Pelvic Floor Exercises in Patients With Sjögren's

NCT ID: NCT05079581

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-08-15

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.

Conditions

Sjögren; Sjögren Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Pelvic floor exercises

Group Type: OTHER

Pelvic floor exercises

Intervention Type: 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.

Control group

Education session

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Sebahat Yaprak Cetin, PT

Principal Investigators

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 10929962 (View on PubMed)

Other Identifiers

2021-086

Identifier Type: -

Identifier Source: org_study_id