Pelvic Floor Muscle ExerciseAGDNCT07363174
The Clinical Role of Anogenital Distance
A study testing Anogenital Distance Measurements and pelvic floor muscle strengthening exercises in people with Pelvic Floor Muscle Exercise, run by Cigdem Cinar at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Muscle Exercise
- What is being tested?
- Anogenital Distance Measurements and pelvic floor muscle strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2023to 23 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Role of Anogenital Distance in Predicting Pelvic Floor Training Outcomes for Stress Urinary Incontinence
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).
Read more
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.
Read the 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
- Pelvic Floor Muscle Exercise
- Being tested
- Anogenital Distance Measurements, pelvic floor muscle strengthening exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anogenital Distance MeasurementsOther
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.
pelvic floor muscle strengthening exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Training Outcomes for Stress Urinary Incontinence | Other | 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. Receives: Other: Anogenital Distance Measurements; Other: pelvic floor muscle strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
anogenital distance (AGD) parameters
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.
Measured: 15 minutes
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
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
Measured: 1-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start23 Dec 2023
- Primary completion23 Mar 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cigdem Cinar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cigdem Cinar, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363174
- Sponsor's protocol ID
- 2015-KAEK-80-23-51
- Acronym
- AGD
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Role of Anogenital Distance in Predicting Pelvic Floor Training Outcomes for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07363174
- Acronym / sponsor ID
- AGD / 2015-KAEK-80-23-51
- Conditions
- Pelvic Floor Muscle Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cigdem CinarUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 23 Mar 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Training Outcomes for Stress Urinary Incontinence | Other | Other: Anogenital Distance Measurements, Other: pelvic floor muscle strengthening exercisesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anogenital Distance MeasurementsAll 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 Training Outcomes for Stress Urinary Incontinence |
| pelvic floor muscle strengthening exercisesFollowing 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 | Other | Pelvic Floor Training Outcomes for Stress Urinary Incontinence |
Primary outcome
anogenital distance (AGD) parameters
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anogenital Distance Measurements and pelvic floor muscle strengthening exercises in people with Pelvic Floor Muscle Exercise, run by Cigdem Cinar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anogenital distance (AGD) parameters (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.