Dyspareunia and Central Sensitization

NCT03216330 | Completed Results

• 1 other identifier: H16-02903
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Endometriosis affects 10% of reproductive aged females, and can have a negative impact on sexual quality of life. Endometriosis can cause pelvic pain with deep penetration during intercourse, as well as other sexual and non-sexual pains. This study will allow us to determine if an increase in sexual pain is related to central sensitization. Purpose: The purpose of this study is to determine if there is an association between the severity of sexual pain and central sensitization in women with endometriosis. Measurement tools: Data will be collected from the Clinic's Data Registry, an online questionnaire, a quantitative sensory test (QST) to measure pain-pressure threshold (PPT) as a marker of central sensitization, and daily entry to an online survey. Primary Hypothesis: Central sensitization (measured by lower pain-pressure threshold) will be associated with an increased severity of deep dyspareunia, as well as a tenderness of the bladder/pelvic floor and depression, in women with endometriosis.

Conditions

Endometriosis; Central Sensitisation; Dyspareunia

Keywords

Quantitative sensory test (QST); Deep dyspareunia; Electronic Thimble Algometer

Outcome Measures

Primary Outcomes (1)

• Deep Dyspareunia Score

  Self reported response to the question: "In the last 24 hours, how painful was deep penetration during sexual intercourse?" on an 11-point numeric rating scale (Not applicable (no intercourse), 0= no pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10= worst pain imaginable). The average of the deep dyspareunia scores in the prospective 6 week period was calculated.

  Case only: daily for 6 weeks after QST testing date

Secondary Outcomes (2)

• Superficial Dyspareunia Score

  Case only: daily for 6 weeks after QST testing date

• Chronic Pelvic Pain Score

  Case only: daily for 6 weeks after QST testing date

Study Arms (2)

Case

* Consented to participate in the Data Registry (H16-00264) prior to their physician appointment at the BC Women's Health Centre. * New or re-referred to the BC Women's Health Centre for Pelvic Pain and Endometriosis. * Endometriosis (previously surgically diagnosed, or current endometrioma, or current nodule) * Willing and committed to indicating pain scores and menstrual data on a REDCap survey every day for 6 weeks after the test date. * At least 18 years old

Other: No Intervention

Control

* Reproductive aged female with no suspected or diagnosed endometriosis. * Have not experienced any sexual pain scores over 4/10 on a 11-point numeric rating scale, as determined on an online questionnaire prior to test day. * At least 18 years old

Other: No Intervention

Interventions

No Intervention OTHER

There is no treatment intervention. We are assigning measurement tools such as the Electronic Thimble Algometer for QST and questionnaires to both groups.

Case; Control

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary care centre (BC Women's Health Centre for Pelvic Pain and Endometriosis) for case participants. Community sample for control participants.

You may qualify if:

• Case:
• Consented to participate in the Data Registry (H16-00264) prior to their physician appointment at the BC Women's Health Centre.
• New or re-referred to the BC Women's Health Centre for Pelvic Pain and Endometriosis.
• Endometriosis (previously surgically diagnosed, or current endometrioma, or current nodule)
• Willing and committed to indicating pain scores and menstrual data on a REDCap survey every day for 6 weeks after the test date.
• At least 18 years old
• Control:
• Reproductive aged female with no suspected or diagnosed endometriosis.
• Have not experienced any sexual pain scores over 4/10 on a 11-point numeric rating scale, as determined on an online questionnaire prior to test day.
• At least 18 years old

You may not qualify if:

• \- Case and Control:
• Fibromyalgia.
• Severe and enduring psychological illness(es) affecting cognition (e.g., bipolar disorder, schizophrenia etc.).
• Currently pregnant or breastfeeding.
• Have a peripheral or central neurological disorder.
• Have diabetes mellitus or neuropathic pain.
• Do not speak English.
• Have had previous physical trauma (ex. Surgery) to the test site(s) (deltoid muscle in the shoulder, and first dorsal interosseous muscle).

Sponsors & Collaborators

• BC Women's Hospital & Health Centre: lead

Study Sites (1)

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H2N9, Canada

Location

MeSH Terms

Conditions

Endometriosis; Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

* small sample size due to difficulty with recruitment * the lack of multiple QST modalities * absence of pelvic test site in the assessment * results may not be generalizable to the general population since the participants were from a tertiary center for endometriosis * we included people on hormonal therapy, in order to capture representative endometriosis population, however due to the limited sample size we were not able to control for hormonal effects

Results Point of Contact

• Title: Paul Yong
• Organization: BC Women's Hospital and University of British Columbia

paul.yong@vch.ca

604-875-2534

Study Officials

• Paul Yong, MD/PhD

  BC Children's and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Research Director, BC Women's Centre for Pelvic Pain and Endometriosis.

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 13, 2017
• Study Start: July 19, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)