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BACKGROUND: Female sexual dysfunction is common in the general population, with age emerging as a significant determinant of sexual activity and functioning. AIM: To establish age-specific reference scores for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in the general Dutch female population. METHODS: A retrospective, cross-sectional, questionnaire-based study was conducted in the Netherlands. The study population comprised 2518 Dutch-speaking women aged ≥18 years, representing a cross section of the general Dutch population. The PISQ-12 was used to assess sexual functioning in heterosexual women. The Groningen Defecation and Fecal Continence questionnaire was utilized to demonstrate demographic factors. OUTCOMES: We established age-specific reference scores for the PISQ-12 in the general Dutch population. RESULTS: Of the 2518 women, 1592 (63.2%) were sexually active and 926 (36.8%) were not. Further analysis focused on the sexually active group: we found a decrease in mean total PISQ scores, ranging from 38.34 among 18- to 34-year-olds to 36.98 among ≥65-year-olds. Older women scored lower in the behavior domain, specifically pertaining to sexual desire (P < .001) and sexual excitement (P < .001). They also had lower scores in the partner-related domain regarding partner problems of erection (P < .001) and orgasm perception (P < .001). With increasing age, negative emotional reaction scores were higher (P < .001). In the physical domain, we observed significantly different scores for pain during sexual intercourse (P < .001) and restrictions in sexual activity due to fear of urinary leakage (P < .001), with the lowest scores in the youngest group. CLINICAL IMPLICATIONS: These age-specific references scores of the PISQ-12 provide an overview of sexual functioning of a general population, which enables caregivers to assess and interpret patients' individual scores more accurately. STRENGTHS AND LIMITATIONS: We included only sexually active women in our subanalyses, potentially introducing selection bias for older women with better physical conditions. The study's strength lies in its extensive sample size, representing a cross section of the general Dutch population. Furthermore, the self-administered questionnaire approach helped minimize embarrassment and obtain realistic responses. CONCLUSION: Our study demonstrated age-specific PISQ-12 reference scores and highlighted associations between aging and diminishing scores of sexual desire, sexual excitement, erection problems, and orgasm perception, while women aged 18 to 34 years reported the lowest scores for pain during intercourse and limited sexual activity due to fear of urinary leakage.
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Conducta Sexual , Humanos , Femenino , Países Bajos , Adulto , Estudios Retrospectivos , Estudios Transversales , Persona de Mediana Edad , Encuestas y Cuestionarios , Conducta Sexual/psicología , Adulto Joven , Anciano , Factores de Edad , Adolescente , Prolapso de Órgano Pélvico , Incontinencia Urinaria/psicología , Disfunciones Sexuales Fisiológicas , Valores de ReferenciaRESUMEN
INTRODUCTION AND HYPOTHESIS: Pelvic floor damage can contribute to pelvic floor dysfunction, including constipation. Most studies focus on constipation during pregnancy, whereas information regarding the mode of delivery in relation to constipation is limited. We hypothesise that women with a history of vaginal delivery report constipation more often than women with a history of caesarean section. METHODS: This was a retrospective cross-sectional multicentre study conducted in the Netherlands. All included patients (n = 2,643) completed the Groningen Defecation and Fecal Continence questionnaire to assess bowel problems of the last 6 months. Parametric tests, Chi-squared, univariable and multivariable regression analyses were performed. RESULTS: Among 2,643 parous women, 2,248 delivered vaginally (85.1%) and 395 (14.9%) by caesarean section. Altogether, 649 women (24.6%) suffered from constipation. Women in the vaginal delivery group were constipated more often than women in the caesarean section group (25.5% versus 19.0%, p = 0.005). For women who had delivered vaginally, multivariable regression analysis showed an odds ratio for constipation of 1.47 (95% confidence interval, 1.109-1.938, p = 0.007). The odds ratio for constipation in women with a spontaneous perineal tear was 1.4 times higher than in women with an intact perineum (p = 0.030). Furthermore, the vaginal delivery group reported difficulties regarding bowel emptying (p = 0.048), straining (p = 0.027), incomplete defecation (p = 0.043), not able to defecate daily (p = 0.018), manually assisted defecation (p = 0.015) and had higher Renzi scores (p = 0.043) more often. CONCLUSIONS: Women in the vaginal delivery group have higher prevalences and odds ratios for constipation. Furthermore, a perineal tear during vaginal delivery increases the odds ratio for constipation.
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Cesárea , Estreñimiento , Parto Obstétrico , Humanos , Estreñimiento/epidemiología , Estreñimiento/etiología , Femenino , Estudios Retrospectivos , Adulto , Estudios Transversales , Parto Obstétrico/efectos adversos , Parto Obstétrico/estadística & datos numéricos , Encuestas y Cuestionarios , Embarazo , Cesárea/estadística & datos numéricos , Cesárea/efectos adversos , Países Bajos/epidemiología , Persona de Mediana EdadRESUMEN
OBJECTIVE: To investigate women's preference for modified Manchester (MM) or sacrospinous hysteropexy (SH) as surgery for uterine prolapse. DESIGN: Labelled discrete choice experiment (DCE). SETTING: Eight Dutch hospitals. POPULATION: Women with uterine prolapse, eligible for primary surgery and preference for uterus preservation. METHODS: DCEs are attribute-based surveys. The two treatment options were labelled as MM and SH. Attributes in this survey were treatment success ( levels SH: 84%, 89%, 94%; levels MM: 89%, 93%, 96%), dyspareunia (levels: 0%, 5%, 10%), cervical stenosis (levels: 1%, 6%, 11%) and severe buttock pain (levels: 0%, 1%). A different combination of attribute levels was used in each choice set. Women completed nine choice sets, making a choice based on attribute levels. Data were analysed in multinomial logit models. MAIN OUTCOME MEASURES: Women's preference for MM or SH. RESULTS: 137 DCEs were completed (1233 choice sets). SH was chosen in 49% of the choice sets, MM in 51%. Of all women, 39 (28%) always chose the same surgery. After exclusion of this group, 882 choice sets were analysed, in which women preferred MM, likely associated with a labelling effect, i.e. description of the procedure, rather than the tested attributes. In that group, MM was chosen in 53% of the choice sets and SH in 47%. When choosing MM, next to the label, dyspareunia was relevant for decision-making. For SH, all attributes were relevant for decision-making. CONCLUSIONS: The preference of women for MM or SH seems almost equally divided. The variety in preference supports the importance of individualised healthcare.
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Dispareunia , Prolapso Uterino , Femenino , Humanos , Prolapso Uterino/cirugía , Prioridad del Paciente , Dispareunia/etiología , Útero/cirugía , Encuestas y Cuestionarios , Resultado del Tratamiento , Conducta de ElecciónRESUMEN
OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were 3567 and 6688. ICER for MUS surgery cost 15 598 per IIQ QALY and 37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of 25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.
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Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Humanos , Femenino , Incontinencia Urinaria de Esfuerzo/cirugía , Análisis Costo-Beneficio , Calidad de Vida , Estudios de Cohortes , Estudios Prospectivos , Dimetilpolisiloxanos , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.
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Laparoscopía , Prolapso de Órgano Pélvico , Femenino , Humanos , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Vagina/cirugía , Prolapso de Órgano Pélvico/cirugía , Prolapso de Órgano Pélvico/etiología , Histerectomía/efectos adversos , Resultado del Tratamiento , Mallas Quirúrgicas/efectos adversos , Laparoscopía/efectos adversosRESUMEN
OBJECTIVES: Midurethral slings are considered the gold standard for the surgical treatment of stress urinary incontinence (SUI), with an efficacy up to 80%. Another therapeutic option is the use of bulking agents, which create an artificial mass in the urethral submucosa, with an efficacy varying from 64% to 74%. Although bulking agents have a lower risk of complications than midurethral sling surgery, they are mainly used in case a midurethral sling is not an option or if midurethral sling surgery failed to cure stress urinary incontinence. In this study, we offer all patients with SUI in secondary care a choice between a single-incision midurethral sling procedure and treatment with a bulking agent. We want to examine patient preference and patient satisfaction for both procedures. We expect that offering both interventions in combination with standardized counselling will result in high patient satisfaction. DESIGN: In this non-randomized controlled trial, 266 patients will be objectively counselled for both interventions, after which all patients will choose between single-incision midurethral slings and polyacrylamide hydrogel (PAHG), followed by the standard care procedure for women with SUI. PARTICIPANTS/MATERIALS, SETTING, METHODS: From January 1, 2021, onward, all consecutive adult patients (between 18 and 80 years of age) attending the outpatient gynaecology department with objectively confirmed, moderate to severe SUI will be eligible for enrolment in this non-randomized study. The primary outcome is patient satisfaction at 1 year, measured by the Patient Global Impression of Improvement; secondary outcomes are patient satisfaction at 3 months, objective and subjective cure at 3 months and 1 year, adverse events, post-operative pain, and cost-effectiveness. Differences in outcome measures will be assessed through logistic and linear regression analyses, both unadjusted and adjusted with covariate adjustment using the propensity score. RESULTS: No results are available yet. LIMITATIONS: The major disadvantage of this study design is the potential confounding bias. We intend to eliminate this bias by applying propensity scoring. CONCLUSION: By designing a non-randomized patient preference trial, we not only expect to demonstrate high patient satisfaction with both interventions but also provide insight into the possible role of PAHG-injections in the treatment of female SUI as a first-choice non-conservative treatment.
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Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Adulto , Femenino , Humanos , Resultado del Tratamiento , Cabestrillo Suburetral/efectos adversos , Incontinencia Urinaria de Esfuerzo/cirugía , Dolor Postoperatorio/etiología , Satisfacción del PacienteRESUMEN
OBJECTIVES: This study was designed to develop an algorithm for the diagnosis of cervical high-grade squamous intraepithelial lesions (HSIL), based on patterns of volatile organic compounds, evaluated using an e-nose. METHODS: For this pilot study, the study population consisted of a group of 25 patients with histologically confirmed HSIL and a group of 26 controls. Controls consisted of women visiting the outpatient department for gynecological complaints unrelated to cancer. Women had a negative high-risk human papillomavirus and/or normal cytology (negative for intraepithelial lesions of malignancy) of their most recent test performed in the context of participation in routine cervical cancer screening. Breath tests were performed and labeled with the correct diagnosis. Machine-learning techniques were used to develop a model for predicting HSIL. Based on the receiver operating characteristics curve, both sensitivity and specificity were calculated. RESULTS: Individual classifications of all patients with HSIL and controls, as calculated by the model, showed a sensitivity of 0.88 (95% CI = 0.68-0.97) and specificity of 0.92 (95% CI = 0.73-0.99). The positive predictive value and the negative predictive value were 0.92 (95% CI = 0.72-0.99) and 0.89 (95% CI = 0.70-0.97), respectively. The Cohen κ coefficient was 0.80. CONCLUSIONS: E-nose can detect distinctive patterns of volatile organic compounds between cervical HSIL patients and controls. Validation of the algorithm in further studies is necessary before possible implementation into daily practice.
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Carcinoma in Situ , Carcinoma de Células Escamosas , Infecciones por Papillomavirus , Lesiones Intraepiteliales Escamosas de Cuello Uterino , Lesiones Intraepiteliales Escamosas , Displasia del Cuello del Útero , Neoplasias del Cuello Uterino , Compuestos Orgánicos Volátiles , Humanos , Femenino , Neoplasias del Cuello Uterino/patología , Detección Precoz del Cáncer/métodos , Proyectos Piloto , Carcinoma de Células Escamosas/patología , Algoritmos , Displasia del Cuello del Útero/patología , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/epidemiología , Papillomaviridae , Lesiones Intraepiteliales Escamosas de Cuello Uterino/diagnósticoRESUMEN
Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure. Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent. Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen. Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217). Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications. Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups. Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure. Trial Registration: TrialRegister.nl Identifier: NTR 6978.
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Prolapso de Órgano Pélvico , Prolapso Uterino , Femenino , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Ginecológicos/métodos , Prolapso de Órgano Pélvico/cirugía , Resultado del Tratamiento , Prolapso Uterino/cirugía , Útero/cirugía , AncianoRESUMEN
INTRODUCTION AND HYPOTHESIS: Great variety in clinical management of pelvic organ prolapse (POP) has been described over the last years. Practice pattern variation (PPV) reflects differences in care that cannot be explained by the underlying condition. We aim to explore whether PPV in management of POP in The Netherlands has changed between 2011 and 2017. METHODS: We conducted a multicenter cohort study, using prospective routinely collected benchmark data from LOGEX, a healthcare analytics company (Amsterdam, The Netherlands). Data of patients with a diagnosis POP from 50 hospitals (16 teaching and 34 non-teaching hospitals) were collected for the years 2011 and 2017. All treatments were categorized into three groups: conservative treatment, uterus-preserving or uterus-removing surgery. Using meta-analysis, we evaluated whether the proportions of conducted treatments changed over time and estimated the between-center variation (Cochran's Q), reflecting the PPV in 2011 and 2017. This variation was analyzed using F-tests. RESULTS: Compared to 2011, referral for POP in 2017 decreased by 16.2% (-4505 patients), and the percentage of hysterectomies decreased by 33.6% (p < 0.0001). The PPV of POP surgery decreased significantly by 47.2% (p = 0.0137) and of hysterectomies by 41.5% (p = 0.0316). CONCLUSIONS: We found a decline in PPV for POP surgery between 2011 and 2017. Furthermore, the number of surgical interventions decreased, which was mostly due to a decline of hysterectomies. This indicates a shift toward more conservative therapy and uterus preservation. A further reduction of PPV would be beneficial for the quality of health care.
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Prolapso de Órgano Pélvico , Estudios de Cohortes , Femenino , Humanos , Estudios Multicéntricos como Asunto , Países Bajos , Prolapso de Órgano Pélvico/cirugía , Estudios Prospectivos , Resultado del Tratamiento , Útero/cirugíaRESUMEN
INTRODUCTION AND HYPOTHESIS: Pelvic organ mobility is defined as the displacement of pelvic organs between rest and maximal straining. We hypothesized that pelvic organ mobility after vaginal sacrospinous hysteropexy (SSHP) might be increased compared with other surgeries for uterine descent, which may contribute to the high occurrence of postoperative cystocele after this surgery. Pelvic organ mobility and the vaginal axes after SSHP are compared with other surgical procedures for uterine descent: vaginal hysterectomy with uterosacral suspension (VH) and laparoscopic sacrohysteropexy (LSH). METHODS: In this prospective pilot study, 15 women were included (5 for each procedure). Six months postoperatively, POP-Q examination and dynamic MRI were performed and questionnaires were filled out regarding prolapse complaints. Pelvic organ mobility on MRI was defined as vertical displacement of pelvic organs at rest and maximal straining. The displacements and angles were measured using an image registration method. Furthermore, the angle of displacement of cervix/vaginal vault and vaginal axes were assessed. RESULTS: No anatomical recurrences of pelvic organ prolapse were found. No difference in pelvic organ mobility was demonstrated. After VH, a more posterior position of the upper vagina was found compared with SSHP and LSH. CONCLUSIONS: Based on these data, the higher recurrence risk in the anterior compartment after SSHP cannot be explained. Larger sample sizes, studying women with recurrence or de novo cystocele after SSHP or using an upright MRI scanner would be of interest to further assess the relationship between pelvic organ mobility and the occurrence of anterior vaginal wall prolapse.
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Procedimientos Quirúrgicos Ginecológicos , Prolapso de Órgano Pélvico , Femenino , Humanos , Imagen por Resonancia Magnética , Prolapso de Órgano Pélvico/diagnóstico por imagen , Prolapso de Órgano Pélvico/cirugía , Proyectos Piloto , Estudios Prospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION AND HYPOTHESIS: The laparoscopic sacrocolpopexy (LSC) is performed to support DeLancey's level I in patients with pelvic organ prolapse (POP). Although several studies have been conducted on the safety, objective and subjective outcomes of LSC, the specific effect of retroperitonealisation of mesh is unknown. This study is aimed at analysing the safety, objective and subjective outcomes of the LSC without peritoneal closure of mesh. METHODS: The patients included have undergone an LSC for POP between 2004 and 2014. Retrospectively, a cohort of n = 178 was identified and asked to participate in a follow-up study. Chart research was performed. When informed consent was obtained, questionnaires were sent and the patients underwent a physical examination, including a POP-Q assessment. Each complication was scored by four reviewers for possibly being related to the non-peritonealisation of mesh. RESULTS: The data on the outcome cohorts were complete for safety n = 178, objective n = 124, and subjective n = 61. The Patient Global Impression of Improvement (PGI-I) score is provided in 106 questionnaires. In this study, 77 complications were observed in 49 different patients. The total success rate (no reoperation, no descent beyond the hymen and no bulging symptoms) is 59.0% with a median follow-up (IQR) of 35 months (18-51). Seventy-six patients (71.7%) described their condition as being (much) improved after LSC. CONCLUSIONS: Three serious complications observed during the 178 LSCs were, by full consensus, thought to be possibly related to the non-peritonealisation of mesh. More than 70% of the patients found their condition to be (much) improved after the procedure.
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Laparoscopía , Prolapso de Órgano Pélvico , Femenino , Estudios de Seguimiento , Humanos , Laparoscopía/efectos adversos , Prolapso de Órgano Pélvico/cirugía , Estudios Retrospectivos , Mallas Quirúrgicas/efectos adversos , Resultado del Tratamiento , Vagina/cirugíaRESUMEN
AIMS: To evaluate the adjustable single-incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. METHODS: In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. RESULTS: At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). CONCLUSION: The performance of a cough test during the placement of an adjustable single-incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.
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Sedación Consciente , Dolor Postoperatorio/etiología , Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. METHODS: The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. DISCUSSION: This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. TRIAL REGISTRATION: Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.
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Prolapso de Órgano Pélvico/cirugía , Ligamento Redondo del Útero/cirugía , Útero/cirugía , Vagina/cirugía , Adulto , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Persona de Mediana Edad , Países Bajos , Prolapso de Órgano Pélvico/psicología , Calidad de Vida , Índice de Severidad de la Enfermedad , Mallas Quirúrgicas , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
AIMS: To assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. METHODS: A prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15 mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as "a little better" to "very much better" on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. RESULTS: Subjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150 mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. CONCLUSIONS: PBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery.
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Dimetilpolisiloxanos/uso terapéutico , Polivinilos/uso terapéutico , Incontinencia Urinaria de Esfuerzo/tratamiento farmacológico , Anciano , Femenino , Humanos , Inyecciones , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Resultado del TratamientoRESUMEN
INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the functional outcome after laparoscopic sacrocolpopexy versus open sacrocolpopexy in women with vault prolapse. METHODS: A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months' follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05). RESULTS: Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0-0) for the domain "genital prolapse", which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50-2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2-3) versus 4 (IQR 3-5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months. CONCLUSION: Our trial provides evidence to support a laparoscopic approach when performing sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.
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Procedimientos Quirúrgicos Ginecológicos/estadística & datos numéricos , Prolapso de Órgano Pélvico/cirugía , Anciano , Femenino , Humanos , Persona de Mediana Edad , Calidad de Vida , Resultado del TratamientoRESUMEN
BACKGROUND: Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse. METHODS: We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. DISCUSSION: The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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Colposcopía/métodos , Procedimientos Quirúrgicos Ginecológicos/métodos , Histerectomía/efectos adversos , Laparoscopía/métodos , Prolapso de Órgano Pélvico/cirugía , Complicaciones Posoperatorias/cirugía , Adulto , Protocolos Clínicos , Femenino , Humanos , Tiempo de Internación , Persona de Mediana Edad , Países Bajos , Músculos Paraespinales/cirugía , Prolapso de Órgano Pélvico/etiología , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Región Sacrococcígea/cirugía , Resultado del Tratamiento , Vagina/cirugíaRESUMEN
INTRODUCTION: Studies on pelvic organ prolapse (POP) surgery show conflicting evidence regarding the impact of uterus preservation and hysterectomy on sexual function and no large randomized trials with long-term follow-up have been published on this topic. AIMS: The aim of this secondary analysis was to evaluate and compare sexual function after sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse. METHODS: This is a secondary analysis of the SAVE U trial data, a multicenter trial in 4 nonuniversity hospitals in the Netherlands comparing sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments in primary surgery of uterine prolapse stage II or higher. Primary outcome of the original study was recurrent prolapse stage II or higher of the uterus or vaginal vault (apical compartment) evaluated by POP-Q examination in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months follow-up. Secondary outcomes were overall anatomical recurrences, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning. Data from patients who had completed the POP/urinary incontinence sexual questionnaire (PISQ-12) at baseline and 24 months after surgery were used in the present trial. Total, subscale, and individual question analyses were performed. The SAVE U trial is registered in the Dutch trial registry, number NTR1866. MAIN OUTCOME MEASURES: Differences and changes in sexual function 24 months after surgery, measured by the PISQ-12 questionnaire. RESULTS: Between November 2009 and March 2012, 208 women were randomized between sacrospinous hysteropexy (n = 103) and vaginal hysterectomy with suspension of the uterosacral ligaments (n = 105). Of these, 99 women completed questionnaires at baseline and after 24 months follow-up and were included in the present study. During a follow-up period of 24 months, no significant differences in total PISQ-12 scores were observed between the groups. After both interventions the item "avoidance of intercourse due to prolapse" significantly improved, as did the physical subscale of the PISQ-12 questionnaire. CONCLUSION: There was no statistically significant difference in overall sexual functioning (total PISQ-12 scores) between uterus-preserving sacrospinous hysteropexy and vaginal hysterectomy with suspension of the uterosacral ligaments after a follow-up period of 24 months.
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Coito/fisiología , Procedimientos Quirúrgicos Ginecológicos/métodos , Ligamento Redondo del Útero/cirugía , Incontinencia Urinaria/epidemiología , Prolapso Uterino/cirugía , Adulto , Femenino , Procedimientos Quirúrgicos Ginecológicos/instrumentación , Humanos , Tiempo de Internación , Persona de Mediana Edad , Países Bajos/epidemiología , Periodo Posoperatorio , Mallas Quirúrgicas , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Incontinencia Urinaria/cirugía , Prolapso Uterino/epidemiología , Salud de la MujerRESUMEN
INTRODUCTION: Stress urinary incontinence has a negative impact on sexual function. AIM: To assess the effect of midurethral sling surgery on sexual activity and function in women with stress urinary incontinence. METHODS: This is a secondary analysis of the Value of Urodynamics Prior to Stress Incontinence Surgery (VUSIS-II) study, which assessed the value of urodynamics in women with (predominantly) stress urinary incontinence. Patients who underwent retropubic or transobturator sling surgery were included in the present study if information was available on sexual activity before and 12 months after surgery. Data were collected from a self-report validated questionnaire combined with non-validated questions. The association between midurethral sling surgery and sexual function (coital incontinence, satisfaction, and dyspareunia) was compared with McNemar χ(2) tests for nominal data and paired t-tests for ordinal data. Potentially influential factors were analyzed with univariable and multivariable logistic regression analyses. MAIN OUTCOME MEASURES: Changes in sexual activity and sexual function after midurethral sling surgery. RESULTS: Information on sexual activity was available in 293 of the 578 women (51%) included in the VUSIS-II study. At baseline, 252 of 293 patients (86%) were sexually active vs 244 of 293 (83%) after 12 months. More patients with cured stress urinary incontinence were sexually active postoperatively (213 of 247 [86%] vs 31 of 46 [67%], P < .01). There was a significant decrease in coital incontinence (120 of 236 [51%] preoperatively vs 16 of 236 [7%] postoperatively, P < .01). De novo dyspareunia was present in 21 of 238 women (9%). There was a greater improvement in coital incontinence after placement of the retropubic sling compared with the transobturator sling (odds ratio = 2.04, 95% CI = 1.10-3.80, P = .02). CONCLUSION: These data show that midurethral sling surgery has an overall positive influence on sexual function in women with stress urinary incontinence. The retropubic sling is more effective than the transobturator sling for improvement of coital incontinence. De novo dyspareunia was present in 1 of 11 women.
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Conducta Sexual/psicología , Disfunciones Sexuales Fisiológicas/etiología , Cabestrillo Suburetral/efectos adversos , Procedimientos Quirúrgicos Urológicos/efectos adversos , Salud de la Mujer , Adulto , Dispareunia/etiología , Femenino , Humanos , Persona de Mediana Edad , Oportunidad Relativa , Disfunciones Sexuales Fisiológicas/psicología , Parejas Sexuales/psicología , Cabestrillo Suburetral/psicología , Encuestas y Cuestionarios , Incontinencia Urinaria/cirugía , Urodinámica , Procedimientos Quirúrgicos Urológicos/psicologíaRESUMEN
INTRODUCTION: Practice pattern variation (PPV) is the difference in care that cannot be explained by the underlying medical condition. The aim of this study was to describe PPV among Dutch gynecologists regarding treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). MATERIALS AND METHODS: PPV was calculated from data of healthcare declaration codes of 2010. Data were provided by Vektis and Kiwa Carity. PPV for POP and UI in general was calculated per hospital and per region. Furthermore, PPV for transvaginal mesh and surgical treatment of uterine descent was assessed. RESULTS: PPV of surgical treatment for POP and UI in general was assessed for 91 hospitals. PPV for surgical treatment of uterine descent and transvaginal mesh placement was calculated for 88 hospitals. A high PPV per hospital and per region was found. In some hospitals, a hysterectomy was performed in all cases of uterovaginal prolapse, while in other hospitals, uterus-preserving techniques were mostly performed. A high PPV of transvaginal mesh placement was observed. CONCLUSION: In the small country of The Netherlands, we found a high PPV in surgical management of POP and UI with respect to the choice for surgical treatment and the type of surgery. This finding might be due to the absence of clearly defined guidelines. Studies with respect to conservative versus surgical treatment and the type of surgery are of need to establish evidence-based guidelines.
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Ginecología/estadística & datos numéricos , Prolapso de Órgano Pélvico/cirugía , Pautas de la Práctica en Medicina/estadística & datos numéricos , Incontinencia Urinaria/cirugía , Femenino , Humanos , Países Bajos , Cabestrillo Suburetral/estadística & datos numéricosRESUMEN
INTRODUCTION AND HYPOTHESIS: Laparoscopic techniques for pelvic organ prolapse surgery using mesh are gaining interest. A standard approach or published guideline for the laparoscopic sacrohysteropexy (LSH) or laparoscopic sacrocolpopexy (LSC) is lacking. The purpose of this study is to assess the variation between Dutch gynecologists in executing LSH and LSC. METHODS: A questionnaire was developed to evaluate the technique of LSH and LSC. All members of the Dutch Society for Gynecological Endoscopy and Minimally Invasive Surgery and the Dutch Society for Urogynecology were invited by email to participate in a web-based survey. RESULTS: With 357 respondents, the response rate was 71%. Of the respondents, a total of 49 gynecologists (13.7%) perform LSH and/or LSC. Gynecologists who perform both procedures use the same surgical technique for LSH and LSC. There are variations among gynecologists on several key points such as the level of dissection along the anterior and posterior walls of the vagina, the type of mesh used, the type of sutures used, the tension of the implanted mesh and reperitonealization of the mesh. CONCLUSIONS: There is a high practice variation in LSH and LSC performed by a selected group of Dutch gynecologists. Different methods have been described in the literature and there is no consensus on how to perform these procedures. A well-designed prospective study or randomized controlled trial with regard to the specific parts of these procedures is needed to provide evidence for the best surgical technique. The outcomes of these studies will help to establish evidence-based guidelines.