Objective: Primary: To evaluate whether the vaginal mucosa of women with pSS shows histological signs of local inflammation. Secondary: A) To evaluate whether levels of pSS-related autoantibodies, (pro-inflammatory) cytokines and cellular markers,…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Immunohistochemistry of vaginal and endocervical mucosa
Secondary outcome
- Immunological parameters in the vagina, e.g. the local expression of
chemokines and cytokines in the vaginal and cervical tissue and secretions.
- Gynaecological parameters, e.g. the vaginal health index (VHI)
- Clinical disease parameters, e.g. disease activity
- patient reported parameters, e.g. sexual function, vaginal complaints,
patient reported symptoms of pSS
Background summary
Primary Sjögren*s Syndrome (pSS) is a common systemic autoimmune disease, which
is characterized by chronic inflammation of salivary and lacrimal glands,
resulting in dryness of the eyes and mouth. Dryness complaints are, however,
not restricted to these exocrine glands and women with pSS also suffer from
vaginal dryness. Vaginal dryness in pSS can cause discomfort in daily life, an
increased risk of vaginal infections and sexual dysfunction. Very little data
is available on the pathogenesis of vaginal dryness in pSS. Possible
explanations for the vaginal dryness in pSS are the presence of vasculitis or
epitheliitis of the vaginal mucosa, or cervicitis.
Study objective
Objective: Primary: To evaluate whether the vaginal mucosa of women with pSS
shows histological signs of local inflammation.
Secondary:
A) To evaluate whether levels of pSS-related autoantibodies, (pro-inflammatory)
cytokines and cellular markers, related to inflammation, are elevated in
vaginal secretions of patients with pSS.
B) To evaluate whether women with pSS have impaired vaginal health, infectious
vaginitis, bacterial vaginosis or atrophic vaginitis.
C) To evaluate whether inflammation of the vaginal mucosa is associated with
systemic and patient reported disease activity in pSS.
D) To evaluate whether inflammation of the vagina is associated with vaginal
sicca symptoms and sexual dysfunction.
Study design
Case-control pilot study
Study burden and risks
Patients will be asked to bring 1 extra visit to the UMCG. Healthy controls
Controls will not have to pay any extra visits to the UMCG. Participants will
be asked to undergo gynaecological evaluation with collection of vaginal
samples (15 min) and to fill in a questionnaire (20 min). In addition, patients
will be asked to undergo an rheumatological evaluation of disease activity,
during which a history is taken and physical examination is done (45 min).
Participation in this study involves two minor invasive procedures: vaginal and
cervical biopsy (in patients and controls), and venapunction (only in
patients). The vaginal and cervical biopsy is a safe procedure without major
risks, but might cause some bleeding or discharge. The inconvenience of this
procedure will be minimalised by using local anesthesics in patients and
performing the procedure under total anaesthesia in healthy controls who
undergo RRSO. For the control group, women will be selected who are scheduled
to undergo a surgical or diagnostic gynaecological procedure such as
risk-reducing salpingo-oophorectomy (RRSO), diagnostic laparoscopy,
laparoscopic sterilization or other (minor) surgical procedures, and who do not
have any auto-immune, inflammatory or infectious disease of the cervix or
vagina. In patients one extra venapunction is done, during which 27 ml of blood
is collected. In healthy controls, an extra 8,5 ml of blood will be drawn
during a routine venapunction. Venapunction is also a very safe procedure but
might cause some bruising. Patients will be asked to collect a urine portion.
Participants will not experience direct benefits of participation in this
study. However, this pilot study will provide a basis for further research into
the pathogenesis of vaginal sicca symptoms in pSS and give direction to the
development of a better treatment for this complaint. At the moment, local and
systemic treatment options for vaginal dryness are insufficient, and there is a
need for research on the topic of vaginal dryness as part of Sjögren*s
syndrome. Therefore, we believe the advantages of participation outweigh the
burden and risk associated with participation.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patients:
• Diagnosis of pSS according to the American European Consensus Group (AECG) classification criteria.
• Presence of vaginal sicca symptoms ;All participants:
• Female gender
• Age >=18
• Premenopausal status according to the World Health Organisation definition.
• Written informed consent
Exclusion criteria
• Presence of other systemic autoimmune disease
• Use of systemische corticosteroids within 1 month before inclusion.
• Use of disease modifying anti-rheumatic drugs (DMARDs), except hydroxychloroquine, within 1 month before inclusion.
• Use of biological DMARDs within 6 months before inclusion.
• Use of hormone replacement therapy or use of vaginal oestrogen supplementation
• Use of a intrauterine contraceptive device
• Pregnancy
• Presence of a known infectious or non-infectious inflammatory disorder of the vagina or cervix (e.g. lichen sclerosis or lichen planus of the vagina, sexually transmitted infections)
• Other gynaecological or non-gynaecological comorbidity which is expected to influence the vaginal or cervical health and/or gynaecological immune markers according to the investigators, including previous chemotherapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52349.042.15 |