Trial reportBMC cancer2021
Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.
Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Prevention and management of radiotherapy-related toxicities in gynecological malignancies. Position paper on behalf of AIRO (Italian Association of Radiotherapy and Clinical Oncology).La Radiologia medica · 2024Guideline
- Post Treatment Sexual Function and Quality of Life of Patients Affected by Cervical Cancer: A Systematic Review.Medicina (Kaunas, Lithuania) · 2023Pooled it
- Vaginal dilator therapy for pelvic cancer patients: a review.Gynecologic oncology reports · 2026Review
- Evidence-based supportive care for patients undergoing radiotherapy: Recommendations from the updated German national S3 guideline for oncological patients.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026Article
- The effectiveness of a 3-dimensional printed vaginal dilator in mitigating radiation-induced vaginal stenosis for patients with cervical cancer.Journal of gynecologic oncology · 2026Article
- Clinical practice guidelines: sexual dysfunction in gynecological cancer patients.Sexual medicine · 2025Review
- From diagnosis to survivorship addressing the sexuality of women during cancer.The oncologist · 2024Review
- Inadvertent Intrauterine Instillation of Trichloroacetic Acid During Sonohysterography.Cureus · 2024Article
- Vulvovaginal Atrophy Following Treatment for Oncogynecologic Pathologies: Etiology, Epidemiology, Diagnosis, and Treatment Options.Medicina (Kaunas, Lithuania) · 2024Review
- Laser Therapy in Heavily Treated Oncological Patients Improves Vaginal Health Parameters.Cancers · 2024Article
- Integration of Ultrasound in Image-Guided Adaptive Brachytherapy in Cancer of the Uterine Cervix.Bioengineering (Basel, Switzerland) · 2024Review
- Effects of neoadjuvant chemotherapy combined with radical laparoscopic surgery with quality nursing care on clinical efficacy and sex hormones in patients with cervical cancer.American journal of translational research · 2024Article
- Modern approach to the management of genitourinary syndrome in women with gynecological malignancies.Radiology and oncology · 2023Review
- Article
- Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
backgroundWe aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer.
methodsopen-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression.
resultsthe mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37).
conclusionsthere was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment.
trial registrationBrazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.