Rectal sensitivity correlated with gastrointestinal-mediated glucose disposal, but not the incretin effect.

OBJECTIVE: The mechanisms behind the diminished incretin effect in type 2 diabetes are uncertain, but impaired vagal transmission has been suggested. We aimed to investigate the association between the incretin effect and autonomic neuropathy, and the degree of dysglycaemia and duration of diabetes. DESIGN AND METHODS: For a cross-sectional study, we included participants with either longstanding type 2 diabetes, recent onset, untreated diabetes and controls without diabetes matched for age, sex and body mass index. Autonomic nerve function was assessed with cardiovascular reflex tests, heart rate variability and sudomotor function. Visceral afferent nerves in the gut were tested performing rapid rectal balloon distention. An oral glucose tolerance test and an intravenous isoglycaemic glucose infusion were performed to calculate the incretin effect and gastrointestinal-mediated glucose disposal (GIGD). RESULTS: Sixty-five participants were recruited. Participants with diabetes had rectal hyposensitivity for earliest sensation (3.7 ± 1.1 kPa in longstanding, 4.0 ± 1.3 in early), compared to controls (3.0 ± 0.9 kPa), p = .005. Rectal hyposensitivity for earliest sensation was not associated with the incretin effect (rho = -0.204, p = .106), but an association was found with GIGD (rho -0.341, p = .005). Incretin effect and GIGD were correlated with all glucose values, HbA1c and duration of diabetes. CONCLUSIONS: Rectal hyposensitivity was uncovered in both longstanding and early type 2 diabetes, and was not associated with the incretin effect, but with GIGD, implying a potential link between visceral neuropathy and gastrointestinal handling of glucose. Both the incretin effect and GIGD were associated with the degree of dysglycaemia and the duration of diabetes. PREVIOUSLY PUBLISHED: Some of the data have previously been published and presented as a poster on the American Diabetes Association 83rd Scientific Sessions: Meling et al; 1658-P: Rectal Hyposensitivity, a Potential Marker of Enteric Autonomic Nerve Dysfunction, Is Significantly Associated with Gastrointestinally Mediated Glucose Disposal in Persons with Type 2 Diabetes. Diabetes 20 June 2023; 72 (Supplement_1): 1658-P. https://doi.org/10.2337/db23-1658-P.

Application of rectal balloon ice water stimulation for the rehabilitation of stroke patients with neurogenic bowel dysfunction.

BACKGROUND: Neurogenic bowel dysfunction (NBD) is a common complication in stroke patients. OBJECTIVE: To investigate the effect of rectal balloon ice water stimulation on the rehabilitation of patients with NBD after a cerebral stroke. METHODS: Forty stroke patients with NBD were selected between March and August 2022 and randomly divided into a study group (n = 20) and a control group (n = 20). Based on routine rehabilitation training, rectal balloon ice water stimulation or finger rectal stimulation were performed on the study or control group, respectively. After two weeks, the changes in the NBD, self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores were compared between the two groups. RESULTS: Before the intervention, there were no significant differences in age, sex ratio, and NBD, SDS and SAS scores between the two groups (p > 0.05). The NBD, SDS and SAS scores of both groups were significantly decreased following intervention (p < 0.05). After 2 weeks of intervention, the NBD score of the study group was significantly lower than that of the control group (5.50±1.28 vs 6.45±1.05; p = 0.014). The SDS score of the study group was lower than that of the control group, and the difference was statistically significant (32.30±2.81 vs 44.05±2.19; p = 0.014). The study group also had significantly lower SAS scores than the control group (p = 0.024). In addition, the incidence of dizziness, headaches, nausea, vomiting and abdominal pain and distension in the study group was significantly lower than in the control group (p < 0.05). CONCLUSION: Rectal balloon ice water stimulation can significantly improve stroke patients with NBD's intestinal function and psychological status.

Focal salvage high-dose-rate brachytherapy with implantable rectum spacer for locally recurrent prostate cancer after initial low-dose-rate with grade 3 rectal toxicity.

Purpose: Locally recurrent prostate cancer after previous radiation therapy remains challenging. One of the curative options for these patients is salvage brachytherapy. There are no reports available on the use of a biodegradable rectal balloon implantation (RBI) in combination with brachytherapy in patients with recurrent prostate cancer after previous radiotherapy. Case presentation: Here, we report on a patient with a local recurrence at five years after previous low-dose-rate brachytherapy with a prescribed dose of 145 Gray (Gy) for a low-risk prostate adenocarcinoma. The patient experienced grade 3 rectal toxicity, which was resolved at the time of local recurrence. He was treated with focal high-dose-rate (HDR) brachytherapy of 2 fr. × 13 Gy after RBI implantation. Four years post-salvage treatment, there was no evidence of biochemical recurrence according Phoenix definition, and no gastro-intestinal or genitourinary toxicity. Conclusions: This case describes the use of RBI implantation in combination with a focal salvage HDR in a patient with recurrent disease, with significant initial grade 3 rectal toxicity after previous irradiation. The use of a biodegradable RBI proved to be a promising solution for such a patient; however, this method needs to be further investigated.

The PanGut-study: Evoked potentials following rectal balloon distention, a way of evaluating diabetic autonomic neuropathy in the gut?

AIM: There is a lack of methods for investigating the autonomic nerves of the gastrointestinal tract. Our aim was to explore a novel test measuring visceral sensory evoked potentials (EPs) in response to rapid balloon distention in the rectum and compare it to established tests for diabetic neuropathy. METHOD: Participants with longstanding type 2 diabetes, newly onset, untreated diabetes <1 year, and matched controls, were included. Tests included cardiovascular reflex tests, orthostatic blood pressure, electrical skin conductance assessment, sural nerve testing and monofilament test. The rectal balloon distention pressure at earliest sensation and threshold of unpleasantness were identified and used to elicit mechanical EPs. RESULTS: The pressure at earliest sensation was higher in people with diabetes, 0.038 (0.012) bar vs. controls 0.030 (0.009) bar, p = 0.002, and in people with signs of peripheral neuropathy, 0.045 (0.014) bar, p < 0.01. Clinical correlations between EP amplitude and latency, and other tests were found. CONCLUSIONS: Rectal hyposensitivity was associated with both longstanding and early diabetes, indicating enteric sensory dysfunction already in early stages of diabetes. Correlation analyses may indicate that central afferent processing is affected in parallel with peripheral neuronal function.

Use of a Biodegradable, Contrast-Filled Rectal Spacer Balloon in Intensity-Modulated Radiotherapy for Intermediate-Risk Prostate Cancer Patients: Dosimetric Gains in the BioPro-RCMI-1505 Study.

BACKGROUND/PURPOSE: Dose-escalated external beam radiotherapy (RT) is effective in the control of prostate cancer but is associated with a greater incidence of rectal adverse events. We assessed the dosimetric gain and safety profile associated with implantation of a new biodegradable rectal spacer balloon. MATERIALS/METHODS: Patients scheduled for image-guided, intensity-modulated RT for intermediate-risk prostate cancer were prospectively included in the French multicenter BioPro-RCMI-1505 study (NCT02478112). We evaluated the dosimetric gain, implantation feasibility, adverse events (AEs), and prostate-cancer-specific quality of life associated with use of the balloon spacer. RESULTS: After a scheduled review of the initial recruitment target of 50 patients by the study's independent data monitoring committee (IDMC), a total of 24 patients (including 22 with dosimetry data) were included by a single center between November 2016 and May 2018. The interventional radiologist who implanted the balloons considered that 86% of the procedures were easy. 20 of the 24 patients (83.3%) received IMRT and 4 (16.7%) received volumetric modulated arc therapy (78-80 Gy delivered in 39 fractions). The dosimetric gains associated with spacer implantation were highly significant (p<0.001) for most variables. For the rectum, the median (range) relative gain ranged from 15.4% (-9.2-47.5) for D20cc to 91.4% (36.8-100.0) for V70 Gy (%). 15 patients (62%) experienced an acute grade 1 AE, 8 (33%) experienced a late grade 1 AE, 1 (4.2%) experienced an acute grade 2 AE, and 3 experienced a late grade 2 AE. No grade 3 AEs were reported. Quality of life was good at baseline (except for sexual activity) and did not markedly worsen during RT and up to 24 months afterwards. CONCLUSION: The use of a biodegradable rectal spacer balloon is safe, effective and associated with dosimetric gains in modern RT for intermediate-risk prostate cancer.

Prospective switch study comparing two irrigation systems for transanal irrigation in children.

BACKGROUND AND STUDY AIMS: Transanal irrigation (TAI) is used in children to treat constipation and incontinence. Belgium has 2 systems available: Colotip® (cheaper, however not designed for TAI) or Peristeen®. PATIENTS AND METHODS: This patient-control switch study is the first to compare 2 TAI systems. Children regularly using Colotip® for TAI were asked to participate, after consent, a visual analogue scale (VAS) rating the system and a 2-week diary (fecal continence, self-reliance, time spent on the toilet, pain, Bristol stool scale, irrigation volume and frequency of enema) were completed. Non-parametric statistics were used. RESULTS: Out of 26 children using Colotip®, 18 (69%) children participated and 5 refused (fear n=1, satisfaction Colotip® system n=7). Of these 18 children (interquartile range: 3-18 years, median 12.5 years, 9 girls) 5 patients stopped Peristeen® (pain n=1, fear n=1 and balloon loss n=3) and 2 were lost from follow up. Dropouts and included patients showed no statistical difference. In the 11 remaining patients, pseudo-continence (p 0.015), independence (p 0.01) and VAS score (p 0.007) were significantly better with Peristeen®, no difference was found in time spent on the toilet (p 0.288) and presence of pain (p 0.785). CONCLUSIONS: In children Peristeen® offered significantly higher pseudo-continence and independency. 30% refused participation because of satisfaction with the Colotip® and 30% spina bifida patients reported rectal balloon loss due to sphincter hypotony. To diminish Peristeen® failure, a test-catheter could be of value. Considering Colotip® satisfaction, both systems should be available. Patient selection for Peristeen® needs further research.

A comparative study of prostate PTV margins for patients using hydrogel spacer or rectal balloon in proton therapy.

PURPOSE: To compare the planning target volume (PTV) margins needed for prostate patients who have used hydrogel spacer or rectal balloon during proton treatments. METHOD: Total of 190 prostate patients treated with proton therapy during 2017 were selected for this study. Of these patients, 96 had hydrogel spacer injection and 94 patients had only rectal balloons insertion. All patients had implanted gold markers inside the prostate for daily target alignment. Post-treatment radigraphs were obtained to evaluate prostate intrafraction motion. The systematic and random components of patient setup residual error and prostate intrafraction motion error were obtained. PTV margins were calculated using the van Herk formula for both patient groups. RESULTS: For setup residual error, the mean values in the superior-inferior (SI) direction and the variances in the left-right (LR) direction were statistically different between the two groups. For intrafraction motion, there were significant differences of the mean values in the SI direction and of the variances in both LR and anterior-posterior (AP) directions. The population PTV margins for hydrogel spacer group were 2.6 mm, 3.3 mm, and 1.6 mm in LR, SI, AP directions, respectively. For the rectal balloon group, the PTV margins were 2.1 mm, 3.1 mm, and 2.0 mm in LR, SI, AP directions, respectively. CONCLUSION: Statistically significant differences were observed in the patient setup and prostate intrafraction motion errors of the two patient groups. However, under the current protocol of bladder preparation and daily marker-based x-ray image-guidance, population PTV margins were comparable between the two patient groups.

Comparative safety and efficacy of balloon use in air enema reduction for pediatric intussusception.

BACKGROUND: Intussusception, a common cause of bowel obstruction in young children, is primarily treated with air enema reduction. There is little literature comparing the safety and efficacy of air reduction without or with a rectal balloon. OBJECTIVE: To determine the safety and efficacy of a rectal balloon seal in air enema reduction. MATERIALS AND METHODS: We retrospectively reviewed the records of children who underwent air reduction for ileocolic or ileo-ileocolic intussusception over an 8-year period. We sorted data from 566 children according to whether a rectal balloon was used in the reduction, and further sorted them by type and experience level of the practitioner. Using logistic regression analyses, we identified risk factors for iatrogenic bowel perforation or failed reduction. RESULTS: Significant associations with bowel perforation included balloon use (P=0.038), age <1 year (P<0.0001), and attending physician's level of experience <5 years (P=0.043). Younger age was associated with both perforation (P<0.0001) and procedural failure (P=0.001). The risk-adjusted predicted probability of perforation decreased with age, approaching zero by 10 months regardless of balloon use. For cases without bowel resection, the risk-adjusted predicted probability of failure decreased toward zero by 30 months with balloon use, while remaining constant at 3-12% regardless of age when not using a balloon. CONCLUSION: The likelihood of a successful air reduction might be safely increased by using an inflated rectal balloon in children older than 9 months. Use of a balloon in younger infants is associated with a higher risk of iatrogenic bowel injury.

Rectal balloon use limits vaginal displacement, rectal dose, and rectal toxicity in patients receiving IMRT for postoperative gynecological malignancies.

Pelvic radiotherapy for gynecologic malignancies traditionally used a 4-field box technique. Later trials have shown the feasibility of using intensity-modulated radiotherapy (IMRT) instead. But vaginal movement between fractions is concerning when using IMRT due to greater conformality of the isodose curves to the target and the resulting possibility of missing the target while the vagina is displaced. In this study, we showed that the use of a rectal balloon during treatment can decrease vaginal displacement, limit rectal dose, and limit acute and late toxicities. Little is known regarding the use of a rectal balloon (RB) in treating patients with IMRT in the posthysterectomy setting. We hypothesize that the use of an RB during treatment can limit rectal dose and acute and long-term toxicities, as well as decrease vaginal cuff displacement between fractions. We performed a retrospective review of patients with gynecological malignancies who received postoperative IMRT with the use of an RB from January 1, 2012 to January 1, 2015. Rectal dose constraint was examined as per Radiation Therapy Oncology Group (RTOG) 1203 and 0418. Daily cone beam computed tomography (CT) was performed, and the average (avg) displacement, avg magnitude, and avg magnitude of vector were calculated. Toxicity was reported according to RTOG acute radiation morbidity scoring criteria. Acute toxicity was defined as less than 90 days from the end of radiation treatment. Late toxicity was defined as at least 90 days after completing radiation. Twenty-eight patients with postoperative IMRT with the use of an RB were examined and 23 treatment plans were reviewed. The avg rectal V40 was 39.3% ± 9.0%. V30 was65.1% ± 10.0%. V50 was 0%. Separate cone beam computed tomography (CBCT) images (n = 663) were reviewed. The avg displacement was as follows: superior 0.4 + 2.99 mm, left 0.23 ± 4.97 mm, and anterior 0.16 ± 5.18 mm. The avg magnitude of displacement was superior/inferior 2.22 ± 2.04 mm, laterally 3.41 ± 3.62 mm, and anterior/posterior 3.86 ± 3.45 mm. The avg vector magnitude was 6.60 ± 4.14 mm. For acute gastrointestinal (GI) toxicities, 50% experienced grade 1 toxicities and 18% grade 2 GI toxicities. For acute genitourinary (GU) toxicities, 21% had grade 1 and 18% had grade 2 toxicities. For late GU toxicities, 7% had grade 1 and 4% had grade 2 toxicities. RB for gynecological patients receiving IMRT in the postoperative setting can limit V40 rectal dose and vaginal displacement. Although V30 constraints were not met, patients had limited acute and late toxicities. Further studies are needed to validate these findings.

A biodegradable rectal balloon implant to protect the rectum during prostate cancer radiotherapy for a patient with active Crohn's disease.

BACKGROUND: Radiotherapy in patients with active inflammatory bowel disease (IBD) is usually considered an absolute exclusion criterion for prostate cancer radiotherapy treatment.There are no reports available on the use of a biodegradable rectal balloon implantation (RBI) in patients with active IBD for prostate cancer radiotherapy. CASE PRESENTATION: We report on a patient with high-risk prostate cancer with the comorbidity of an active IBD with pancolitis location. He was treated with neo-adjuvant hormonal therapy and high-dose external beam radiotherapy to the prostate and the seminal vesicles. Before radiotherapy treatment, a biodegradable RBI was implanted between the prostate and the anterior rectal wall to push the rectum outside of the high-dose area. This patient at high-risk for rectal toxicity was successfully irradiated to his prostate with only a grade I urinary toxicity, no acute rectal toxicity or toxicity flare of the IBD. CONCLUSIONS: This case describes the use of a RBI implantation in patients with active IBD for prostate cancer radiotherapy. The use of a biodegradable RBI proved to be a promised solution for such patients, and have to be further investigated.

Dosimetric comparison of rectal-sparing capabilities of rectal balloon vs injectable spacer gel in stereotactic body radiation therapy for prostate cancer: lessons learned from prospective trials.

This study aimed to compare the rectal-sparing capabilities of rectal balloons vs absorbable injectable spacer gel in stereotactic body radiation therapy (SBRT) for prostate cancer. Patient samples included in this analysis were obtained from 2 multi-institutional prospective trials of SBRT for prostate cancer using a rectal balloon (n = 36 patients) and injectable spacer gel (n = 36). Treatment prescription dose was 45 Gy in 5 fractions in 42 patients; for equal comparison, the remaining 30 patients were rescaled to 45 Gy from 47.5 Gy prescription (n = 6) and 50 Gy prescription (n = 24). The median prostate volumes and body mass index in the 2 patient samples were not statistically significantly different (p= 0.67 and 0.45, respectively), supporting anatomic similarity between cohorts. The injectable spacer gel achieved dosimetric superiority over the rectal balloon with respect to the maximum dose to the rectum (42.3 vs 46.2 Gy, p < 0.001), dose delivered to 33% of the rectal circumference (28 vs 35.1 Gy, p < 0.001), and absolute volume of rectum receiving 45 Gy (V45Gy), V40Gy, and V30Gy (0.3 vs 1.7 cc, 1 vs 5.4 cc, and 4.1 vs 9.6 cc, respectively; p < 0.001 in all cases). There was no difference between the 2 groups with respect to the V50Gy of the rectum or the dose to 50% of the rectal circumference (p= 0.29 and 0.06, respectively). The V18.3Gy of the bladder was significantly larger with the rectal balloon (19.9 vs 14.5 cc, p= 0.003). In this analysis of patients enrolled on 2 consecutive multi-institutional prospective trials of SBRT for prostate cancer, the injectable spacer gel outperformed the rectal balloon in the majority of the examined and relevant dosimetric rectal-sparing parameters. The rectal balloon did not outperform the injectable spacer gel in any measured rectal dose parameter.

Methods of Evaluation of Anorectal Causes of Obstructed Defecation.

Obstructed defecation is a complex disorder that results in impaired propagation of stool from the rectum. It is one of the major subtypes of functional constipation and can be secondary to either functional or anatomic etiologies. Patients with obstructed defecation typically present with symptoms of abdominal discomfort, a sensation of incomplete evacuation and rectal obstruction, passage of hard stools, the need for rectal or vaginal digitation, excessive straining, and reduced stool frequency. Evaluation of obstructed defecation is multimodal, starting with a thorough history and physical examination with focus on the abdominal, perineal, and rectal examination. Additional modalities to elicit the diagnosis of obstructed defecation include proctoscopy, colonic transit time studies, anorectal manometry, a rectal balloon expulsion test, defecography, electromyography, and ultrasound. The results from these studies should be taken in the context of each patient's clinical situation, as there is no single criterion standard for the diagnosis of obstructed defecation. Surgery is typically a last resort for these patients and the majority of patients will have good symptomatic management with diet and lifestyle changes. Patients who are found to have functional mechanisms behind their obstructed defecation also benefit from pelvic floor exercises and biofeedback therapy.

Open prostatectomy with a rectal balloon: A new technique to control postoperative blood loss.

OBJECTIVES: To evaluate a new technique, the rectal balloon (RB), to control blood loss after transvesical prostatectomy (TVP). PATIENTS AND METHODS: Over 2 years 100 patients were prospectively randomised into two equal groups. All patients underwent TVP for their benign prostatic hyperplasia but a RB (a balloon fixed to a three-way Foley catheter tip by a plaster strip, making it airtight) was used in group 2. The RB was placed in the rectum opposing the prostate and inflated (pressure controlled) for 15 min. Haemoglobin levels were assessed before and after TVP. Blood transfusion, the amount of saline used for irrigation, duration of catheterisation, hospital stay, and rectal complaints were recorded. Patients were followed up at 1 and 3 months after TVP. RESULTS: The enucleated adenoma weight was 102 g in group 1 and 106 g in group 2. There was a significant difference between groups 1 and 2 in haemoglobin loss within the first 24 h after TVP, and in total loss, of 0.9 g and 0.2 g (P = 0.008), and 1.9 g and 1 g (P = 0.001), respectively. There was also a significant difference between the groups in the saline volume used for irrigation (11.4 vs. 2.5 L), catheter duration (5.7 vs. 4.3 days), and hospital stay (6.2 vs. 5.1 days), favouring group 2. Blood transfusions were needed in four patients in group 1 and one in group 2. There were no rectal complaints. CONCLUSION: The use of an inflated RB after TVP is a simple and safe procedure with no specific operative technique, that reduces postoperative blood loss, the incidence of blood transfusion, the volume of saline for irrigation, and shortens the catheterisation period and hospital stay, with no rectal complications.

Treatment outcome of localized prostate cancer by 70 Gy hypofractionated intensity-modulated radiotherapy with a customized rectal balloon.

PURPOSE: We aimed to analyze the treatment outcome and long-term toxicity of 70 Gy hypofractionated intensity-modulated radiotherapy (IMRT) for localized prostate cancer using a customized rectal balloon. MATERIALS AND METHODS: We reviewed medical records of 86 prostate cancer patients who received curative radiotherapy between January 2004 and December 2011 at our institution. Patients were designated as low (12.8%), intermediate (20.9%), or high risk (66.3%). Thirty patients received a total dose of 70 Gy in 28 fractions over 5 weeks via IMRT (the Hypo-IMRT group); 56 received 70.2 Gy in 39 fractions over 7 weeks via 3-dimensional conformal radiotherapy (the CF-3DRT group, which served as a reference for comparison). A customized rectal balloon was placed in Hypo-IMRT group throughout the entire radiotherapy course. Androgen deprivation therapy was administered to 47 patients (Hypo-IMRT group, 17; CF-3DRT group, 30). Late genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated according to the Radiation Therapy Oncology Group criteria. RESULTS: The median follow-up period was 74.4 months (range, 18.8 to 125.9 months). The 5-year actuarial biochemical relapse-free survival rates for low-, intermediate-, and high-risk patients were 100%, 100%, and 88.5%, respectively, for the Hypo-IMRT group and 80%, 77.8%, and 63.6%, respectively, for the CF-3DRT group (p < 0.046). No patient presented with acute or late GU toxicity ≥grade 3. Late grade 3 GI toxicity occurred in 2 patients (3.6%) in the CF-3DRT group and 1 patient (3.3%) in the Hypo-IMRT group. CONCLUSION: Hypo-IMRT with a customized rectal balloon resulted in excellent biochemical control rates with minimal toxicity in localized prostate cancer patients.

[Prostate-rectum spacers: optimization of prostate cancer irradiation]. / Spacers entre prostate et rectum : optimisation des techniques d'irradiation du cancer de la prostate.

In the curative radiotherapy of localized prostate cancer, improvements in biochemical control observed with dose escalation have been counterbalanced by an increase in radiation-induced toxicity. The injection of biodegradable spacers between prostate and rectum represents a new frontier in the optimization of radiotherapy treatments for patients with localized disease. Transperineal injection of different types of spacers under transrectal ultrasound guidance allows creating a 7-to-20 mm additional space between the prostate and the anterior rectal wall lasting 3 to 12 months. Dosimetrically, a relative reduction in the rectal volume receiving at least 70 Gy (V70) in the order of 43% to 84% is observed with all types of spacers, regardless of the radiotherapy technique used. Preliminary clinical results show for all spacers a good tolerance and a possible reduction in the acute side effects rate. The aim of the present systematic review of the literature is to report on indications as well as dosimetric and clinical advantages of the different types of prostate-rectum spacers commercially available (hydrogel, hyaluronic acid, collagen, biodegradable balloon).

Treatment outcome of localized prostate cancer by 70 Gy hypofractionated intensity-modulated radiotherapy with a customized rectal balloon

PURPOSE: We aimed to analyze the treatment outcome and long-term toxicity of 70 Gy hypofractionated intensity-modulated radiotherapy (IMRT) for localized prostate cancer using a customized rectal balloon. MATERIALS AND METHODS: We reviewed medical records of 86 prostate cancer patients who received curative radiotherapy between January 2004 and December 2011 at our institution. Patients were designated as low (12.8%), intermediate (20.9%), or high risk (66.3%). Thirty patients received a total dose of 70 Gy in 28 fractions over 5 weeks via IMRT (the Hypo-IMRT group); 56 received 70.2 Gy in 39 fractions over 7 weeks via 3-dimensional conformal radiotherapy (the CF-3DRT group, which served as a reference for comparison). A customized rectal balloon was placed in Hypo-IMRT group throughout the entire radiotherapy course. Androgen deprivation therapy was administered to 47 patients (Hypo-IMRT group, 17; CF-3DRT group, 30). Late genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated according to the Radiation Therapy Oncology Group criteria. RESULTS: The median follow-up period was 74.4 months (range, 18.8 to 125.9 months). The 5-year actuarial biochemical relapse-free survival rates for low-, intermediate-, and high-risk patients were 100%, 100%, and 88.5%, respectively, for the Hypo-IMRT group and 80%, 77.8%, and 63.6%, respectively, for the CF-3DRT group (p or =grade 3. Late grade 3 GI toxicity occurred in 2 patients (3.6%) in the CF-3DRT group and 1 patient (3.3%) in the Hypo-IMRT group. CONCLUSION: Hypo-IMRT with a customized rectal balloon resulted in excellent biochemical control rates with minimal toxicity in localized prostate cancer patients.

Positional reproducibility and effects of a rectal balloon in prostate cancer radiotherapy.

Despite the increasing use of the rectal balloon in prostate cancer radiotherapy, many issues still remain to be verified objectively including its positional reproducibility and relevance to treatment morbidity. We have developed a custom rectal balloon that has a scale indicating the depth of insertion and dilates symmetrically ensuring positional reproducibility. Fifty patients with prostate cancer treated by definitive 3D-conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) with rectal balloon were analyzed. Each of first five patients undergone computed tomography (CT) three times with a rectal balloon. The positional reproducibility was tested by Intraclass Correlation Coefficient (ICC) from the CT-to-CT fusion images. Planning variables and clinical acute toxicities were compared between when or not applying balloon. An ICC of greater than 0.9 in all directions revealed an excellent reproducibility of the balloon. Rectal balloon improved considerably the mean dose and V(45Gy)-V(65Gy) in plan comparison, and especially in 3D-CRT the rectal volume exposed to more than 60 Gy dropped from 41.3% to 19.5%. Clinically, the balloon lowered acute toxicity, which was lowest when both the balloon and IMRT were applied simultaneously. The rectal balloon carries excellent reproducibility and reduces acute toxicity in 3D-CRT and IMRT for prostate cancer.

Positional Reproducibility and Effects of a Rectal Balloon in Prostate Cancer Radiotherapy

Despite the increasing use of the rectal balloon in prostate cancer radiotherapy, many issues still remain to be verified objectively including its positional reproducibility and relevance to treatment morbidity. We have developed a custom rectal balloon that has a scale indicating the depth of insertion and dilates symmetrically ensuring positional reproducibility. Fifty patients with prostate cancer treated by definitive 3D-conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) with rectal balloon were analyzed. Each of first five patients undergone computed tomography (CT) three times with a rectal balloon. The positional reproducibility was tested by Intraclass Correlation Coefficient (ICC) from the CT-to-CT fusion images. Planning variables and clinical acute toxicities were compared between when or not applying balloon. An ICC of greater than 0.9 in all directions revealed an excellent reproducibility of the balloon. Rectal balloon improved considerably the mean dose and V(45Gy)-V(65Gy) in plan comparison, and especially in 3D-CRT the rectal volume exposed to more than 60 Gy dropped from 41.3% to 19.5%. Clinically, the balloon lowered acute toxicity, which was lowest when both the balloon and IMRT were applied simultaneously. The rectal balloon carries excellent reproducibility and reduces acute toxicity in 3D-CRT and IMRT for prostate cancer.