NCT04001244|CompletedDMC
Translational Research in Pelvic Pain
TRiPP
Loading search results
TRiPP
Sponsor study identifier
observational
787
2 countries
2
Study Start
September 1, 2019
Actual (reported)Primary Completion
September 1, 2021
Actual (reported)Study Completion
February 23, 2023
Actual (reported)This study aims to better understand the pathways leading to pain in women with two types of pelvic pain condition (endometriosis-associated pain and bladder pain syndrome) and determine whether these pathways can be used to subgroup patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 23, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2019
Actual (reported)June 28, 2019
Actual (reported)September 1, 2019
Actual (reported)September 1, 2021
Actual (reported)February 23, 2023
Actual (reported)Quantitative Sensory Testing (QST)
QST of the dorsal of the foot and midline lower abdomen according to the German Neuropathic Pain Network Protocol.
1 year
Presence of abdominal wall muscle tenderness
Assessment of the abdominal wall specifically looking for muscle tenderness according to a standardised protocol (an enhanced Carnetts test as described by Scheltinga and Roumen 2017). Subjects will be categorised into muscle tenderness present or absent.
1 year
Change of pressure pain threshold (PPT)
A standardised conditioned pain modulation (CPM) paradigm will be used to investigate the change in pressure pain threshold on the dorsum of the foot. An ischaemic stimulus to the contralateral arm will be used as the conditioned stimulus. The foot PPT will be measured before the conditioned stimulus and immediately after. The change will be reported as the (PPTbefore - PPTafter).
1 year
Area under the curve (AUC) of single day salivary cortisol profile
Saliva will be collected at home at the specified times allowing a daily AUC of salivary cortisol for each subject to be calculated. Collection times: waking; 30-45 minutes after waking; before lunch; before dinner; bedtime.
1 year
Metabolomic data
Baseline
Proteomic data
Baseline
Transcriptomic data
Baseline
Comorbidities
Baseline
Past trauma
Baseline
Surgical diagnosis of endometriosis (aim equal distribution of stage I/II and stage III/IV disease); at least one pelvic pain \>3/10; pain not perceived by the patient as arising from the bladder; no urinary symptoms (e.g. urge, frequency)
Bladder pain syndrome (as defined by ESSIC criteria: pelvic pain, pressure or discomfort for greater than 6 months, perceived to be related to the urinary bladder accompanied by at least one other urinary symptom like persistent urge to void or frequency); no history of endometriosis
Surgical diagnosis of endometriosis; at least one pelvic pain \>3/10; pain perceived by the patient as arising from the bladder AND from other area(s) of the pelvis; at least one urinary symptom (e.g. urge, frequency)
No endometriosis; No pelvic pain (or dysmenorrhea; NRS \<3/10)
At least one pelvic pain \>3/10; no endometriosis; pain not perceived by the patient as arising from the bladder; no urinary symptoms (e.g. urge, frequency)
Controls, EAP and EABP will be selected from already recruited cohorts, with permission to be recontacted, in the ENDOX (University of Oxford) and BCE (Boston Childrens Hospital) studies. BPS will be recruited from secondary/tertiary care clinics and from adverts on patient support group sites and in local media.
IBMC
Porto, Portugal
University of Oxford
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Coxon L, Tan E, Krassowski M, Mendes PA, Gomes JF, Lunde CE, Meijlink J, Perro D, Arendt-Nielsen L, Aziz Q, Becker CM, Birch J, Charrua A, Demetriou L, Evans E, Hoffman A, Horne AW, Hummelshoj L, Missmer SA, Passarella E, Pogatzki-Zahn E, Treede RD, Vollert J, Zondervan KT, Sieberg CB, Cruz F, Nagel J, Vincent K. The value of a non-invasive bladder sensitivity paradigm in chronic pelvic pain. Reprod Fertil. 2026 Mar 4;7(1):RAF250091. doi: 10.1530/RAF-25-0091. Print 2026 Jan 1.
Saliva Blood Urine Bladder biopsies (for BPS patients) Eutopic and ectopic endometrium (for endometriosis patients and Oxford controls) N.B. Biospecimens have already been collected for all Endometriosis (with and without bladder symptoms) and Control subjects, therefore new bio specimens are only being collected for the BPS cohort or if necessary for additional analyses (e.g. salivary cortisol), in which case samples will not be retained.
Katy Vincent, DPhil
University of Oxford
787 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2019
First Posted
June 28, 2019
Study Start
September 1, 2019
Actual (reported)Virtual Mindfulness and Endometriosis
Change in salivary cortisol
A saliva sample will be collected at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as Cortisol(before)-Cortisol(after).
Saliva collected immediately before and immediately after CPM paradigm (outcome 3).
Heart rate (HR)
Assessed over a 20 minute period at rest.
1 year
Change in heart rate
Assessed at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as HR(before) - HR(after).
HR assessed immediately before and immediately after the CPM paradigm (outcome 3)
Blood pressure (BP)
Assessed over a 20 minute period at rest. Measured in mmHG.
1 year
Change in Blood pressure
Assessed at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as BP(before) - BP(after).
BP assessed immediately before and immediately after the CPM paradigm (outcome 3)
Bladder sensitivity to filling
Assessed with standardised non-invasive bladder filling paradigm, measured as time to verbal reports of different sensations of bladder fullness (first sensation, first urge) and then need to void (maximum tolerance) after drinking 600 ml water. Subjects will be categorised into those with bladder sensitivity compared to published norms for reproductive age women and those with normal bladder sensation.
1 year
Volume voided at maximum tolerance
Assessed with standardised non-invasive bladder filling paradigm described in outcome 10. The volume of urine voided when maximum tolerance is reached will be measured in mls.
1 year
fMRI scan
fMRI scan with response to punctate stimuli of midline lower abdomen.
1 year
Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan)
Measured with the Pain Catastrophising Scale (Sullivan). Scores range from 0 - 52 with high scores representing higher levels of pain catastrophising. Although three sub scales exist they will not be assessed for the purposes of these main analyses.
Baseline
Comorbid psychological distress
Measured with the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 - 21 for each of the two sub scales measuring anxiety and depression. The two sub scales will be summed as a unidimensional measure of psychological distress in initial analyses (0 - 42 with higher scores representing greater distress).
Baseline
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2021
Actual (reported)Study Completion
February 23, 2023
Actual (reported)Last Updated
April 4, 2023
Record last verified: 2022-11
Once the study and all follow up analyses are complete de-identified data will be deposited in a publically accessible repository as required by the funders.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: