Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Unit of Psychodiagnostics and Clinical Psychology, University of Catania, Catania, Italy.
Adv Ther. 2019 Aug;36(8):1936-1949. doi: 10.1007/s12325-019-01006-4. Epub 2019 Jun 17.
The aim of this study was to evaluate the dimensions of the vaginal canal in patients undergoing gynaecological brachytherapy and the effect of the use of vaginal dilators (VD) used in the follow-up of pelvic physiotherapy.
A total of 88 patients were randomly allocated to the control group (CG) and intervention group (IG). Three evaluations were performed: pre-brachytherapy, post-brachytherapy and follow-up of 3 months. The CG received standard guidance from the health team while the IG was instructed to use VD for 3 months. The dimensions of the vaginal canal (main outcome) were defined by the length of the vagina (centimetres), width (number of full clockwise turns of the opening thread of a gynaecological speculum) and area (defined by the size of the VD). Quality of life and pelvic floor (PF) functionality were also evaluated.
There was no effect of the VD on vaginal length, width and area among the intention-to-treat (ITT) population. However, in the analysis stratified by adhesion, the CG had a significant decrease in the vaginal area. PF was predominantly hypoactive throughout the follow-up. Quality of life improved in both groups, but the reduction of constipation, vaginal dryness and stress urinary incontinence manifested only in the IG.
The use of VD did not alter the dimensions of the vaginal canal within the first 3 months after the end of radiotherapy treatment. However, there was a large sample loss during follow-up so studies with a larger sample number and longer follow-up time need to be conducted.
ClinicalTrials.gov Identifier NCT03090217.
本研究的目的是评估妇科近距离放射治疗患者阴道管的维度，以及在盆腔物理治疗随访中使用阴道扩张器（VD）的效果。
共 88 例患者随机分为对照组（CG）和干预组（IG）。进行了三次评估：近距离治疗前、近距离治疗后和 3 个月随访。CG 接受了来自医疗团队的标准指导，而 IG 则被指示使用 VD 3 个月。阴道管的维度（主要结果）通过阴道长度（厘米）、宽度（妇科窥器开口线的完整顺时针匝数）和面积（由 VD 的大小定义）来定义。还评估了生活质量和盆底（PF）功能。
在意向治疗（ITT）人群中，VD 对阴道长度、宽度和面积没有影响。然而，在粘连分层分析中，CG 的阴道面积有显著下降。PF 在整个随访期间主要表现为低活动度。两组的生活质量都有所改善，但便秘、阴道干燥和压力性尿失禁的减少仅在 IG 中表现出来。
在放射治疗结束后的前 3 个月内，VD 的使用并没有改变阴道管的维度。然而，在随访过程中有大量样本丢失，因此需要进行样本量更大、随访时间更长的研究。
ClinicalTrials.gov 标识符 NCT03090217。
