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SEVEN-YEAR OUTCOMES OF THE TVT PROCEDURE FOR TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
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THE JOURNAL OF UROLOGY®
score pre-implant of grade 1 and the presence of significant pelvic organ prolapse were found to diminish the efficacy of the procedure. Patient’s quality of life was significantly improved according to all questionnaires. The most common complications that required explant were balloon migration (N=22), port erosion (N=14) and balloon erosion (N=9), but 11 of them could be reimplanted. Sexual activity and previous incontinence surgery were associated with a higher complication rate. When comparing results between patients with or without UH or with or without ISD, all groups demonstrated significant (p<0,001) and similar improvement of all efficacy endpoints compared to baseline. There were no significant differences in complication rates between groups. CONCLUSIONS: The long term results demonstrate that ACT® is an effective, safe and durable procedure for recurrent SUI. There is no difference observed for patients with or without UH or ISD. Source of Funding: None
1519 SEVEN-YEAR OUTCOMES OF THE TVT PROCEDURE FOR TREATMENT OF FEMALE STRESS URINARY INCONTINENCE Chang Ho Hyun, Phil Hyun Song*, Hyun Tae Kim, Ki Hak Moon, Tong Choon Park, Daegu, Republic of Korea; Joon Hyung Seo, Kumi, Republic of Korea; Eun Sang Yoo, Hong Seok Shin, Duk Yoon Kim, Choal Hee Park, Chun Il Kim, Hee Chang Jung, Daegu, Republic of Korea INTRODUCTION AND OBJECTIVES: We evaluated the longterm results and predictive risk factor to affect the efficacy after the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence (SUI). METHODS: Three hundred six (mean age, 50.7±8.7 years) women who underwent the TVT procedure for SUI were selected and followed up for at least 7 yr (mean, 83.9 months; range, 62-110 months) after the surgery. We analyzed the long-term results and the predictive parameters for cure rates and patients’ satisfaction. RESULTS: The overall 7-year cure rate was 84.6%, with a satisfaction rate of 69.3%. The cure rates were lower in patients with high grade of SUI (50.0% in grade III; 82.8% in grade II; 90.7% in grade I, p<0.001). On multivariate analysis, there was no independent risk factors related to cure rate, and urgency was the only factor independently associated with patients’ satisfaction (p=0.008; odds ratio=2.468). Seventy one patients (23.2%) had postoperative complications at 1-month follow-up after surgery. But only 8 patients (2.6%) had postoperative complications at 7-year follow-up after surgery, including mesh exposure in 6 patients and de novo urgency in 2 patients. CONCLUSIONS: The absence of long-term adverse events associated with the TVT procedure and high subjective and objective 7-year postoperative success rates without any independent predictive factors affecting long-term cure rate make the TVT procedure a recommendable surgical treatment for female SUI. Source of Funding: None
1520 ONE YEAR RESULTS FROM A WORLD-WIDE REGISTRY OF TVTSECUR™ IN WOMEN WITH STRESS URINARY INCONTINENCE Roger R Dmochowski*, Nashville, TN; Douglas Grier, Edmonds, WA; Nicholas Franco, Naples, FL; TVT-WORLD Investigators INTRODUCTION AND OBJECTIVES: Whilst there is a wealth of long-term data for GYNECARE TVT™, there still exists a paucity of data on newly introduced single-incision mid-urethral slings. A prospective, multicentre registry was established to gather long-term evidence for all GYNECARE mid-urethral slings. Here we report interim results on GYNECARE TVT SECUR™. METHODS: This registry is ongoing at 29 sites in 8 countries. IRB approval and written informed consent was obtained. Candidates for TVT SECUR were invited to participate. Diagnosis of SUI was confirmed by a positive cough stress test and / or urodynamic assessment preoperatively. Evaluations were: baseline, peri-operatively, and at 3, 6, 12
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
months and annually to 5 years. Effectiveness was evaluated by standing cough stress test at 6 and 12 months, and Incontinence Quality of Life instrument (I-QOL). Device-related adverse events were collected. RESULTS: 642 women with SUI underwent a TVT SECUR. ”Hammock“ placement was used in 64.5% and “U“ in 35.5%. Mean age was 54 years (SD 11.6) and mean BMI was 28 (6). 58% were postmenopausal. 39% had a prior hysterectomy and 9.6% previous continence surgery. 65.3% had SUI, while 34.7% had mixed incontinence with predominant symptoms of SUI. In patients without concomitant surgery (81%) mean surgical duration was 17.7 minutes (11.4). 66.5% required local anesthesia with sedation only. Day surgery occurred in 86.8%. Normal voiding at discharge was 89.7%. Mean postoperative pain-score was 1.7 (2.2, score 0 to 10). One (0.2%) patient had a bladder perforation: 3 (0.5%) bleeding >200cc; 1 postoperative retention (0.2%); 10 (1.6%) urinary tract infection; 6 (0.9%) voiding dysfunction; 15 (2.3%) de novo urgency. 5 (0.8%) mesh exposures were detected. Mean number of days to return to social life was 11.4 days (13.8), employment: 14.1 days (18.8) and sexual activity: 43.8 days (29.6). Mean change from baseline in I-QOL to 1 year was 30.8 (95%CI: 23.7-37.8). Improvements in I-QOL observed at 3 months appeared to be maintained at 12 months (Mean score: Baseline 48.4 (23.8, n=592): 3 months 83.2 (19.5, n=517) and 12 months 84 (21.9, n=236)). Objectively, leakage upon cough stress test was observed in 11% patients after 6 months and in 12.5% (95%CI: 7.1-17.9%) at 1 year. CONCLUSIONS: This prospective study reports on the largest series to date of TVT SECUR patients with a follow up of one year. Objective cure rate was 87.5%, accompanied by a significant improvement in the quality of life that does not seem to deteriorate over a period of one year. Source of Funding: Ethicon Women’s Health and Urology
1521 INITIAL EXPERINCE WITH THE MINIARC™ SINGLE INCISION SLING SYSTEM FOR THE TREATMENT OF STRESS URINARY INCONTINENCE Ryan B Pickens*, Wesley M White, Frederick A Klein, W Bedford Waters, Joe D Mobley, III, Knoxville, TN INTRODUCTION AND OBJECTIVES: Over the past decade there have been several advancements for the treatment of stress urinary incontinence (SUI) in females. We report our initial experience with the use of the MiniArc™ Single Incision Sling System. METHODS: This study was a prospective analysis of patients with stress urinary incontinence who underwent surgical intervention with the MiniArc™ Single Incision Sling System. Preoperative evaluation included detailed history, physical exam, Marshall test, IIQ-7and UDI6 forms, and urodynamics (UDS) on all patients. Clinical success was defined as complete resolution of stress uninary incontinence requiring no pads. Patients were followed for persistent leakage quantified by pad usage, pain, urinary urgency, and urinary retention. Statistical analysis was performed. RESULTS: From September 2007 to October 2008, a total of 120 patients underwent placement of the MiniArc™ Single Incision Sling System at our institution for stress urinary incontinence. Mean patient age was 58.4 years (range 26-87). Forty-two(35%) patients had concomitant urge incontinence. The average Body Mass Index (BMI) of our patients was 27.7. Preoperative pad usage was 2.40 per day per patient. At 13 months, 113 out of our 120 patients (94%) had complete resolution of their SUI while 6 reported significant improvement and one patient was a treatment failure. Average pads per day use postoperatively was 0.1 (p<0.05). IIQ-7 and UDI-6 scores went from 2.7 preoperative to 0.1 at one month post-op. Visual pain scores went from 40 at post-op day 1 to 2 at one week post-op. Ten of the 42(24%) patients with preoperative urge incontinence had resolution of urinary urgency postoperatively. There were three intra-operative complications both being bladder perforations during needle passage that healed spontaneously with overnight foley drainage. Two patients had urinary retention immediately postoperative;
THE JOURNAL OF UROLOGY®
score pre-implant of grade 1 and the presence of significant pelvic organ prolapse were found to diminish the efficacy of the procedure. Patient’s quality of life was significantly improved according to all questionnaires. The most common complications that required explant were balloon migration (N=22), port erosion (N=14) and balloon erosion (N=9), but 11 of them could be reimplanted. Sexual activity and previous incontinence surgery were associated with a higher complication rate. When comparing results between patients with or without UH or with or without ISD, all groups demonstrated significant (p<0,001) and similar improvement of all efficacy endpoints compared to baseline. There were no significant differences in complication rates between groups. CONCLUSIONS: The long term results demonstrate that ACT® is an effective, safe and durable procedure for recurrent SUI. There is no difference observed for patients with or without UH or ISD. Source of Funding: None
1519 SEVEN-YEAR OUTCOMES OF THE TVT PROCEDURE FOR TREATMENT OF FEMALE STRESS URINARY INCONTINENCE Chang Ho Hyun, Phil Hyun Song*, Hyun Tae Kim, Ki Hak Moon, Tong Choon Park, Daegu, Republic of Korea; Joon Hyung Seo, Kumi, Republic of Korea; Eun Sang Yoo, Hong Seok Shin, Duk Yoon Kim, Choal Hee Park, Chun Il Kim, Hee Chang Jung, Daegu, Republic of Korea INTRODUCTION AND OBJECTIVES: We evaluated the longterm results and predictive risk factor to affect the efficacy after the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence (SUI). METHODS: Three hundred six (mean age, 50.7±8.7 years) women who underwent the TVT procedure for SUI were selected and followed up for at least 7 yr (mean, 83.9 months; range, 62-110 months) after the surgery. We analyzed the long-term results and the predictive parameters for cure rates and patients’ satisfaction. RESULTS: The overall 7-year cure rate was 84.6%, with a satisfaction rate of 69.3%. The cure rates were lower in patients with high grade of SUI (50.0% in grade III; 82.8% in grade II; 90.7% in grade I, p<0.001). On multivariate analysis, there was no independent risk factors related to cure rate, and urgency was the only factor independently associated with patients’ satisfaction (p=0.008; odds ratio=2.468). Seventy one patients (23.2%) had postoperative complications at 1-month follow-up after surgery. But only 8 patients (2.6%) had postoperative complications at 7-year follow-up after surgery, including mesh exposure in 6 patients and de novo urgency in 2 patients. CONCLUSIONS: The absence of long-term adverse events associated with the TVT procedure and high subjective and objective 7-year postoperative success rates without any independent predictive factors affecting long-term cure rate make the TVT procedure a recommendable surgical treatment for female SUI. Source of Funding: None
1520 ONE YEAR RESULTS FROM A WORLD-WIDE REGISTRY OF TVTSECUR™ IN WOMEN WITH STRESS URINARY INCONTINENCE Roger R Dmochowski*, Nashville, TN; Douglas Grier, Edmonds, WA; Nicholas Franco, Naples, FL; TVT-WORLD Investigators INTRODUCTION AND OBJECTIVES: Whilst there is a wealth of long-term data for GYNECARE TVT™, there still exists a paucity of data on newly introduced single-incision mid-urethral slings. A prospective, multicentre registry was established to gather long-term evidence for all GYNECARE mid-urethral slings. Here we report interim results on GYNECARE TVT SECUR™. METHODS: This registry is ongoing at 29 sites in 8 countries. IRB approval and written informed consent was obtained. Candidates for TVT SECUR were invited to participate. Diagnosis of SUI was confirmed by a positive cough stress test and / or urodynamic assessment preoperatively. Evaluations were: baseline, peri-operatively, and at 3, 6, 12
Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009
months and annually to 5 years. Effectiveness was evaluated by standing cough stress test at 6 and 12 months, and Incontinence Quality of Life instrument (I-QOL). Device-related adverse events were collected. RESULTS: 642 women with SUI underwent a TVT SECUR. ”Hammock“ placement was used in 64.5% and “U“ in 35.5%. Mean age was 54 years (SD 11.6) and mean BMI was 28 (6). 58% were postmenopausal. 39% had a prior hysterectomy and 9.6% previous continence surgery. 65.3% had SUI, while 34.7% had mixed incontinence with predominant symptoms of SUI. In patients without concomitant surgery (81%) mean surgical duration was 17.7 minutes (11.4). 66.5% required local anesthesia with sedation only. Day surgery occurred in 86.8%. Normal voiding at discharge was 89.7%. Mean postoperative pain-score was 1.7 (2.2, score 0 to 10). One (0.2%) patient had a bladder perforation: 3 (0.5%) bleeding >200cc; 1 postoperative retention (0.2%); 10 (1.6%) urinary tract infection; 6 (0.9%) voiding dysfunction; 15 (2.3%) de novo urgency. 5 (0.8%) mesh exposures were detected. Mean number of days to return to social life was 11.4 days (13.8), employment: 14.1 days (18.8) and sexual activity: 43.8 days (29.6). Mean change from baseline in I-QOL to 1 year was 30.8 (95%CI: 23.7-37.8). Improvements in I-QOL observed at 3 months appeared to be maintained at 12 months (Mean score: Baseline 48.4 (23.8, n=592): 3 months 83.2 (19.5, n=517) and 12 months 84 (21.9, n=236)). Objectively, leakage upon cough stress test was observed in 11% patients after 6 months and in 12.5% (95%CI: 7.1-17.9%) at 1 year. CONCLUSIONS: This prospective study reports on the largest series to date of TVT SECUR patients with a follow up of one year. Objective cure rate was 87.5%, accompanied by a significant improvement in the quality of life that does not seem to deteriorate over a period of one year. Source of Funding: Ethicon Women’s Health and Urology
1521 INITIAL EXPERINCE WITH THE MINIARC™ SINGLE INCISION SLING SYSTEM FOR THE TREATMENT OF STRESS URINARY INCONTINENCE Ryan B Pickens*, Wesley M White, Frederick A Klein, W Bedford Waters, Joe D Mobley, III, Knoxville, TN INTRODUCTION AND OBJECTIVES: Over the past decade there have been several advancements for the treatment of stress urinary incontinence (SUI) in females. We report our initial experience with the use of the MiniArc™ Single Incision Sling System. METHODS: This study was a prospective analysis of patients with stress urinary incontinence who underwent surgical intervention with the MiniArc™ Single Incision Sling System. Preoperative evaluation included detailed history, physical exam, Marshall test, IIQ-7and UDI6 forms, and urodynamics (UDS) on all patients. Clinical success was defined as complete resolution of stress uninary incontinence requiring no pads. Patients were followed for persistent leakage quantified by pad usage, pain, urinary urgency, and urinary retention. Statistical analysis was performed. RESULTS: From September 2007 to October 2008, a total of 120 patients underwent placement of the MiniArc™ Single Incision Sling System at our institution for stress urinary incontinence. Mean patient age was 58.4 years (range 26-87). Forty-two(35%) patients had concomitant urge incontinence. The average Body Mass Index (BMI) of our patients was 27.7. Preoperative pad usage was 2.40 per day per patient. At 13 months, 113 out of our 120 patients (94%) had complete resolution of their SUI while 6 reported significant improvement and one patient was a treatment failure. Average pads per day use postoperatively was 0.1 (p<0.05). IIQ-7 and UDI-6 scores went from 2.7 preoperative to 0.1 at one month post-op. Visual pain scores went from 40 at post-op day 1 to 2 at one week post-op. Ten of the 42(24%) patients with preoperative urge incontinence had resolution of urinary urgency postoperatively. There were three intra-operative complications both being bladder perforations during needle passage that healed spontaneously with overnight foley drainage. Two patients had urinary retention immediately postoperative;