Sexual DysfunctionNCT04415710
Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome
An observational study of Sexual Dysfunction and Pelvic Floor Disorders, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sexual Dysfunction, Pelvic Floor Disorders, Pelvic Organ Prolapse
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2019to 2 Jun 2020
- How long will I take part?
- 1 Day
- 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 65 years
- Women only
- Adult, Older adult
Study population: 94 women with Sjögren syndrome with an average age of 48.15 ± 8.73 years were included in the study. 94 women diagnosed as SS according to 2016 ACR-EULAR Classification Criteria for primary Sjögren's syndrome were included in the study by Rheumatology Clinic of Hospital. Ethical approval of the study was obtained from the Interventional Clinical Research Ethics Committee. All women were informed verbally and informed consent forms were signed.
Who may be able to join
- being between the ages of 18-65
- being a woman,
- having sex partner,
- no smoking, no alcohol
Who cannot join
- physical, psychological, cognitive impairment,
- having a non-Sjögren additional disease,
- malignancy,
- pregnancy,
- no urogenital disease,
- sarcoidosis,
Show all 9Show fewer
- AIDS,
- anticholinergic drug use,
- had a gynecological or urological operation other than cesarean
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome
Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.
Read the detailed description
Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.
- Conditions
- Sexual Dysfunction, Pelvic Floor Disorders, Pelvic Organ Prolapse, Urinary Incontinence, Constipation
- Keywords
- pelvic pain, sexual dysfunction, unirary incontinence, constipation, pelvic floor dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological, Pelvic Floor Disorders, Pelvic Organ Prolapse, Urinary Incontinence, Constipation, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group | Women with diagnosed Sjogren syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Distress Inventory PFDI-20
Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales
Measured: 1 week
Pelvic Floor Impact Questionnaire PFIQ
Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
Measured: 1 week
Female Sexual Dysfunction Index FSFI
The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Feb 2019
- Primary completion30 May 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
- Investigators
- Ayse Ayan, Study director, University of Health Sciences Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415710
- Sponsor's protocol ID
- 2019-166
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
PubMed 25652072Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.
PubMed 26965411
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT04415710
- Acronym / sponsor ID
- 2019-166
- Conditions
- Sexual Dysfunction, Pelvic Floor Disorders, Pelvic Organ Prolapse, Urinary Incontinence, Constipation
- Keywords
- pelvic pain, sexual dysfunction, unirary incontinence, constipation, pelvic floor dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 4 Jun 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.
Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.
Detailed description
Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | –Women with diagnosed Sjogren syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 94 women with Sjögren syndrome with an average age of 48.15 ± 8.73 years were included in the study. 94 women diagnosed as SS according to 2016 ACR-EULAR Classification Criteria for primary Sjögren's syndrome were included in the study by Rheumatology Clinic of Hospital. Ethical approval of the study was obtained from the Interventional Clinical Research Ethics Committee. All women were informed verbally and informed consent forms were signed.
Key inclusion criteria (4 listed)
- being between the ages of 18-65
- being a woman,
- having sex partner,
- no smoking, no alcohol
Key exclusion criteria (9 listed)
- physical, psychological, cognitive impairment,
- having a non-Sjögren additional disease,
- malignancy,
- pregnancy,
- no urogenital disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic Floor Distress Inventory PFDI-20
Time frame: 1 week
Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales
Pelvic Floor Impact Questionnaire PFIQ
Time frame: 1 week
Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
Female Sexual Dysfunction Index FSFI
Time frame: 1 week
The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
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 19 Nov 2024.
- Background: PubMed 25652072van Nimwegen JF, Arends S, van Zuiden GS, Vissink A, Kroese FG, Bootsma H. The impact of primary Sjogren's syndrome on female sexual function. Rheumatology (Oxford). 2015 Jul;54(7):1286-93. doi: 10.1093/rheumatology/keu522. Epub 2015 Feb 4.
- Results publication: PubMed 26965411Budden AK, Te West NI, Sturgess AD, Moore KH. Pelvic floor dysfunction in female Sjogren's syndrome: an 8-year audit. Int Urogynecol J. 2016 Sep;27(9):1367-73. doi: 10.1007/s00192-016-2985-9. Epub 2016 Mar 10.
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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.
Ayse Ayan study director
University of Health Sciences Antalya Training and Research Hospital
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 Sexual Dysfunction and Pelvic Floor Disorders, run by Akdeniz 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 4 inclusion and 9 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 19 Nov 2024. 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?
Pelvic Floor Distress Inventory PFDI-20 (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415710, which also lists 2 linked publications.
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 19 Nov 2024.