Partially Absorbable Mesh (SERATOM® PA) for Vaginal Pelvic Organ Prolapse Surgery is a Safe and Effective Option: A Multi-Center and Prospective Study

Introduction. The prolapse quality-of-life questionnaire (P-QoL) is one of a few standardized questionnaires developed to assess the impact of pelvic organ prolapse (POP) on the quality of life (QoL) of patients and determine the effectiveness of reconstructive surgery. The lack of a validated Russian-language version of the P-QoL questionnaire limits studies assessing the severity of symptoms and QoL in women with POP before and after reconstructive surgery in Russia. Materials and methods. Assessment of the reliability and validity of the adapted P-QoL questionnaire for Russian-speaking patients. Study participants (n=303) were asked to fill out the P-QoL, PFDI-20, SF-36 questionnaires and a medical and social questionnaire before reconstructive surgery and 2 months after the treatment. Then they underwent gynecological examination using the POP-Quantification System (POP-Q). Results. The language adaptation of the P-QoL questionnaire was carried out and its reliability and validity were established. Indicators of general health perception (p<0.001), role limitations (p=0.001), physical limitations (p=0.004), social limitations (p<0.001) and symptom severity (p<0.001) were significantly higher in women with POP-Q stages 3 and 4 compared to women with POP-Q stage 2. General health perception scores were higher in women with POP-Q stage 4 than with POP-Q stage 3 (p=0.002). Statistically significant differences in sleep/energy scores were found between women with POP-Q stages 2 and 3 (p=0.033). Statistically significant improvement in QoL 2 months after surgery (p < 0.05) indicated that P-QoL is sensitive to change. Conclusion. The adapted P-QoL questionnaire is a reliable tool for determination of the severity of POP symptoms, QoL impairment and assessment of the treatment outcomes.

Anterior-Apical Transvaginal Mesh (Surelift) for Advanced Urogenital Prolapse: Surgical and Functional Outcomes at 1 Year

OBJECTIVES: Surgeons are aware that the arbitrarily adopted stages of the POP-Q system do not correlate well with symptoms or differentiate clinically important subgroups. POP-Q stage is an ordinal (rather than continuous) variable, which has statistical limitations as a surgical outcome measure. We defined three continuous summary scores, based on POP-Q measures, to describe support loss and assessed their correlation with prolapse symptoms. MATERIALS AND METHODS: We used baseline data from 1141 subjects in 3 randomized trials of the Pelvic Floor Disorders Network (CARE 322, OPUS 380, ATLAS 439) to test the utility of three support loss scores: SL (Support Loss) = (TVL + C) + (Aa + 3) + (Ap + 3) + (Ba + 3) + (Bp + 3); SL3 = (TVL + C) + (Ap + 3) + (Bp + 3); and SLmax = location of single most distal point. Zero is the theoretical lower limit of SL and SL3 and −3 is the limit for SLmax, and represent perfect support. Higher values of SL measures represent greater support loss. Each support loss measure was correlated with POP-Q stage, total scores for responses to the Pelvic Organ Prolapse Distress Inventory (POPDI) and the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and responses to questions 4 (“usually have a sensation of bulging or protrusion”) and 5 (“usually have a bulge or something falling out seen/felt”) of the Pelvic Floor Distress Inventory (PFDI). Two-year CARE data were used to assess utility of these support loss measures for describing anatomical outcomes. RESULTS: All POP-Q stages were represented within the 1141 subjects: Stage 0 (4%), 1 (18%), 2 (29%), 3 (41%), 4 (8%). Symptomatic subjects were moderately (11%) or quite often (32%) bothered. Subjects had a wide range of support loss scores (mean [range]): SL [18.1 (0 to 60)], SL3 [10.7 (0 to 41)] and SLmax [1.5 (−3 to 12)]. Support loss scores were comparable to POP-Q stage with respect to correlation with baseline prolapse symptoms (Table 1). The anatomic improvement in the CARE population is displayed using continuous support loss measures and POP-Q stage (Table 2). However, anatomic change, as measured by support loss or POP-Q stage, was not well correlated with prolapse symptom improvement. CONCLUSION: Summary measures of support loss that more closely correlate with prolapse symptoms are desirable. These new support loss measures have a statistical advantage as continuous variables and may improve the transparency of surgical outcome reporting, augmenting the current POP-Q staging.

After vaginal pelvic organ prolapse (POP) surgery a vaginal pack and indwelling bladder catheter are inserted to reduce blood loss and bladder overdistension. The ideal timing of removal remains unclear. In this study we compared removal of vaginal pack and indwelling catheter 3 h post-surgery with removal the next day. This retrospective cohort study performed in the Netherlands included patients undergoing POP surgery between 1 January 2019 and 31 December 2020. Patients in whom the vaginal pack and catheter were removed the day after surgery (group A) were compared with patients in which the vaginal pack and catheter were removed 3h post-surgery (group B). Both groups were compared regarding urinary retention and the need for re-intervention owing to active blood loss within 6weeks postoperatively. Baseline characteristics, such as age, type of operation and type of anaesthesia in group A (n = 280) and group B (n = 207) were comparable. No significant differences were found regarding complications such as urinary retention (17.2 versus 23.2%; p = 0.255). The rates of re-intervention because of active blood loss and occurrence of infection were also comparable. Removal of the indwelling catheter and vaginal pack 3h after vaginal POP surgery does not lead to more postoperative complications than removal the 1st day after surgery. Therefore, early removal is a feasible and safe alternative to the standard timing of removal the morning after surgery of women undergoing POP surgery. In the future this could help with introducing same-day discharge.

The effects of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) on sexual activity and female sexual dysfunction (FSD) remain unknown. How female sexual function is affected by surgery to treat SUI and/or POP remains controversial. The objectives of this study were to identify the prevalence of FSD and potential risk factors in women with POP and/or SUI and to assess whether pelvic floor surgery leads to alterations in female sexual function. This investigation was prospective and observational. Informed consent was obtained from women who were scheduled to undergo pelvic floor surgery to manage POP and/or SUI at Peking University People's Hospital, which is an urban medical center. Sexual function was assessed by an investigator preoperatively and 12months postoperatively. Sexual activity and sexual function before and after surgery were investigated with potential risk factors. Sexual function was measured by 2 validated questionnaires: the Female Sexual Function Index and the PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire Short Form). A total of 233 women were recruited, and all were ethnically Chinese. The average age was 63 years (range, 31-83), and 47.2% were sexually active. The lack of sexual activity before surgery was associated with increasing age (mean ± SD, 56.3 ± 9.5 vs 68.4 ± 8.1 years; P < .001) and postmenopausal status (70.0% vs 97.6%, P < .001). Among the sexually active women, 62.7% were diagnosed with FSD. Increasing age (58.6 ± 9.6 vs 52.3 ± 7.8 years, P < .001) and postmenopausal status (82.6% vs 48.8%, P < .001) were associated with the presence of FSD. Overall there was no significant difference between the PISQ-12 score before and 12months after surgery (34.7 ± 6.7 vs 33.9 ± 6.6, P = .14). Lubrication of the vagina (P = .044) was an independent factor associated with the improvement in quality of sexual life after surgery. Menopause negatively affected the improvement in quality of sexual life after surgery (P = .024). Menopause and lubrication of the vagina might affect the improvement in sexual function after surgery. Strengths include the prospective design, validated questionnaires, and adequate follow-up time. As a limitation, this study is a single-center study that included only Chinese patients with advanced POP/SUI, so it may not be generalizable to other populations. Nearly half of women with symptomatic POP and/or SUI are still sexually active. Increasing age and menopause are associated with a lack of sexual activity. Premenopausal status and better lubrication of the vagina before surgery might lead to an improvement in sexual function after pelvic floor surgery.

: Pelvic organ prolapse (POP) is a condition in which one or more of the female pelvic organs, such as the bladder, uterus, vaginal cuff, rectum, and intestine dip into the vagina. The muscles and tissues surrounding the uterus weakens resulting in uterine prolapse.: To study was done to describe the correlation of symptoms, risk factors and the quality of life with POP-Q in pelvic organ support defects in a tertiary care center in North Kerala.: This study was conducted in the Department of Obstetrics and Gynecology, KMCT Medical college, Kozhikode from June 1 2021 to May 30 2022 after clearance from ethical committee in which 140 cases of uterovaginal prolapse were included. : The proportion of patients with cystocele and rectocele was found to be gradually increasing across the stages of disease as per the POP-Q staging and the maximum proportion was seen in stage 4.Occupation, obesity, chronic constipation, chronic cough had no association with the severity of pelvic organ support defects The menopausal status of the study population didn’t have any significant association between POP -Q staging. When comparing socio-economic status with POP-Q staging it was found that there wasn’t any significant statistical association between them which indicates that the comparison was comparable. Stage 1 prolapse in the POP- Q needed only conservative management while all other stages required vaginal hysterectomy and pelvic floor repair (p &amp;#60; 0.01).: Pelvic organ support defects such as cystocele and rectocele was found to be gradually increasing across the stages of disease as per the POP-Q staging and the maximum proportion was seen in stage 4. In stage 1, the quality of sexual life was not reported to be affected by the prolapse in any of the patients (p&amp;#60;0.01), while stage 4 defects necessitated surgical treatment to improve the overall quality of life.

Our aim was to evaluate the safety, feasibility, and effectiveness of a vaginolaparoscopic sacrocolpopexy (VLS) technique for treating apical pelvic organ prolapse (POP). This was a prospective interventional case series (design classification: Canadian Task Force II3) performed in the endoscopic unit of a tertiary care referral facility and university hospital. We assessed 15 symptomatic parous women with stage ≥2 apical POP according to the POP Quantification (POP-Q) classification. Interventions comprised posterior colpotomy with mesh fixation to the uterosacral ligaments and the back of the uterus that was further fixed to the anterior longitudinal ligament of the sacrum using a tacker via laparoscopy. The main outcome was a significant postoperative improvement in prolapse and resultant improvement in quality of life (QoL) after VLS. Six patients required concomitant reconstructive procedures. Mean operative time for the vaginal phase was 8.54 ± 3.10 (7-12) min and 32.36 ± 8.2 (27-41) min. for the laparoscopic phase Mean duration of VLS ranged from 30 to 50min. At the 6-months follow-up, the procedure was successful in 14 of 15 patients (93.34%); one woman (6.66%) presented with recurrence at a lower stage. Neither mesh complications nor sacral ostitis were encountered. There was significant improvement in vaginal symptoms, sexual well-being, QoL, and clinical staging after the procedure. By eliminating all forms of intraperitoneal suturing, performing a posterior colpotomy, and the advent of tackers without evidence of sacral ostitis, VLS seems to be a simple, feasible, effective, and fast approach for treating POP.

0705 The treatment of certain cancers is often accompanied by serious psychological and physiological side effects that can greatly reduce the quality of life (QOL) in cancer survivors. These include: decreased aerobic capacity, muscular atrophy, decreased strength and flexibility, adverse body composition changes, depression, anxiety and fatigue. Previous studies have shown exercise to be effective in reducing or alleviating many of these side effects, leading to an improvement in overall QOL. However, most studies have utilized a pretest-posttest design that is sufficiently insensitive to recognize the exercise dose needed to generate significant change in QOL. PURPOSE: The purpose of this study was to investigate the exercise dose required to significantly improve QOL in cancer survivors. METHODS: Twenty cancer survivors (15 female, 5 male, 43–79 years of age) served as subjects. Subjects participated in a ten-week low to moderate intensity (25–40% heart rate reserve) exercise program for 14–20 minutes, three times a week. QOL was assessed weekly with the Quality of Life Index for Patients with Cancer. This scale is composed of 14 items evaluating physical condition, normal activities, and personal attitudes on general quality of life. RESULTS: ANOVA results revealed a significant increase in QOL over the ten weeks (p = .0001). Followup analysis (Scheffe post-hoc test) revealed a significant improvement in overall QOL by week 6 (p < .05). Of the 14 sub-scale components that compose the overall QOL score, the subjects improved most on their perceived strength, ability to sleep and their ability to perform daily tasks. CONCLUSIONS: These results indicate that low to moderate intensity aerobic exercise is beneficial in improving QOL and at least six weeks of aerobic activity are needed to see a significant improvement in QOL. This relatively low dose-response relationship should be beneficial in optimizing cancer survivor adherence to an exercise program.

0705 The treatment of certain cancers is often accompanied by serious psychological and physiological side effects that can greatly reduce the quality of life (QOL) in cancer survivors. These include: decreased aerobic capacity, muscular atrophy, decreased strength and flexibility, adverse body composition changes, depression, anxiety and fatigue. Previous studies have shown exercise to be effective in reducing or alleviating many of these side effects, leading to an improvement in overall QOL. However, most studies have utilized a pretest-posttest design that is sufficiently insensitive to recognize the exercise dose needed to generate significant change in QOL. PURPOSE: The purpose of this study was to investigate the exercise dose required to significantly improve QOL in cancer survivors. METHODS: Twenty cancer survivors (15 female, 5 male, 43–79 years of age) served as subjects. Subjects participated in a ten-week low to moderate intensity (25–40% heart rate reserve) exercise program for 14–20 minutes, three times a week. QOL was assessed weekly with the Quality of Life Index for Patients with Cancer. This scale is composed of 14 items evaluating physical condition, normal activities, and personal attitudes on general quality of life. RESULTS: ANOVA results revealed a significant increase in QOL over the ten weeks (p = .0001). Followup analysis (Scheffe post-hoc test) revealed a significant improvement in overall QOL by week 6 (p < .05). Of the 14 sub-scale components that compose the overall QOL score, the subjects improved most on their perceived strength, ability to sleep and their ability to perform daily tasks. CONCLUSIONS: These results indicate that low to moderate intensity aerobic exercise is beneficial in improving QOL and at least six weeks of aerobic activity are needed to see a significant improvement in QOL. This relatively low dose-response relationship should be beneficial in optimizing cancer survivor adherence to an exercise program.

Introduction and Objective: Despite advancements in diabetes technology, such as continuous glucose monitoring (CGM) and automated insulin pumps, hypoglycemia remains a limiting factor for individuals with type 1 diabetes (T1D), often leading to fear of hypoglycemia (FOH) and reduced quality of life (QoL). This secondary analysis examined the effect of a cognitive behavioral therapy (CBT) intervention, designed to reduce FOH, on QoL in young adults with T1D. Methods: Fifty young adults (18 to 35 years) with T1D ≥1 year, in endocrinology care, who screened positive for FOH, and had previously attended a basic diabetes education program were recruited to the study. Participants were randomized to an 8-week CBT intervention or an attention control (diabetes education). Exclusion criteria included pregnancy, breastfeeding, and any chronic condition or medications (excluding insulin) that could affect diabetes self-management or glucose control. All participants wore unblinded CGM devices. QoL was measured with the 46-item, 5-point Likert scale (1=best QoL, 5=worst), encompassing satisfaction (general satisfaction with diabetes management), impact (effects on daily life and functioning), and worry (fear of complications and health outcomes). Descriptive statistics and generalized estimation equation were used to assess CBT’s impact on QoL. Results: Participants receiving the CBT intervention experienced a statistically significant improvement in overall QoL (β = -14.048, p = 0.020), compared to controls. Specifically, the CBT intervention demonstrated a significant improvement in QoL satisfaction and impact subscales β = -7.122, p = 0.018 and β = -5.568, p = 0.015 respectively. Conclusion: The CBT intervention resulted in improvement in overall QoL. The most substantial gains were observed in satisfaction and impact, highlighting immediate and tangible experiences. Disclosure E. Peprah Osei: None. A.H. Saleh: None. C.G. Park: None. P. Martyn-Nemeth: Stock/Shareholder; Pfizer Inc. Funding NIH (R21DK116146)

The study aims to compare the efficacy and safety of bulking agents and single-incision slings in the treatment of urinary incontinence in 159 patients during a 29-month follow-up period. Of the 159 patients suffering from stress urinary incontinence, 64 were treated with bulking agents (PAHG Bulkamid®) and 75 with a single-incision sling (Altis®). The ICIQ-UI-SF (Incontinence Questionnaire-Urine Incontinence-Short Form), PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires short form), FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Scale), and PGI-I (Patient Global Improvement Index) were used to assess efficiency and quality of life. The bulking agents showed high efficacy and safety during the 29-month follow-up. Post-operative complications were recorded in both groups, with only two significant differences. The Bulkamid group experienced no pain, while 10.8% of the ALTIS group experienced groin pain and 5% experienced de novo urgency. Furthermore, patients treated with bulking agents experienced reduced nicturia (0.78 vs. 0.92 in patients treated with single-incision slings.). In both groups, we noticed a significant improvement in QoL (quality of life), with a halved ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urine Incontinence-Short Form) score which was completed to assess the impact of urine symptoms. After 24 months of therapy, the Bulkamid group saw a decrease from 14.58 ± 5.11 at baseline to 5.67 ± 1.90 (p < 0.0001), whereas the ALTIS group experience a decrease from 13.75 ± 5.89 to 5.83 ± 1.78. Similarly, we observed an improvement in sexual function, with the number of sexually active patients increasing from 29 to 44 (56.4%) in the Bulkamid group (p = 0.041) and from 31 to 51 (61.7%) in the ALTIS group (p = 0.034). According to the most recent statistics, the PISQ-12, FSFI, and FSDS scores all demonstrated an improvement in women's sexual function. In terms of efficacy and safety, bulking agents had notable results over the 29-month follow-up period. Furthermore, the patients treated with bulking agents reported a lower incidence of postoperative complications and a no discernible difference in terms of quality of life and sexual activity compared to the ones treated with single-incision slings. Bulking agents can be considered a very reliable therapeutic option based on accurate patient selection.

ISEE-341 Objective: Recent studies have documented asthma symptom improvements among urban children with indoor allergen-reducing environmental interventions. Less attention has been attributed, however, to auxiliary effects on caregivers and other family members. The Healthy Public Housing Initiative (HPHI), a collaboration of university, government, and community partners, explored whether indoor environmental interventions (intensive cleaning, integrated pest management) may alleviate symptoms among urban children, and which factors may influence benefits for children and caregivers. Material and Methods: Trained Community Health Advocates visited with families monthly, administered Juniper Asthma Quality of Life (QOL) questionnaires for child and caregiver, and collected reports of child's symptoms, unplanned ED/clinic visits, and medication use. Data on perceived stress, violence exposures, and social support were also collected monthly for caregivers. Monthly quality-of-life data were analyzed for 51 caregivers of 58 asthmatic children in 3 public housing developments over 13 months. Longitudinal analysis with random intercepts was used to explore caregiver QOL improvements over the course of study, and in multiple periods. Several pathways for benefits in caregiver QOL are being explored, including (1) improvements in child's QOL, (2) direct influence of environmental improvements, (3) improved social support, and (4) asthma management. Results: Longitudinal analyses indicate significant improvement in caregiver QOL over the course of study. As previously shown for child's symptoms and QOL, caregivers show significant improvements in QOL before environmental intervention, indicating potential benefits of case management and support. Further analyses will explore the roles of social support and participation effects in predicting these preintervention QOL benefits. Conclusions: Results suggest that benefits of environmental interventions may be due to social as well as environmental aspects of intervention. Further analyses will explore the role of social support, caregiver stress, and other factors to explain observed improvements in caregiver QOL.

Invited Commentary

Modeling Longitudinal Quality of Life Changes in Patients Diagnosed with Lymphomas: Heatmap Analysis of Electronic Patient-Reported Outcomes (ePRO) Data from the Bison-PRO Quality of Life Study

Effects of progressive muscular relaxation training on anxiety, depression and quality of life of endometriosis patients under gonadotrophin-releasing hormone agonist therapy