Clinical trial NCT05079581: Pelvic Floor Exercises in Patients With Sjögren's
Official title: Investigation of the Effects of Pelvic Floor Exercises on Pain, Sexual Dysfunction and Quality of Life in Female Patients With Sjögren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjögren
Sjögren Syndrome
Keywords: Sjögren
Pelvic floor exercises
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group will perform pelvi floor exercises at home, control group will take education session
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic Pain Impact Questionnaire
timeFrame: 8 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
measure: Pelvic Floor Distress Scale-20
timeFrame: 8 weeks
measure: Female Sexual Function Inventory
timeFrame: 8 weeks
Secondary outcomes:
measure: Pelvic floor impact questionnaire-7
timeFrame: 8 weeks
measure: Health Assessment Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
References:
citation: 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.