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1.
Int Urogynecol J ; 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38739290

RESUMO

INTRODUCTION AND HYPOTHESIS: This study is aimed at developing and validating a new integral parameter, the Biomechanical Integrity score (BI-score) of the female pelvic floor for stress urinary incontinence conditions. METHODS: A total of 130 subjects were included in the observational cohort study; 70 subjects had normal pelvic floor conditions, and 60 subjects had stress urinary incontinence (SUI). A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t test, correlation) to identify the VTI parameters sensitive to the pelvic SUI conditions. RESULTS: Twenty-seven parameters were identified as statistically sensitive to SUI development. They were subdivided into five groups to characterize tissue elasticity (group 1), pelvic support (group 2), pelvic muscle contraction (group 3), involuntary muscle relaxation (group 4), and pelvic muscle mobility (group 5). Every parameter was transformed to its standard deviation units using the dataset for normal pelvic conditions, similar to the T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups 1-5 and to the BI-score in standard deviation units. The p value for the BI-score has p = 4.0 × 10-28 for SUI versus normal conditions. CONCLUSIONS: Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the SUI BI-score in future research and clinical applications.

2.
Int Urogynecol J ; 34(7): 1593-1598, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36645441

RESUMO

INTRODUCTION AND HYPOTHESIS: Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System. METHODS: An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter). RESULTS: Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N. CONCLUSION: The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.


Assuntos
Prolapso de Órgão Pélvico , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Ligamentos Articulares , Vagina/cirurgia , Pelve , Cadáver , Ligamentos/cirurgia , Resultado do Tratamento , Procedimentos Cirúrgicos em Ginecologia/métodos
3.
Int Urogynecol J ; 33(6): 1617-1631, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35230483

RESUMO

INTRODUCTION AND HYPOTHESIS: The aim of this study is to develop and validate a new integral parameter, the Biomechanical Integrity score (BI-score), for the characterization of the female pelvic floor. METHODS: A total of 253 subjects with normal and pelvic organ prolapse (POP) conditions were included in the multi-site observational, case-control study; 125 subjects had normal pelvic floor conditions, and 128 subjects had POP stage II or higher. A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t-test, correlation) to identify the VTI parameters sensitive to the pelvic conditions. RESULTS: Twenty-six parameters were identified as statistically sensitive to POP development. They were subdivided into five groups to characterize (1) tissue elasticity, (2) pelvic support, (3) pelvic muscle contraction, (4) involuntary muscle relaxation, and (5) pelvic muscle mobility. Every parameter was transformed to its standard deviation units against the patient age similar to T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups (1)-(5) and the BI-score in standard deviation units. The p-value for the BI-score has p = 4.3 × 10-31 for POP versus normal conditions. A reference BI-score curve against age for normal pelvic floor conditions was defined. CONCLUSIONS: Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the BI-score in future research and practical applications.


Assuntos
Distúrbios do Assoalho Pélvico , Prolapso de Órgão Pélvico , Estudos de Casos e Controles , Feminino , Humanos , Contração Muscular/fisiologia , Diafragma da Pelve/fisiologia
4.
Open J Obstet Gynecol ; 11(6): 674-688, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35812797

RESUMO

Introduction: The true etiology of pelvic organ prolapse and urinary incontinence and variations observed among individuals are not entirely understood. Tactile (stress) and ultrasound (anatomy, strain) image fusion may furnish new insights into the female pelvic floor conditions. This study aimed to explore imaging performance and clinical value of vaginal tactile and ultrasound image fusion for characterization of the female pelvic floor. Methods: A novel probe with 96 tactile and 192 ultrasound transducers was designed. Women scheduled for a urogynecological visit were considered eligible for enrollment to observational study. Intravaginal tactile and ultrasound images were acquired for vaginal wall deformations at probe insertion, elevation, rotation, Valsalva maneuver, voluntary contractions, involuntary relaxation, and reflex pelvic muscle contractions. Biomechanical mapping has included tactile/ultrasound imaging and functional imaging. Results: Twenty women were successfully studied with the probe. Tactile and ultrasound images for tissues deformation as well as functional images were recorded. Tactile (stress) and ultrasound (strain) images allowed creation of stress-strain maps for the tissues of interest in absolute scale. Functional images allowed identification of active pelvic structures and their biomechanical characterization (anatomical measurements, contractive mobility and strength). Fusion of the modalities has allowed recognition and characterization of levator ani muscles (pubococcygeal, puborectal, iliococcygeal), perineum, urethral and anorectal complexes critical in prolapse and/or incontinence development. Conclusions: Vaginal tactile and ultrasound image fusion provides unique data for biomechanical characterization of the female pelvic floor. Bringing novel biomechanical characterization for critical soft tissues/structures may provide extended scientific knowledge and improve clinical practice.

5.
Female Pelvic Med Reconstr Surg ; 27(1): e28-e38, 2021 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-31625957

RESUMO

OBJECTIVE: This study examined biomechanical changes in pelvic floor after urogynecological surgery. METHODS: This multisite clinical study was designed to explore changes in tissue elasticity, pelvic support, and certain functions (contractive strength, muscle relaxation speed, muscle motility) after pelvic organ prolapse (POP) surgery. A biomechanical mapping of the pelvic floor was performed before and 4 to 6 months after the surgery. The biomechanical data for 52 parameters were acquired by vaginal tactile imaging for manually applied deflection pressures to vaginal walls and pelvic muscle contractions. The two-sample t-test (P < 0.05) was used to test the null hypothesis that presurgery data in group 1 (positive parameter change after surgery) and presurgery data in group 2 (negative parameter change after surgery) belonged to the same distribution. RESULTS: A total of 78 subjects with 255 surgical procedures were analyzed across 5 participating clinical sites. All 52 t-tests for group 1 versus group 2 had P value in the range from 4.0 × 10-10 to 4.3 × 10-2 associating all of the 52 parameter changes after surgery with the presurgical conditions. The P value of before and after surgery correlation ranged from 3.7 × 10-18 to 1.6 × 10-2 for 50 of 52 tests, with Pearson correlation coefficient ranging from -0.79 to -0.27. Thus, vaginal tactile imaging parameters strongly correlated weak pelvic floor presurgery with the positive POP surgery outcome of improved biomechanical properties. CONCLUSIONS: Pelvic organ prolapse surgery, in general, improves the biomechanical conditions and integrity of the weak pelvic floor. The proposed biomechanical parameters can predict changes resulting from POP surgery.


Assuntos
Técnicas de Imagem por Elasticidade/métodos , Elasticidade , Contração Muscular , Diafragma da Pelve/diagnóstico por imagem , Fenômenos Biomecânicos , Feminino , Humanos , Diafragma da Pelve/fisiopatologia , Prolapso de Órgão Pélvico/cirurgia
6.
Open J Obstet Gynecol ; 10(4): 493-503, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32395394

RESUMO

BACKGROUND: Tactile imaging provides biomechanical mapping of soft tissues. Objective biomechanical and anatomical assessment of critical structures within the vagina and pelvis may allow development and validation of a clinical tool that could assist with clinical decisions regarding obstetrical procedures and mode of delivery. Objective: To assess intraobserver reproducibility of measurements of perineal elasticity and pubic bone-perineal critical distance with a novel tactile probe in pregnant women. METHODS: An Antepartum Tactile Imager (ATI) was designed with a vaginal probe resembling a fetal skull. The probe comprises 128 tactile sensors on a double curved surface and measures 46 mm in width and 72 mm in length. The probe has a motion tracking sensor that allows acquisition of 3D tactile images. There were two arms of the study. In the first arm, biomechanical mapping of the perineum and pelvic bone location was performed in 10 non-pregnant women for purposes of demonstrating safety and feasibility. In the second arm, biomechanical mapping was performed in 10 pregnant women to explore intraobserver reproducibility. Each subject had two standardized examinations over 3 - 5 minutes by the same observer. Examination comfort and pain levels were assessed by post-procedure survey. Reproducibility was analyzed by intraclass correlation coefficients (ICC) with 95% confidence intervals and Bland-Altman plots. Bias and the 95% limits of agreement were also calculated. RESULTS: The safety and feasibility arm of the study demonstrated high degree of safety and tolerability and reliable acquisition of tactile signals. In the reproducibility arm, 10 pregnant women were recruited at mean gestational age of 34.2 ± 6.5 weeks. The mean perineum elasticity (Young's modulus, E) was 9.8 ± 5.9 kPa, and the mean pubic bone-perineal critical distance (D) at 20 kPa load was 34.6 ± 6.2 mm. The ICC was 0.97 [95% confidence interval (CI) 0.91, 0.99] and 0.82 [CI 0.44, 0.95] for E and D respectively, consistent with excellent intrarater agreement. The bias and the 95% limits of agreement of E were -6.3% and -29.4% to +16.7%, respectively. The bias and the 95% limits of agreement of D were -2.6% and -25.3% to +20.2%, respectively. CONCLUSIONS: The tactile imaging data obtained in the study reproducibly characterized perineal elasticity and pubic bone-perineal critical distance. Further evaluation of this tool in clinical settings is warranted.

7.
Open J Obstet Gynecol ; 10(1): 85-99, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32133244

RESUMO

BACKGROUND: Premature cervical softening and shortening may be considered an early mechanical failure that predisposes to preterm birth. Preliminary clinical studies demonstrate that cervical elastography may be able to quantify this phenomenon and predict spontaneous preterm delivery. OBJECTIVE: To explore a new approach for cervix elasticity and length measurements with tactile-ultrasound probe. METHODS: Cervix probe has tactile array and ultrasound transducer designed to apply controllable load to cervix and acquire stress-strain data for calculation of cervical elasticity (Young's modulus) and cervical length for four cervix sectors. Average values, standard deviations, intraclass correlation coefficients and the 95% limits of agreement (Bland-Altman plots) were estimated. RESULTS: Ten non-pregnant and ten pregnant women were examined with the probe. The study with non-pregnant women demonstrated a reliable acquisition of the tactile signals. The ultrasound signals had a prolonged appearance; identification of the internal os of the cervix in these signals was not reliable. The study with pregnant women with the gestational age of 25.4 ± 2.3 weeks demonstrated reliable data acquisition with real-time visualization of the ultrasound signals. Average values for cervical elasticity and standard deviations of 19.7 ± 15.4 kPa and length of 30.7 ± 6.6 mm were calculated based on two measurements per 4 sectors. Measurement repeatability calculated as intraclass correlation coefficients between two measurements at the same cervix sector on pregnant women was found to be 0.97 for cervical elasticity and 0.93 for the cervical length. The 95% limits of agreement of 1) cervical elasticity were from -22.4% to +14.9%, and 2) cervical length from -13.3% to +16.5%. CONCLUSIONS: This study demonstrated clinically acceptable measurement performance and reproducibility. The availability of stress-strain data allowed the computation of cervical elasticity and length. This approach has the potential to provide cervical markers to predict spontaneous preterm delivery.

8.
Pelviperineology ; 38(1): 3-11, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31341548

RESUMO

Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into the pathophysiology of pelvic floor disorders including pelvic organ prolapse (POP). An innovative approach - vaginal tactile imaging - allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The objective of this study is to explore an extended set of 52 biomechanical parameters to characterize pelvic floor changes with age, parity, and subject weight for normal pelvic floor conditions. 42 subjects with normal pelvic conditions (no POP, no stress urinary incontinence) were included in the data analysis from an observational, case-controlled study. The Vaginal Tactile Imager (VTI) was used with an analytical software package to automatically calculate 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Val-salva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 12 VTI parameters were identified as statistically sen-sitive (p < 0.05; t-test) to the subject age; 9 parameters were identified as statistically sensitive (p < 0.05; t-test) to the subject parity; no sensitivity was found to subject weight. Among the 12 parameters sensitive to women's age, 6 parameters show changes (decrease) in tissue elasticity and 6 parameters show weakness in pelvic muscle functions with age. Among the 9 parameters sensitive to parity, 5 parameters show changes (decrease) in tissue elasticity and 4 parameters show weakness in pelvic muscle functions after giving birth. The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing pelvic changes with age and parity. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions may be used in future research and practical applications.

9.
Open J Obstet Gynecol ; 8(10): 900-924, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31080695

RESUMO

BACKGROUND: Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into pathophysiology of pelvic organ prolapse (POP). An innovative approach-vaginal tactile imaging-allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The Vaginal Tactile Imager (VTI) records high definition pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. OBJECTIVE: To explore an extended set of 52 biomechanical parameters for differentiation and characterization of POP relative to normal pelvic floor conditions. METHODS: 96 subjects with normal and POP conditions were included in the data analysis from multi-site observational, case-controlled studies; 42 subjects had normal pelvic floor conditions and 54 subjects had POP. The VTI, model 2S, was used with an analytical software package to calculate automatically 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The groups were equalized for subject age and parity. RESULTS: The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 33 of 52 parameters were identified as statistically sensitive (p < 0.05; t-test) to the POP development. Among these 33 parameters, 11 parameters show changes (decrease) in tissue elasticity, 8 parameters show deteriorations in pelvic support and 14 parameters show weakness in muscle functions for POP versus normal conditions. CONCLUSIONS: The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing POP versus normal conditions. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions under POP may be used in future research and practical applications.

10.
Sex Med ; 6(1): 39-48, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29273316

RESUMO

INTRODUCTION: Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. AIM: To develop a new approach for quantitative biomechanical characterization of the vagina. METHODS: Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. RESULTS: Data were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26-90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age. CONCLUSIONS: VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding "normal" vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome. Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39-48.

11.
EC Gynaecol ; 7(11): 431-446, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31093608

RESUMO

INTRODUCTION: Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into the pathophysiology of pelvic organ prolapse (POP). Vaginal tactile imaging is an innovative approach to the biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The Vaginal Tactile Imager (VTI) records high definition pressure patterns through the vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. OBJECTIVE: The objective of this study is to explore an extended set of 52 biomechanical parameters of the female pelvis for the differentiation and characterization of uterine prolapse relative to normal pelvic floor conditions. METHODS: Sixty subjects were included in the data analysis from observational and case-controlled studies. Out of these 60, forty-two subjects had normal pelvic floor conditions and 18 subjects had uterine prolapse (no anterior, no posterior prolapse). The VTI, model 2S, was used with an analytical software package to automatically calculate 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). RESULTS: The ranges, mean values, and standard deviations for all 52 VTI parameters were established. Twenty-two of 52 parameters were identified as statistically sensitive (p < 0.05; t-test) to the development of uterine prolapse. Among these 21 parameters, 6 parameters show changes (decrease) in tissue elasticity, 5 parameters show deteriorations in pelvic support, and 10 parameters show weakness in muscle functions for uterine prolapsed versus normal conditions. CONCLUSION: The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing uterine prolapse versus normal conditions. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions under the prolapse conditions may be useful in future research and practical applications.

12.
Int J Womens Health ; 9: 521-550, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28831274

RESUMO

BACKGROUND: Further progress in restoring a woman's health may be possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic tests. The results of such tests could contribute to the analysis of multiple treatment options and suggest the optimal one for that patient. AIM: To develop a new approach for the biomechanical characterization of vaginal conditions, muscles, and connective tissues in the female pelvic floor. METHODS: Vaginal tactile imaging (VTI) allows biomechanical assessment of the soft tissue along the entire length of the anterior, posterior, and lateral vaginal walls at rest, with manually applied deflection pressures and with muscle contraction, muscle relaxation, and Valsalva maneuver. VTI allows a large body of measurements to evaluate individual variations in tissue elasticity, support defects, as well as pelvic muscle function. Presuming that 1) the female pelvic floor organs are suspended by ligaments against which muscles contract to open or close the outlets and 2) damaged ligaments weaken the support and may reduce the force of muscle contraction, we made an attempt to characterize multiple pelvic floor structures from VTI data. RESULTS: All of the 138 women enrolled in the study were successfully examined with the VTI. The study subjects have had normal pelvic support or pelvic organ prolapse (stages I-IV). The average age of this group of subjects was 60±15 years. We transposed a set of 31 VTI parameters into a quantitative characterization of pelvic muscles and ligamentous structures. Interpretation of the acquired VTI data for normal pelvic floor support and prolapse conditions is proposed based on biomechanical assessment of the functional anatomy. CONCLUSION: Vaginal tactile imaging allows biomechanical characterization of female pelvic floor structures and tissues in vivo, which may help to optimize treatment of the diseased conditions such as prolapse, incontinence, atrophy, and some forms of pelvic pain.

13.
Open J Obstet Gynecol ; 5(9): 505-515, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26389014

RESUMO

The Vaginal Tactile Imager (VTI) records pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. The objective of this study is to validate tactile imaging and muscle contraction parameters (markers) sensitive to the female pelvic floor conditions. Twenty-two women with normal and prolapse conditions were examined by a vaginal tactile imaging probe. We identified 9 parameters which were sensitive to prolapse conditions (p < 0.05 for one-way ANOVA and/or p < 0.05 for t-test with correlation factor r from -0.73 to -0.56). The list of parameters includes pressure, pressure gradient and dynamic pressure response during muscle contraction at identified locations. These parameters may be used for biomechanical characterization of female pelvic floor conditions to support an effective management of pelvic floor prolapse.

14.
Int Urogynecol J ; 26(4): 607-9, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25344223

RESUMO

INTRODUCTION AND HYPOTHESIS: Tactile imaging (TI) is the high-definition pressure mapping technology which allows recording pressure patterns from vaginal walls under applied load and during pelvic floor muscle contraction. The objective of this study was to identify new tactile imaging and muscle contraction markers to characterize female pelvic floor conditions. METHODS: The study subjects included 22 women with normal and prolapse conditions. They were examined by a new vaginal tactile imaging probe that images the entire vagina, the pelvic floor support structures, and pelvic floor muscle contractions. RESULTS: We identified 11 parameters as potential markers to characterize the female pelvic floor conditions. These parameters correlate with prolapse conditions, patient age, and parity. CONCLUSIONS: Our findings suggest that the tactile imaging markers such as pressure, pressure gradient, and dynamic pressure response during muscle contraction may be used for further quantitative characterization of female pelvic floor conditions.


Assuntos
Diagnóstico por Imagem/métodos , Contração Muscular , Distúrbios do Assoalho Pélvico/diagnóstico , Pressão , Tato , Vagina/fisiopatologia , Adulto , Idoso , Fenômenos Biomecânicos , Estudos de Casos e Controles , Elasticidade , Feminino , Humanos , Pessoa de Meia-Idade , Diafragma da Pelve/fisiopatologia
15.
Int Urogynecol J ; 23(1): 5-9, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22086260

RESUMO

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.


Assuntos
Prolapso de Órgão Pélvico/cirurgia , Falha de Prótese , Telas Cirúrgicas/efeitos adversos , Medicina Baseada em Evidências , Feminino , Humanos , Segurança do Paciente , Implantação de Prótese , Estados Unidos , United States Food and Drug Administration
16.
Int Urogynecol J ; 23(4): 459-66, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22072417

RESUMO

INTRODUCTION AND HYPOTHESIS: Vaginal tactile imaging (VTI) is based on principles similar to those of manual palpation. The objective of this study is to assess the clinical suitability of new approach for imaging and tissue elasticity quantification under normal and prolapse conditions. METHODS: The study subjects included 31 women with normal and prolapse conditions. The tissue elasticity (Young's modulus) was calculated from spatial gradients in the resulting 3-D tactile images. RESULTS: Average values for tissue elasticity for the anterior and posterior compartments for normal conditions were 7.4 ± 4.3 kPa and 6.2 ± 3.1 kPa respectively. For Stage III prolapse the average values for tissue elasticity for anterior and posterior compartments were 1.8 ± 0.7 kPa and 1.8 ± 0.5 kPa respectively. CONCLUSIONS: VTI may serve as a means for 3-D imaging of the vagina and a quantitative assessment of vaginal tissue elasticity, providing important information for furthering our understanding of pelvic organ prolapse and surgical treatment.


Assuntos
Elasticidade/fisiologia , Imageamento Tridimensional/métodos , Prolapso de Órgão Pélvico/diagnóstico , Prolapso de Órgão Pélvico/fisiopatologia , Percepção do Tato , Vagina/fisiopatologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Diagnóstico por Imagem/métodos , Módulo de Elasticidade , Feminino , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
17.
IEEE Trans Biomed Eng ; 57(7): 1736-44, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20483695

RESUMO

Changes in the elasticity of the vaginal walls, connective support tissues, and muscles are thought to be significant factors in the development of pelvic organ prolapse, a highly prevalent condition affecting at least 50% of women in the United States during their lifetimes. It creates two predominant concerns specific to the biomechanical properties of pelvic support tissues: how does tissue elasticity affect the development of pelvic organ prolapse and how can functional elasticity be maintained through reconstructive surgery. We designed a prototype of vaginal tactile imager (VTI) for visualization and assessment of elastic properties of pelvic floor tissues. In this paper, we analyze applicability of tactile imaging for evaluation of reconstructive surgery results and characterization of normal and pelvic organ prolapse conditions. A pilot clinical study with 13 patients demonstrated that VTI allows imaging of vaginal walls with increased rigidity due to implanted mesh grafts following reconstructive pelvic surgery and VTI has the potential for prolapse characterization and detection.


Assuntos
Técnicas de Imagem por Elasticidade , Prolapso Uterino/fisiopatologia , Vagina/fisiologia , Idoso , Elasticidade , Técnicas de Imagem por Elasticidade/instrumentação , Técnicas de Imagem por Elasticidade/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Próteses e Implantes
18.
Female Pelvic Med Reconstr Surg ; 16(5): 272-7, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22453505

RESUMO

INTRODUCTION: : Previous investigations have shown an increased risk of mesh erosion when concomitant vaginal hysterectomy is performed at the time of transvaginal reconstruction with mesh. We hypothesize that vaginal hysterectomy can be performed without a high risk of erosion. METHODS: : This is a retrospective, repeated-measures study of women with uterovaginal prolapse who underwent vaginal hysterectomy and pelvic reconstruction with a transvaginal mesh technique using the Prolift system. Mesh was never placed behind the cuff closure and "T" incisions were not used. We compared preoperative quality-of-life and Pelvic Organ Prolapse Quantification values to postoperative values. RESULTS: : Forty women met the study criteria. The median length of follow-up was 12 months (range 4-43 months). Thirty-two (80%) of the women had at least 1 year of follow-up. Significant improvements were found in all quality-of-life measures. Except for genital hiatus and perineal body length, a significant change was seen in all Pelvic Organ Prolapse Quantification measures. The greatest mean change found was for point "C" going from +2.4 to -6.8 cm (P < 0.001). There was 1 (2.5%) mesh erosion. CONCLUSIONS: : When incisions for mesh placement are kept separate from the vaginal cuff, transvaginal mesh reconstruction can be safely performed at the time of hysterectomy.

19.
J Sex Med ; 7(2 Pt 2): 1023-8, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19912488

RESUMO

INTRODUCTION: In a previous study, sexual function was related to a woman's self-perceived body image and degree of bother from pelvic organ prolapse (POP). AIMS: To evaluate sexual function, prolapse symptoms, and self-perceived body image 6 months following treatment for POP and to explore differences in body image perception and sexual function following conservative and surgical treatment for POP. METHODS: After institutional review board approval, consecutive women with > or = stage II POP were invited to participate. In addition to routine urogynecologic history and physical examination, including Pelvic Organ Prolapse Quantification (POP-Q), the participants completed three validated questionnaires before, and 6 months after, treatment for POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Modified Body Image Perception Scale and Prolapse subscale of Pelvic Floor Distress Inventory to assess condition specific bother from POP. Main Outcome Measures. Changes in sexual function and body image perception following treatment for POP. RESULTS: A total of 235 women with a mean age of 62 +/- 12 years returned for a 6-month follow-up. The majority of our participants had surgical repair for POP (88%). At 6-month follow-up visits, the patients reported significant improvement in sexual function from baseline (33 +/- 0.6 vs. 43 +/- 0.8, respectively P < 0.0001). Improvement in sexual function, as measured by PISQ-12, was not significant among sexually active patients treated with a pessary compared with those treated surgically (-2.5 +/- 5.5 vs. 11.5 +/- 1, respectively P < 0.0001). A multivariate linear regression model demonstrated that body mass index and changes in body image perception were the only independent factors associated with changes in PISQ score following POP treatment (beta = -0.5, P < 0.01 and beta = -0.4, P < 0.03, respectively). CONCLUSIONS: Resolution of POP symptoms after treatment improves women's self-perceived body image and sexual function. Not surprisingly, pessary is less effective in improving sexual function compared with surgical repair of POP.


Assuntos
Imagem Corporal , Prolapso de Órgão Pélvico/psicologia , Prolapso de Órgão Pélvico/cirurgia , Sexualidade , Índice de Massa Corporal , Estudos de Coortes , Feminino , Feminilidade , Indicadores Básicos de Saúde , Humanos , Modelos Lineares , Pessoa de Meia-Idade , Análise Multivariada , Satisfação do Paciente , Prolapso de Órgão Pélvico/terapia , Pessários , Estudos Prospectivos , Psicometria , Qualidade de Vida , Disfunções Sexuais Psicogênicas/etiologia , Disfunções Sexuais Psicogênicas/psicologia , Inquéritos e Questionários , Resultado do Tratamento
20.
J Sex Med ; 6(8): 2286-91, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19493287

RESUMO

INTRODUCTION: A previous study demonstrated that women seeking treatment for advanced pelvic organ prolapsed (POP) reported decreased self-perceived body image and decreased quality of life. AIMS: To determine the relationship between: (i) sexual function and POP, (ii) self-perceived body image and POP; and (iii) sexual function and self-perceived body image in women with prolapse. METHODS: After IRB approval, consecutive women with POP stage II or greater presenting for urogynecologic care at one of eight academic medical centers in the United States were invited to participate. In addition to routine urogynecologic history and physical examination, including pelvic organ prolapse quantification (POPQ), consenting participants completed three validated questionnaires: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) to assess sexual function; Modified Body Image Perception Scale (MBIS) to assess self-perceived body image; Prolapse subscale of Pelvic Floor Distress Inventory (POPDI-6) to assess condition specific bother from POP. Pearson's correlations were used to investigate the relationship between independent variables. MAIN OUTCOME MEASURES: Sexual function and modified body image score and its correlation with symptoms of POP. RESULTS: Three hundred eighty-four participants with a mean age of 62 +/- 12 years were enrolled. Median POPQ stage was 3 (range 2-4). 62% (N = 241) were sexually active and 77% (N = 304) were post-menopausal. Mean PISQ-12, MBIS, and POPDI scores were (33 +/- 7, 6 +/- 5, 39 +/- 23, respectively). PISQ-12 scores were not related to stage or compartment (anterior, apical, or posterior) of POP (P > 0.5). Worse sexual function (lower PSIQ-12 scores) correlated with lower body image perception (higher MBIS scores) (rho = -0.39, P < 0001) and more bothersome POP (higher POPDI scores) (rho = -0.34, P < 0001). CONCLUSIONS: Sexual function is related to a woman's self-perceived body image and degree of bother from POP regardless of vaginal topography. Sexual function may be more related to a woman's perception of her body image than to actual topographical changes from POP.


Assuntos
Imagem Corporal , Libido , Prolapso de Órgão Pélvico/complicações , Percepção , Qualidade de Vida , Comportamento Sexual , Disfunções Sexuais Psicogênicas/etiologia , Adaptação Psicológica , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Estudos Transversais , Feminino , Indicadores Básicos de Saúde , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Psicometria , Percepção Social , Estatística como Assunto , Estresse Psicológico , Inquéritos e Questionários
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