Pelvic Floor Exercises in Patients With Sjögren's

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.

Study Overview

• Status: Completed
• Conditions: Sjögren Syndrome; Sjögren
• Intervention / Treatment: Other: Pelvic floor exercises

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; Pelvic floor exercises	Other: Pelvic floor exercises; 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.
No Intervention: Control group; Education session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Akdeniz University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Pelvic floor exercises; Sjögren
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Sjogren's Syndrome
• Other Study ID Numbers: 2021-086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No