The Clinical Role of Anogenital Distance in Predicting Pelvic Floor Training Outcomes for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- anogenital distance (AGD) parameters
研究概览
简要总结
Aims:
To evaluate the predictive value of anogenital distance (AGD) measurements, including the anus-to-clitoris distance (AGDAC) and genital hiatus (GH), on the success of pelvic floor muscle training (PFMT) in women with stress urinary incontinence (SUI).
Methods:
This cross-sectional, case-control study included 150 adult women with clinically confirmed stress urinary incontinence who completed a three-month PFMT program. All patients' demographic data were recorded, and the anogenital distance (AGDAC, AGDAF) and genital hiatus (GH) were measured using a digital caliper in the lithotomy position. All participants performed supervised Kegel exercises three times daily with monthly follow-up to ensure proper technique and compliance. Patients were then classified as responders or non-responders based on clinical improvement. Associations between PFMT outcomes and AGD parameters, BMI, parity, and other demographic factors were analyzed. All patients will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after treatment.
详细描述
Clinical and demographic data, including age, weight, height, body mass index (BMI), and number of births, were recorded for all patients at baseline.
All anogenital distance (AGD) parameters were measured with participants in the lithotomy position, with the legs positioned at approximately 45°, during the Valsalva maneuver. Measurements were conducted in accordance with standardized protocols to ensure accuracy and reproducibility (6). A stainless-steel digital caliper (VWR® International, LLC, West Chester, PA, USA) was used for all assessments. After each use, the caliper was cleaned with soapy water and disinfected with a 2% alcohol-based chlorhexidine solution.
Two AGD parameters were recorded: the distance from the anus to the clitoris (AGDAC) and the distance from the anus to the posterior fourchette (AGDAF). In addition, the genital hiatus (GH) was measured from the center of the urethral meatus to the posterior hymenal rim or the perineal midline. To minimize measurement error, all evaluations were performed by the same experienced gynecologist on three separate occasions, and the mean value was used as the final estimate. All patients will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older with confirmed SUI diagnosis who agreed to participate in a 12 weeks pelvic floor rehabilitation program were included in the study
排除标准
- •(1) Current pregnancy, (2) history of urinary tract or kidney infection within the last four weeks, (3) diagnosis of diabetes mellitus, (4) previous surgical intervention due to urinary incontinence, (5) known psychiatric disorders, (6) neuromuscular disease, (7) presence of genitourinary fistula, (8) active urogenital malignancy, (9) permanent urinary catheter use, (10) failure to comply with the prescribed exercise program or (11) Pelvic Organ Prolapse Quantification System (POP-Q) Stage 2 (including asymptomatic cases) and above.
研究组 & 干预措施
Pelvic Floor Training Outcomes for Stress Urinary Incontinence
All participants will be given pelvic floor muscle strengthening exercises. After 3 months, they will be divided into two groups: those who benefited from the exercises and those who did not.
干预措施: Anogenital Distance Measurements (Other)
Pelvic Floor Training Outcomes for Stress Urinary Incontinence
All participants will be given pelvic floor muscle strengthening exercises. After 3 months, they will be divided into two groups: those who benefited from the exercises and those who did not.
干预措施: pelvic floor muscle strengthening exercises (Other)
结局指标
主要结局
anogenital distance (AGD) parameters
时间窗: 15 minutes
Two AGD parameters were recorded: the distance from the anus to the clitoris (AGDAC) and the distance from the anus to the posterior fourchette (AGDAF). In addition, the genital hiatus (GH) was measured from the center of the urethral meatus to the posterior hymenal rim or the perineal midline. To minimize measurement error, all evaluations were performed by the same experienced gynecologist on three separate occasions, and the mean value was used as the final estimate.
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
时间窗: 1-2 minutes
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a validated patient-reported outcome measure used to assess the severity and impact of urinary incontinence on quality of life. It consists of four items evaluating the frequency of urinary leakage, the amount of urine lost, and the extent to which incontinence affects daily activities, with total scores ranging from 0 to 21 derived from the first three items, while the fourth item identifies situations in which leakage occurs and aids in incontinence subtype classification but is not included in the total score. Higher scores indicate greater symptom severity, and the questionnaire is sensitive to clinical change, with a reduction of 3-4 points considered clinically meaningful and a score of 0 often defined as complete cure. The ICIQ-UI SF is recommended by the International Continence Society, has been translated and validated in multiple languages including Turkish, and is w
次要结局
未报告次要终点
研究者
Cigdem Cinar
Associate professor doctor
Biruni University