Vaginal Application Research Articles

Efficacy of Honey Vaginal Application on A Wide Scale of Patients with Dyspareunia

Efficacy of Honey Vaginal Application on A Wide Scale of Patients with Dyspareunia

In vivo effect of vaginal seminal plasma application on the human endometrial transcriptome: a randomized controlled trial.

Studies in humans and animals suggest that seminal plasma, the acellular seminal fluid component, stimulates the endometrium to promote immune tolerance and facilitate implantation. We designed a randomized, double-blinded, placebo-controlled trial to investigate changes in the endometrial transcriptomic profile after vaginal application of seminal plasma. The study participants were randomized into two groups. Five women received a vaginal application of seminal plasma, and four received a placebo application with saline solution. The application was performed 2 days after HCG-triggered ovulation in an unstimulated cycle. After 5-8 days, an endometrial biopsy was collected to analyze differences in the endometrial transcriptomic profile using microarray analyses. A differential gene expression analysis and a gene set analysis were performed. The gene set enrichment analysis showed a positive enrichment of pathways associated with the immune response, cell viability, proliferation, and cellular movement. Moreover, pathways involved in implantation, embryo development, oocyte maturation, and angiogenesis were positively enriched. The differential gene expression analysis, after adjusting for multiple testing, showed no significantly differentially expressed genes between the two groups. A comparative analysis was also performed with similar studies conducted in other animals or in vitro using human endometrial cells. The comparative analysis showed that the effect of seminal plasma effect on the endometrium is similar in pigs, mice, and in vitro human endometrial cells. The present study provides evidence that seminal plasma might impact the endometrium during the implantation window, with potential to affect endometrial receptivity and embryo development.

Laser and Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial.

Pelvic floor muscle training (PFMT) is considered the first option as a conservative treatment for female stress urinary incontinence (SUI). However, there is still debate whether energy-based devices are effective for treating SUI. The objective of this study was to assess whether PFMT and fractional CO2 laser therapy may improve symptoms in women with SUI. A parallel, randomized, nonblinded, noninferiority trial included 94 of 144 women 18 years or older with SUI randomized into 2 groups. The CO2 laser group (n = 47) received 3 vaginal applications at monthly intervals. The PFMT group (n = 47) underwent 2 weekly sessions. Primary outcome was the mean difference of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI-SF) total scores between groups after 3 and 6 months. Main secondary outcomes were questionnaires for assessment of pelvic floor symptoms (Pelvic Floor Impact Questionnaire-Short Form 7 [PFIQ-7]), sexual function (Female Sexual Function Index [FSFI]), and improvement after treatment (Patient Global Impression of Improvement [PGI-I]). A reduction in the ICIQ-UI-SF total score, PFIQ total score, and the Urinary Impact Questionnaire score was perceived between baseline and 3-6 months in both groups. CO2 laser did not reach the noninferiority margin when compared with PFMT in both follow-up periods and analyses. Pelvic floor muscle training has improved the FSFI desire domain between baseline and 3-6 months, whereas CO2 laser improved the FSFI orgasm, pain, and total score after 3 months and FSFI orgasm and total score after 6 months. PGI-I assessment has shown an improvement in both groups. Fractional CO2 laser therapy was noninferior to PFMT after 3-6 months of treatment. Both groups presented a reduction in the ICIQ-UI-SF scores, and both methods could be considered for women with SUI.

Methods of mathematical planning of the experiment and their use in the development of the composition of the ointment with essential oil thymus vulgaris l. For vaginal application

One of the most important pharmaceutical factors is excipients, their nature and quantity, which increase the pharmacological activity and safety of APIs by creating dosage forms that are optimal in composition, properties, and type, and/or by changing the chemical modification of the molecule responsible for the pharmacological effect of the active substance. Variability or variation in the number of excipients and the use of different excipients with the same intended functionality can complicate the release rate and bioavailability of drugs. The use of mathematical methods at the stage of the experiment planning reduces the total number of experiments and at the same time provides reliable results. Aim. To study the most used types of mathematical planning of the experiment, and select the most acceptable model for developing the optimal composition of a vaginal ointment with the thyme (Thymus vulgaris L.) essential oil. Results and discussions. To develop the optimal composition of the ointment, 10 bases containing various excipients (factor A) and 6 excipients as an emulsifier (factor B) were used. The concentration of the thyme essential oil was 5 % in all samples. The degree of thymol release in the in vitro study using the equilibrium dialysis method was chosen as the criterion for choosing the optimal composition. The selection of excipients for the development of a soft dosage form was carried out using the method of the a priori ranking since both bases and emulsifiers were selected as the most widely used in the pharmaceutical technology, with known characteristics, safety profile, application experience. Conclusions. The degree of influence of each factor has been determined, and the series of Duncan’s test have been constructed for each factor – by factor a: а3 > а5 > а4 > а6 > а2 > а8 > а7 > а10 > а9> а1, and by factor b: b2 > b3 > b5 > b4 > b6 > b1. Based on the mathematical planning of the experiment, an ointment base and an emulsifier for developing the composition of a vaginal gel with the thyme oil have been determine.

Physicochemical characterization of a lycopene‐loaded mesoporous silica nanoparticle formulation

AbstractLycopene (LYC), a carotenoid extracted mainly from tomatoes, has several biological properties, making its use desirable as a nutraceutical and pharmaceutical active ingredient. Among its various applications vulvovaginal candidiasis stands out. However, the use of LYC in therapy has limitations related to its solubility and stability. In this study, mesoporous silica nanoparticles (MSNs) are used to load and protect LYC from degradation. The exact amount of drug incorporated was determined by analytical techniques, such as high‐performance liquid chromatography (HPLC) and thermal analysis. For this, we developed and validated an HPLC method for LYC quantification and evaluated LYC impregnation in MSNs, followed by thermogravimetry analysis (TGA). Differential scanning calorimetry (DSC) was also used in order to confirm drug incorporation. Additionally, an in vitro release study in simulated vaginal fluid was also carried out. The HPLC method was duly validated for the range of 26–125 µg mL−1 and proved to be suitable for LYC quantification. DSC measurements suggest an improvement in the stability of the impregnated drug, which was reinforced by the release assay. Overall, the developed method is suitable to quantify LYC‐loaded porous materials enabling its use in vaginal applications.

Chitosan-(poly)acrylic acid polyelectrolyte complexes: Enhanced mucoadhesion and sustained drug release in vaginal tablets

Polyelectrolyte complexes (PECs) have emerged as promising vehicles for medical applications, attributable to their non-toxicity, non-immunogenicity, and ability for controlled drug release. Notably, their inherent mucoadhesive properties are being leveraged for sustained drug delivery across mucosal barriers, including vaginal, ocular, nasal, and buccal membranes. This study delves into the formulation and effects of chitosan-(poly)acrylic acid-based PEC for vaginal tablet applications. A comparative analysis of various polymer combinations was conducted, emphasizing the differential impacts of low versus high-molecular weight chitosan. Results highlighted that PECs augmented the flowability of powder mixtures and bolstered the tablets' physical properties. Moreover, PEC-enhanced formulations exhibited a pronounced increase in swelling efficiency, with swelling index values reaching up to 92.67 % ± 1.90, ensuring structural integrity during dissolution. In ex vivo mucoadhesion tests, tablets from PEC mixes demonstrated extended adhesion, surpassing 48 h for certain formulations. The optimized PEC formulation successfully achieved sustained drug release while retaining tablet adhesion for the duration of the release period.

Development and verification of mechanistic vaginal absorption and metabolism model to predict systemic exposure after vaginal ring and gel application.

The current work describes the development of mechanistic vaginal absorption and metabolism model within Simcyp Simulator to predict systemic concentrations following vaginal application of ring and gel formulations. Vaginal and cervix physiology parameters were incorporated in the model development. The study highlights the model assumptions including simulation results comparing systemic concentrations of 5 different compounds, namely, dapivirine, tenofovir, lidocaine, ethinylestradiol and etonogestrel, administered as vaginal ring or gel. Due to lack of data, the vaginal absorption parameters were calculated based on assumptions or optimized. The model uses release rate/in vitro release profiles with formulation characteristics to predict drug mass transfer across vaginal tissue into the systemic circulation. For lidocaine and tenofovir vaginal gel, the predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits. The average fold error (AFE) and absolute AFE indicating bias and precision of predictions range from 0.62 to 1.61. For dapivirine, the pharmacokinetic parameters are under and overpredicted in some studies due to lack of formulation composition details and relevance of release rate used in ring model. The predicted to observed AUC0-t and Cmax ratios were well within 2-fold error limits for etonogestrel and ethinylestradiol vaginal ring (AFEs and absolute AFEs from 0.84 to 1.83). The current study provides first of its kind physiologically based pharmacokinetic framework integrating physiology, population and formulation data to carry out in silico mechanistic vaginal absorption studies, with the potential for virtual bioequivalence assessment in the future.

Design and development of additivemanufactured multi-channel brachytherapy applicators for cancer treatment

Additive manufacturing (AM) is emerging as an effective manufacturing technology that benefits the medical field with its ease of quickly realizing complex designs. Brachytherapy is a process to cure cancer patients through a high dose rate of gamma radiation. This work aimed at AM-based development of multi-channel vaginal and penile brachytherapy applicators for selectively treating cancer cells in a direction sideways to the applicator rather than the uniform radiation dose possible around the conventional applicator used in cancer treatment. An analytical model was proposed to predict the maximum surface temperature on applicators during Ir-192 source radiation. Also, the predicted values of multi-physics-based finite element method simulation were experimentally validated using a thermal imaging camera. Thermal imaging is a non-contact measurement that is found superior to the brachytherapy scale to position radioactive sources inside the applicator. Experimentally examined multi-channel applicator shows dosimetry advantage in effective radiation control and shows promise of curing cancerous cells with minimal effects on normal cells.

Intensity-modulated vaginal brachytherapy applicator and single- and multi-channel applicators in vaginal cuff brachytherapy.

To compare the dosimetric performance of vaginal intensity-modulated brachytherapy (IM-BRT) applicator and single- (SC-BRT) and multi-channel brachytherapy (MC-BRT) applicators for vaginal cuff brachytherapy (VC-BRT). Fifteen patients with uterine-confined endometrium cancer who received adjuvant VC-BRT were included in this study. IM-BRT, SC-BRT, and MC-BRT treatment plans were created for two different clinical target volume (CTV) definitions: 1. Standard CTV, called CTVs; and 2. Virtually defined CTV, called CTVv, with asymmetrical tumor extension > 5 mm in thickness. Plan comparison was performed using dose-volume histogram (DVH) and treatment planning parameters. According to DVH analysis, D98 for CTVv and D2 for both CTVs and CTVv showed statistically significant differences between IM-BRT and SC-BRT plans, but there was no significant difference between IM-BRT and MC-BRT plans in terms of D98 and D2 for both CTVs and CTVv. Additionally, for CTVv plans, IM-BRT was found to be significantly superior to SC-BRT for the rectum (D2cc, V5Gy, and V7Gy), bladder (D2cc and V7Gy), and small bowel (D2cc, V5Gy, and V7Gy). On the other hand, DVH parameters of the sigmoid showed large difference between IM-BRT and SC-BRT plans, but it was not statistically significant. Similarly, the use of IM-BRT applicator demonstrated a noticeable dose reduction in all defined OARs when compared with MC-BRT applicator, but statistically significant for the rectum V7Gy (p = 0.03) only. While the IM-BRT applicator is still in pre-clinical phase, our investigation demonstrated the proof-of-concept in real patient treatment plans with promising dosimetric results compared with SC-BRT and MC-BRT plans in selected patient group.

Comparison of Misoprostol for Labor Induction: Vaginal Insert Versus Oral Application Concerning Efficiency and Safety.

The aim of the present retrospective study was to examine the efficiency and safety of the induction of labor with Misoprostol, administered either vaginally or orally. This retrospective cohort study included pregnant women with a gestational age of ≥36 +0 weeks and a singleton pregnancy who underwent induction of labor with Misoprostol as vaginal insert or as tablet (oral) between January 2014 and January 2019 at the Department of Obstetrics and Gynecology of the University Hospital of Cologne. The objective of this study was to analyze the time until delivery and the maternal and neonatal outcomes. A total of 1,511 patients were included in this retrospective analysis, of whom 1,035 patients (68.5%) underwent induction of labor with a misoprostol vaginal insert (MVI) and 476 (31.5%) with tablets (oral misoprostol: OM). MVI significantly shortened the time from application to delivery (p<0.001) in comparison to OM, reduced the need for epidural anesthesia (EA) (p=0.018) without an increase in caesarean sections (CS) (p=1), ventouse deliveries (VD) (p=0.715), maternal birth injuries or a reduced neonatal outcome (APGAR-Score, umbilical cord pH). MVI is superior to OM in terms of efficiency (primary outcome: time from application to delivery) and is equally safe (primary outcome: CS rate). Our study, along with existing literature, highlights the need for further research, particularly regarding neonatal outcomes. Additionally, it underscores the importance of careful consideration when inducing labor and ensuring informed consent.

Xanthan-carrageenan film containing sesame seed oil: A nanocomposite pharmaceutical platform for trichomoniasis treatment

Trichomoniasis is a common sexually transmitted infection that poses significant complications for women. Challenges in treatment include adverse effects and resistance to standard antimicrobial agents. Given this context, a sesame seed oil nanoemulsion (SONE) was developed and showed anti-Trichomonas vaginalis activity. To facilitate the local application of SONE, a polysaccharide film was developed using xanthan gum (XG) and κ-carrageenan gum (CG). A blend of XG and CG (at 2 %, ratio 1:3) plasticized with glycerol produced a more promising film (XCF) than using the gums individually. The film containing SONE (SONE-XCF) was successfully obtained by replacing the aqueous solvent with SONE via solvent evaporation technique. The hydrophilic SONE-XCF exhibited homogeneity and suitable mechanical properties for vaginal application. Furthermore, SONE-XCF demonstrated mucoadhesive properties and high absorption capacity for excessive vaginal fluids produced in vaginitis. It also had a disintegration time of over 8 h, indicating long retention at the intended site of action. Hemolysis and chorioallantoic membrane tests confirmed the safety of the film. Therefore, SONE-XCF is a biocompatible film with a natural composition and inherent activity against T. vaginalis, possessing exceptional characteristics that make it appropriate for vaginal application, offering an interesting alternative for trichomoniasis treatment.

Evaluating dose distributions of high dose rate 60Co brachytherapy in an asymmetric tumor: A comparison of different designs of vaginal cylindrical applicators

The aim of this study is to evaluate organ-at-risk (OAR) doses obtained from different designs of intracavitary cylinder applicators during high-dose-rate (HDR) brachytherapy of an asymmetric vaginal tumor. Dose distributions around five cylinder applicators were obtained using the Geant4 toolkit. Three of these applicators are commercially available: single-channel, multi-channel, and shielded. Additionally, two proposed sub-configurations were evaluated: (I) a combination of the multichannel applicator with a central shield and (II) a dynamically modulated cylinder (DMC). The dose distributions of the proposed applicators were compared to those of the single-channel cylinder applicator. The results showed that using a cylindrical applicator with a higher degree of freedom in plan optimization can improve OAR, sparing up to 60% for the rectum and 20% for the bladder. In conclusion, this work suggests using a new design of a cylindrical applicator to enhance the therapeutic ratio of brachytherapy for asymmetric and irregularly shaped vaginal tumors.

Assessment of Live Lactobacilli Recovery from Probiotic Products for Vaginal Application

The interest in the use of probiotics to treat and prevent vaginal infections is known. The new regulation of medical devices by the European Medical Agency (EMA) introduced big changes in Europe regarding probiotic products for vaginal application, as they are no longer considered as medical devices. As the future classification will be as drugs, it will stress the need to define robust and reliable pre-clinical in vitro testing in order to assess the quality, safety and efficacy of probiotics for human use. Before discussing the efficacy in human pathology, it is mandatory to evaluate the survival and multiplication potential of probiotic strains when brought into contact with vaginal fluid. In this work, our objective was to assess the recovery and stability profile of lactobacilli from six vaginal probiotic formulations brought in contact with specific culture media or vaginal fluid simulants (VFS). Overall, the recovery of viable lactobacilli cells from a modified vaginal fluid simulant (MVFS) solution was comparable to the recovery pattern obtained in standard culture medium. Therefore, we conclude that the MVFS seems to better simulate the conditions of the human vaginal fluid, in contrast with other simulants, and may be used to predict the viability of probiotics over time in the normal vaginal milieu. We discovered that each probiotic product has a unique profile that requires stand-alone studies in conditions that mimic the in vivo status in order to assess their preclinical effectiveness and promote their differential use by the medical community.

Mucosal application of the broadly neutralizing antibody 10-1074 protects macaques from cell-associated SHIV vaginal exposure

Passive immunization using broadly neutralizing antibodies (bNAbs) is investigated in clinical settings to inhibit HIV-1 acquisition due to the lack of a preventive vaccine. However, bNAbs efficacy against highly infectious cell-associated virus transmission has been overlooked. HIV-1 transmission mediated by infected cells present in body fluids likely dominates infection and aids the virus in evading antibody-based immunity. Here, we show that the anti-N-glycans/V3 loop HIV-1 bNAb 10-1074 formulated for topical vaginal application in a microbicide gel provides significant protection against repeated cell-associated SHIV162P3 vaginal challenge in non-human primates. The treated group has a significantly lower infection rate than the control group, with 5 out of 6 animals fully protected from the acquisition of infection. The findings suggest that mucosal delivery of potent bnAbs may be a promising approach for preventing transmission mediated by infected cells and support the use of anti-HIV-antibody-based strategies as potential microbicides in human clinical trials.

Vaginal Application of K-Y Gel During Labor in Nulliparous, Term Pregnant Women: A Case Control Study

Vaginal Application of K-Y Gel During Labor in Nulliparous, Term Pregnant Women: A Case Control Study

Antibiotics therapy combined with probiotics administered intravaginally for the treatment of bacterial vaginosis: A systematic review and meta-analysis.

The objective was to examine the pooled effects of antibiotic-probiotic combinations by examining the cure rate and recurrence rate for bacterial vaginosis (BV). A systematic literature search was conducted from electronic databases. All parallel randomized controlled trials (RCTs) that focused on the effects of antibiotics combined with intravaginal probiotics were included. Cure rate and recurrence rate were the primary and secondary outcomes to be analyzed. Meta-analysis was conducted following the Cochrane handbook for Systematic Reviews of Interventions. As a result, of 923 studies identified, 11 articles involving 1,493 BV patients met the inclusion criteria and nine were available for meta-analysis. A meta-analysis of two studies evaluated the recurrence rate 12-16 weeks after treatment. Results showed a statistically significant difference favoring the antibiotics plus probiotics group vs the antibiotics plus placebo group (relative risk 0.62, 95% confidence interval [CI]: 0.45-0.85). The narrative review in one study indicated that the cure rate was higher in the antibiotics plus probiotics group, giving a significant HR ratio of 0.73 (95% CI 0.54-0.98) (p = 0.042). In conclusion, vaginal application of Lactobacillus in combination with antibiotics for the treatment of BV could be a promising method for both reducing the recurrence rate and relieving symptoms of BV.

Imiquimod-Loaded Chitosan-Decorated Di-Block and Tri-Block Polymeric Nanoparticles Loaded In Situ Gel for the Management of Cervical Cancer.

Cervical intraepithelial neoplasia, the predisposing factor for cervical cancer (CC), is caused by human papillomavirus (HPV) infection and can be treated with imiquimod (IMQ). However, poor water solubility and side effects such as local inflammation can render IMQ ineffective. The aim of this study is to design a prolonged release nano system in combination with mucoadhesive-thermosensitive properties for an effective vaginal drug delivery. Polylactic-co-glycolic acid (PLGA), polycaprolactone (PCL), poly lactide-co-caprolactone (PLA-PCL), and poly L-lactide-co-caprolactone-co-glycolide (PLGA-PCL) were used to create IMQ nanoparticles. Chitosan (CS) was then added to the surfaces of the IMQ NPs for its mucoadhesive properties. The NPs were then incorporated into poloxamer hydrogels. The NPs' size and morphology, encapsulation efficiency (EE), in vitro drug release, gel characterization, ex vivo drug permeation, and in vitro safety and efficacy were characterized. Two batches of NPs were prepared, IMQ NPs and CS-coated NPs (CS-IMQ NPs). In general, both types of NPs were uniformly spherical in shape with average particle sizes of 237.3 ± 4.7 and 278.2 ± 5.4 nm and EE% of 61.48 ± 5.19% and 37.73 ± 2.88 for IMQ NPs and CS-IMQ NPs, respectively. Both systems showed prolonged drug release of about 80 and 70% for IMQ NPs and CS-IMQ NPs, respectively, within 48 h. The gelation temperatures for the IMQ NPs and CS-IMQ NPs were 30 and 32 °C, respectively; thus, suitable for vaginal application. Although ex vivo permeability showed that CS-IMQ NPs showed superior penetration compared to IMQ NPs, both systems enhanced drug penetration (283 and 462 µg/cm2 for IMQ NPs and CS-IMQ NPs, respectively) relative to the control (60 µg/cm2). Both systems reduced the viability of cervical cancer cells, with a minimal effect of the normal vaginal epithelium. However, IMQ NPs exhibited a more pronounced cytotoxic effect. Both systems were able to reduce the production of inflammatory cytokines by at least 25% in comparison to free IMQ. IMQ and CS-IMQ NP in situ gels enhanced stability and drug release, and improved IMQ penetration through the vaginal tissues. Additionally, the new systems were able to increase the cytotoxic effect of IMQ against CC cells with a reduction in inflammatory responses. Thus, we believe that these systems could be a good alternative to commercial IMQ systems for the management of CC.

PO04: A Novel Ergonomic Vaginal Applicator (EVA)

PO04: A Novel Ergonomic Vaginal Applicator (EVA)

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair

Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. ClinicalTrials.gov Identifier: NCT02431897.

Non-operative management involving chemoradiation therapy combined with high-dose-rate brachytherapy for T3 rectal cancer using a vaginal shielded cylindrical applicator: a technical report.

It has been shown that a group of rectal cancer patients will achieve a pathological complete response following preoperative chemoradiotherapy, and non-operative management has recently gained attention. To escalate the tumour dose and increase the likelihood of pathological complete response, brachytherapy can play an important role in safely increasing the total dose. However, at the time this report was published, an applicator dedicated to rectal brachytherapy was unaffordable in Japan. Here, we report two T3 rectal cancer patients who were inoperable or refused surgery and treated by chemoradiotherapy following intracavitary brachytherapy involving a vaginal cylinder applicator with lead shielding.