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477Chemical ablation of the bladder urothelium and intestinal de-epithelialization in augmentation cystoplasty: An experimental study
478
477 CHEMICAL ABLATION OF THE BLADDER UROTHELIUM AND INTESTINAL DE-EPITHELIALIZATION IN AUGMENTATION CYSTOPLASTY: AN EXPERIMENTAL STUDY
CLINICAL CHARACTERISTICS AND FEMALE URETHRAL DIVERTICULUM
SURGICAL
OUTCOMES
OF
Jeon~ "KS., Hart D.H., Lee K.S. Abou Hashem S. 1, Kandeel A. 2, Mostafa S. 3, Gaballa A.4 1Zagazig University, Urology, Zagazig, Egypt, 2Zagazig University Egypt, Surgery Vetrenary, Zagazig, Egypt, 3Zagazig University Egypt, Pathology, Zagazig, Egypt, 4Zagazig University Egypt, Clinical Pathology, Zagazig, Egypt INTRODUCTION & OBJECTIVES: Interposing intestinal segment in the urinary tract in augmentation cystoplasty or ileal neobladder may lead to metabolic complications as that of altered solute reabsorption by the intestine from the urine that it contains. In an experimental study, the effect of protamine sulphate and urea treatments on the bladder epithelium and mucosa of the intestinal segments used in augmentation cystoplasty using ileal segment was evaluated. MATERIAL & METHODS: Three groups of dogs (5 dogs in each one) were used in the study, all groups underwent augmentation cystoplasty using ileal segment. The first one (group I) was a cuntrol group with no treatments after operation, the bladder was filled with normal saline and emptied after 30 minutes and the catheter was removed, the second group (group II) was treated through infusion of the augmented bladder by 5mg/ml protamine sulphate for 15 minutes then the bladder was emptied and filled with urea at concentration of 100 gra/L solution for 15 minutes then emptied, and the catheter is removed. The third group (group III) was infused with the two drugs but in a double concentration. Biopsies from the intestinal and bladder segments were taken immediately after augmentation cystoplasty and after an interval of one month and evaluated microscopically for epithelial changes. At the same times, 24 hours urine was collected for determination of urine mucoprotins among studied groups.
The Samsung Medical Center, Sungkynnkwan University School of Medicine, Department of Urology, Seoul, South Korea INTRODUCTION & OBJECTIVES: Urethral diverticulectomy was generally performed for the treatment of symptomatic urethral diverticulnnr. However the surgical outcome has not been clearly assessed. In this study, we evaluated clinical characteristics and surgical outcomes of female urethral diverticulum. MATERIAL & METHODS: A total of 30 women were surveyed who were followed-up at least five months after urethral diverticulectomy. Before operation, physical examination, VCUG, transvaginal USG, MRI and urethroscopy were performed to confirm the presence of diverticulum and to characterize it. All urethral diverticulums were classified into simple, U-shaped, and circumferential type by their radiological features. During operation, we incised anteriur vaginal wall on urethra level then identified and mobilized the diverticulum. After removing diverticular sac, urethra, periurethral fascia and vaginal wall were closed layer by layer. Cure was defined as no existence of diverticulum and disappearance of symptoms.
RESULTS: Serum electrolytes, urea nitrogen and creatinine were within normal values in all groups of the study. The use of protamine sulphate and urea as chemical de-epithelialization agents for the bowel segment had led to atrophy of the mucosal villi and decrease number of goblet cells significantly so decreasing the absorptive capacity of the villi and secretory capacity of the goblet cells. Mucoprotein measurement immediate and at one month postoperatively showed that there was insignificant difference in mucoprotein in urine of 24 hours immediate postoperative between all groups. On the other hand, there was a significant difference between all groups after one month. Also, mucoprotein secretion in group II was significantly less than that of group h While as regard mucoprotein secretion in group III, the decrease was highly significant than that in group I and I.
RESULTS: Mean patient age was 46.4 years (range 31-73) and follow-up period was 29 months (range 5-93). Symptom duration was mean 26.6 months (range 1-120). Presenting symptoms included dysuria in 11, palpable mass in 7, post-void dribbling in 6, pus discharge from urethra in 5, perineal pain in 5 and recurrent cystitis in 3. Seventeen (57%) cases were simple type, 3(10%) were U-shaped and 10(33%) were circumferential. Eight (27%) cases were located at proximal urethra, 15(50%) middle and 7(23%) distal. Diverticulum was single in 26 cases and multiple in 4. Mean maximal diameter was 2.4em (range 0.5-5.0). Mean operation time was 87.8rain (range 20-210). Postoperative catheterization period and hospital stay was 4.9(±3.1) and 4.1 (~-1.7) days. Anti-incontinence surgery was performed in 1 case, due to coexistent stress urinary incontinence. Afier operation, 23(73%) cases were cured whereas 7(24%) failed. None of simple types recurred. But 33% of U-shaped diverticulums and 60% of circumferential were recurred. Four of 7 reanrred cases underwent reoperation but 3 did not need because their symptoms had resolved. Three of 4 cases underwent reoperation were cured and 1 was cured after two additional operation. The success rate of circumferential diverticulum was significantly lower than simple or U-shaped (p<0.05). Preoperative factors such as location of diverticulum, multiplicity and size did not affect the outcome of diverticulectomy(p>0.05). Operative complications included 2 bladder injuries, and 2 stress incontinences. There was no operation-related transfusion or wound problems.
CONCLUSIONS: De-epithelialization of both the bladder and intestinal segments occurred promptly by using protamine sulphate and urea. This is supposed to be followed by reepithelialization by transitional epithelium later one. These results were confirmed by the decreased mucoprotein secretion in urine. This approach may be of possible use as a chemical ablation for the intestinal mucosa used in the augmentation cystoplasty or ileal neobladder.
CONCLUSIONS: Urethral diverticulum has various clinical presentations mimicking other urological problems and clinical suspicion is important for diagnosis. Urethral diverticulectomy is considered as an effective treatment modality for female urethral diverticulum. But in the case of circumferential type, additional treatment method may be necessary because of the lower cure rate.
INITIAL RESULTS OF PELVIC FLOOR ELECTROSTIMULATION SYMPTOM RELIEF IN INTERSTITIAL CYSTITIS USING MINIATUROTM-I SYSTEM
479
480
FOR THE
AN ANALYSIS OF RESOURCE CONSUMPTION AND UTILITY OF TREATMENT W I T H T H E Z U I D E X TM S Y S T E M A EUROPEAN PERSPECTIVE -
Famsworth B.
Kobelt G.
Centre for Pelvic Reconstructive Surgery, Sydney Adventist Hospital, Sydney, Australia
European Health Economics SAS, Speracedes, France
INTRODUCTION & OBJECTIVES: Interstitial Cystitis (IC) is a disabling chronic condition of the lower urinary tract. The etiology is not known. The treatment of IC is mainly empirical and includes multimodal behavioural therapy, pharmacological treatment, bladder instillations, and bladder hydro-distension. However, all treatments provide only temporary relief from the IC symptoms. The purpose of our study has been to assess the efficacy of chronic pelvic floor stimulation using a novel active implantable system on IC symptoms.
INTRODUCTION & OBJECTIVES: An open, multicentre, European study investigated the efficacy and safety of the ZuidexT M system (Q-Med AB, Uppsala, Sweden) for the treatment of stress urinary incontinence (SUI). This system comprises 4 pre-filled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and the ImplacerT M device. The effect of Zuidex on patients' overall health was investigated using a generic utility instrument (EQ-5D), and detailed resource utilisation was recorded throughout the study. The results are presented for 3 months, for Sweden and France.
MATERIAL & METHODS: Adult women patients with diagnosed IC for more than 12 months and who have failed to achieve adequate improvement through conservative management are eligible for the study. After passing a 6-24 hours of stimulation test, patients undergo a simple surgical procedure during which the system is implanted. The pulse generator is implanted through a 4-5 cm suprapubic incision and stitched to the fascia. The bipolar stimulation lead is inserted paraurethrally and connected subcutaneously to the pulse generator. The system delivers intermittent pulses through the lead to the pelvic floor with the intensity determined according to patient sensations. Treatment success was measured by pain and voiding diary and response to quality of life questionnaires (QoL) including "O'Leary-Sant symptoms and problem Indices" (O'Leary-Sant Indices), "Shortform McGill Pain Questionnaire" (SF-MPQ) and "Pelvic pain and Urgency/Frequency patient symptoms scale" (PUF) at 1, 3, 6 and 12 nrunths following implantation. RESULTS: So far, 13 patients have enrolled in this study. Two out of the thirteen patients enrolled (15%) were excluded from the study, because they failed the initial test stimulation; and three patients withdrew due to personal reasons. Out of the eleven active patients, ten patients had completed one to nine months of follow-up post implantation and were statistically evaluated on an intention to treat basis. Ten patients demonstrated substantially decreased in pain level either measured by VAS (on scale from 1 to 10) or by Short Form McGill Pain Questionnaire: from 6.6+/-1.5 and 36.5+/-8.2 at baseline to 3.3+/-1.9 to 18.5+/-8.0 after treatment (p<0.01 for both parameters), respectively. O'Leary-Sant Indices score reduced from 32.5+/-4.0 to 25.9+/-6.7 (p<0.01). An additional quality of life tool, the Pelvic Pain and Urgency/Frequency scale (PUF), kept the same trend as the score reduced significantly from 26.5+/-3.7 to 19.9+/-3.5 (p<0.01). The mean urinary frequency also decreased by 11% but the change is insignificant. CONCLUSIONS: Pelvic floor electro stimulation has a positive effect on IC symptoms. Larger number of patients and longer follow-up are still required in order to establish this mode of treatment as a viable alternative for treatment of intractable IC.
European Urology Supplements 4 (2005) No. 3, pp. 122
MATERIAL & METHODS: The EQ-5D was completed at baseline and 3 months, and responses were converted into utility scores (a weight between 0 [death] and 1 [full health]). The economic analysis was performed for 82 Zuidex-treated patients with complete data and compared to 77 patients treated with tension-free vaginal tape (TVT). Resource utilisation included the initial procedures, hospital stays, outpatient and primary care visits, pads, drugs, tests and lost working time. Country-specific unit costs for Sweden (Swedish Kronor; SEK) and France (Euro; EUR) were used to estimate the total cost associated with treatment. The primary procedures were costed using diagnostic-related group (DRG) costs. RESULTS: The mean baseline utility score was 0.83, with 35 patients having a baseline score of 1.0 (full health) and therefore no potential for improvement. At 3 months, the mean utility score was 0.86, a gain of 0.03 versus baseline (p<0.001). The corresponding gain was 0.09 (p<0.001) for patients with a baseline utility score <1.0 (n=60). In Sweden, the mean total cost per patient treated with Zuidex was SEK 22,500, compared with SEK 29,000-32,000 for TVT. In France, the difference between the two treatment costs was much greater, with the corresponding values being EUR 2500-2700 for Zuidex and EUR 5200-5500 for TVT. This difference was due to the higher inpatient DRG cost for TVT in France, as a result of longer hospitalisation (4 clays in France versus 2 days in Sweden). CONCLUSIONS: Zuidex conservatively produces a similar utility gain to TVT - the latter was previously reported as 0.03 (Manca A, et al. B JOG 2003; 110: 255-62), though inclusion/exclusion of patients with a baseline score of 1.0 was not clarified. Zuidex is also associated with lower overall costs than TVT, therefore Zuidex may be considered as the more cost-effective treatment option. Health economics analyses are dependent on country-specific data, so it is notable that Zuidex was associated with lower overall costs in both Sweden and France. Further analysis will determine whether this difference extends to other European countries.
477 CHEMICAL ABLATION OF THE BLADDER UROTHELIUM AND INTESTINAL DE-EPITHELIALIZATION IN AUGMENTATION CYSTOPLASTY: AN EXPERIMENTAL STUDY
CLINICAL CHARACTERISTICS AND FEMALE URETHRAL DIVERTICULUM
SURGICAL
OUTCOMES
OF
Jeon~ "KS., Hart D.H., Lee K.S. Abou Hashem S. 1, Kandeel A. 2, Mostafa S. 3, Gaballa A.4 1Zagazig University, Urology, Zagazig, Egypt, 2Zagazig University Egypt, Surgery Vetrenary, Zagazig, Egypt, 3Zagazig University Egypt, Pathology, Zagazig, Egypt, 4Zagazig University Egypt, Clinical Pathology, Zagazig, Egypt INTRODUCTION & OBJECTIVES: Interposing intestinal segment in the urinary tract in augmentation cystoplasty or ileal neobladder may lead to metabolic complications as that of altered solute reabsorption by the intestine from the urine that it contains. In an experimental study, the effect of protamine sulphate and urea treatments on the bladder epithelium and mucosa of the intestinal segments used in augmentation cystoplasty using ileal segment was evaluated. MATERIAL & METHODS: Three groups of dogs (5 dogs in each one) were used in the study, all groups underwent augmentation cystoplasty using ileal segment. The first one (group I) was a cuntrol group with no treatments after operation, the bladder was filled with normal saline and emptied after 30 minutes and the catheter was removed, the second group (group II) was treated through infusion of the augmented bladder by 5mg/ml protamine sulphate for 15 minutes then the bladder was emptied and filled with urea at concentration of 100 gra/L solution for 15 minutes then emptied, and the catheter is removed. The third group (group III) was infused with the two drugs but in a double concentration. Biopsies from the intestinal and bladder segments were taken immediately after augmentation cystoplasty and after an interval of one month and evaluated microscopically for epithelial changes. At the same times, 24 hours urine was collected for determination of urine mucoprotins among studied groups.
The Samsung Medical Center, Sungkynnkwan University School of Medicine, Department of Urology, Seoul, South Korea INTRODUCTION & OBJECTIVES: Urethral diverticulectomy was generally performed for the treatment of symptomatic urethral diverticulnnr. However the surgical outcome has not been clearly assessed. In this study, we evaluated clinical characteristics and surgical outcomes of female urethral diverticulum. MATERIAL & METHODS: A total of 30 women were surveyed who were followed-up at least five months after urethral diverticulectomy. Before operation, physical examination, VCUG, transvaginal USG, MRI and urethroscopy were performed to confirm the presence of diverticulum and to characterize it. All urethral diverticulums were classified into simple, U-shaped, and circumferential type by their radiological features. During operation, we incised anteriur vaginal wall on urethra level then identified and mobilized the diverticulum. After removing diverticular sac, urethra, periurethral fascia and vaginal wall were closed layer by layer. Cure was defined as no existence of diverticulum and disappearance of symptoms.
RESULTS: Serum electrolytes, urea nitrogen and creatinine were within normal values in all groups of the study. The use of protamine sulphate and urea as chemical de-epithelialization agents for the bowel segment had led to atrophy of the mucosal villi and decrease number of goblet cells significantly so decreasing the absorptive capacity of the villi and secretory capacity of the goblet cells. Mucoprotein measurement immediate and at one month postoperatively showed that there was insignificant difference in mucoprotein in urine of 24 hours immediate postoperative between all groups. On the other hand, there was a significant difference between all groups after one month. Also, mucoprotein secretion in group II was significantly less than that of group h While as regard mucoprotein secretion in group III, the decrease was highly significant than that in group I and I.
RESULTS: Mean patient age was 46.4 years (range 31-73) and follow-up period was 29 months (range 5-93). Symptom duration was mean 26.6 months (range 1-120). Presenting symptoms included dysuria in 11, palpable mass in 7, post-void dribbling in 6, pus discharge from urethra in 5, perineal pain in 5 and recurrent cystitis in 3. Seventeen (57%) cases were simple type, 3(10%) were U-shaped and 10(33%) were circumferential. Eight (27%) cases were located at proximal urethra, 15(50%) middle and 7(23%) distal. Diverticulum was single in 26 cases and multiple in 4. Mean maximal diameter was 2.4em (range 0.5-5.0). Mean operation time was 87.8rain (range 20-210). Postoperative catheterization period and hospital stay was 4.9(±3.1) and 4.1 (~-1.7) days. Anti-incontinence surgery was performed in 1 case, due to coexistent stress urinary incontinence. Afier operation, 23(73%) cases were cured whereas 7(24%) failed. None of simple types recurred. But 33% of U-shaped diverticulums and 60% of circumferential were recurred. Four of 7 reanrred cases underwent reoperation but 3 did not need because their symptoms had resolved. Three of 4 cases underwent reoperation were cured and 1 was cured after two additional operation. The success rate of circumferential diverticulum was significantly lower than simple or U-shaped (p<0.05). Preoperative factors such as location of diverticulum, multiplicity and size did not affect the outcome of diverticulectomy(p>0.05). Operative complications included 2 bladder injuries, and 2 stress incontinences. There was no operation-related transfusion or wound problems.
CONCLUSIONS: De-epithelialization of both the bladder and intestinal segments occurred promptly by using protamine sulphate and urea. This is supposed to be followed by reepithelialization by transitional epithelium later one. These results were confirmed by the decreased mucoprotein secretion in urine. This approach may be of possible use as a chemical ablation for the intestinal mucosa used in the augmentation cystoplasty or ileal neobladder.
CONCLUSIONS: Urethral diverticulum has various clinical presentations mimicking other urological problems and clinical suspicion is important for diagnosis. Urethral diverticulectomy is considered as an effective treatment modality for female urethral diverticulum. But in the case of circumferential type, additional treatment method may be necessary because of the lower cure rate.
INITIAL RESULTS OF PELVIC FLOOR ELECTROSTIMULATION SYMPTOM RELIEF IN INTERSTITIAL CYSTITIS USING MINIATUROTM-I SYSTEM
479
480
FOR THE
AN ANALYSIS OF RESOURCE CONSUMPTION AND UTILITY OF TREATMENT W I T H T H E Z U I D E X TM S Y S T E M A EUROPEAN PERSPECTIVE -
Famsworth B.
Kobelt G.
Centre for Pelvic Reconstructive Surgery, Sydney Adventist Hospital, Sydney, Australia
European Health Economics SAS, Speracedes, France
INTRODUCTION & OBJECTIVES: Interstitial Cystitis (IC) is a disabling chronic condition of the lower urinary tract. The etiology is not known. The treatment of IC is mainly empirical and includes multimodal behavioural therapy, pharmacological treatment, bladder instillations, and bladder hydro-distension. However, all treatments provide only temporary relief from the IC symptoms. The purpose of our study has been to assess the efficacy of chronic pelvic floor stimulation using a novel active implantable system on IC symptoms.
INTRODUCTION & OBJECTIVES: An open, multicentre, European study investigated the efficacy and safety of the ZuidexT M system (Q-Med AB, Uppsala, Sweden) for the treatment of stress urinary incontinence (SUI). This system comprises 4 pre-filled syringes of non-animal stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and the ImplacerT M device. The effect of Zuidex on patients' overall health was investigated using a generic utility instrument (EQ-5D), and detailed resource utilisation was recorded throughout the study. The results are presented for 3 months, for Sweden and France.
MATERIAL & METHODS: Adult women patients with diagnosed IC for more than 12 months and who have failed to achieve adequate improvement through conservative management are eligible for the study. After passing a 6-24 hours of stimulation test, patients undergo a simple surgical procedure during which the system is implanted. The pulse generator is implanted through a 4-5 cm suprapubic incision and stitched to the fascia. The bipolar stimulation lead is inserted paraurethrally and connected subcutaneously to the pulse generator. The system delivers intermittent pulses through the lead to the pelvic floor with the intensity determined according to patient sensations. Treatment success was measured by pain and voiding diary and response to quality of life questionnaires (QoL) including "O'Leary-Sant symptoms and problem Indices" (O'Leary-Sant Indices), "Shortform McGill Pain Questionnaire" (SF-MPQ) and "Pelvic pain and Urgency/Frequency patient symptoms scale" (PUF) at 1, 3, 6 and 12 nrunths following implantation. RESULTS: So far, 13 patients have enrolled in this study. Two out of the thirteen patients enrolled (15%) were excluded from the study, because they failed the initial test stimulation; and three patients withdrew due to personal reasons. Out of the eleven active patients, ten patients had completed one to nine months of follow-up post implantation and were statistically evaluated on an intention to treat basis. Ten patients demonstrated substantially decreased in pain level either measured by VAS (on scale from 1 to 10) or by Short Form McGill Pain Questionnaire: from 6.6+/-1.5 and 36.5+/-8.2 at baseline to 3.3+/-1.9 to 18.5+/-8.0 after treatment (p<0.01 for both parameters), respectively. O'Leary-Sant Indices score reduced from 32.5+/-4.0 to 25.9+/-6.7 (p<0.01). An additional quality of life tool, the Pelvic Pain and Urgency/Frequency scale (PUF), kept the same trend as the score reduced significantly from 26.5+/-3.7 to 19.9+/-3.5 (p<0.01). The mean urinary frequency also decreased by 11% but the change is insignificant. CONCLUSIONS: Pelvic floor electro stimulation has a positive effect on IC symptoms. Larger number of patients and longer follow-up are still required in order to establish this mode of treatment as a viable alternative for treatment of intractable IC.
European Urology Supplements 4 (2005) No. 3, pp. 122
MATERIAL & METHODS: The EQ-5D was completed at baseline and 3 months, and responses were converted into utility scores (a weight between 0 [death] and 1 [full health]). The economic analysis was performed for 82 Zuidex-treated patients with complete data and compared to 77 patients treated with tension-free vaginal tape (TVT). Resource utilisation included the initial procedures, hospital stays, outpatient and primary care visits, pads, drugs, tests and lost working time. Country-specific unit costs for Sweden (Swedish Kronor; SEK) and France (Euro; EUR) were used to estimate the total cost associated with treatment. The primary procedures were costed using diagnostic-related group (DRG) costs. RESULTS: The mean baseline utility score was 0.83, with 35 patients having a baseline score of 1.0 (full health) and therefore no potential for improvement. At 3 months, the mean utility score was 0.86, a gain of 0.03 versus baseline (p<0.001). The corresponding gain was 0.09 (p<0.001) for patients with a baseline utility score <1.0 (n=60). In Sweden, the mean total cost per patient treated with Zuidex was SEK 22,500, compared with SEK 29,000-32,000 for TVT. In France, the difference between the two treatment costs was much greater, with the corresponding values being EUR 2500-2700 for Zuidex and EUR 5200-5500 for TVT. This difference was due to the higher inpatient DRG cost for TVT in France, as a result of longer hospitalisation (4 clays in France versus 2 days in Sweden). CONCLUSIONS: Zuidex conservatively produces a similar utility gain to TVT - the latter was previously reported as 0.03 (Manca A, et al. B JOG 2003; 110: 255-62), though inclusion/exclusion of patients with a baseline score of 1.0 was not clarified. Zuidex is also associated with lower overall costs than TVT, therefore Zuidex may be considered as the more cost-effective treatment option. Health economics analyses are dependent on country-specific data, so it is notable that Zuidex was associated with lower overall costs in both Sweden and France. Further analysis will determine whether this difference extends to other European countries.