Trials / Completed
CompletedNCT07363174
The Clinical Role of Anogenital Distance
The Clinical Role of Anogenital Distance in Predicting Pelvic Floor Training Outcomes for Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Cigdem Cinar · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Anogenital Distance Measurements | 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. |
| OTHER | pelvic floor muscle strengthening exercises | Following AGD assessment, all patients underwent a standardized pelvic floor muscle training program. Kegel exercises were instructed and supervised by physiatrists with more than ten years of clinical experience in pelvic rehabilitation. Before initiating the exercise program, it was essential to confirm that patients could correctly identify and contract their pelvic floor muscles. To achieve this, patients were instructed in Kegel exercises over five consecutive days, performing three sets per day, each set consisting of 8-12 contractions with each contraction lasting 8-10 seconds. Following this initial training, patients were advised to perform the exercises three times daily for a period of three months. During monthly outpatient follow-up visits, adherence to the exercise regimen was assessed, and the correctness of the performed exercises was verified. Patients who were unable to perform the exercises correctly received additional instruction. Pelvic floor strengthening exercis |
Timeline
- Start date
- 2023-12-23
- Primary completion
- 2024-03-23
- Completion
- 2024-06-23
- First posted
- 2026-01-23
- Last updated
- 2026-01-23
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07363174. Inclusion in this directory is not an endorsement.