PDF(Pubmed)
Abstract：
Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed.
This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months.
This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons.
A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects\' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject\'s own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported.
Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.
This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months.
This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons.
A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects\' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject\'s own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported.
Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.
摘要：
背景：子宫托是治疗盆腔器官脱垂的有效方法，然而，目前可用的子宫托可能会导致移除和插入的不适。一项研究的早期可行性试验，可折叠子宫托先前在简短的15分钟办公室试验中证明了机械可行性。长期而言,需要以患者为中心的安全性和有效性数据.
目的：评估3个月时阴道子宫托治疗盆腔器官脱垂的有效性和安全性。
方法：这是一个前瞻性的，七个中心，开放标签等效性研究，参与者作为自己的对照。受试者是患有≥II期脱垂的Gellhorn或环形子宫托的当前使用者。基线主观和客观数据收集一个月，使用他们目前的子宫托，然后使用研究子宫托收集3个月治疗期的数据.主要结果是骨盆底窘迫量表-20评分的变化。次要结果指标包括脱垂支持的客观评估，盆底冲击问卷-7的变化，以及在视觉模拟量表上测量的插入和移除疼痛。将符合研究子宫托的受试者作为治疗意向进行分析，而那些辍学的受试者则以预定义的等效极限的上限分配分数。根据方案的次要分析包括完成治疗的受试者。该研究的动力达到80％，在骨盆底窘迫清单-20量表上的最小重要变化等效极限为18.3点。对于非参数数据使用平方根变换,并且针对多重比较调整P值。
结果：共纳入78名受试者，尽管16人在研究子宫托放置前退出。62名受试者（50个戒指和12个Gellhorn子宫托使用者）装有研究子宫托，48人(62%)完成了为期3个月的干预.与受试者的基线分数相比，三个月时骨盆底窘迫量表-20分数的变化证明了等效，(平均差-3.96(改进)，90%置信区间(CI)[-11.99，4.08]，p=0.002)。根据骨盆底窘迫清单-20的方案分析，得分不支持研究子宫托（平均差-10.45，90％CI，[-20.35，0.54]（p=0.095））。次要结果包括：类似的客观支持措施，平均差Ba=0.54cm，Bp=0.04cm,有利于研究子宫托；完成试验的人的平均盆底冲击问卷-7得分提高（pre=32.23，post=16.86，p=0.019）；插入和移除疼痛，与受试者自己的子宫托相比，研究子宫托的水平较低（平均差异视觉模拟评分=9.91mm（p=0.019），去除=11.23毫米（p=0.019））。未报告与子宫托相关的严重不良事件。
结论：与目前的非塌陷子宫托相比，研究子宫托的主要结局在盆底症状的严重程度和困扰方面的变化是等效的。在完成试验的参与者中，盆底撞击问卷-7随着研究子宫托的改善而改善，盆底不适量表-20得分的变化是不相等的，偏爱研究子宫托。受试者报告说，与标准子宫托相比，使用新型可折叠子宫托插入和取出子宫托的疼痛评分显着降低。
目的：评估3个月时阴道子宫托治疗盆腔器官脱垂的有效性和安全性。
方法：这是一个前瞻性的，七个中心，开放标签等效性研究，参与者作为自己的对照。受试者是患有≥II期脱垂的Gellhorn或环形子宫托的当前使用者。基线主观和客观数据收集一个月，使用他们目前的子宫托，然后使用研究子宫托收集3个月治疗期的数据.主要结果是骨盆底窘迫量表-20评分的变化。次要结果指标包括脱垂支持的客观评估，盆底冲击问卷-7的变化，以及在视觉模拟量表上测量的插入和移除疼痛。将符合研究子宫托的受试者作为治疗意向进行分析，而那些辍学的受试者则以预定义的等效极限的上限分配分数。根据方案的次要分析包括完成治疗的受试者。该研究的动力达到80％，在骨盆底窘迫清单-20量表上的最小重要变化等效极限为18.3点。对于非参数数据使用平方根变换,并且针对多重比较调整P值。
结果：共纳入78名受试者，尽管16人在研究子宫托放置前退出。62名受试者（50个戒指和12个Gellhorn子宫托使用者）装有研究子宫托，48人(62%)完成了为期3个月的干预.与受试者的基线分数相比，三个月时骨盆底窘迫量表-20分数的变化证明了等效，(平均差-3.96(改进)，90%置信区间(CI)[-11.99，4.08]，p=0.002)。根据骨盆底窘迫清单-20的方案分析，得分不支持研究子宫托（平均差-10.45，90％CI，[-20.35，0.54]（p=0.095））。次要结果包括：类似的客观支持措施，平均差Ba=0.54cm，Bp=0.04cm,有利于研究子宫托；完成试验的人的平均盆底冲击问卷-7得分提高（pre=32.23，post=16.86，p=0.019）；插入和移除疼痛，与受试者自己的子宫托相比，研究子宫托的水平较低（平均差异视觉模拟评分=9.91mm（p=0.019），去除=11.23毫米（p=0.019））。未报告与子宫托相关的严重不良事件。
结论：与目前的非塌陷子宫托相比，研究子宫托的主要结局在盆底症状的严重程度和困扰方面的变化是等效的。在完成试验的参与者中，盆底撞击问卷-7随着研究子宫托的改善而改善，盆底不适量表-20得分的变化是不相等的，偏爱研究子宫托。受试者报告说，与标准子宫托相比，使用新型可折叠子宫托插入和取出子宫托的疼痛评分显着降低。
