Trial Outcomes & Findings for Dyspareunia and Central Sensitization (NCT NCT03216330)
NCT ID: NCT03216330
Last Updated: 2026-04-08
Results Overview
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.
COMPLETED
56 participants
Case only: daily for 6 weeks after QST testing date
2026-04-08
Participant Flow
Case participants: People with endometriosis from a tertiary endometriosis care center were approached after their baseline visit with their gynecologist and recruited for the study. Control participants: People with no suspected/diagnosed endometriosis and no pelvic pain scores above 4/10 were recruited from poster advertisements, in-person information sessions, and institutional research newsletters at the BC Women's Hospital.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
19
|
|
Overall Study
COMPLETED
|
36
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
Baseline characteristics by cohort
| Measure |
Case
n=36 Participants
* 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
n=19 Participants
* 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
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 7 • n=36 Participants
|
31 years
STANDARD_DEVIATION 8 • n=19 Participants
|
32 years
STANDARD_DEVIATION 7 • n=55 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=36 Participants
|
19 Participants
n=19 Participants
|
55 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=36 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=55 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=36 Participants
|
13 Participants
n=19 Participants
|
36 Participants
n=55 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=36 Participants
|
6 Participants
n=19 Participants
|
19 Participants
n=55 Participants
|
|
Pain-pressure threshold
Deltoid
|
15.3 Newtons
STANDARD_DEVIATION 6.9 • n=36 Participants
|
14.6 Newtons
STANDARD_DEVIATION 5.7 • n=19 Participants
|
15.1 Newtons
STANDARD_DEVIATION 6.5 • n=55 Participants
|
|
Pain-pressure threshold
First dorsal interosseous
|
14.5 Newtons
STANDARD_DEVIATION 7.7 • n=36 Participants
|
11.9 Newtons
STANDARD_DEVIATION 7.1 • n=19 Participants
|
13.6 Newtons
STANDARD_DEVIATION 7.5 • n=55 Participants
|
|
Bladder and/or pelvic floor tenderness
Bladder and/or pelvic floor tenderness
|
11 Participants
n=36 Participants • Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
0 Participants
Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
11 Participants
n=36 Participants • Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
|
Bladder and/or pelvic floor tenderness
No bladder or pelvic floor tenderness
|
25 Participants
n=36 Participants • Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
0 Participants
Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
25 Participants
n=36 Participants • Variable was collected for case participants only (people with endometriosis who are patients at the BC Women's Centre for Pelvic Pain and Endometriosis). Control participants were not patients at the Centre and did not receive a pelvic exam to assess for this variable.
|
PRIMARY outcome
Timeframe: Case only: daily for 6 weeks after QST testing datePopulation: 36 case participants total in the study. 6 participants did not attempt intercourse during the 6-week study period. 30 participants had dyspareunia data.
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.
Outcome measures
| Measure |
Case
n=30 Participants
* 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
|
|---|---|
|
Deep Dyspareunia Score
Low (<5)
|
3.08 scores on a scale
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: Case only: daily for 6 weeks after QST testing datePopulation: 36 case participants total in the study. 6 participants did not attempt intercourse during the 6-week study period. 30 participants had dyspareunia data.
Self reported response to the question: "In the last 24 hours, how painful was initial penetration (entry) 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 superficial dyspareunia scores in the prospective 6 week period was calculated.
Outcome measures
| Measure |
Case
n=30 Participants
* 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
|
|---|---|
|
Superficial Dyspareunia Score
|
2.34 scores on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Case only: daily for 6 weeks after QST testing dateSelf reported response to the question: "What was your average level of pelvic pain in the last 24 hours?" on an 11-point numeric rating scale (0= no pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10= worst pain imaginable). The average of the chronic pelvic pain scores in the prospective 6 week period was calculated.
Outcome measures
| Measure |
Case
n=36 Participants
* 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
|
|---|---|
|
Chronic Pelvic Pain Score
|
2.68 scores on a scale
Standard Deviation 1.76
|
Adverse Events
Case
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Paul Yong
BC Women's Hospital and University of British Columbia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place