Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-64
SponsorIstanbul University - Cerrahpasa

About this trial

Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

female gender

being between 18-64 years old

having a diagnosis of systemic sclerosis (SSc)

being sexually active, and not having entered menopause

Disqualifiers

the presence of current or past rheumatologic diseases other than SSc

the presence of current urogynecological diseases

a history of urological or gynecological surgeries other than cesarean section.

Trial population

70 women with systemic sclerosis and 70 healthy women

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 2 trial groups
Group A: study group
Group B: Control group

Trial outcomes

Primary outcomes

1

pelvic floor dysfunction

Pelvic Floor Distress Inventory-20 (PFDI-20) will be used.The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory-8 (CRADI-8).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100. The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.

Time frame
1 day
2

sexual dysfunction

Female Sexual Function Index (FSFI) will be used.The FSFI is a 19-item patient-reported outcome measure, consisting of 6 separate domains of female sexual function, namely desire (items 1-2), arousal (3-6), lubrication (7-10), orgasm (11-13), satisfaction (14-16), and pain (17-19).Total scores range from 2-30 with lower scores corresponding to worse sexual functioning.

Time frame
1 day
3

Pelvic Floor Dysfunction

Pelvic Floor Impact Questionnaire-7(PFIQ-7). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out. It includes scales from the Urinary Impact Questionnaire (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7), and the Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7), which are short-forms of their the longer versions.The PFIQ-7 consists of 7 questions that need to be answered 3 times each considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

Time frame
1 day

Secondary outcomes

1

Functional Capacity

Scleroderma Health Assessment Questionnaire will be used.

Time frame
1 day
2

disease activity

Modified Rodnan Skin Score will be used.

Time frame
1 day

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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