized report · primary | — | 2-year composite success, as-randomized analysis; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 151/196 (77.0%) vs 172/197 (87.3%); difference -10.3; CI -17.8–-2.8; P 0.007 Not met 2-year composite success, per-protocol analysis; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 145/187 (77.5%) vs 171/195 (87.7%); difference -10.2; CI -17.7–-2.6; P 0.008 Not met Component of the composite, as-randomized; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 170/196 (86.7%) vs 187/195 (95.9%); difference -9.2; CI -14.7–-3.7; P 0.001 Component of the composite, as-randomized; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 179/200 (89.5%) vs 183/201 (91.0%); difference -1.5; CI -7.3–4.3; P 0.60 Component of the composite, as-randomized; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 187/199 (94.0%) vs 195/201 (97.0%); difference -3; CI -7.1–1; P 0.14 POP-Q Ba greater than 0 at 2 years; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 20/196 (10.2%) vs 5/195 (2.6%); difference 7.6; CI 2.9–12.4; P 0.002 POP-Q C greater than 0 at 2 years; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 2/196 (1.0%) vs 0/195 (0%); difference 1; CI -0.9–2.9; P 0.48 POP-Q Bp greater than 0 at 2 years; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 4/196 (2.0%) vs 3/195 (1.5%); difference 0.5; CI -2.1–3.1; P 0.71 POP-Q stage 2 or higher in the anterior compartment at 2 years; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 124/196 (63.3%) vs 87/195 (44.6%); difference 18.6; CI 8.9–28.4; P <0.001 POP-Q stage 2 or higher in the posterior compartment at 2 years; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 22/196 (11.2%) vs 54/195 (27.7%); difference -16.5; CI -24.1–-8.8; P <0.001 Reoperation for recurrence in a previously operated vaginal compartment through 2 years: 9/207 (4.3%) vs 0; — Pessary treatment starting at some point in year 1; risk difference in percentage points (sacrospinous hysteropexy minus Manchester procedure): 8/200 (4.0%) vs 5/201 (2.5%); difference 1.5; CI -2–5; P 0.39 (Very) much improved at 2 years: 156/195 (80.0%) vs 160/195 (82.1%); — | Enklaar RA, Schulten SFM, van Eijndhoven HWF, et al. Manchester procedure vs sacrospinous hysteropexy for treatment of uterine descent: a randomized clinical trial. *JAMA.* 2023;330(7):626-635. doi:10.1001/jama.2023.13140 DOI |
| 2025-11-07 | Economic evaluation · secondary | — | Mean 2-year societal cost in euros at 2019 prices (multiple imputation, base case); mean difference, Manchester procedure minus sacrospinous hysteropexy: €9,869 (SE 506) vs €8,410 (SE 419); difference -1458.34; CI -2746.16–-170.52 Mean 2-year direct healthcare cost in euros at 2019 prices (multiple imputation); mean difference, Manchester procedure minus sacrospinous hysteropexy: €4,737 (SE 179) vs €4,426 (SE 148); difference -310.85; CI -767.06–145.36 QALYs over 2 years from EQ-5D-5L (generalized linear model): 1.67 (95% CI 1.63–1.71) vs 1.68 (95% CI 1.65–1.72); P 0.346 | Schulten SFM, Enklaar RA, Weemhoff M, et al. Economic evaluation of Manchester procedure versus sacrospinous hysteropexy: a follow-up analysis of a randomized clinical trial. *PLoS One.* 2025;20(11):e0336030. doi:10.1371/journal.pone.0336030 DOI |
| 2025-12-17 | Sexual function at 24 months · pro | — | Mean change in PISQ-IR score from baseline to 24 months in sexually active participants (Manchester procedure n = 101, sacrospinous hysteropexy n = 99); mean difference, Manchester procedure minus sacrospinous hysteropexy: 0.20 (95% CI 0.11–0.29) vs 0.27 (95% CI 0.19–0.34); difference 0.09; CI 0.01–0.17 Met De novo dyspareunia at 24 months among participants sexually active at baseline: 13% vs 5%; — De novo dyspareunia at 24 months after counting outcomes of women who became nonsexually active after surgery: 11% (n = 12) vs 6% (n = 7); — Change in PISQ-IR condition-impact score in participants not sexually active (Manchester procedure n = 59, sacrospinous hysteropexy n = 64): −0.21 (95% CI −0.41 to 0.00) vs −0.25 (95% CI −0.43 to 0.08); — Descriptive | Stoter LM, Peters K, Enklaar RA, et al. Sexual function after the Manchester procedure versus sacrospinous hysteropexy in women treated for uterine prolapse: a planned analysis of a randomized clinical trial. *Am J Obstet Gynecol.* 2026;234(4):1112-1120. doi:10.1016/j.ajog.2025.12.035 DOI |
References
1. Enklaar RA, Schulten SFM, van Eijndhoven HWF, et al. "Manchester Procedure vs Sacrospinous Hysteropexy for Treatment of Uterine Descent: A Randomized Clinical Trial." JAMA. 2023;330(7):626-635. doi:10.1001/jama.2023.13140
2. Schulten SFM, Enklaar RA, Weemhoff M, et al. "Economic evaluation of Manchester procedure versus sacrospinous hysteropexy: A follow-up analysis of a randomized clinical trial." PLoS One. 2025;20(11):e0336030. doi:10.1371/journal.pone.0336030
3. Stoter LM, Peters K, Enklaar RA, et al. "Sexual function after the Manchester procedure versus sacrospinous hysteropexy in women treated for uterine prolapse: a planned analysis of a randomized clinical trial." Am J Obstet Gynecol. 2026;234(4):1112-1120. doi:10.1016/j.ajog.2025.12.035
4. Chang OH, Carter Ramirez A, Edwards A, et al. "The Role of Uterine Preservation at the Time of Pelvic Organ Prolapse Surgery." Urogynecology (Phila). 2025;31(5):482-495. doi:10.1097/SPV.0000000000001667