Winkler Harvey, Jacoby Karny, Kalota Susan, Snyder Jeffrey, Cline Kevin, Robertson Kaiser, Kahan Randall, Green Lonny, McCammon Kurt, Rovner Eric, Rardin Charles
Female Pelvic Med Reconstr Surg. 2018 May/Jun;24(3):222-231. doi: 10.1097/SPV.0000000000000488.
The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months.
The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months.
A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%).
In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.
“压力性尿失禁控制、疗效与安全性研究”（SUCCESS）是一项针对保守治疗失败且手术失败、不适合手术或选择不进行手术的压力性尿失禁女性患者的Vesair球囊III期研究。本文报告了治疗组中那些选择在3个月的主要终点后继续参与SUCCESS试验的参与者在12个月时球囊的安全性和疗效。
SUCCESS试验是一项多中心、前瞻性、单盲、随机、假对照研究。参与者按2.33:1的比例随机分为Vesair球囊置入组或安慰剂组。主要疗效终点是1小时激发性尿垫重量试验较基线减少超过50%，以及在3个月研究访视时失禁生活质量问卷上症状改善至少10分的综合指标。选择继续参与试验的治疗组患者进行前瞻性随访，直至12个月。
共有221名参与者被随机分组，其中治疗组157名，对照组64名。治疗组中有67名参与者（占入组参与者的42.7%）在12个月时接受了评估，在符合方案分析中，56.3%的参与者达到了综合终点，78.7%的参与者尿垫重量较基线减少超过50%。在意向性分析中，将所有未继续使用球囊的参与者视为治疗失败，24%的参与者达到了综合终点，33.6%的参与者尿垫重量较基线减少超过50%。该组与治疗相关的不良事件包括排尿困难（40.1%）、肉眼血尿（36.9%）和尿路感染（26.1%）。
在这项III期试验中，继续治疗12个月的参与者症状得到缓解。研究发现球囊是安全的，未报告与器械或操作相关的严重不良事件。有必要进行更多研究以确定哪些患者群体对球囊的耐受性更高，并评估其长期使用的疗效和安全性。有必要采用额外的筛查方法，包括筛查患者对球囊的耐受性，以减少参与者退出试验的情况。
