SjögrenNCT05079581
Pelvic Floor Exercises in Patients With Sjögren's
A study testing Pelvic floor exercises in people with Sjögren and Sjögren Syndrome, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, the positive effects of pelvic floor exercises on sexual functions have been supported by studies. However, the effectiveness of pelvic floor exercises on pelvic floor problems in women with sjögren has not been examined in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjögren, Sjögren Syndrome
- What is being tested?
- Pelvic floor exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Aug 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be woman
- Having a diagnosis of primary sjogren's
- No comorbidities other than Sjögren's syndrome
- Not having had pelvic floor surgery
- Being sexually active
- Voluntary and consent to participate in the study
Who cannot join
- Other rheumatological diseases
- Urogynecological diseases
- Sarcoidosis
- lymphoma
- Having had a non-cesarean gynecological operation
- Infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Investigation of the Effects of Pelvic Floor Exercises on Pain, Sexual Dysfunction and Quality of Life in Female Patients With Sjögren
When the literature is examined, the positive effects of pelvic floor exercises on sexual functions have been supported by studies. However, the effectiveness of pelvic floor exercises on pelvic floor problems in women with sjögren has not been examined in the literature. The aim of this study is in order to examine the effect of pelvic floor exercises on sexual function in women with primer Sjögren Syndrome (pSS), since these negativities affect both the quality of life and sexual functions in women with pSS.
This is a randomized controlled trial examining the effect of 8 weeks of home-based pelvic floor exercises on pain, sexual dysfunction and quality of life on women with sjogren's.
Read the detailed description
Demographic information form, HAQ, VAS, Pelvic Pain Impact Questionnaire (PPIQ), Pelvic Floor Distress Scale-20, Female Sexual Function Inventory (FSFI), Pelvic Floor Impact Questionnaire (PFIQ-7) will be applied to female patients with Sjögren's who meet the inclusion criteria.After the initial evaluation, patients will be randomized to intervention and control groups. The intervention group will be taught home exercises including fast and slow contraction and keeping the muscles around the pelvic floor in different positions (sitting, standing, lying) and will be asked to do them every day for 8 weeks according to the determined protocol. For eight weeks, the patients will be supported by the phone by the physiotherapist and at the same time, they will be checked whether they do the exercises. The control group will be given training on pelvic floor anatomy. At the end of eight weeks, patients will be given a final evaluation and the results will be analyzed.
- Conditions
- Sjögren, Sjögren Syndrome
- Being tested
- Pelvic floor exercises
- Keywords
- Sjögren, Pelvic floor exercises
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercisesOther
The participants in the intervention group will be taught exercises involving strengthening the muscles around the pelvic floor in sitting, standing and lying positions by a physiotherapist who has been trained in women's health for 4 years and will be asked to perform them as home exercises every day for 8 weeks. The exercises are as follows:
They will be asked to tighten the muscles around the urethra, vagina and rectum as hard as possible, upwards and inwards (from the bottom up) and hold it in this way for 8-10 seconds. It will be applied in different positions as in the table.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Pelvic floor exercises Receives: Other: Pelvic floor exercises |
| Control group | No intervention | Education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Pain Impact Questionnaire
The clinical assessment of the impact of pelvic pain on women questionnaire consists of 10 questions. The first 8 questions of the questionnaire are in the form of Likert type and are scored between 0-4. The total score is reached by adding the scores given for each item, and the last two questions are not included in the calculation.
Measured: 8 weeks
Visual Analog Scale (VAS)
It is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: 8 weeks
Pelvic Floor Distress Scale-20
Scale is a 20-item symptom questionnaire used to measure the degree of discomfort caused by pelvic symptoms in women. Each item consists of 4 options (Never, Rarely, Moderately, Quite often) and is scored between 1 and 4. PFDI consists of 3 sub-dimensions: Urinary distress inventory, Colo-rectal-anal distress inventory, Pelvic organ prolapse distress inventory. The mean scores of the items in each sub-dimension are calculated and these scores are multiplied by 25 and PFDI subscale scores ranging from 0-100 are calculated. Then, the 3 subscale scores are summed to find the PFDI total score, which ranges from 0-300. A higher score indicates worse health.
Measured: 8 weeks
Female Sexual Function Inventory
This scale consists of 19 items and is a Likert type scale that evaluates sexual dysfunction in women. The validity and reliability study of FSFI was conducted by Rosen et al. (2000). The Turkish validity and reliability analysis of the scale was performed by Öksüz and Malhan (2005). The scale consists of six separate headings: desire, arousal, lubrication, orgasm, sexual success and pain. Each title is scored 0 or between 1 and 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. If the FSFI score is >30, it is classified as good, between 23-29 as moderate, and <23 as bad.
Measured: 8 weeks
Secondary outcomes (2)
Pelvic floor impact questionnaire-7
This scale evaluates the effects of bladder, bowel and pelvic organ symptoms on an individual's activities of daily living, social relationships and emotions. Pelvic organ prolapse impact questionnaire (POPIQ-7); urinary effects questionnaire (IIQ-7); and the colorectal-anal effect questionnaire (CRAIQ-7). Each section consists of 7 questions. The questions are scored between 0 and 3 (not at all, slightly affected, moderately affected, highly affected). When calculating the total score, the average of each scale is calculated separately, multiplied by 100 and divided by 3. The scores found are summed up. The total score ranges from 0 to 300, with a low score indicating less impact of symptoms on quality of life.
Measured: 8 weeks
Health Assessment Questionnaire
This scale is consisting of 20 questions used to question functional disability and physical disability. A high score from the scale indicates low functionality. Each item is scored between 0-3 (0: I do it with no difficulty; 1: I do it with some difficulty; 2: I do it with great difficulty; 3: I can't do it at all). In addition, the use of assistive devices and the help requested from another person are also taken into account in the scoring. The sections that make up the scale are dressing, straightening, eating, walking, hygiene, reaching, grasping and daily tasks, and each section contains two or three items. Each section is scored separately, and a single HAQ score, which can vary between 0-3, is determined by taking the average of the scores of the 8 sections. In scoring the sections, the highest score among the items forming that section is accepted as the section score.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Oct 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SjögrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group will perform pelvi floor exercises at home, control group will take education session
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin, PT, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079581
- Sponsor's protocol ID
- 2021-086
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be recorded on Statistical Package Social Sciences program and then they will share only the other researches which are included in the study.
Publications
Bo K, Talseth T, Vinsnes A. Randomized controlled trial on the effect of pelvic floor muscle training on quality of life and sexual problems in genuine stress incontinent women. Acta Obstet Gynecol Scand. 2000 Jul;79(7):598-603.
PubMed 10929962
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pelvic Floor Exercises on Pain, Sexual Dysfunction and Quality of Life in Female Patients With Sjögren
- ClinicalTrials.gov ID
- NCT05079581
- Acronym / sponsor ID
- 2021-086
- Conditions
- Sjögren, Sjögren Syndrome
- Keywords
- Sjögren, Pelvic floor exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 15 Oct 2021 (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.
When the literature is examined, the positive effects of pelvic floor exercises on sexual functions have been supported by studies. However, the effectiveness of pelvic floor exercises on pelvic floor problems in women with sjögren has not been examined in the literature. The aim of this study is in order to examine the effect of pelvic floor exercises on sexual function in women with primer Sjögren Syndrome (pSS), since these negativities affect both the quality of life and sexual functions in women with pSS.
This is a randomized controlled trial examining the effect of 8 weeks of home-based pelvic floor exercises on pain, sexual dysfunction and quality of life on women with sjogren's.
Detailed description
Demographic information form, HAQ, VAS, Pelvic Pain Impact Questionnaire (PPIQ), Pelvic Floor Distress Scale-20, Female Sexual Function Inventory (FSFI), Pelvic Floor Impact Questionnaire (PFIQ-7) will be applied to female patients with Sjögren's who meet the inclusion criteria.After the initial evaluation, patients will be randomized to intervention and control groups. The intervention group will be taught home exercises including fast and slow contraction and keeping the muscles around the pelvic floor in different positions (sitting, standing, lying) and will be asked to do them every day for 8 weeks according to the determined protocol. For eight weeks, the patients will be supported by the phone by the physiotherapist and at the same time, they will be checked whether they do the exercises. The control group will be given training on pelvic floor anatomy. At the end of eight weeks, patients will be given a final evaluation and the results will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group will perform pelvi floor exercises at home, control group will take education session
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Pelvic floor exercisesPelvic floor exercises |
| Control group | No intervention | –Education session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be woman
- Having a diagnosis of primary sjogren's
- No comorbidities other than Sjögren's syndrome
- Not having had pelvic floor surgery
- Being sexually active
Key exclusion criteria (6 listed)
- Other rheumatological diseases
- Urogynecological diseases
- Sarcoidosis
- lymphoma
- Having had a non-cesarean gynecological operation
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 |
|---|---|---|
| Pelvic floor exercisesThe participants in the intervention group will be taught exercises involving strengthening the muscles around the pelvic floor in sitting, standing and lying positions by a physiotherapist who has been trained in women's health for 4 years and will be asked to perform them as home exercises every day for 8 weeks. The exercises are as follows: They will be asked to tighten the muscles around the urethra, vagina and rectum as hard as possible, upwards and inwards (from the bottom up) and hold it in this way for 8-10 seconds. It will be applied in different positions as in the table. | Other | Intervention group |
Primary outcome
Pelvic Pain Impact Questionnaire
Time frame: 8 weeks
The clinical assessment of the impact of pelvic pain on women questionnaire consists of 10 questions. The first 8 questions of the questionnaire are in the form of Likert type and are scored between 0-4. The total score is reached by adding the scores given for each item, and the last two questions are not included in the calculation.
Visual Analog Scale (VAS)
Time frame: 8 weeks
It is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Pelvic Floor Distress Scale-20
Time frame: 8 weeks
Scale is a 20-item symptom questionnaire used to measure the degree of discomfort caused by pelvic symptoms in women. Each item consists of 4 options (Never, Rarely, Moderately, Quite often) and is scored between 1 and 4. PFDI consists of 3 sub-dimensions: Urinary distress inventory, Colo-rectal-anal distress inventory, Pelvic organ prolapse distress inventory. The mean scores of the items in each sub-dimension are calculated and these scores are multiplied by 25 and PFDI subscale scores ranging from 0-100 are calculated. Then, the 3 subscale scores are summed to find the PFDI total score, which ranges from 0-300. A higher score indicates worse health.
Female Sexual Function Inventory
Time frame: 8 weeks
This scale consists of 19 items and is a Likert type scale that evaluates sexual dysfunction in women. The validity and reliability study of FSFI was conducted by Rosen et al. (2000). The Turkish validity and reliability analysis of the scale was performed by Öksüz and Malhan (2005). The scale consists of six separate headings: desire, arousal, lubrication, orgasm, sexual success and pain. Each title is scored 0 or between 1 and 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. If the FSFI score is >30, it is classified as good, between 23-29 as moderate, and <23 as bad.
2 secondary outcomes
Pelvic floor impact questionnaire-7
Time frame: 8 weeks
Health Assessment Questionnaire
Time frame: 8 weeks
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 12 Oct 2022.
- Results publication: PubMed 10929962Bo K, Talseth T, Vinsnes A. Randomized controlled trial on the effect of pelvic floor muscle training on quality of life and sexual problems in genuine stress incontinent women. Acta Obstet Gynecol Scand. 2000 Jul;79(7):598-603.
- Individual participant dataSharing planned: No. Data will be recorded on Statistical Package Social Sciences program and then they will share only the other researches which are included in the study.
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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 Pelvic floor exercises in people with Sjögren and Sjögren Syndrome, 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 6 inclusion and 6 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 12 Oct 2022. 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 Pain Impact Questionnaire (time frame: 8 weeks). The study lists 4 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 NCT05079581, which also lists 1 linked publication.
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 12 Oct 2022.