CoChat
Sign Up
Cited by 9Pelvic floor disorders treatmentsUterine Myomas and TreatmentsReproductive Health and Contraception

Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study

Open access
Scime, Natalie V, Ramage, Kaylee, Brennand, Erin A·2021·BMJ Open
DOI 10.1136/bmjopen-2021-053679PMC PMC8491422
Open this paper in CoChat — free accountOpen PDF

Abstract

Introduction: Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a long-standing practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision making by patients and their healthcare providers. The objective of this study is to evaluate POP-specific health outcomes and service utilisation of women electing uterine suspension compared with those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year postsurgery. Methods and analysis: This is a prospective cohort study planning to enrol 321 adult women with stage ≥2 POP from multiple sites in Alberta, Canada. Following standardised counselling from study surgeons, participants self-select either a hysterectomy based or uterine preservation surgical group. Data are being collected through participant questionnaires, medical records and administrative data linkage at four time points spanning from the presurgical consultation to 1-year postsurgery. The primary outcome is anatomic failure to correct POP, and secondary outcomes include changes in positioning of pelvic structures, retreatment, subjective report of bulge symptoms, pelvic floor distress and impact, sexual function and health service use. Data will be analysed using inverse probability weighting of propensity scores and generalised linear models. Ethics and dissemination: This study is approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB19-2134). Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, and educational handouts for patients. Trial registration number: NCT04890951.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1136/bmjopen-2021-053679

Cites

10 of 10 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The study protocol was registered and approved by the Conjoint Health Research Ethics Board at the University of Calgary.

    “The study protocol 35 was registered (https:// clinicaltrials.gov/study/NCT04890951)and approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB19-2134).36”

    From Hysterectomy versus uterine preservation for pelvic organ prolapse surgery: a prospective cohort study (2025) · cites this paper as [36]

  • A target sample size of 321 was estimated to provide 80% power to detect a 15% group difference for the primary outcome of anatomic recurrence at 1 year, assuming 15% recurrence in the hysterectomy group, 35% of patients selecting UP surgery, and 20% attrition.

    “A target sample size of 321 was estimated to provide 80% power to detect a 15% group difference for the primary outcome of anatomic recurrence at 1 year, assuming 15% recurrence in the hysterectomy group, 35% of patients selecting UP surgery, and 20% attrition.36”

    From Hysterectomy versus uterine preservation for pelvic organ prolapse surgery: a prospective cohort study (2025) · cites this paper as [36]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 43

  1. [1]Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet 2007; 369: 1027– 38. 10.1016/S0140-6736(07)60462-0 17382829 · DOI
  2. [2]Ellerkmann RM, Cundiff GW, Melick CF, et al. Correlation of symptoms with location and severity of pelvic organ prolapse. Am J Obstet Gynecol 2001; 185: 1332– 8. 10.1067/mob.2001.119078 11744905 · DOI
  3. [5]Ai F, Deng M, Mao M, et al. Depressive symptoms screening in postmenopausal women with symptomatic pelvic organ prolapse. Menopause 2018; 25: 314– 9. 10.1097/GME.0000000000001006 29040216 · DOI
  4. [6]Ai F, Deng M, Mao M, et al. Screening for general anxiety disorders in postmenopausal women with symptomatic pelvic organ prolapse. Climacteric 2018; 21: 35– 9. 10.1080/13697137.2017.1392502 29095064 · DOI
  5. [7]Lowder JL, Ghetti C, Nikolajski C, et al. Body image perceptions in women with pelvic organ prolapse: a qualitative study. Am J Obstet Gynecol 2011; 204: 441.e1– 441.e5. 10.1016/j.ajog.2010.12.024 21292234 · DOI
  6. [8]Zielinski R, Miller J, Low LK, et al. The relationship between pelvic organ prolapse, genital body image, and sexual health. Neurourol Urodyn 2012; 31: 1145– 8. 10.1002/nau.22205 22473490 PMC3394912 · DOI
  7. [9]Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J 2013; 24: 1783– 90. 10.1007/s00192-013-2169-9 24142054 · DOI · Paper page
  8. [10]Wu JM, Vaughan CP, Goode PS, et al. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol 2014; 123: 141– 8. 10.1097/AOG.0000000000000057 24463674 PMC3970401 · DOI
  9. [11]Abdel-Fattah M, Familusi A, Fielding S, et al. Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study. BMJ Open 2011; 1: e000206– 10. 10.1136/bmjopen-2011-000206 PMC3221293 22102637 · DOI · Paper page
  10. [12]Smith FJ, Holman C D'Arcy J, Moorin RE, et al. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol 2010; 116: 1096– 100. 10.1097/AOG.0b013e3181f73729 20966694 · DOI · Paper page
  11. [13]Ridgeway BM. Does prolapse equal hysterectomy? the role of uterine conservation in women with uterovaginal prolapse. Am J Obstet Gynecol 2015; 213: 802– 9. 10.1016/j.ajog.2015.07.035 26226554 · DOI · Paper page
  12. [14]Chen I, Lisonkova S, Allaire C, et al. Routes of hysterectomy in women with benign uterine disease in the Vancouver coastal health and Providence health care regions: a retrospective cohort analysis. CMAJ Open 2014; 2: E273– 80. 10.9778/cmajo.20130080 PMC4251519 25485254 · DOI
  13. [15]Anglim B, O'Sullivan O, O'Reilly B. How do patients and surgeons decide on uterine preservation or hysterectomy in apical prolapse? Int Urogynecol J 2018; 29: 1075– 9. 10.1007/s00192-018-3685-4 29947819 · DOI · Paper page
  14. [16]Blandon RE, Bharucha AE, Melton LJ, et al. Incidence of pelvic floor repair after hysterectomy: a population-based cohort study. Am J Obstet Gynecol 2007; 197: 664.e1– 664.e7. 10.1016/j.ajog.2007.08.064 18060973 PMC2562278 · DOI · Paper page
  15. [17]Meriwether KV, Antosh DD, Olivera CK, et al. Uterine preservation vs hysterectomy in pelvic organ prolapse surgery: a systematic review with meta-analysis and clinical practice guidelines. Am J Obstet Gynecol 2018; 219: 129– 46. 10.1016/j.ajog.2018.01.018 29353031 · DOI · Paper page
  16. [18]Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials 2009; 10: 1– 9. 10.1186/1745-6215-10-37 19493350 PMC2700087 · DOI
  17. [19]Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer 2014; 110: 551– 5. 10.1038/bjc.2013.725 24495873 PMC3915111 · DOI
  18. [20]Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet 2005; 365: 82– 93. 10.1016/S0140-6736(04)17670-8 15639683 · DOI · Paper page
  19. [21]Kennedy-Martin T, Curtis S, Faries D, et al. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials 2015; 16: 1– 14. 10.1186/s13063-015-1023-4 26530985 PMC4632358 · DOI · Paper page
  20. [22]van IJsselmuiden MN, Detollenaere RJ, Gerritse MBE, et al. Dutch women's attitudes towards hysterectomy and uterus preservation in surgical treatment of pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol 2018; 220: 79– 83. 10.1016/j.ejogrb.2017.11.016 29175132 · DOI
  21. [25]Houlihan S, Kim-Fine S, Birch C, et al. Uterosacral vault suspension (USLS) at the time of hysterectomy: laparoscopic versus vaginal approach. Int Urogynecol J 2019; 30: 611– 21. 10.1007/s00192-018-3801-5 30393822 · DOI
  22. [26]Mowat A, Wong V, Goh J, et al. A descriptive study on the efficacy and complications of the Capio (Boston scientific) suturing device for sacrospinous ligament fixation. Aust N Z J Obstet Gynaecol 2018; 58: 119– 24. 10.1111/ajo.12720 28940223 · DOI
  23. [27]Leone Roberti Maggiore U, Alessandri F, Remorgida V, et al. Vaginal sacrospinous colpopexy using the Capio suture-capturing device versus traditional technique: feasibility and outcome. Arch Gynecol Obstet 2013; 287: 267– 74. 10.1007/s00404-012-2540-y 22941353 · DOI
  24. [29]Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 2005; 193: 103– 13. 10.1016/j.ajog.2004.12.025 16021067 · DOI · Paper page
  25. [31]Rogers RG, Rockwood TH, Constantine ML, et al. A new measure of sexual function in women with pelvic floor disorders (PFD): the pelvic organ Prolapse/Incontinence sexual questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J 2013; 24: 1091– 103. 10.1007/s00192-012-2020-8 23632798 · DOI
  26. [32]Globerman D, Robert M. Heterogeneity in post-intervention prolapse and urinary outcome reporting: a one-year review of the International Urogynecology Journal. Int Urogynecol J 2015; 26: 1373– 8. 10.1007/s00192-015-2720-y 25944659 · DOI · Paper page
  27. [33]Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009; 114: 600– 9. 10.1097/AOG.0b013e3181b2b1ae 19701041 PMC2904469 · DOI · Paper page
  28. [34]Guralnick ML, Fritel X, Tarcan T, et al. Ics educational module: cough stress test in the evaluation of female urinary incontinence: introducing the ICS-Uniform cough stress test. Neurourol Urodyn 2018; 37: 1849– 55. 10.1002/nau.23519 29926966 · DOI
  29. [35]Brennand EA, Wu G, Houlihan S, et al. Two intraoperative techniques for midurethral sling Tensioning: a randomized controlled trial. Obstet Gynecol 2020; 136: 471– 81. 10.1097/AOG.0000000000004027 32769657 PMC7431154 · DOI
  30. [36]Barber MD, Spino C, Janz NK, et al. The minimum important differences for the urinary scales of the pelvic floor distress inventory and pelvic floor impact questionnaire. Am J Obstet Gynecol 2009; 200: 580.e1– 580.e7. 10.1016/j.ajog.2009.02.007 19375574 PMC2680021 · DOI · Paper page
  31. [37]Mamik MM, Rogers RG, Qualls CR, et al. The minimum important difference for the pelvic organ Prolapse-Urinary incontinence sexual function questionnaire. Int Urogynecol J 2014; 25: 1321– 6. 10.1007/s00192-014-2342-9 24562789 · DOI
  32. [39]Ross S, Robert M, Swaby C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence: a randomized controlled trial. Obstet Gynecol 2009; 114: 1287– 94. 10.1097/AOG.0b013e3181c2a151 19935032 · DOI
  33. [41]Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 2008; 111: 891– 8. 10.1097/AOG.0b013e31816a2489 18378748 · DOI
  34. [42]Gutman RE, Rardin CR, Sokol ER, et al. Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study. Am J Obstet Gynecol 2017; 216: 38.e1– 38.e11. 10.1016/j.ajog.2016.08.035 27596620 · DOI
  35. [44]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. 10.1136/bmj.h3717 26206451 PMC4512203 · DOI · Paper page
  36. [45]Brennand EA, Kim-Fine S. A randomized clinical trial of how to best position retropubic slings for stress urinary incontinence: development of a study protocol for the mid-urethral sling tensioning (must) trial. Contemp Clin Trials Commun 2016; 3: 60– 4. 10.1016/j.conctc.2016.04.004 29736458 PMC5935876 · DOI
  37. [46]Brennand EA, Tang S, Birch C, et al. Early voiding dysfunction after midurethral sling surgery: comparison of two management approaches. Int Urogynecol J 2017; 28: 1515– 26. 10.1007/s00192-017-3302-y 28285398 · DOI
  38. [47]Robert M, Girard I, Brennand E, et al. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstet Gynecol 2014; 123: 288– 94. 10.1097/AOG.0000000000000105 24402595 · DOI
  39. [48]Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med 2015; 34: 3661– 79. 10.1002/sim.6607 26238958 PMC4626409 · DOI · Paper page
  40. [50]Payet C, Polazzi S, Obadia J-F, et al. High-Dimensional propensity scores improved the control of indication bias in surgical comparative effectiveness studies. J Clin Epidemiol 2021; 130: 78– 86. 10.1016/j.jclinepi.2020.10.003 33065165 · DOI
  41. [52]Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine — reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357: 2189– 94. 10.1056/NEJMsr077003 18032770 · DOI · Paper page
  42. [53]Groenwold RHH, Donders ART, Roes KCB, et al. Dealing with missing outcome data in randomized trials and observational studies. Am J Epidemiol 2012; 175: 210– 7. 10.1093/aje/kwr302 22262640 · DOI · Paper page
  43. [54]Centers for Disease Control and Prevention (CDC). Trends in aging—United States and worldwide. MMWR Morb Mortal Wkly Rep 2003; 52: 101– 6. 12645839

Cited by

Sorted by citations

Authors
Scime, N. V., Ramage, K., & Brennand, E. A.
Affiliations
University of Calgary (CA)
Corresponding author
Brennand, Erin A
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2021-10
Volume
11
Issue
10
Pages
e053679
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2021-053679
PMC
PMC8491422
OpenAlex
W3204635080
Cited by
9
References
10
Citations by year
2026: 1 · 2025: 1 · 2024: 1 · 2023: 3 · 2022: 2 · 2021: 1
FWCI
1.32
Type
journal article
Language
en
Open access
Licence
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • Canadian Institutes of Health Research (No grant number)
  • M.S.I. Foundation (No grant number)
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
Keywords
pelvic organ prolapse, hysterectomy, uterine preservation, vaginal vault suspension, apical prolapse, surgical decision-making, health care utilization, sexual function, pelvic floor symptoms, retreatment
MeSH terms
Aged, 80 and over, Alberta, Female, Humans, Hysterectomy, Prospective Studies, Gynecologic Surgical Procedures, Uterine Prolapse, Vagina, Cohort Studies, Treatment Outcome, Pelvic Organ Prolapse

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review