RESEARCH

Sacrospinous hysteropexy versus vaginal hysterectomy with

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uterosacral ligament suspension in women with uterine ­prolapse
stage 2 or higher: observational follow-up of a multicentre
­randomised trial
Sascha F M Schulten,1,2 Renée J Detollenaere,1 Jelle Stekelenburg,3,4 Joanna IntHout,2
Kirsten B Kluivers,5 Hugo W F van Eijndhoven1
1
Department of Obstetrics and ABSTRACT anatomical failure (recurrent prolapse stage 2 or
Gynaecology, Isala Clinics, PO OBJECTIVE higher in apical, anterior, or posterior compartment),
Box 10400, 8000 GK Zwolle,
To evaluate the effectiveness and success of uterus composite outcome of success (defined as no
Netherlands
2 preserving sacrospinous hysteropexy as an alternative prolapse beyond the hymen, no bothersome bulge
Radboud University Medical
Center, Radboud Institute for to vaginal hysterectomy with uterosacral ligament symptoms, and no repeat surgery or pessary use for
Health Sciences, Nijmegen, suspension in the surgical treatment of uterine recurrent prolapse), functional outcome, quality of
Netherlands prolapse five years after surgery. life, repeat surgery, and sexual functioning.
3
Department of Obstetrics and
Gynaecology, Medical Centre DESIGN RESULTS
Leeuwarden, Leeuwarden, Observational follow-up of SAVE U (sacrospinous At five years, surgical failure of the apical
Netherlands fixation versus vaginal hysterectomy in treatment of compartment with bothersome bulge symptoms or
4
Department of Health sciences, uterine prolapse ≥2) randomised controlled trial. repeat surgery occurred in one woman (1%) after
University Medical Center
Groningen, Global health, SETTING sacrospinous hysteropexy compared with eight
Groningen, Netherlands Four non-university teaching hospitals, the women (7.8%) after vaginal hysterectomy with
5
Department of Obstetrics Netherlands. uterosacral ligament suspension (difference−6.7%,
and Gynaecology, Radboud 95% confidence interval −12.8% to−0.7%). A
University Medical Center, PARTICIPANTS
statistically significant difference was found in
Nijmegen, Netherlands 204 of 208 healthy women in the initial trial (2009-
composite outcome of success between sacrospinous
Correspondence to: 12) with uterine prolapse stage 2 or higher requiring
R J Detollenaere hysteropexy and vaginal hysterectomy (89/102 (87%)
surgery and no history of pelvic floor surgery who
r.j.detollenaere@isala.nl v 77/102 (76%). The other secondary outcomes did
(ORCID 0000-0001-9707-5647) had been randomised to sacrospinous hysteropexy
not differ. Time-to-event analysis at five years showed
Cite this as: BMJ 2019;366:l5149 or vaginal hysterectomy with uterosacral ligament
no differences between the interventions.
http://dx.doi.org/10.1136/bmj.l5149 suspension. The women were followed annually for
five years after surgery. This extended trial reports the CONCLUSIONS
Accepted: 22 July 2019
results at five years. At five year follow-up significantly less anatomical
recurrences of the apical compartment with
MAIN OUTCOME MEASURES
bothersome bulge symptoms or repeat surgery were
Prespecified primary outcome evaluated at five year
found after sacrospinous hysteropexy compared
follow-up was recurrent prolapse of the uterus or
with vaginal hysterectomy with uterosacral ligament
vaginal vault (apical compartment) stage 2 or higher
suspension. After hysteropexy a higher proportion of
evaluated by pelvic organ prolapse quantification
women had a composite outcome of success. Time-
system in combination with bothersome bulge
to-event analysis showed no differences in outcomes
symptoms or repeat surgery for recurrent apical
between the procedures.
prolapse. Secondary outcomes were overall
TRIAL REGISTRATION
trialregister.nl NTR1866.
WHAT IS ALREADY KNOWN ON THIS TOPIC
Vaginal hysterectomy is the standard treatment for uterine prolapse, but uterus
preservation is gaining popularity Introduction
Uterine prolapse is a common health problem, with
Sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with
increasing incidence due to aging populations and
suspension of the uterosacral ligaments for recurrent prolapse of the apical
rising obesity rates.1 2 Women’s lifetime risk for
compartment with bothersome bulge symptoms or repeat surgery after 12
prolapse surgery is 11-20%, and worldwide vaginal
months’ follow-up
hysterectomy is the most common surgical procedure
Overall anatomical outcome, quality of life, subjective outcome, hospital stay, for uterine prolapse.3 4 Studies comparing vaginal
recovery, complications, and sexual functioning did not differ hysterectomy with uterus preserving procedures
WHAT THIS STUDY ADDS are limited, and no data are available on long term
follow-up. Guidelines for pelvic organ prolapse
Follow-up at five years shows that uterine preservation is more effective than
are therefore ambiguous, resulting in variation in
vaginal hysterectomy with uterosacral ligament suspension, and the risk for
treatment.5 The SAVE U (sacrospinous fixation versus
retreatment of recurrent prolapse or malignancy is low
vaginal hysterectomy in treatment of uterine prolapse
Women who require surgical correction of uterine prolapse should be given the ≥2) randomised trial compared uterus preservation
opportunity to choose uterus preservation and avoid hysterectomy with hysterectomy on a large scale with relevant

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outcome measures.6 Treatment with sacrospinous prolapse after 12 months follow-up. This outcome was

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hysteropexy was non-inferior to vaginal hysterectomy also used as the primary outcome after five years. The
with suspension of the uterosacral ligaments for predefined secondary outcomes at five year follow-
surgical failure of the apical compartment after 12 up included overall anatomical failure (pelvic organ
months’ follow-up. No notable differences were found prolapse stage 2 or higher in any compartment), a
between the interventions for overall anatomical composite outcome of success (defined as no prolapse
and surgical failure, functional outcome, quality of beyond the hymen, no bothersome bulge symptoms,
life, complications, postoperative recovery, length and no repeat surgery or pessary use for recurrent
of hospital stay, and sexual functioning. One of the prolapse), functional outcome, quality of life, repeat
study’s limitations was short duration of follow-up surgery, and sexual functioning.
(12 months). Two recent systematic reviews with
meta-analysis on apical pelvic organ prolapse surgery Interventions
confirmed the short term results of the SAVE U trial.7 The surgeons were provided with a detailed guideline
8
The studies also concluded that long term follow-up of the study interventions to ensure a uniform
of the comparison between vaginal hysterectomy with technique.6 9
apical suspension and vaginal hysteropexy is necessary Sacrospinous hysteropexy—Vaginal sacrospinous
because the impact of the uterus on prolapse outcomes hysteropexy was performed unilaterally to the right
many years after surgery is still unknown. We report sacrospinous ligament. The posterior vaginal wall
the five year outcomes in women after sacrospinous was incised and the sacrospinous ligament accessed
hysteropexy or vaginal hysterectomy with suspension through the pararectal space. Two permanent sutures
of the uterosacral ligaments enrolled in the SAVE U (Prolene 1.0; Ethicon, Somerville, NJ) were placed
randomised trial. under direct vision through the sacrospinous ligament
at least 2 cm from the ischial spine. Additional anterior
Methods or posterior vaginal wall repair or incontinence surgery
Study design was performed as required. Both ends of the permanent
Details of the trial protocol have been published sutures were placed through the posterior side of the
previously.6 9 All women gave written informed consent cervix and tightened and the uterus redressed. The
before randomisation. posterior vaginal wall was closed with absorbable
In the original trial, women with uterine prolapse sutures (Vicryl 2; Ethicon, Somerville, NJ). (For further
at stage 2 (uterine prolapse 1 cm above or beyond details see www.youtube.com/watch?v=ySSfy2A1_RM
the hymen, according to the Pelvic Organ Prolapse and www.youtube.com/watch?v=wjct1r37sTw).
Quantification (POP-Q) system) or higher were Vaginal hysterectomy—The vaginal wall around
randomly assigned to sacrospinous hysteropexy or the cervix was circumcised. After bladder and bowel
vaginal hysterectomy with suspension of the uterosacral dissection the anterior and posterior peritoneum were
ligaments in a non-blinded multicentre randomised opened. The uterosacral ligaments—strong supportive
controlled non-inferiority trial. Concomitant repair of ligaments that attach the cervix to the sacrum— were
anterior or posterior vaginal prolapse (colporrhaphy) identified, ligated, and transected. The uterus was
was allowed, as was anti-incontinence surgery. released in several steps using clamps and sutures.
We excluded women with previous pelvic floor or After removal of the uterus, the surgical pedicles
prolapse surgery, known malignancy, an abnormal were inspected for haemostasis and the adnexa were
cervical smear test result, a wish to preserve fertility, inspected for abnormalities. The peritoneum was
language barriers, immunological or haematological closed using a delayed absorbable suture (Vicryl 1.0;
disorders interfering with recovery after surgery, Ethicon, Somerville, NJ). Additional vault suspension
abnormal ultrasound findings of the uterus or ovaries, in this study was performed by suspension of the
and abnormal uterine bleeding. The women were uterosacral ligaments. This technique has been
randomly allocated in a 1:1 ratio using a web based described previously and involves the attachment of
application with computer generated randomisation the uterosacral ligaments to the vaginal vault with two
tables in blocks of four, stratified by hospital and stage delayed absorbable sutures (Vicryl 1.0, Ethicon).9 The
of uterine prolapse. The trial was non-blinded as it sutures were placed as high as possible on the visible
was impossible to blind surgeons and women to the part of the ligament, which in general was caudal
allocated surgical procedure. An independent doctor to the level of the ischial spine thereby restoring
or specialist nurse not involved in treatment carried normal support to the apical compartment.10 Again,
out the follow-up visits. concomitant anterior or posterior vaginal wall repair or
anti-incontinence surgery was performed if indicated.
Outcome measures
The primary outcome of the original SAVE U study was Measurements and procedures
surgical failure of the apical compartment, defined as After the initial 12 month follow-up, women attended
a recurrent prolapse stage 2 or higher of the uterus annual appointments at hospital for five years after
or vaginal vault (apical compartment) evaluated by surgery. Pelvic organ prolapse was staged during
the POP-Q system in combination with bothersome follow-up using the POP-Q system, and women
bulge symptoms or repeat surgery for recurrent apical completed validated health related and disease specific

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quality of life questionnaires: short form-36, Euroqol Results

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5D, urogenital distress inventory, defecatory distress In the original trial, 208 women were randomly
inventory, and incontinency impact questionnaire.11-14 assigned to sacrospinous hysteropexy (n=103) or
The presence of bothersome bulge symptoms after vaginal hysterectomy with uterosacral ligament
surgery was defined as a positive answer to any of suspension (n=105) between 27 November 2009 and
the following questions from the urogenital distress 12 March 2012. Figure 1 shows the flow of women
inventory: “Do you experience a sensation of bulging through the study. A total of 204 women were eligible
or protrusion from the vagina?” and “Do you have a for the last observation carried forward analysis at
bulge or something fallen out that you can see in the five year follow-up. One woman developed severe
vagina?” in combination with a response “somewhat complications during hospital stay after vaginal
bothered” to “ very much bothered” to the question hysterectomy and died eight days after surgery. Three
“how much does this bother you?” To assess sexual women withdrew consent before the first follow-up
functioning, we used the 12 item pelvic organ prolapse/ visit at six months. All four women were excluded from
urinary incontinence sexual questionnaire, translated the last observation carried forward analysis.
from the validated questionnaire but not validated for Two women were lost to follow-up because they
Dutch language at that time.15 died. These deaths were from causes unrelated to the
study and we applied last observation carried forward
Statistical analysis on their outcomes.
The sample size for this trial was based on the primary Two women received sacrospinous hysteropexy
outcome of the original trial at 12 months’ follow-up instead of vaginal hysterectomy owing to technical
and reported previously.9 We assessed study outcomes difficulties during surgery.6 According to the intention-
by intention-to-treat analysis and surgical failure and to-treat principle, we included these women in the
composite outcome of success also by per protocol intention-to-treat analysis, with all women analysed as
analysis. This analysis included women who completed randomised. For the per protocol analysis, we excluded
the entire treatment protocol as originally planned, women with major protocol deviations (n=9), women
with availability of the POP-Q scores at five year follow- who were lost to follow-up (n=22,) and women with
up and absence of major deviations from the protocol. missing or incomplete POP-Q scores (n=18).
We evaluated the outcomes at five year follow-up by Baseline characteristics of women did not differ
frequencies and proportions and used the Agresti- noticeably (table 1). Table 2 and figure 2 show the results
Coull method to calculate 95% confidence intervals for surgical and anatomical failure, success, and repeat
for differences in proportions.16 To account for missing surgery. Surgical failure of the apical compartment with
data on anatomical outcome at five year follow-up, we bothersome bulge symptoms or repeat surgery occurred
applied two strategies. For the first strategy, we used in only one of 102 women (1%) after sacrospinous
the last observation carried forward with data from the hysteropexy compared with eight of 102 women (8%)
last available follow-up visit. If data were not available, after vaginal hysterectomy with uterosacral ligament
we excluded the woman from the intention-to-treat last suspension (difference −6.7%, 95% confidence interval
observation carried forward analysis. Furthermore, we −12.8% to −0.7%) for the last observation carried
applied conservative imputation by imputing a failure forward approach. In the intention-to-treat analysis
for all women with missing data at five year follow-up with conservative imputation, surgical failure of the
(worst case scenario). If questionnaires were missing, apical compartment with bothersome bulge symptoms
we obtained information on the presence or absence or repeat surgery occurred in 16 of 103 women (16%)
of bothersome bulge symptoms from the case record after sacrospinous hysteropexy and 27 of 105 women
form of the follow-up visit. For the second strategy, (26%) after vaginal hysterectomy (difference −9.8%, 95%
we performed time-to-event (survival) analysis using confidence interval −20.9 to 1.2). The per protocol analysis
a Kaplan-Meier approach to estimate the cumulative showed surgical failure of the apical compartment in none
incidence at five years of follow-up, and calculated the of 88 women after sacrospinous hysteropexy and four of
difference in cumulative incidences with corresponding 78 women (5%) after vaginal hysterectomy (difference
95% confidence intervals. −5.1%, 95% confidence interval −10.9% to 0.7%). In
Statistical significance was evaluated using Fisher’s the time-to-event analysis surgical failure was found in
exact tests and Mann-Whitney U tests to compare four of 102 women (4%) after sacrospinous hysteropexy
proportions and continuous variables between the and nine of 102 women (9%) after vaginal hysterectomy
groups. We used paired sample t tests to compare mean (difference −4.7%, 95% confidence interval −11.4% to
continuous data within groups. All statistical analyses 2.0%). Table 3 shows the characteristics of women with
were performed with SPSS for windows (version surgical failure of the apical compartment.
24.0.0.1). Overall anatomical failure occurred in 46 of 102
women (45%) after sacrospinous hysteropexy and
Patient and public involvement 51 of 102 women (50%) after vaginal hysterectomy
No patients were involved in the design and (difference −4.8%, 95% confidence interval −18.5%
implementation of the study, the dissemination of to 8.9%). No differences were found for anatomical
results, setting the research question or the outcome failure in the different compartments except for the
measures, or recruitment. posterior compartment: five of 102 women (5%) had

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BMJ: first published as 10.1136/bmj.l5149 on 10 September 2019. Downloaded from http://www.bmj.com/ on 24 September 2019 by guest. Protected by copyright.
389
Assessed for eligibility

181
Excluded
11 Did not meet inclusion criteria
155 Declined to participate
15 Other

208
Randomised

103 105
Allocated to sacrospinous hysteropexy Allocated to vaginal hysterectomy
105 Received sacrospinous hysteropexy 102 Received vaginal hysterectomy
2 Received sacrospinous hysteropexy 2 Received sacrospinous hysteropexy
instead of vaginal hysterectomy owing to instead of vaginal hysterectomy owing to
technical difficulties during surgery technical difficulties during surgery
1 Underwent abdominal hysterectomy owing
to adhesions identified by laparoscopy

5 Discontinued follow-up at 1 year 3 Discontinued follow-up at 1 year

4 Lost to follow-up 2 Lost to follow-up
1 Laparoscopic hysterectomy 1 Died
owing to endometrial cancer 4 Missing POP-Q scores

102 Analysed for primary outcome intention to 100 Analysed for primary outcome intention to
treat with last observation carried treat with last observation carried
forward at 1 year forward at 1 year
103 Analysed for primary outcome intention to 105 Analysed for primary outcome intention to
treat with conservative imputation treat with conservative imputation
98 Analysed for primary outcome per protocol 90 Analysed for primary outcome per protocol

9 Discontinued follow-up at 5 years 13 Discontinued follow-up at 5 years

8 Lost to follow-up 11 Lost to follow-up
1 Died 2 Died
7 Missing POP-Q scores 11 Missing POP-Q scores

102 Analysed for primary outcome intention to 102 Analysed for primary outcome intention to
treat with last observation carried treat with last observation carried
forward at 5 years* forward at 5 years*
103 Analysed for primary outcome intention to 105 Analysed for primary outcome intention to
treat with conservative imputation† treat with conservative imputation†
88 Analysed for primary outcome per protocol‡ 78 Analysed for primary outcome per protocol‡
102 Analysed for time to event 102 Analysed for time to event

Last observed POP-Q score Last observed POP-Q score

available at end of trial available at end of trial
3 6 month follow-up 3 3 year follow-up 0 6 month follow-up 5 3 year follow-up
1 1 year follow-up 7 4 year follow-up 4 1 year follow-up 6 4 year follow-up
1 2 year follow-up 87 5 year follow-up 6 2 year follow-up 81 5 year follow-up

Fig 1 | Flow of women through study. *Intention to treat: two women allocated to vaginal hysterectomy received
sacrospinous hysteropexy and were analysed in the vaginal hysterectomy group. One woman after vaginal
hysterectomy had recurrent apical prolapse, but pelvic organ prolapse quantification (POP-Q) score was missing;
this woman was included in the intention-to-treat last observation carried forward analysis. †Missed data imputed as
failure. ‡Per protocol analysis: two women did not receive intended treatment. Excluded from per protocol analysis:
discontinued follow-up at five year (n=22), missing or incomplete POP-Q score (n=18), and major protocol deviations
(n=9); seven patients met two criteria for exclusion from per protocol analysis

prolapse stage 2 or higher of the posterior vaginal wall and 78 of 102 women (77%) after vaginal hysterectomy
after sacrospinous hysteropexy and 18 of 101 women (difference −5.0%, −17.1% to 7.1%).
(18%) after vaginal hysterectomy (difference −12.7%, In the last observation carried forward approach,
95% confidence interval −21.5% to −3.9%). Time-to- treatment success was significant in 89 of 102
event analysis showed overall anatomical failure in 73 women (87%) in the sacrospinous hysteropexy group
of 102 women (72%) after sacrospinous hysteropexy compared with 77 of 102 women (76%) in the vaginal

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Table 1 | Baseline characteristics of women in the extended trial. Value are numbers (percentages) unless stated

BMJ: first published as 10.1136/bmj.l5149 on 10 September 2019. Downloaded from http://www.bmj.com/ on 24 September 2019 by guest. Protected by copyright.
otherwise
Characteristics Sacrospinous hysteropexy (n=102) Vaginal hysterectomy (n=102)
Median (range) age (years) 63 (45-85) 61 (33-82)
Highest educational level:
  Primary or secondary school 14 (14) 6 (6)
  High school 77 (77) 80 (81)
  Bachelor, master or academic degree 9 (9) 13 (13)
Comorbidity:
  Cardiovascular disease 39 (38) 31 (30)
  Diabetes mellitus 5 (5) 5 (5)
  Respiratory disease 3 (3) 7 (7)
Smoker 13 (15) 9 (10)
Median (range) No of vaginal deliveries 2 (0-7) 3 (0-7)
Median (range) No of caesarean deliveries 0 (0-1) 0 (0-2)
Mean (SD) body mass index 25.9 (3.3) 25.9 (3.5)
POP-Q stage uterine prolapse (point C)*:
 2 66 (65) 65 (64)
 3 28 (28) 28 (28)
 4 8 (8) 9 (9)
POP-Q stage 2-4:
  Anterior prolapse (Ba ≥1) 93 (94) 92 (92)
  Posterior prolapse (Bp ≥1) 29 (29) 32 (32)
Prolapse beyond hymen:
  Apical (POP-Q C >0) 47 (48) 40 (40)
  Anterior (POP-Q Aa or Ba >0) 70 (71) 70 (70)
  Posterior (POP-Q Ap or Bp >0) 11 (11) 11 (11)
Overall POP-Q stage*:
 2 25 (25) 35 (35)
 3 69 (70) 61 (61)
 4 5 (5) 4 (4)
POP-Q=pelvic organ prolapse quantification.
Percentages were calculated using non-missing data. Women were analysed as allocated.
*System involves quantitative measurements of various points of vaginal wall, with hymen as reference point. Degree of prolapse of anterior vaginal
wall (Aa and Ba), posterior vaginal wall (Ap and Bp), and uterus or vaginal vault (C) measured in centimetres both above or proximal to hymen (negative
number) or beyond or distal to hymen (positive number), with plane of hymen defined as zero. A represents the descent of a measurement point 3 cm
proximal to the hymen on the anterior (Aa) and posterior (Ap) vaginal wall. B is the most descended edge on the anterior (Ba) and posterior (Bp) vaginal
wall. POP-Q stage 2: most distal prolapse is between 1 cm above and 1 cm beyond hymen; stage 3: most distal prolapse is prolapsed >1 cm beyond
hymen but no further than 2 cm less than total vaginal length; stage 4: total prolapse.

hysterectomy group (difference 11.5%, 0.8% to the symptoms resolved. Subsequent surgical treatment
22.2%). Time-to-event analysis showed success in 70% for stress urinary incontinence was necessary in two
of the women in the sacrospinous hysteropexy group of 102 women (2%) in the sacrospinous hysteropexy
and 65% of the women in the vaginal hysterectomy group compared with six of 102 women (6%) in the
group (difference 5.3, −7.9 to 18.5). vaginal hysterectomy group (difference −3.8%, 95%
Three of 102 women (3%) underwent surgery for confidence interval −9.7% to 2.0%). Tables 4 and 5
recurrent prolapse in the sacrospinous hysteropexy provide information on functional outcome, quality of
group compared with seven of 102 women (7%) in life, and sexual functioning. Functional outcome and
the vaginal hysterectomy group (difference −3.8%, quality of life did not differ statistically significantly
−10.2% to 2.5%). No women (0%) had recurrent between the groups (table 4). Among the women
surgery for pelvic organ prolapse in a non-operated who completed the pelvic organ prolapse/urinary
compartment in the sacrospinous hysteropexy group incontinence sexual questionnaire before and five years
compared with four of 102 women (4%) in the after surgery, scores showed statistically significant
vaginal hysterectomy group (difference −3.8%, 95% improvement in both groups but no significant
confidence interval −8.4% to 0.7%). In the time-to- difference in total scores between both interventions
event analysis three of 102 women (3%) had repeat (table 5). All serious adverse events potentially related
surgery in any compartment in the sacrospinous to surgical treatment occurred in the first 12 months
hysteropexy group compared with nine of 102 women after surgery and have been described previously.6
(9%) in the vaginal hysterectomy group (difference
−5.9%, 95% confidence interval −12.3% to 0.5%). Discussion
During follow-up two women (2%) underwent This study provides evidence that treatment of uterine
hysterectomy after sacrospinous hysteropexy. Stage prolapse with sacrospinous hysteropexy is effective
1 endometrial carcinoma was diagnosed in one and has lower risk of recurrent bothersome uterine
woman (1%) and laparoscopic hysterectomy was prolapse or retreatment of the apical compartment
performed. The other woman had persistent buttock compared with vaginal hysterectomy with uterosacral
pain immediately after surgery, and the sutures and ligament suspension. We found no differences in
uterus were removed four months after surgery and overall anatomical failure, functional outcome, quality

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Table 2 | Outcomes for pelvic organ prolapse at five year follow-up. Values are numbers (percentages) of women unless

BMJ: first published as 10.1136/bmj.l5149 on 10 September 2019. Downloaded from http://www.bmj.com/ on 24 September 2019 by guest. Protected by copyright.
stated otherwise
Outcomes Sacrospinous hysteropexy Vaginal hysterectomy % difference (95% CI)
Surgical failure of apical compartment*:
  ITT analysis with LOCF 1/102 (1) 8/102 (8) −6.7 (−12.8 to −0.7)
  ITT analysis with conservative imputation 16/103 (16) 27/105 (26) −9.8 (−20.9 to 1.2)
  Per protocol analysis 0/88 (0) 4/78 (5) −5.1 (−10.9 to 0.7)
  Time-to-event analysis† 4/102 (4) 9/102 (9) −4.7 (−11.4 to 2.0)
Anatomical failure‡:
  Overall anatomical failure 46/102 (45) 51/102 (50) −4.8 (−18.5 to 8.9)
  Apical compartment 3/102 (3) 7/102 (7) −3.8 (−10.2 to 2.5)
  Anterior compartment 41/102 (40) 36/101 (36) 4.5 (−8.9 to 17.8)
  Posterior compartment 5/102 (5) 18/101 (18) −12.7 (−21.5 to −3.9)
  Time-to-event analysis 73/102 (72) 78/102 (77) −5.0 (−17.1 to 7.1)
Composite outcome success§:
  ITT analysis with LOCF 89/102 (87) 77/102 (76) 11.5 (0.8 to 22.2)
  ITT analysis with conservative imputation 77/103 (75) 65/105 (62) 12.6 (0.0 to 25.2)
  Per protocol analysis 77/88 (88) 62/78 (80) 7.9 (−3.6 to 19.4)
  Time-to-event analysis 71/102 (70) 65/102 (64) 5.3 (−7.9 to 18.5)
Prolapse beyond the hymen¶:
  Apical (POP-Q C >0) 0/102 (0) 4/101 (4) −3.9 (−8.5 to 0.7)
  Anterior (POP-Q Ba >0) 6/102 (6) 8/101 (8) −2.0 (−9.4 to 5.3)
  Posterior (POP-Q Bp >0) 0/102 (0) 3/101 (3) −2.9 (−7.1 to 1.3)
Repeat surgery¶:
  Recurrent prolapse 3/102 (3) 7/102 (7) −3.8 (−10.2 to 2.5)
  Apical compartment 1/102 (1) 4/102 (4) −2.9 (−7.8 to 2.0)
  Anterior compartment 3/102 (3) 4/102 (4) −1.0 (−6.5 to 4.6)
  Posterior compartment 0/102 (0) 2/102 (2) −1.9 (−5.7 to 1.8)
  Different site from primary surgery** 0/102 (0) 4/102 (4) −3.8 (−8.4 to 0.7)
  Time-to-event analysis 3/102 (3) 9/102 (9) −5.9 (−12.3 to 0.5)
Surgery for non-prolapse conditions:
  Surgery for stress urinary incontinence 2/102 (2) 6/102 (6) −3.8 (−9.7 to 2.0)
 Hysterectomy 2/102 (2) - -
 Other 1/102 (1) 1/102 (1) 0 (−3.8 to 3.8)
ITT=intention to treat; LOCF=last observation carried forward; POP-Q=pelvic organ prolapse quantification. Percentages were calculated using non-
missing data. Agresti-Coull method used to calculate 95% confidence intervals.
*Recurrent apical prolapse stage ≥2 with bothersome symptoms or repeat surgery for apical prolapse.
†Time-to-event analysis using Kaplan-Meier to calculate cumulative incidence until five year follow-up.
‡Prolapse POP-Q stage ≥2.
§No prolapse beyond hymen, absence of bothersome bulge symptoms, and no repeat surgery or pessary use.
¶ITT with LOCF.
**Reoperation for pelvic organ prolapse in non-operated compartment.

of life, repeat surgery, and sexual functioning between for subjective outcomes and retreatment rates and
sacrospinous hysteropexy and vaginal hysterectomy analysed a composite outcome measure in which
with uterosacral ligament suspension at five year treatment was considered as success when women
follow-up. However, the proportion of women with had no bothersome symptoms of prolapse, no surgical
successful treatment was statistically significantly retreatment or pessary use, and no pelvic organ
higher after sacrospinous hysteropexy. prolapse beyond the hymen as different studies have
Time-to-event analysis showed no differences in shown that the hymen is an important cut off point for
surgical failure of the apical compartment, overall symptom development.18-20
anatomical failure, success, and repeat surgery The trial also has some limitations. We used the last
between sacrospinous hysteropexy and vaginal observation carried forward method for missing data,
hysterectomy with uterosacral ligament suspension. with the advantage that it minimises the number of
dropouts. In our trial, five out of nine (56%) women
Strengths and limitations of this study with recurrent pelvic organ prolapse of the apical
This randomised trial evaluated efficacy and safety compartment with bothersome symptoms or repeat
of uterus preserving sacrospinous hysteropexy and surgery for recurrent apical prolapse withdrew from
vaginal hysterectomy with uterosacral ligament the study before the last study visit. As we evaluated
suspension after five year follow-up. A major strength outcomes solely at five year follow-up, these recurrences
of this trial is the sample size and the large group of would not have been taken into account. However, there
women who completed follow-up. POP-Q scores of is a possibility that this method gives a biased estimate
168 women (81%) were available for analysis. A of the treatment effect and underestimates the variability
recent systematic review on definitions of success in of the estimated result. Prolapse recurrence could have
pelvic organ prolapse surgery concluded that most occurred after withdrawal. By adding a time-to-event
studies on such surgery use definitions solely based analysis using Kaplan-Meier this bias was minimised.
on anatomical criteria.17 We included definitions Another limitation is the use of different types of sutures.

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Surgical failure apical compartment Overall anatomical failure

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Cumulative incidence 1.0
Vaginal hysterectomy
Sacrospinous hysteropexy
0.8

0.6

0.4
Hazard ratio (95% CI) = 0.43 (0.13 to 1.41) Hazard ratio (95% CI) = 0.95 (0.69 to 1.30)
P = 0.16 P = 0.77
0.2

Composite outcome of success Repeat surgery any compartment

1.0
Cumulative incidence

0.8

0.6

0.4
Hazard ratio (95% CI) = 0.82 (0.51 to 1.31) Hazard ratio (95% CI) = 0.33 (0.09 to 1.23)
P = 0.40 P = 0.09
0.2

0
0 1 2 3 4 5 0 1 2 3 4 5
Time (years) Time (years)
Fig 2 | Survival analysis to estimate the cumulative incidence of surgical failure of the apical compartment, overall anatomical failure, composite
outcome of success and repeat surgery in any compartment at five year follow-up after sacrospinous hysteropexy and vaginal hysterectomy with
uterosacral ligament suspension. *Cumulative incidence was number of events (%) that occurred during five year follow-up. Hazard ratios and
95% confidence intervals were calculated using Cox regression. (Top left) Recurrent apical prolapse stage ≥2 with bothersome symptoms or repeat
surgery for apical prolapse. (Top right) Pelvic organ prolapse quantification (POP-Q) stage ≥2 in any compartment. (Bottom left) No prolapse beyond
the hymen, no bothersome bulge symptoms and no repeat surgery or pessary use for recurrent prolapse. (Bottom right) Repeat surgery in any
compartment

Permanent sutures were used in the sacrospinous one used internationally in scientific research at this
hysteropexy procedure and delayed absorbable sutures moment. Overall, a clinically relevant worsening of
in uterosacral ligament suspension after vaginal cystoceles over time seems unlikely.
hysterectomy as this was the standard procedure in Finally, it was not possible to blind the independent
the participating hospitals at that time. This difference doctor or specialist nurse at follow-up to surgical
corresponds in general with the way both procedures intervention, because the cervix is present or absent in
are described in the literature. Currently, evidence is POP-Q. This is a limitation as it could lead to potential
unclear about which type of suture material is preferable bias.
(delayed absorbable versus permanent or a combination
of the two) and more research is needed on this topic. Comparison with other studies
In the sacrospinous hysteropexy group the proportion Other randomised studies evaluating uterus preserving
of women with anterior compartment anatomical surgery versus vaginal hysterectomy with apical
failure, defined as a stage 2 pelvic organ prolapse or suspension after long term follow-up are not available.
higher of the anterior vaginal wall, was greater after The risk of recurrent vaginal prolapse in a five year
12 months (47%) compared with the results at five retrospective cohort study was 20% after vaginal
year follow-up (40%). The most plausible explanation hysterectomy with uterosacral ligament suspension
seems to be interobserver and intraobserver variability. based on a composite outcome definition of any
The variability of the POP-Q score is, however, regarded anatomical prolapse beyond the hymen, or pessary,
as low and this scoring system is the only accepted or repeat surgery.20 The risk of recurrent surgery

Table 3 | Details for women with surgical failure of apical compartment at 60 months follow-up
Type of surgical failure by procedure Time after primary surgery (follow-up)
Sacrospinous hysteropexy:
  Repeat surgery for apical prolapse 28 months (5 years)
Vaginal hysterectomy:
  Repeat surgery for apical prolapse 27 months (5 years); 11 months (5 years); 10 months (48 months);
23 months (48 months)
  Recurrent apical prolapse with bothersome symptoms 48 months (5 years); 12 months (24 months); 24 months (24 months)
12 months (12 months)

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Table 4 | Functional outcome and quality of life after sacrospinous hysteropexy and vaginal hysterectomy of women

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included in extended trial at baseline and five year follow-up. Values are medians (interquartile ranges) of domain
scores unless stated otherwise
Before surgery 5 years after surgery
Sacrospinous Vaginal Sacrospinous Vaginal
Domains hysteropexy hysterectomy hysteropexy hysterectomy P value*
Urogenital distress inventory†:
  Overactive bladder 22 (0-44) 22 (0-33) 11 (0-22) 0 (0-19) 0.31
  Urinary incontinence 17 (0-33) 17 (0-33) 0 (0-17) 0 (0-17) 0.33
  Obstructive micturition 0 (0-33) 17 (0-33) 0 (0-17) 0 (0-17) 0.75
  Genital prolapse 50 (33-67) 67 (33-67) 0 (0-0) 0 (0-0) 0.50
 Pain 17 (0-33) 17 (0-33) 0 (0-8) 0 (0-17) 0.72
Defecatory distress inventory†:
 Obstipation 0 (0-17) 0 (0-17) 0 (0-0) 0 (0-0) 0.81
  Obstructive defecation 0 (0-17) 0 (0-15) 0 (0-8) 0 (0-8) 0.93
 Pain 0 (0-0) 0 (0-0) 0 (0-0) 0 (0-0) 0.60
 Incontinence 0 (0-0) 0 (0-0) 0 (0-0) 0 (0-0) 0.93
 Flatus 33 (0-33) 33 (0-33) 33 (0-33) 33 (0-33) 0.23
Incontinence impact questionnaire‡:
 Mobility 11 (0-33) 11 (0-22) 0 (0-11) 0 (0-11) 0.61
 Physical 0 (0-33) 0 (0-33) 0 (0-0) 0 (0-0) 0.32
 Social 11 (0-22) 0 (0-11) 0 (0-0) 0 (0-0) 0.49
 Embarrassment 0 (0-17) 0 (0-17) 0 (0-0) 0 (0-0) 0.43
 Emotion 0 (0-33) 0 (0-22) 0 (0-11) 0 (0-0) 0.18
Short form-36§:
  Physical functioning 80 (55-90) 80 (70-90) 90 (75-100) 90 (75-100) 0.71
  Social functioning 100 (75-100) 88 (75-100) 88 (75-100) 100 (88-100) 0.18
  Role limitations physical 75 (25-100) 100 (63-100) 100 (94-100) 100 (100-100) 0.99
  Role limitations emotional 100 (100-100) 100 (100-100) 100 (100-100) 100 (100-100) 0.62
  Mental health 84 (72-92) 84 (72-88) 80 (68-88) 84 (76-92) 0.18
 Vitality 70 (50-80) 70 (55-80) 70 (55-80) 75 (61-85) 0.07
  Bodily pain 78 (65-100) 80 (67-100) 90 (67-100) 100 (78-100) 0.39
  General health perception 75 (58-85) 75 (65-85) 75 (60-90) 75 (60-90) 0.72
  Health change 50 (25-50) 50 (50-50) 50 (50-50) 50 (50-50) 0.29
All women were analysed as allocated.
*P value for exploratory purposes: Mann-Whitney U test of sacrospinous hysteropexy versus vaginal hysterectomy at 5 years after surgery.
†0=no symptoms or not bothersome to 100=most bothersome symptoms.
‡0=best quality of life to 100=worst quality of life.
§0=worst quality of life to 100=best quality of life.

was 10%. Additional analysis of our data using this the procedures. Because of the low percentage of
definition confirmed this finding. The risk of recurrent surgical failure of the apical compartment we analysed
prolapse after vaginal hysterectomy with uterosacral the anatomical features of this compartment. We
ligament suspension was 20% (20/102 women). In the compared the level of the cervix or vaginal vault in
sacrospinous hysteropexy group this risk was lower relation to the hymen (POP-Q point C) at five year
(9%, 9/102 women, P=0.04). The risk of recurrent follow-up. Overall this was significantly lower after
surgery after vaginal hysterectomy was 9% (9/102 vaginal hysterectomy with uterosacral ligament
women) when we included women who had surgery for suspension compared with sacrospinous hysteropexy
recurrent pelvic organ prolapse or primary surgery for a (−5.9 cm v −7.2 cm, P=0.01). Women with posterior
prolapse in a non-treated compartment, or both. After vaginal wall prolapse stage 2 or higher after both types
sacrospinous hysteropexy this was 3% (3/102 women). of surgery had statistically significantly lower POP-Q
After five years we found more anatomical recurrences point C scores compared with women without posterior
of the posterior compartment after vaginal hysterectomy vaginal wall prolapse. Other anatomical differences
with suspension of the uterosacral ligaments, that could affect the posterior vaginal wall such as
although more posterior repairs were performed in preoperative and postoperative genital hiatus (distance
the vaginal hysterectomy group (50%) compared with between the external urethral meatus and posterior
sacrospinous hysteropexy group (29%). This finding midline hymen) were not found, and perineorrhaphy,
is in line with the results after 12 months’ follow-up. which can influence the genital hiatus, was not
Generally, it is believed that the more dorsal axis of the routinely performed in both procedures. After vaginal
vagina after sacrospinous hysteropexy might prevent hysterectomy, two thirds of the repeat surgeries were
recurrent prolapse of the posterior vaginal wall. This is, performed because of recurrent or de novo pelvic organ
however, speculative because the POP-Q system is not prolapse of the posterior compartment. The number
an appropriate instrument to show this change in axis, of women who underwent repeat surgery was overall
and studies with, for example, magnetic resonance low, however, and most recurrences were proximal to
imaging are lacking. Another possible explanation the hymen. The clinical significance of these findings is
could be the difference in apical suspension between therefore debatable.

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A recent published cohort study from Denmark More randomised trials comparing other uterus

BMJ: first published as 10.1136/bmj.l5149 on 10 September 2019. Downloaded from http://www.bmj.com/ on 24 September 2019 by guest. Protected by copyright.
showed that the highest risk for undergoing reoperation preserving surgical techniques are needed to compare
is within the first year.21 We found that 50% of the efficacy and safety of the different procedures. In the
reoperations were in the first year and 83% in the two Netherlands two large randomised controlled studies
years after primary surgery. Endometrial carcinoma comparing modified Manchester procedure with
was diagnosed in one woman during follow-up (1%) sacrospinous hysteropexy (trialregister.nl NTR 6978)
and she underwent laparoscopic hysterectomy. In most and laparoscopic hysteropexy with sacrospinous
cases, endometrial carcinoma presents with symptoms hysteropexy (trialregister.nl NTR 4029) have started.31
at a low stage, as was the case here. We believe that
future risk of malignancy should not be regarded as a Conclusions
valid reason for removal of the uterus before adequate We conclude that, based on results five years after
preoperative investigations have been done.6 surgery, sacrospinous hysteropexy is an effective
and safe alternative to vaginal hysterectomy with
Clinical implications and future research suspension of the uterosacral ligaments for treatment
Vaginal hysterectomy is still widely regarded as of uterine prolapse. Surgical failure, defined as
the ideal treatment for uterine prolapse. A recent recurrent apical prolapse with bothersome symptoms
survey among UK practitioners showed that vaginal or repeat surgery for recurrent apical prolapse, was
hysterectomy and repair is still the procedure of first less often found after uterus preservation, and the
choice (75%) for uterovaginal prolapse.22 Comparable proportion of women with successful treatment was
findings were described in a study from Australia and higher at five year follow-up. Overall anatomical
New Zealand.23 However, uterus preserving surgery failure, functional outcome, repeat surgery, and
is gaining popularity among doctors and women. A sexual functioning did not differ between the two
recent published study on trends in prolapse surgery procedures. Furthermore, time-to-event (survival)
in England found an increase in uterine sparing analysis at five years showed no differences in surgical
surgery.24 This trend is in line with a change in women’s failure of the apical compartment, overall anatomical
attitudes and preference for uterus preservation.25-27 failure, surgical retreatment, and composite outcome
On the other hand, in response to our previous report of success between sacrospinous hysteropexy
on the SAVE U study, some argued that the uterus is and vaginal hysterectomy with suspension of the
an atrophic, non-functional organ and that uterus uterosacral ligaments.
preservation on cultural or ideological grounds should We thank the staff at the study centres for assistance with follow-up of
be rejected.28 In our opinion this reflects a serious participants.
disregard of women’s attitudes and feelings. Although Contributors: All authors had full access to all of the data in the
vaginal hysterectomy is still the preferred treatment we study and take responsibility for the integrity of the data and the
accuracy of the data analysis. HWFvE and RJD conceived and designed
believe that the results of our study together with the
the study, obtained funding, provided administrative, technical, or
increasing knowledge of women’s preference will lead material support, and supervised the study. HWFvE and RJD are the
to better informed decision making by women and their guarantors. SFMS, JS, HWFvE, and RJD acquired the data. SFMS, JS,
JIH, KBK, HWFvE, and RJD analysed and interpreted the data. SFMS,
gynaecologists, in which sacrospinous hysteropexy is
JS, JIH, KBK, HWFvE, and RJD drafted the manuscript. SFMS, JS, JIH,
a valid option. KBK, HWFvE, and RJD critically revised the manuscript for important
A recent review discussed several variations in intellectual content. SFMS, JIH, and RJD did the statistical analysis. The
corresponding author attests that all listed authors meet authorship
technique of the sacrospinous hysteropexy.29 In
criteria and that no others meeting the criteria have been omitted.
our study the sutures were placed under direct
Funding: The SAVE U trial received an unrestricted grant from the Isala
vision through the sacrospinous ligament. Newer research foundation. The funder did not play any role in the design
disposable ligature carriers are used to facilitate and conduct of the study; in the collection, management, analysis, or
interpretation of the data; or in the preparation, review, or approval of
blind suture application using minimal dissection. A
the manuscript.
study comparing open sacrospinous colpopexy with
Competing interests: All authors have completed the ICMJE uniform
colpopexy using the Capio suture capturing device disclosure form at http://www.icmje.org/coi_disclosure.pdf and
(Boston Scientific, MA) in 86 women after hysterectomy declare: no support from any organisation for the submitted work;
reported no difference in objective and subjective no financial relationships with any organisations that might have an
interest in the submitted work in the previous three years, no other
success after three years.30 However, no randomised relationships or activities that could appear to have influenced the
trials are available that compare this device or other submitted work. HWFvE receives honorariums as trainer for Coloplast
suture capturing devices with open sacrospinous and BARD outside the submitted work.

hysteropexy, as performed in our study. Although Ethical approval: The study protocol was approved by the ethics
committees of the four participating centres.
suturing devices might be potentially beneficial for
Data sharing: No additional data available.
blood loss and duration of operation, they should
The study guarantor (RJD) affirms that the manuscript is an honest,
only be implemented after adequate clinical research. accurate, and transparent account of the study being reported;
The SAVE U study group consisted of women with No important aspects of the study have been omitted and any
POP-Q stage 2 and higher. The effect of sacrospinous discrepancies from the study as planned have been explained.

hysteropexy in a lower stage pelvic organ prolapse This is an Open Access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
still needs to be established, as well as the effect on a which permits others to distribute, remix, adapt, build upon this work
predominant cystocele or rectocele. non-commercially, and license their derivative works on different

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terms, provided the original work is properly cited and the use is non- 17  Kowalski JT, Mehr A, Cohen E, Bradley CS. Systematic review

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