Reproductive System DisorderNCT04398186
The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
An observational study of Reproductive System Disorder and Urinary Incontinence, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1). Although its etiopathogenesis is still not clear, it is known that it is due to the disregulation of ovarian steroidogenesis under the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive System Disorder, Urinary Incontinence, Urogenital Disease
- What is being tested?
- Anogenital distance measurement
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Mar 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive aged females, age between 18-40 yrs.
Who may be able to join
- Nulliparity
Who cannot join
- Endocrine disorders
- Anabolic drug usage Multiparity
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1). Although its etiopathogenesis is still not clear, it is known that it is due to the disregulation of ovarian steroidogenesis under the influence of some environmental and genetic factors. Diagnosis of ESHRE / ASRM has set Rotterdam criteria in 2003; one of these criteria is the presence of hyperandrogenism (2). Hyperandrogenism leads to an increase in general muscle mass in the body (1, 3, 4).
Pelvic floor muscles are associated with urethra in the anterior compartment, rectum and anus in the posterior compartment, and uterine support in the apex; major urinary and fecal continence ensuring its functions in order to stop in the appropriate position of the pelvic organs (5). The well-being of the pelvic floor muscle strength has a protective effect from urinary and fecal incontinence.
Read more
It has been emphasized that the "anogenital distance" determined by the measurement of the anal region anterior to the clitoris anterior may also be a criteria in the diagnosis of Polycystic Ovary Syndrome (7,8,9).
In this study, patients in the reproductive age between 18-40 years, who applied to our gynecology outpatient clinic and were diagnosed as PCOS according to Rotterdam criteria wil be study gorup and the women without PCOS will be control group. We aimed to evaluate the pelvic muscle strength with perineometry, to measure anogenital distance and to determine possible relationships with each other. In addition to demographic information, ICIQ-SF (Urinary incontinence inquiry short form) will also be taken to evaluate pelvic floor function (10).
- Conditions
- Reproductive System Disorder, Urinary Incontinence, Urogenital Disease, Polycystic Ovary Syndrome
- Being tested
- Anogenital distance measurement
- Keywords
- polycystic ovary syndrome, urinary incontinence, anogenital distance
- Medical subject headings
- Urinary Incontinence, Urogenital Diseases, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anogenital distance measurementDiagnostic test
Measurements of AGD and perineal muscle strength
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Hiperandrogenism + ultrasonographic PCO Receives: Diagnostic Test: Anogenital distance measurement | |
| Study group 2 | Menstruel cycle irregular + ultrasonographic PCO Receives: Diagnostic Test: Anogenital distance measurement | |
| Study group 3 | Menstruel cycle irregular + ultrasonographic PCO + hyperandrogenism Receives: Diagnostic Test: Anogenital distance measurement | |
| Control group | Do not have PCOS Receives: Diagnostic Test: Anogenital distance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anogenital distance measurement in PCOS
Measured: 01.06.2020- 01.11.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jun 2020
- Primary completion30 Oct 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive System DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebnem Alanya Tosun, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398186
- Sponsor's protocol ID
- GiresunU
- Status last verified
- Mar 2021
- First submitted
- 18 May 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
- ClinicalTrials.gov ID
- NCT04398186
- Acronym / sponsor ID
- GiresunU
- Conditions
- Reproductive System Disorder, Urinary Incontinence, Urogenital Disease, Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, urinary incontinence, anogenital distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 21 May 2020 (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.
Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1). Although its etiopathogenesis is still not clear, it is known that it is due to the disregulation of ovarian steroidogenesis under the influence of some environmental and genetic factors. Diagnosis of ESHRE / ASRM has set Rotterdam criteria in 2003; one of these criteria is the presence of hyperandrogenism (2). Hyperandrogenism leads to an increase in general muscle mass in the body (1, 3, 4).
Pelvic floor muscles are associated with urethra in the anterior compartment, rectum and anus in the posterior compartment, and uterine support in the apex; major urinary and fecal continence ensuring its functions in order to stop in the appropriate position of the pelvic organs (5). The well-being of the pelvic floor muscle strength has a protective effect from urinary and fecal incontinence.
It has been emphasized that the "anogenital distance" determined by the measurement of the anal region anterior to the clitoris anterior may also be a criteria in the diagnosis of Polycystic Ovary Syndrome (7,8,9).
In this study, patients in the reproductive age between 18-40 years, who applied to our gynecology outpatient clinic and were diagnosed as PCOS according to Rotterdam criteria wil be study gorup and the women without PCOS will be control group. We aimed to evaluate the pelvic muscle strength with perineometry, to measure anogenital distance and to determine possible relationships with each other. In addition to demographic information, ICIQ-SF (Urinary incontinence inquiry short form) will also be taken to evaluate pelvic floor function (10).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Diagnostic Test: Anogenital distance measurementHiperandrogenism + ultrasonographic PCO |
| Study group 2 | – | Diagnostic Test: Anogenital distance measurementMenstruel cycle irregular + ultrasonographic PCO |
| Study group 3 | – | Diagnostic Test: Anogenital distance measurementMenstruel cycle irregular + ultrasonographic PCO + hyperandrogenism |
| Control group | – | Diagnostic Test: Anogenital distance measurementDo not have PCOS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive aged females, age between 18-40 yrs.
Key inclusion criteria (1 listed)
- Nulliparity
Key exclusion criteria (2 listed)
- Endocrine disorders
- Anabolic drug usage Multiparity
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 measurementMeasurements of AGD and perineal muscle strength | Diagnostic test | Control group, Study group 1, Study group 2, Study group 3 |
Primary outcome
Anogenital distance measurement in PCOS
Time frame: 01.06.2020- 01.11.2020
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 2 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Reproductive System Disorder
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
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?
An observational study of Reproductive System Disorder and Urinary Incontinence, run by Giresun University 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 2 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 2 Mar 2021. 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 measurement in PCOS (time frame: 01.06.2020- 01.11.2020). 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 2 Mar 2021.