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Clinical Trials/NCT05079581
NCT05079581
Completed
Not Applicable

Investigation of the Effects of Pelvic Floor Exercises on Pain, Sexual Dysfunction and Quality of Life in Female Patients With Sjögren

Akdeniz University1 site in 1 country46 target enrollmentOctober 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sjögren
Sponsor
Akdeniz University
Enrollment
46
Locations
1
Primary Endpoint
Pelvic Pain Impact Questionnaire
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
August 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sebahat Yaprak Cetin, PT

Principal Investigators

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • 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
  • Having had a non-cesarean gynecological operation
  • Infection

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Pelvic floor impact questionnaire-7(8 weeks)
  • Health Assessment Questionnaire(8 weeks)

Study Sites (1)

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