Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial
Open accessAbstract
Objective: To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery. Design and setting: A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015–August 2016). Participants: Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment. Intervention: Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery. Outcome measures: The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial. Results: 325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use. Conclusions: A large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation. Trial registration number: ISRCTN46661996 .
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.
Integrity signals
Registry
Cites
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.
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 administration of preoperative oestrogen is widely practised, although there is little data to evidence benefit.
“The administration of preoperative oestrogen is widely practised, although there is little data to evidence benefit [24].”
From How Can We Improve the Assessment and Indifferent Outcomes From Pelvic Organ Prolapse Management From Conservative and Surgical Therapies? ICI‐RS 2025 (2026) · cites this paper as [24]
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
CONSORT 2010 statement: extension to randomised pilot and feasibility trials.
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016) · BMJ · doi:10.1136/bmj.i5239 · Cited by 3,404 · see citing works
CONSORT 2010 statement: extension to randomised pilot and feasibility trials
on behalf of the PAFS consensus group, Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016) · Pilot and Feasibility Studies · doi:10.1186/s40814-016-0105-8 · Cited by 2,843 · see citing works
Barber, M. D., Walters, M. D., & Bump, R. C. (2005) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2004.12.025 · Cited by 1,357 · see citing works
A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Rogers, R. G., Coates, K. W., KAMMERER-DOAK, D. N., Khalsa, S., & Qualls, C. (2003) · International Urogynecology Journal · doi:10.1007/s00192-003-1063-2 · Cited by 754 · see citing works
Haylen, B. T., Maher, C. F., Barber, M. D., Camargo, S., Dandolu, V., Digesu, A., Goldman, H. B., Huser, M., Milani, A. L., Moran, P. A., et al. (2016) · International Urogynecology Journal · doi:10.1007/s00192-015-2932-1 · Cited by 461 · see citing works
Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse
Srikrishna, S., Robinson, D., & Cardozo, L. (2009) · International Urogynecology Journal · doi:10.1007/s00192-009-1069-5 · Cited by 439 · see citing works
Haylen, B. T., Maher, C., Barber, M. D., Camargo, S., Dandolu, V., Digesu, G. A., Goldman, H. B., Hüser, M., Milani, A. L., Moran, P. A., et al. (2016) · Neurourology and Urodynamics · doi:10.1002/nau.22922 · Cited by 427 · see citing works
Glazener, C. M., Breeman, S., Elders, A., Hemming, C., Cooper, K. G., Freeman, R. M., Smith, A. R., Reid, F., Hagen, S., Montgomery, I., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(16)31596-3 · Cited by 259 · see citing works
Remodeling of Vaginal Connective Tissue in Patients With Prolapse
Moalli, P., Shand, S. H., Zyczynski, H. M., Gordy, S. C., & Meyn, L. A. (2005) · Obstetrics and Gynecology · doi:10.1097/01.aog.0000182584.15087.dd · Cited by 233 · see citing works
The vaginal epithelium in the postmenopause — cytology, histology and pH as methods of assessment
Nilsson, K., Risberg, B. Å., & Heimer, G. M. (1995) · Maturitas · doi:10.1016/0378-5122(94)00863-3 · Cited by 160 · see citing works
Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
Blatch-Jones, A. J., Pek, W., Kirkpatrick, E., & Ashton-Key, M. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-022233 · Cited by 139 · see citing works
Oestrogens for treatment or prevention of pelvic organ prolapse in postmenopausal women
Ismail, S. I. M. F., Bain, C., & Hagen, S. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007063.pub2 · Cited by 122 · see citing works
Felding, C., Mikkelsen, A. L., Clausen, H. V., et al. (1992) · Maturitas · doi:10.1016/0378-5122(92)90208-l · Cited by 49 · see citing works
Karp, D. R., Jean‐Michel, M., Johnston, Y., et al. (2012) · Urogynecology · doi:10.1097/spv.0b013e31825e6401 · Cited by 48 · see citing works
Histologic and Cytologic Effects of Vaginal Estrogen in Women With Pelvic Organ Prolapse
Vaccaro, C. M., Mutema, G. K., Fellner, A. N., Crisp, C. C., Estanol, M. V., Kleeman, S. D., & Pauls, R. N. (2013) · Urogynecology · doi:10.1097/spv.0b013e318278cc40 · Cited by 32 · see citing works
Clinical Effects of Preoperative Oestradiol Treatment before Vaginal Repair Operation
Mikkelsen, A. L., Felding, C., & Clausen, H. V. (2010) · Gynecologic and Obstetric Investigation · doi:10.1159/000292320 · Cited by 25 · see citing works
Verghese, T. S., Leighton, L., DANIELS, J. P., et al. (2017) · ics.org · Cited by 1 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Rahn, D. D., Richter, H. E., Sung, V. W., Pruszynski, J. E., & Hynan, L. S. (2023) · JAMA · doi:10.1001/jama.2023.12317 · Cited by 28 · see citing works
Impact of Lifestyle Modifications on the Prevention and Treatment of Pelvic Organ Prolapse
Jeppson, P. C., Balgobin, S., Wheeler, T., Forner, L., Caagbay, D., Thompson, J., Muffly, T. M., Meyer, I., Beestrum, M., Collins, S., et al. (2025) · International Urogynecology Journal · doi:10.1007/s00192-024-05992-0 · Cited by 8 · see citing works
Kearney, R., Wagg, A., Bower, W., Chapple, C., Khullar, V., Robinson, D., Taithongchai, A., Hobson, P. T., Wein, A., & Abrams, P. (2026) · Neurourology and Urodynamics · doi:10.1002/nau.70272 · Cited by 1 · see citing works
- Authors
- Verghese, T. S., Middleton, L., Cheed, V., Leighton, L., Daniels, J., & Latthe, P. M.
- Affiliations
- University of Birmingham (GB)
- University of Nottingham (GB)
- Birmingham Women’s and Children’s NHS Foundation Trust (GB)
- Corresponding author
- Verghese, Tina Sara
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2020-09
- Volume
- 10
- Issue
- 9
- Pages
- e025141
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC7485245
- OpenAlex
- W3085404464
- Cited by
- 11
- References
- 17
- Citations by year
- 2026: 3 · 2024: 1 · 2023: 4 · 2022: 1 · 2021: 2
- FWCI
- 1.32
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMJ Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- HighWire Press Open Archive (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- Funders
- National Institute for Health Research (PB-PG-0213-30126)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Keywords
- postmenopausal women, pelvic organ prolapse, pelvic organ prolapse surgery, trial feasibility, medication adherence, recurrent pelvic organ prolapse
- MeSH terms
- Aged, Estrogens, Feasibility Studies, Female, Humans, Middle Aged, Pilot Projects, Postmenopause, 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
