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Article ; Online: Analysis of safety data in clinical trials using a recurrent event approach.

Gong, Qi / Tong, Barbara / Strasak, Alexander / Fang, Liang

2014 Volume 13, Issue 2, Page(s) 136–144

Abstract: As an important aspect of the clinical evaluation of an investigational therapy, safety data are routinely collected in clinical trials. To date, the analysis of safety data has largely been limited to descriptive summaries of incidence rates or ... ...

Abstract	As an important aspect of the clinical evaluation of an investigational therapy, safety data are routinely collected in clinical trials. To date, the analysis of safety data has largely been limited to descriptive summaries of incidence rates or contingency tables aiming to compare simple rates between treatment arms. Many have argued that this traditional approach failed to take into account important information including severity, onset time, and multiple occurrences of a safety event. In addition, premature treatment discontinuation due to excessive toxicity causes informative censoring and may lead to potential bias in the interpretation of safety events. In this article, we propose a framework to summarize safety data with mean frequency function and compare safety events of interest between treatments with a generalized log-rank test, taking into account the aforementioned characteristics ignored in traditional analysis approaches. In addition, a multivariate generalized log-rank test to compare the overall safety profile of different treatments is proposed. In the proposed method, safety events are considered to follow a recurrent event process with a terminal event for each patient. The terminal event is modeled by a process of two types of competing risks: safety events of interest and other terminal events. Statistical properties of the proposed method are investigated via simulations. An application is presented with data from a phase II oncology trial.
MeSH term(s)	Clinical Trials as Topic ; Data Interpretation, Statistical ; Humans ; Patient Safety
Language	English
Publishing date	2014-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2083706-9
ISSN	1539-1612 ; 1539-1604
ISSN (online)	1539-1612
ISSN	1539-1604
DOI	10.1002/pst.1611
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Article ; Online: Nutrition of preterm infants in relation to bronchopulmonary dysplasia

Tschirch Edda / Ortner Daniel / Wemhöner Andreas / Strasak Alexander / Rüdiger Mario

BMC Pulmonary Medicine, Vol 11, Iss 1, p

2011 Volume 7

Abstract: Background The pathogenesis of bronchopulmonary dysplasia (BPD) is multifactorial. In addition to prenatal inflammation, postnatal malnutrition also affects lung development. Methods A retrospective study was performed to analyse during the first two ... ...

Abstract	Background The pathogenesis of bronchopulmonary dysplasia (BPD) is multifactorial. In addition to prenatal inflammation, postnatal malnutrition also affects lung development. Methods A retrospective study was performed to analyse during the first two weeks of life the total, enteral and parenteral nutrition of premature infants (<31 weeks, birth weight ≤1500 g) born between 08/04 and 12/06. Results Ninety-five premature infants were analysed: 26 with BPD (27 ± 1 weeks) and 69 without BPD (28 ± 1 weeks). There was no statistical significant difference in the total intake of fluids, calories, glucose or protein and weight gain per day in both groups. The risk of developing BPD was slightly increased in infants with cumulative caloric intake below the minimal requirement of 1230 kcal/kg and a cumulative protein intake below 43.5 g/kg. Furthermore, the risk of developing BPD was significantly higher when infants had a cumulative fluid intake above the recommended 1840 ml/kg. In infants who developed BPD, the enteral nutrition was significantly lower than in non-BPD infants [456 ml/kg (IQR 744, 235) vs. 685 (IQR 987, 511)]. Infants who did not develop BPD reached 50% of total enteral feeding significantly faster [9.6 days vs. 11.5]. Conclusions Preterm infants developing BPD received less enteral feeding, even though it was well compensated by the parenteral nutrient supply. Data suggest that a critical minimal amount of enteral feeding is required to prevent development of BPD; however, a large prospective clinical study is needed to prove this assumption.
Keywords	Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Internal medicine ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Subject code	610
Language	English
Publishing date	2011-02-01T00:00:00Z
Publisher	BioMed Central
Document type	Article ; Online
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Book: Comparing penalized splines and fractional polynomials for flexible modelling of the effects of continuous predictor variables

Lang, Stefan / Pfeiffer, Ruth / Strasak, Alexander / Umlauf, Nikolaus

(Working papers in economics and statistics ; 2010,11)

2010

Author's details	Alexander Strasak, Nikolaus Umlauf, Ruth Pfeiffer and Stefan Lang
Series title	Working papers in economics and statistics ; 2010,11
Language	English
Size	35 S., graph. Darst.
Publisher	Dep. of Economics (Inst. für Wirtschaftstheorie und Wirtschaftsgeschichte) ; Dep. of Public Finance (Inst. für Finanzwiss.) ; Dep. of Statistics (Inst. für Statistik)
Publishing place	Innsbruck
Document type	Book
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Book ; Online: Comparing penalized splines and fractional polynomials for flexible modelling of the effects of continuous predictor variables

Lang, Stefan / Pfeiffer, Ruth / Strasak, Alexander / Umlauf, Nikolaus

(Working papers in economics and statistics ; 2010-11)

2010

Abstract: P(enalized)-splines and fractional polynomials (FPs) have emerged as powerful smoothing techniques with increasing popularity in several fields of applied research. Both approaches provide considerable flexibility, but only limited comparative ... ...

Author's details	Alexander Strasak; Nikolaus Umlauf; Ruth Pfeiffer; Stefan Lang
Series title	Working papers in economics and statistics ; 2010-11
Abstract	P(enalized)-splines and fractional polynomials (FPs) have emerged as powerful smoothing techniques with increasing popularity in several fields of applied research. Both approaches provide considerable flexibility, but only limited comparative evaluations of the performance and properties of the two methods have been conducted to date. We thus performed extensive simulations to compare FPs of degree 2 (FP2) and degree 4 (FP4) and P-splines that used generalized cross validation (GCV) and restricted maximum likelihood (REML) for smoothing parameter selection. We evaluated the ability of P-splines and FPs to recover the "true" functional form of the association between continuous, binary and survival outcomes and exposure for linear, quadratic and more complex, non-linear functions, using different sample sizes and signal to noise ratios. We found that for more curved functions FP2, the current default implementation in standard software, showed considerably bias and consistently higher mean squared error (MSE) compared to spline-based estimators (REML, GCV) and FP4, that performed equally well in most simulation settings. FPs however, are prone to artefacts due to the specific choice of the origin, while P-splines based on GCV reveal sometimes wiggly estimates in particular for small sample sizes. Finally,we highlight the specific features of the approaches in a real dataset. -- generalized additive models GAMs simulation smoothing
Language	English
Size	Online-Ressource (35 S.), graph. Darst.
Publisher	Univ. of Innsbruck, Inst. für Finanzwiss
Publishing place	Innsbruck
Document type	Book ; Online
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Article ; Online: Pharmacokinetics of trastuzumab emtansine (T-DM1) as a single agent or in combination with pertuzumab in HER2-positive breast cancer patients with recurrent or locally advanced metastatic breast cancer.

Lu, Dan / Li, Chunze / Riggs, Matthew / Polhamus, Daniel / French, Jonathan / Agarwal, Priya / Chen, Shang-Chiung / Vadhavkar, Shweta / Patre, Monika / Strasak, Alexander / Quartino, Angelica / Jin, Jin Yan / Girish, Sandhya

Cancer chemotherapy and pharmacology

2019 Volume 84, Issue 1, Page(s) 175–185

Abstract: Purpose: The phase III MARIANNE study investigated single-agent trastuzumab emtansine (T-DM1) and combination T-DM1 plus pertuzumab as the first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). ... ...

Abstract	Purpose: The phase III MARIANNE study investigated single-agent trastuzumab emtansine (T-DM1) and combination T-DM1 plus pertuzumab as the first-line treatment for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Pharmacokinetic properties of T-DM1 and pertuzumab in these patients and the potential for drug-drug interactions (DDIs) were assessed. Methods: Pharmacokinetic samples of T-DM1-related analytes (T-DM1 conjugate, total trastuzumab, DM1) and pertuzumab were analyzed. Observed pharmacokinetic data were summarized for all analytes. Historical population pharmacokinetic models for T-DM1 conjugate and pertuzumab in HER2-positive MBC were used to derive empirical Bayes estimates of pharmacokinetic parameters. Results: In MARIANNE (N = 375), mean ± standard deviation population pharmacokinetic model-predicted Cycle 1 C Conclusions: Based on the population pharmacokinetic analysis of T-DM1 conjugate and pertuzumab, pharmacokinetics are similar across different lines of treatment and stages of disease including previously untreated MBC patients, and no DDIs were identified for combined use of T-DM1 and pertuzumab.
MeSH term(s)	Ado-Trastuzumab Emtansine/administration & dosage ; Ado-Trastuzumab Emtansine/pharmacokinetics ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Area Under Curve ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Drug Interactions ; Female ; Humans ; Models, Biological ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Receptor, ErbB-2/metabolism
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antineoplastic Agents, Immunological ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; pertuzumab (K16AIQ8CTM) ; Ado-Trastuzumab Emtansine (SE2KH7T06F)
Language	English
Publishing date	2019-05-17
Publishing country	Germany
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	6820-2
ISSN	1432-0843 ; 0344-5704 ; 0943-9404
ISSN (online)	1432-0843
ISSN	0344-5704 ; 0943-9404
DOI	10.1007/s00280-019-03852-z
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Article ; Online: Nutrition of preterm infants in relation to bronchopulmonary dysplasia.

Wemhöner, Andreas / Ortner, Daniel / Tschirch, Edda / Strasak, Alexander / Rüdiger, Mario

BMC pulmonary medicine

2011 Volume 11, Page(s) 7

Abstract: Background: The pathogenesis of bronchopulmonary dysplasia (BPD) is multifactorial. In addition to prenatal inflammation, postnatal malnutrition also affects lung development.: Methods: A retrospective study was performed to analyse during the first ... ...

Abstract	Background: The pathogenesis of bronchopulmonary dysplasia (BPD) is multifactorial. In addition to prenatal inflammation, postnatal malnutrition also affects lung development. Methods: A retrospective study was performed to analyse during the first two weeks of life the total, enteral and parenteral nutrition of premature infants (<31 weeks, birth weight ≤1500 g) born between 08/04 and 12/06. Results: Ninety-five premature infants were analysed: 26 with BPD (27 ± 1 weeks) and 69 without BPD (28 ± 1 weeks). There was no statistical significant difference in the total intake of fluids, calories, glucose or protein and weight gain per day in both groups. The risk of developing BPD was slightly increased in infants with cumulative caloric intake below the minimal requirement of 1230 kcal/kg and a cumulative protein intake below 43.5 g/kg. Furthermore, the risk of developing BPD was significantly higher when infants had a cumulative fluid intake above the recommended 1840 ml/kg. In infants who developed BPD, the enteral nutrition was significantly lower than in non-BPD infants [456 ml/kg (IQR 744, 235) vs. 685 (IQR 987, 511)]. Infants who did not develop BPD reached 50% of total enteral feeding significantly faster [9.6 days vs. 11.5]. Conclusions: Preterm infants developing BPD received less enteral feeding, even though it was well compensated by the parenteral nutrient supply. Data suggest that a critical minimal amount of enteral feeding is required to prevent development of BPD; however, a large prospective clinical study is needed to prove this assumption.
MeSH term(s)	Bronchopulmonary Dysplasia/epidemiology ; Bronchopulmonary Dysplasia/etiology ; Energy Intake ; Enteral Nutrition ; Female ; Glucose ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Male ; Nutrition Assessment ; Nutritional Requirements ; Parenteral Nutrition ; Proteins ; Retrospective Studies ; Risk Factors
Chemical Substances	Proteins ; Glucose (IY9XDZ35W2)
Language	English
Publishing date	2011-02-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2059871-3
ISSN	1471-2466 ; 1471-2466
ISSN (online)	1471-2466
ISSN	1471-2466
DOI	10.1186/1471-2466-11-7
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Article ; Online: Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer.

Krop, Ian E / Modi, Shanu / LoRusso, Patricia M / Pegram, Mark / Guardino, Ellie / Althaus, Betsy / Lu, Dan / Strasak, Alexander / Elias, Anthony

Breast cancer research : BCR

2016 Volume 18, Issue 1, Page(s) 34

Abstract: Background: In pre-clinical studies, the anti-tumor activity of T-DM1 was enhanced when combined with taxanes or pertuzumab. This phase 1b/2a study evaluated the safety/tolerability of T-DM1 + paclitaxel ± pertuzumab in HER2-positive advanced breast ... ...

Abstract	Background: In pre-clinical studies, the anti-tumor activity of T-DM1 was enhanced when combined with taxanes or pertuzumab. This phase 1b/2a study evaluated the safety/tolerability of T-DM1 + paclitaxel ± pertuzumab in HER2-positive advanced breast cancer. Methods: In phase 1b (n = 60), a 3 + 3 dose-escalation approach was used to determine the maximum tolerated dose (MTD) of T-DM1 + paclitaxel ± pertuzumab. The primary objective of phase 2a was feasibility, with 44 patients randomized to T-DM1 + paclitaxel ± pertuzumab at the MTD identified in phase 1b. Results: The MTD was T-DM1 3.6 mg/kg every three weeks (q3w) or 2.4 mg/kg weekly + paclitaxel 80 mg/m(2) weekly ± pertuzumab 840 mg loading dose followed by 420 mg q3w. Phase 2a patients had received a median of 5.0 (range: 0-10) prior therapies for advanced cancer. In phase 2a, 51.2 % received ≥12 paclitaxel doses within 15 weeks, and 14.0 % received 12 paclitaxel doses by week 12. Common all-grade adverse events (AEs) were peripheral neuropathy (90.9 %) and fatigue (79.5 %). A total of 77.3 % experienced grade ≥3 AEs, most commonly neutropenia (25.0 %) and peripheral neuropathy (18.2 %). Among the 42 phase 2a patients with measurable disease, the objective response rate (ORR) was 50.0 % (95 % confidence interval (CI) 34.6-65.4); the clinical benefit rate (CBR) was 56.8 % (95 % CI 41.6-71.0). No pharmacokinetic interactions were observed between T-DM1 and paclitaxel. Conclusions: This regimen showed clinical activity. Although there is potential for paclitaxel to be added to T-DM1 ± pertuzumab, peripheral neuropathy was common in this heavily pretreated population. Trial registration: ClinicalTrials.gov NCT00951665 . Registered August 3, 2009.
MeSH term(s)	Adult ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Breast Neoplasms/drug therapy ; Breast Neoplasms/pathology ; Female ; Humans ; Maximum Tolerated Dose ; Maytansine/administration & dosage ; Maytansine/adverse effects ; Maytansine/analogs & derivatives ; Middle Aged ; Paclitaxel/administration & dosage ; Paclitaxel/adverse effects ; Trastuzumab
Chemical Substances	Antibodies, Monoclonal, Humanized ; Maytansine (14083FR882) ; pertuzumab (K16AIQ8CTM) ; Trastuzumab (P188ANX8CK) ; Paclitaxel (P88XT4IS4D) ; ado-trastuzumab emtansine (SE2KH7T06F)
Language	English
Publishing date	2016-03-15
Publishing country	England
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/s13058-016-0691-7
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Article ; Online: Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens.

Chen, Shang-Chiung / Quartino, Angelica / Polhamus, Daniel / Riggs, Matthew / French, Jonathan / Wang, Xin / Vadhavkar, Shweta / Smitt, Melanie / Hoersch, Silke / Strasak, Alexander / Jin, Jin Yan / Girish, Sandhya / Li, Chunze

British journal of clinical pharmacology

2017 Volume 83, Issue 12, Page(s) 2767–2777

Abstract: Aims: We conducted population pharmacokinetic (PopPK) and exposure-response analyses for trastuzumab emtansine (T-DM1), to assess the need for T-DM1 dose optimization in patients with low exposure by using TH3RESA [A Study of Trastuzumab Emtansine in ... ...

Abstract	Aims: We conducted population pharmacokinetic (PopPK) and exposure-response analyses for trastuzumab emtansine (T-DM1), to assess the need for T-DM1 dose optimization in patients with low exposure by using TH3RESA [A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With human epidermal growth factor receptor 2 (HER2)-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy] study data (NCT01419197). The randomized phase III TH3RESA study investigated T-DM1 vs. treatment of physician's choice (TPC) in patients with heavily pretreated HER2-positive advanced breast cancer. Methods: We compared a historical T-DM1 PopPK model with T-DM1 pharmacokinetics in TH3RESA and performed exposure-response analyses using model-predicted cycle 1 maximum concentration (C Results: T-DM1 concentrations in TH3RESA were described well by the historical PopPK model. Patients with higher cycle 1 C Conclusions: Exposure-response relationships for efficacy were inconsistent across exposure metrics. HRs for survival in patients in the lowest T-DM1 exposure quartile vs. matched TPC-treated patients suggest that, compared with TCP, the approved T-DM1 dose is unlikely to be detrimental to patients with low exposure.
MeSH term(s)	Ado-Trastuzumab Emtansine ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/blood ; Antineoplastic Agents, Immunological/pharmacokinetics ; Area Under Curve ; Breast Neoplasms/blood ; Breast Neoplasms/drug therapy ; Breast Neoplasms/enzymology ; Breast Neoplasms/mortality ; Disease-Free Survival ; Female ; Humans ; Infusions, Intravenous ; Kaplan-Meier Estimate ; Logistic Models ; Maytansine/administration & dosage ; Maytansine/adverse effects ; Maytansine/analogs & derivatives ; Maytansine/blood ; Maytansine/pharmacokinetics ; Metabolic Clearance Rate ; Models, Biological ; Nonlinear Dynamics ; Proportional Hazards Models ; Receptor, ErbB-2/antagonists & inhibitors ; Receptor, ErbB-2/metabolism ; Risk Assessment ; Trastuzumab/administration & dosage ; Trastuzumab/adverse effects ; Trastuzumab/blood ; Trastuzumab/pharmacokinetics ; Treatment Outcome ; Tubulin Modulators/administration & dosage ; Tubulin Modulators/adverse effects ; Tubulin Modulators/blood ; Tubulin Modulators/pharmacokinetics
Chemical Substances	Antineoplastic Agents, Immunological ; Tubulin Modulators ; Maytansine (14083FR882) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; Ado-Trastuzumab Emtansine (SE2KH7T06F)
Language	English
Publishing date	2017-09-03
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13381
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Article ; Online: Single shot of alemtuzumab as induction therapy after kidney transplantation is sufficient.

Boesmueller, Claudia / Sieb, Michael / Pascher, Andreas / Klempnauer, Juergen / Muehlbacher, Ferdinand / Strasak, Alexander / Margreiter, Raimund

Transplant international : official journal of the European Society for Organ Transplantation

2011 Volume 24, Issue 11, Page(s) 1053–1058

Abstract: In an earlier study, we were able to show that Tac monotherapy following 2 × 20 mg alemtuzumab induction is at least as effective as Tac-based triple-drug immunosuppression in cadaveric renal transplantation. We were interested to learn whether 1 × 30 mg ...

Abstract	In an earlier study, we were able to show that Tac monotherapy following 2 × 20 mg alemtuzumab induction is at least as effective as Tac-based triple-drug immunosuppression in cadaveric renal transplantation. We were interested to learn whether 1 × 30 mg of alemtuzumab is as effective as 2 × 20 mg. Patients of the initial study group (group A) received 20 mg alemtuzumab on days 0 and 2, and tac monotherapy from day 2 on. This group acted as control group for the new arm (group C), where patients were given only 1 × 30 mg alemtuzumab on day 0 followed by Tac monotherapy from day 2 on with the same target levels as in the control group. Frequency of rejection at 6 months was 15% in the control group compared to 6% in the study group and 20% at 12 months in group A versus 6% in group C (P = 0.034). Time to rejection was 4.9 months in group A and 0.8 in group C. One-year patient survival was 98.5% in both groups, graft survival 96.9% in group A, and 98.5% in group C. Safety profile was similar in both groups apart from more viral and bacterial infections in group C. Single shot alemtuzumab induction of 30 mg is as effective as 2 × 20 mg in cadaveric renal transplantation.
MeSH term(s)	Adolescent ; Adult ; Aged ; Alemtuzumab ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Neoplasm/administration & dosage ; Cytomegalovirus Infections ; Female ; Graft Rejection ; Graft Survival/drug effects ; Humans ; Immunosuppression/methods ; Immunosuppressive Agents/administration & dosage ; Kidney Transplantation/adverse effects ; Male ; Middle Aged ; Neoadjuvant Therapy ; Tacrolimus/therapeutic use ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antibodies, Neoplasm ; Immunosuppressive Agents ; Alemtuzumab (3A189DH42V) ; Tacrolimus (WM0HAQ4WNM)
Language	English
Publishing date	2011-11
Publishing country	England
Document type	Journal Article
ZDB-ID	639435-8
ISSN	1432-2277 ; 0934-0874
ISSN (online)	1432-2277
ISSN	0934-0874
DOI	10.1111/j.1432-2277.2011.01315.x
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Article ; Online: Single institution experience with the transobturator sling suspension system AdVance® in the treatment of male urinary incontinence: mid-term results.

Berger, Andreas P / Strasak, Alexander / Seitz, Christian / Rein, Patrick / Hobisch, Alfred

International braz j urol : official journal of the Brazilian Society of Urology

2011 Volume 37, Issue 4, Page(s) 488–494

Abstract: Purpose: To evaluate the clinical outcome after placement of AdVance® sling in men with stress urinary incontinence after prostate surgery.: Materials and methods: Incontinence was assessed on basis of number of pad usage. Patients' satisfaction was ... ...

Abstract	Purpose: To evaluate the clinical outcome after placement of AdVance® sling in men with stress urinary incontinence after prostate surgery. Materials and methods: Incontinence was assessed on basis of number of pad usage. Patients' satisfaction was evaluated using a non-validated patient questionnaire at 12 months post-operatively. Results: Incontinence cure rate (no pad usage) was 61.5% (16/26) and improvement (1-2 pads per day) was seen in 26.9% (7/26). No improvement was observed in 11.5% (3/26) of patients. A total of 87.5% (21/24) of patients were very satisfied with the operation 22 months after surgery. Success rate in patients with prior radiation therapy (20% cure; 40% improvement) was significantly worse. Conclusions: Placement of the AdVance® sling represents an effective and safe treatment option for patients with post prostate surgery incontinence. Patients that underwent radiotherapy after prostate surgery had lower success rate.
MeSH term(s)	Aged ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Patient Satisfaction ; Postoperative Complications ; Prostate/surgery ; Prostatectomy/adverse effects ; Retrospective Studies ; Statistics, Nonparametric ; Suburethral Slings ; Treatment Outcome ; Urinary Incontinence, Stress/surgery
Language	English
Publishing date	2011-09-02
Publishing country	Brazil
Document type	Evaluation Studies ; Journal Article
ZDB-ID	2206649-4
ISSN	1677-6119 ; 1677-5538
ISSN (online)	1677-6119
ISSN	1677-5538
DOI	10.1590/s1677-55382011000400008
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