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"Cystitis - therapy"
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Efficacy of a pharmacist care protocol to manage uncomplicated female cystitis in community pharmacies: an open-label, multicenter, randomized, controlled, cluster study: the PharmaCyst’ protocol
2024
Background
Urinary tract infections are common affections, especially for women. Difficult access to a general practitioner to obtain a prescription has led France to offer dispensing under protocol by community pharmacists. The primary objective of this study is to evaluate the effectiveness of a pharmacist care protocol provided to manage women with urinary tract infection symptoms. This objective will be assessed using the Acute Cystitis Symptom Score.
Methods
PharmaCyst’ is an open-label, multicenter, controlled, cluster-randomized study conducted in the Loire region, France. Women aged between 18 and 65 years presenting to a pharmacy complaining of at least one symptom of an uncomplicated urinary tract infection present over the last 3 days (including burning pain during micturition, dysuria, pollakiuria, urgent urination) will be considered for inclusion. All patients will be contacted on day 3, 10, and month 3. A total of 480 patients need to be recruited for the 24 clusters participating in the research. The quantitative data will be described using means and standard deviations and compared using Student’s
t
-test. The qualitative data will be described using numbers and percentages and compared using chi
2
test (or Fisher’s exact test if necessary). The primary and secondary outcomes analyses will consider the intention-to-treat population.
Discussion
PharmaCyst’ is the first clinical trial conducted in France only by community pharmacists. Its results could lead to an extension of the protocol.
Trial registration
The protocol has been approved by the French ethics committee on 2022/12/02 and is registered under the number 49RC22_0240 on ClinicalTrials.gov.
Journal Article
Effectiveness of transurethral resection combined with sapylin for bladder perfusion in glandular cystitis
2025
This study explored the impact of transurethral resection plus sapylin for bladder perfusion in treating glandular cystitis. One hundred and twenty-eight cases of glandular cystitis who accepted therapy in Renmin Hospital of Wuhan University, Wuhan, China from September 2018 to September 2022 were chosen and randomly separated into a control group (CG, n=64) and a research group (RG, n=64). The CG received transurethral resection. In contrast, the RG received sapylin infusion chemotherapy in addition to transurethral resection. The clinical efficacy, urination function, levels of inflammatory factors, quality of life along with adverse reactions in the two groups was compared. Relative to the CG, the RG showed higher total treatment effectiveness rate, better improvements of urination function and inflammation, higher quality of life scores, and lower occurrence of adverse reactions. We conclude that transurethral resection combined with sapylin for bladder perfusion has higher effectiveness in treatment of glandular cystitis when compared to transurethral resection alone.
Cette étude a exploré l'impact de la résection transurétrale associée à la sapyline pour la perfusion vésicale dans le traitement de la cystite glandulaire. Cent vingt-huit cas de cystite glandulaire, traités à l'hôpital Renmin de l'université de Wuhan, en Chine, entre septembre 2018 et septembre 2022, ont été sélectionnés et répartis aléatoirement en un groupe témoin (GC, n = 64) et un groupe de recherche (RG, n = 64). Le GC a bénéficié d'une résection transurétrale. À l'inverse, le RG a reçu une chimiothérapie par perfusion de sapyline en plus de la résection transurétrale. L'efficacité clinique, la fonction urinaire, les niveaux de facteurs inflammatoires, la qualité de vie et les effets indésirables des deux groupes ont été comparés. Par rapport au GC, le RG a montré un taux d'efficacité thérapeutique global plus élevé, une meilleure amélioration de la fonction urinaire et de l'inflammation, des scores de qualité de vie plus élevés et une incidence plus faible d'effets indésirables. Nous concluons que la résection transurétrale associée à la sapyline pour la perfusion vésicale est plus efficace dans le traitement de la cystite glandulaire que la résection transurétrale seule.
Journal Article
Effects of low-intensity extracorporeal shock wave therapy on lipopolysaccharide cystitis in a rat model of interstitial cystitis/bladder pain syndrome
by
Chiba, Hiroki
,
Kamijo, Tadanobu Chuyo
,
Kusakabe, Naohisa
in
Abdomen
,
Anesthesia
,
Animal models
2024
Purpose
To investigate the effect of low-intensity extracorporeal shock wave therapy (LiESWT) on lipopolysaccharide (LPS)-induced cystitis in an animal model of interstitial cystitis/bladder pain syndrome (IC/BPS).
Methods
Sprague–Dawley rats were divided into three groups: control, cystitis (LPS group, intravesical injection of LPS (1 mg) twice), and cystitis with LiESWT (LiESWT group). On the third and fourth days, LiESWT was administered (0.12 mJ/mm
2
, 300 shots each time) on the lower abdomen toward the bladder. On the seventh day, the rats underwent pain assessment and a metabolic cage study. Subsequently, a continuous cystometrogram (CMG) was performed under urethane anaesthesia. Immunohistochemical studies were also performed, including S-100 staining, an immunohistochemical marker of Schwann cells in the bladder.
Results
In the LPS group, the pain threshold in the lower abdomen was significantly lower than that in the control group. In the metabolic cage study, the mean voided volume in the LPS group significantly increased. The CMG also revealed a significant decrease in bladder contraction amplitude, compatible with detrusor underactivity in the LPS group. Immunohistochemical studies showed inflammatory changes in the submucosa, increased fibrosis, and decreased S-100 stain-positive areas in the muscle layer of the LPS group. In the LiESWT group, tactile allodynia and bladder function were ameliorated, and S-100 stain-positive areas were increased.
Conclusion
By restoring nerve damage, LiESWT improved lower abdominal pain sensitivity and bladder function in an LPS-induced cystitis rat model. This study suggests that LiESWT may be a new therapeutic modality for IC/BPS.
Journal Article
Hispidulin targets PTGS2 to improve cyclophosphamide-induced cystitis by suppressing NLRP3 inflammasome
by
Liu, Songlin
,
Li, Shuhang
,
Yu, Jianyong
in
Animals
,
Biomedical and Life Sciences
,
Biomedicine
2024
Interstitial cystitis (IC) is a chronic bladder inflammation. Inhibition of prostaglandin G/H synthase 2 (PTGS2) is the most common method for controlling inflammation-related diseases. This study aimed to analyze the effects of hispidulin on the PTGS2 and NOD-like receptor thermal protein domain-associated protein 3 (NLRP3) inflammation in experimental IC models. A binding activity between hispidulin and PTGS2 was measured using molecular docking. Human urothelial cells (SV-HUC-1) were stimulated by 2 ng/mL of interleukin (IL)-1β for 24 h and cultured in a medium with different concentrations of hispidulin (2.5, 5, 10, 20 µM) for 24 h to observe the expressions of PTGS2 and NLRP3 protein. Cells overexpressing PTGS2 were established by PTGS2 cDNA transfection. In the IL-1β-treated cells, the NLRP3 inflammasome was measured after 20 µM hispidulin treatment. In rats, animals were performed with three injections of 40 mg/kg cyclophosphamide (CYP) and orally treated with 50 mg/kg/day hispidulin or ibuprofen for 3 days. The bladder pain was measured using Von Frey filaments, and the bladder pathology was observed using hematoxylin and eosin (H&E) staining. The expressions of PTGS2 and NLRP3 inflammasome were also observed in the bladder tissues. A good binding activity was found between hispidulin and PTGS2 (score = − 8.9 kcal/mol). The levels of PTGS2 and NLRP3 inflammasome were decreased with the hispidulin dose increase in the IL-1β-treated cells (
p
< 0.05). Cells overexpressing PTGS2 weakened the protective effects of hispidulin in the IL-1β-treated cells (
p
< 0.01). In the CYP-treated rats, hispidulin treatment improved the bladder pain through decreasing the nociceptive score (
p
< 0.01) and suppressed the bladder inflammation through suppressing the expressions of PTGS2 and NLRP3 inflammasome in bladder tissues (
p
< 0.01). Additionally, the results of ibuprofen treatment were similar to the effects of hispidulin in the CYP-treated rats. This study demonstrates that hispidulin may be a new alternative drug for the IC treatment that binds PTGS2 to perform its functions.
Journal Article
Pulsed electromagnetic field (PEMF) as an adjunct therapy for pain management in interstitial cystitis/bladder pain syndrome
2022
Introduction and hypothesisPatients with interstitial cystitis/bladder pain syndrome (IC/BPS) often experience chronic pelvic and even systemic pain that can be difficult to clinically manage.Pulsed electromagnetic field (PEMF) therapy, a non-invasive strategy that has shown significant efficacy for pain reduction in other chronic pain conditions, may provide benefit for pain management in patients with IC/BPS.MethodsPEMF delivery to patients occurs via a bio-electromagnetic-energy device which consists of a flexible mat (180 × 50 cm) that the patient lies on for systemic, full-body delivery and/or a flexible pad (50 × 15 cm) for targeted delivery to a specific body region (e.g., pelvic area). The duration of individual sessions, number of sessions per day, total number of sessions, and follow-up observation period vary between previously published studies. Positive outcomes are typically reported as a significant reduction in visual analog scale (VAS) pain score and functional improvement assessed using validated questionnaires specific to the condition under study.Results and conclusionsThe use of PEMF has been evaluated as a therapeutic strategy for pain management in several clinical scenarios. Randomized, double-blinded, placebo-controlled trials have reported positive efficacy and safety profiles when PEMF was used to treat non-specific low back pain, patellofemoral pain syndrome, chronic post-operative pain, osteoarthritis-related pain, rheumatoid arthritis-related pain, and fibromyalgia-related pain. Based on these positive outcomes in a variety of pain conditions, clinical trials to evaluate whether PEMF can provide a safe, non-invasive therapeutic approach to improve symptoms of chronic pain and fatigue in patients with IC/BPS are warranted.
Journal Article
Acupuncture points used in the prophylaxis against recurrent uncomplicated cystitis, patterns identified and their possible relationship to physiological measurements
2016
ObjectiveTo explore the correlation between single acupoints used and the recurrence rate of cystitis among cystitis-prone women receiving acupuncture as a prophylactic treatment.MethodsIn all, 58 cystitis-prone women were included in the analysis. Customised acupuncture treatments were given twice a week, over 4 weeks. The main effect parameter was the number of cystitis episodes during the 6-month observation time. Residual urine was measured at baseline, 2, 4 and 6 months using portable ultrasound equipment. Sympathetic and vagotone nerve activities were measured by using skin conductance and respiratory sinus arrhythmia, respectively.ResultsThe main acupoints used for patients with Kidney (Shen) qi/yang deficiency were Shenshu (BL23), Taixi (KI3), Zhongji (CV3), Sanyinjiao (SP6) and Pangguangshu (BL28), compared with Taichong (LR3), CV3, BL28, Yinlingquan (SP9) and SP6 for Liver (Gan) qi stagnation, and SP6, CV3, BL28, Zusanli (ST36) and SP9 for Spleen (Pi) qi/yang deficiency patients. The combination BL23 and KI3 were used in 16 women, 13 of which were Kidney pattern related patients. When used, the number of symptomatic episodes were reduced to a third compared with what occurred in the 42 women where this combination was not used (3/16 vs. 28/42, P<0.05). BL23 application correlated to a significant reduction in residual urine measured a few days after treatment. Patients with the pattern of Spleen qi/yang deficiency had an initial increase in residual urine after treatments.ConclusionTreating Kidney pattern related patients with the combination of BL23 and KI3 resulted in far better outcome than other points/combination of points for other Chinese medicine diagnoses. The acupoint SP6 may be less indicated than previously assumed when treating cystitis-prone women prophylactically.
Journal Article
A single-center, phase 1/2a trial of hESC-derived mesenchymal stem cells (MR-MC-01) for safety and efficacy in interstitial cystitis patients
2025
This study investigated the safety and efficacy of MR-MC-01, a mesenchymal stem cell therapy derived from human embryonic stem cells, in patients with interstitial cystitis (IC), particularly those with Hunner lesions unresponsive to pentosan polysulfate sodium (PPS). Conducted as a prospective, randomized, double-blind, placebo-controlled phase I/IIa clinical trial, it enrolled 22 patients, with six completing phase I and 16 participating in phase IIa. Phase I tested 2 doses (2.0 × 107 and 5.0 × 107 cells) to determine the maximum tolerated dose (MTD), revealing no dose-limiting toxicities and only mild adverse events such as transient hemorrhage and bladder pain. In phase IIa, 12 participants received the MTD of 5.0 × 107 cells, and 4 received placebo. Significant reductions in interstitial cystitis questionnaire (ICQ) and pain urgency frequency (PUF) scores were observed in the treatment group. Improvements were noted in nocturnal voiding frequency and Hunner lesion size, with 8 patients showing either a reduction or complete resolution of lesions after 6 months. The global response assessment (GRA) reported moderate to marked improvement in 41.67% of treated patients versus 25% in the placebo group. MR-MC-01 demonstrated no serious drug-related adverse events, highlighting its favorable safety profile. These findings suggest that MR-MC-01 not only alleviates symptoms but also promotes structural recovery in IC, making it a promising treatment option. Further large-scale, long-term studies are warranted to confirm these results and optimize therapeutic protocols. (Identifier: NCT04610359)
Journal Article
Evaluation of clinical efficacy of pelvic ultrasound monitoring combined with scale scoring in the treatment of interstitial cystitis by intravesical instillation regimen combined with hydrodistention and transurethral fulguration
2025
Background
Interstitial cystitis (IC) is a chronic condition with complex symptoms, including pelvic pain and urinary frequency. Current treatments often involve a combination of therapies, but their effectiveness remains a topic of ongoing investigation. This study aimed to evaluate the clinical efficacy of a treatment regimen combining intravesical instillation of heparin and alkalized lidocaine, hydrodistention, and transurethral fulguration, using pelvic ultrasound monitoring and symptom scales to assess patient outcomes.
Methods
From June 2016 to June 2023, patients who were diagnosed as interstitial cystitis in urology department of the xuzhou central hospital were selected. All patients received intravesical instillation regimen of 2% lidocaine 10 ml + 5% sodium bicarbonate 5 ml + heparin 25000 IU for 6 months, and they were randomly divided into two groups according to the simple randomization (coin toss): hydrodistention and transurethral fulguration (HD/TF) group and non-HD/TF group. The 24-h urination frequency, nocturia frequency, pelvic ultrasound measurement results (bladder volume at maximum filling state, bladder wall thickness after urination, residual urine volume), O'Leary-Sant interstitial cystitis symptom index (ICSI), O'Leary-Sant interstitial cystitis problem index (ICPI), pelvic pain and urgency/frequency (PUF), pain visual analogue score (VAS), self-rating anxiety scale (SAS) were recorded before treatment and 3 and 6 months after treatment.
Results
A total of 68 patients were included in this study, including 13 males (19.12%) and 55 females (80.88%), with an average age of 59.07 ± 8.15 years. According to the simple randomization, 68 patients were randomly divided into HD/TF group (
n
= 30) and non-HD/TF group (
n
= 38). After the 3rd and 6 th months of treatment, the 24-h urination frequency and nocturia frequency in both groups decreased significantly (
P
< 0.05), and the 24-h urination frequency and nocturia frequency after the 3rd and 6 th months of treatment in HD/TF group decreased significantly compared with that in non-HD/TF group (
P
< 0.05). After the 3rd and 6 th months of treatment, the bladder volume at maximum filling state in the two groups increased and the residual urine volume decreased (
P
< 0.05). In addition, the bladder volume at maximum filling state of the HD/TF group increased significantly compared to the non-HD/TF group after 3rd and 6 th months of treatment (
P
< 0.05), while the bladder wall thickness after urination decreased compared to the non-HD/TF group after 3rd months of treatment (
P
< 0.05). There was no significant difference in residual urine volume between HD/TF group and non-HD/TF group before and after treatment (
P
> 0.05). The postoperative scores at 3rd and 6 th months of ICPI, ICSI, PUF, SAS and VAS in both groups were significantly lower than those before treatment (
P
< 0.05), and The postoperative scores at 3rd and 6 th months of ICPI, ICSI, PUF, SAS and VAS in HD/TF group were significantly lower than those in non-HD/TF group (
P
< 0.05).
Conclusions
Intravesical instillation of heparin/alkalized lidocaine combined with hydrodistention and transurethral fulguration is an effective treatment for interstitial cystitis, which can significantly reduce patient pain and improve patient prognosis. Moreover, the use of pelvic ultrasound to monitor indicators such as bladder volume at maximum filling state and residual urine volume, combined with ICSI, ICPI, PUF, VAS, and SAS scores, has high application value for evaluating the efficacy of intravesical instillation regimen combined with hydrodistention and transurethral fulguration in the treatment of interstitial cystitis.
Journal Article
Reducing pain by improving brain and muscle activity with motor cortical neuromodulation in women with interstitial cystitis/bladder pain syndrome: a study protocol for a randomized controlled trial
2024
Introduction
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition creating a wide range of urologic and pain symptoms. There is currently limited evidence to understand the mechanisms of IC/BPS. There have been recent studies suggesting that altered function in brain motor areas, particularly the supplementary motor cortex (SMA), relates to altered bladder sensorimotor control and may play an important role in IC/BPS. This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain, as well as better understand the neural mechanism by which this stimulation targets neuromuscular dysfunction.
This study is a two-group quadruple-blinded randomized controlled trial (RCT) of active vs. sham repetitive transmagnetic stimulation (rTMS). In addition, our study will also include functional magnetic resonance imaging (fMRI), pelvic floor electromyography (EMG), pelvic exam, and outcome measures and questionnaires to further study outcomes.
Ethics and dissemination
All aspects of the study were approved by the Institutional Review Board of the University of Southern California (protocol HS-20–01021). All participants provided informed consent by the research coordinator/assistants. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences.
Trial registration
ClinicalTrials.gov NCT04734847. Registered on February 1, 2021.
Journal Article
Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2–3 trial
by
Salling, Lisbeth
,
Mölne, Johan
,
Rosén, Anders
in
Anestesi och intensivvård
,
Anesthesiology and Intensive Care
,
Atmospheric pressure
2019
Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis.
We did a randomised, controlled, phase 2–3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen—A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18–80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30–40 sessions, 100% oxygen, breathed at a pressure of 240–250 kPa, for 80–90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6–8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15.
Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210–262) in the hyperbaric oxygen therapy group and 217 days (195–237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2–18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1–2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.
Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment.
The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.
Journal Article