Pelvic Floor Exercises in Patients With Sjögren's

NCT05079581 | Completed

• 1 other identifier: 2021-086
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sjögren; Sjögren Syndrome

Keywords

Sjögren; Pelvic floor exercises

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  8 weeks

Secondary Outcomes (2)

• Pelvic floor impact questionnaire-7

  8 weeks

• Health Assessment Questionnaire

  8 weeks

Study Arms (2)

Intervention group

OTHER

Pelvic floor exercises

Other: Pelvic floor exercises

Control group

NO INTERVENTION

Education session

Interventions

Pelvic floor exercises OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female patients will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other rheumatological diseases
• Urogynecological diseases
• Sarcoidosis
• lymphoma
• Having had a non-cesarean gynecological operation
• Infection

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 10929962 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigators

Model Details: Intervention group will perform pelvi floor exercises at home, control group will take education session

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: October 15, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)