Contextualization: Emptying the bladder is a challenging problem for the urological community. Intermittent catheterization is the most widely used method to restore bladder emptying mechanism. However, this procedure...Contextualization: Emptying the bladder is a challenging problem for the urological community. Intermittent catheterization is the most widely used method to restore bladder emptying mechanism. However, this procedure can have a negative impact on self-image and result in a decline in the quality of life of patients. In this context, the use of a bladder emptying device (SVCATH3D) proposes to be effective and have a positive impact on the quality of life of different patients. Objective: The objective of the study was to evaluate the functionality of a new device for both intermittent and controlled emptying of the bladder in both sexes and ages. Materials and methods: A randomized clinical trial was conducted with 251 patients, with different bladder problems, from March 2013 to January 2023. After randomization, the patients were divided into two groups: Group I (SVCATH3D) and Group II (Clean Intermittent Catheterization). The primary outcome was defined as the impact on quality of life. Data on episodes of urinary tract infection, adverse effects, number of diaper use and treatment costs were analyzed. Results: The apposition of the SVCATH3D was performed on an outpatient basis, with no complications during the procedures. The patients were followed up for 10 years. There was a significant improvement in quality of life when comparing the moments before and after the use of SVCATH3D (p Conclusion: The study using SVCATH3D showed promising results in relation to functionality, showing improvement in quality of life with a reduction in episodes of urinary infection and amount of diapers/day. This allows us to conclude that SVCATH3D can represent an important step in the treatment of patients suffering from various bladder problems both incontinence and affecting emptying mechanism.展开更多
Background: Urinary incontinence mainly affects women regardless of age and, as it affects their quality of life, influences work, sex life and independence for activities of daily living. The treatment of stress urin...Background: Urinary incontinence mainly affects women regardless of age and, as it affects their quality of life, influences work, sex life and independence for activities of daily living. The treatment of stress urinary incontinence including urethral volume injection therapy can provide an intermediate option over non-surgical and surgical therapies. One of the mechanisms for stress continence depends on the effective coaptation of the urethra during the increase in intra-abdominal pressure. The bulking agents can be injected transurethral or periurethral retrogradely, using direct vision from a cystoscope. Purpose: To evaluate the feasibility and preliminary outcome performance of the bacterial polysaccharide gel used as biological bulking agent applied in female patients with stress urinary incontinence. Methods: A prospective clinical pilot study was performed, in a single institution, including female patients who were admitted to the urologic outpatient clinic with Stress Urinary Incontinence (SUI) without previous treatments and they were selected and underwent bulking agent procedure. The evaluation was performed at the time of enrollment and 6 months after treatment. The primary outcome was Quality of Life (QOL) using the ICIQ-SF Questionnaire. The amount of urine leakage measured by the 1-HOUR PAD-TEST was the second outcome. Results: Fifteen women (with an average age of 53 years) were submitted to the application of bacterial cellulose gel and she was analyzed. Only two patients presented unchanged incontinence. The study considered as primary outcome the improvement or disappearance of symptoms after six months of intervention. Post-intervention Quality of Life (QOL) questionnaire indicated that all of these patients related a better quality of life (62.5%). Through the PAD-test it was possible to observe a decrease in urinary leak of 85% comparing the results pre and post-intervention (BCA—Bacterial Cellulose Application) with p-value equal to 0.000009. Conclusions: The results of this pilot study suggest that the use of biological bulking agent is a promising approach to treat stress urinary incontinence in female patients. Trial registration: Registration number and date of registration should be instated in this section.展开更多
文摘Contextualization: Emptying the bladder is a challenging problem for the urological community. Intermittent catheterization is the most widely used method to restore bladder emptying mechanism. However, this procedure can have a negative impact on self-image and result in a decline in the quality of life of patients. In this context, the use of a bladder emptying device (SVCATH3D) proposes to be effective and have a positive impact on the quality of life of different patients. Objective: The objective of the study was to evaluate the functionality of a new device for both intermittent and controlled emptying of the bladder in both sexes and ages. Materials and methods: A randomized clinical trial was conducted with 251 patients, with different bladder problems, from March 2013 to January 2023. After randomization, the patients were divided into two groups: Group I (SVCATH3D) and Group II (Clean Intermittent Catheterization). The primary outcome was defined as the impact on quality of life. Data on episodes of urinary tract infection, adverse effects, number of diaper use and treatment costs were analyzed. Results: The apposition of the SVCATH3D was performed on an outpatient basis, with no complications during the procedures. The patients were followed up for 10 years. There was a significant improvement in quality of life when comparing the moments before and after the use of SVCATH3D (p Conclusion: The study using SVCATH3D showed promising results in relation to functionality, showing improvement in quality of life with a reduction in episodes of urinary infection and amount of diapers/day. This allows us to conclude that SVCATH3D can represent an important step in the treatment of patients suffering from various bladder problems both incontinence and affecting emptying mechanism.
文摘Background: Urinary incontinence mainly affects women regardless of age and, as it affects their quality of life, influences work, sex life and independence for activities of daily living. The treatment of stress urinary incontinence including urethral volume injection therapy can provide an intermediate option over non-surgical and surgical therapies. One of the mechanisms for stress continence depends on the effective coaptation of the urethra during the increase in intra-abdominal pressure. The bulking agents can be injected transurethral or periurethral retrogradely, using direct vision from a cystoscope. Purpose: To evaluate the feasibility and preliminary outcome performance of the bacterial polysaccharide gel used as biological bulking agent applied in female patients with stress urinary incontinence. Methods: A prospective clinical pilot study was performed, in a single institution, including female patients who were admitted to the urologic outpatient clinic with Stress Urinary Incontinence (SUI) without previous treatments and they were selected and underwent bulking agent procedure. The evaluation was performed at the time of enrollment and 6 months after treatment. The primary outcome was Quality of Life (QOL) using the ICIQ-SF Questionnaire. The amount of urine leakage measured by the 1-HOUR PAD-TEST was the second outcome. Results: Fifteen women (with an average age of 53 years) were submitted to the application of bacterial cellulose gel and she was analyzed. Only two patients presented unchanged incontinence. The study considered as primary outcome the improvement or disappearance of symptoms after six months of intervention. Post-intervention Quality of Life (QOL) questionnaire indicated that all of these patients related a better quality of life (62.5%). Through the PAD-test it was possible to observe a decrease in urinary leak of 85% comparing the results pre and post-intervention (BCA—Bacterial Cellulose Application) with p-value equal to 0.000009. Conclusions: The results of this pilot study suggest that the use of biological bulking agent is a promising approach to treat stress urinary incontinence in female patients. Trial registration: Registration number and date of registration should be instated in this section.
