The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE)
Open accessAbstract
Objectives: To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair. Methods: Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence. Results: Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit. Conclusions: This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.
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This study was a planned ancillary analysis of a randomized superiority trial (NCT02431897).
“This was a planned ancillary analysis of a randomized superiority trial (NCT02431897), the design of which and primary outcome report have been previously published.7,8”
From Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair (2024) · cites this paper as [7]
The Methods identify IMPROVE as NCT02431897, and the Primary Outcome Measure section describes a randomized trial designed to test superiority over placebo. This design paper does not establish that the citing study was a planned ancillary analysis; it also does not report the trial’s primary outcome. (LLM, conf=0.86)
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Barber, M. D., Brubaker, L., Burgio, K. L., Richter, H. E., Nygaard, I., Weidner, A. C., Menefee, S. A., Lukacz, E. S., Norton, P., Schaffer, J., et al. (2014) · JAMA · doi:10.1001/jama.2014.1719 · Cited by 428
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Research works printed but not linked: 26
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- 2001, The effect of estradiol vaginal tablet and conjugated estrogen cream on urogenital symptoms in postmenopausal women: a comparative study, J Obstet Gynaecol Res, 27, 255, 10.1111/j.1447-0756.2001.tb01266.x · DOI
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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
Self-citationCharacteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair
Rahn, D. D., Richter, H. E., Sung, V. W., Hynan, L. S., & Pruszynski, J. E. (2024) · Obstetrics & Gynecology · doi:10.1097/aog.0000000000005478 · Cited by 7
“7,8 IMPROVE (Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen) aimed to determine whether perioperative use of vaginal estrogen cream, compared with placebo, would improve tissue quality in postmenopausal patients with prolapse and affect recurrence rates after surgical…”
BackgroundSelf-citation
Metadata
- Authors
- Rahn, D. D., Richter, H. E., Sung, V. W., Larsen, W. I., & Hynan, L. S.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- University of Alabama at Birmingham (US)
- Brown University (US)
- Baylor Scott & White Medical Center - Temple (US)
- Corresponding author
- Rahn, David D.
- Venue
- Female Pelvic Medicine & Reconstructive Surgery
- Published
- 2021-01
- Volume
- 27
- Issue
- 1
- Pages
- e227-e233
- ISSN
- 2151-8378 (ISSN-L)
- 2154-4212
- PMC
- PMC7769931
- OpenAlex
- W3035633436
- Cited by
- 6
- References
- 1
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 4
- FWCI
- 0.75
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Urogynecology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Aging (R01AG047290)
- Topics
- Health Sciences › Medicine › Urology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
- Keywords
- apical vaginal prolapse, prolapse recurrence, postmenopausal women, pelvic organ prolapse, vaginal atrophy, quality of life, sexual function, body image, medication adherence
- MeSH terms
- Double-Blind Method, Estrogens, Female, Humans, Gynecologic Surgical Procedures, Vagina, Vaginal Creams, Foams, and Jellies, Randomized Controlled Trials as Topic, Pelvic Organ Prolapse, Preoperative Period
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