EndometriosisTRiPPNCT04001244
Translational Research in Pelvic Pain
An observational study of Endometriosis and Bladder Pain Syndrome, run by University of Oxford at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Bladder Pain Syndrome, Chronic Pain
- Type of treatment
- Injection or infusion
- How many people
- 787 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2019to 23 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Female, aged 18 - 50 years.
- Participant is willing and able to give informed consent for participation in the study.
- EAP/EABP/CON: previously enrolled in EndOX or BCE cohorts with consent to be contacted again.
- EAP: Surgical diagnosis of endometriosis; at least one pelvic pain >3/10.
- EABP: 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).
- BPS: fulfil 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).
- fMRI compatible.
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- EAP: pain perceived by the patient as arising from the bladder; urinary symptoms (e.g. urge, frequency).
- CON: previous diagnosis of endometriosis; pelvic pain or dysmenorrhoea (NRS>3/10)
- BPS: previous diagnosis of endometriosis.
- Additionally, for physiological testing:
Show all 10Show fewer
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- And for fMRI:
- Contraindication to fMRI scan i.e. metallic implants, stents, clips, weight greater than acceptable for local fMRI scanner etc.
- Use of centrally acting drugs in the previous 3 months (e.g. anti-epileptics, anti-depressants, anxiolytics, gabapentin, pregabalin, duloxetine). N.B. Regular use of standard analgesics including opiates is not an exclusion criterion, however, women will be asked to refrain from taking such drugs for 8 hours prior to their brain scan if at all possible.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Translational Research in Pelvic Pain. Deep Phenotyping of Women With Endometriosis-associated Pain and Bladder Pain Syndrome
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.
Read the detailed description
Chronic pelvic pain is as common as asthma, migraine and back pain and has a very significant impact on quality of life. However, it is still poorly understood and the available treatments are limited and often not successful. This project focuses on two causes of chronic pelvic pain: endometriosis and interstitial cystitis/bladder pain syndrome. Endometriosis (the presence of tissue resembling the lining of the womb outside of the womb) is very common, affecting ~1 in 10 women, and is associated with often disabling pelvic pain symptoms including painful periods, pain throughout the month, and pain associated with sex, passing urine and opening bowels. Interstitial cystitis/bladder pain syndrome is much less common but dramatically reduces quality of life with many women planning their day around trips to the toilet.
This multi-centre study will be carried out at 3 sites in Europe and 1 in the U.S.. Rather than focusing on the pelvis, the investigators will approach these conditions in the context of other chronic pain conditions with which they share many features and thus consider the many different systems that might contribute to generating and maintaining pain. The investigators will combine detailed clinical and questionnaire data with tests of the function of a variety of systems (including nerve function, stress response and psychology) and the results of analyses of different body fluids and tissues (including blood, urine, endometriosis lesions). No study treatment or intervention will be given during TRiPP. The aim is to identify pathways responsible for pain in these women and determine whether they can be divided into subgroups on the basis of different pain pathways that might therefore respond to different treatments. Ultimately the investigators hope to identify new targets for treatment and contribute to the design of more personalised treatment plans.
- Conditions
- Endometriosis, Bladder Pain Syndrome, Chronic Pain
- Medical subject headings
- Endometriosis, Cystitis, Interstitial, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis (EAP) | 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 (BPS) | 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 | |
| Endometriosis and Bladder Pain (EABP) | 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) | |
| Controls | No endometriosis; No pelvic pain (or dysmenorrhea; NRS <3/10) | |
| Pelvic Pain (PP) | 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Sensory Testing (QST)
QST of the dorsal of the foot and midline lower abdomen according to the German Neuropathic Pain Network Protocol.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 year
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).
Measured: Saliva collected immediately before and immediately after CPM paradigm (outcome 3).
Heart rate (HR)
Assessed over a 20 minute period at rest.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 year
fMRI scan
fMRI scan with response to punctate stimuli of midline lower abdomen.
Measured: 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.
Measured: 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).
Measured: Baseline
Secondary outcomes (6)
Metabolomic data
Discovery study of levels of all known metabolite in plasma using an established validated proprietary tool designed by Metabolon (https://www.metabolon.com).
Measured: Baseline
Proteomic data
Study measuring levels of proteins detected on two panels (inflammation and neurological) as designed by OLink (https://www.olink.com).
Measured: Baseline
Transcriptomic data
Discovery transcriptomic analysis of matched eutopic and ectopic endometrium from endometriosis and control women will be performed on a subgroup of participants. Both descriptive data and pathway analysis will be performed.
Measured: Baseline
Comorbidities
Assessed with the complex medical symptoms inventory (CMSI).
The CMSI contains a 41 item symptom screener, which an increasing score on adds up to a higher functional somatic burden (scores range from 0-41). Additionally, clusters of symptoms point to specific diagnoses for which the full diagnostic criteria questions are provided allowing the commonest overlapping pain conditions to be screened for:
Fibromyalgia temporomandibular disorders irritable bowel syndrome chronic tension type headache migraine chronic low back pain myalgic encephalitis/chronic fatigue syndrome interstitial cystitis/painful bladder syndrome endometriosis vulvodynia
Measured: Baseline
Past trauma
Assessed with the Childhood Traumatic Events Scale (CTES). Scores range from 0 - 42 with higher scores representing more experience of early trauma. No sub scales will be derived.
Measured: Baseline
Recent trauma
Assessed with the Recent Traumatic Events Scale (RTES). Scores range from 0 - 42 with higher scores representing more experience of recent trauma. No sub scales will be derived.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 787 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Michigan State University, Bayer, Grünenthal GmbH, Esteve, Queen Mary University of London, Aalborg University, Endometriosis.org, International Painful Bladder Foundation, Pelvic Pain Support Network, King's College London, Heidelberg University, University of Edinburgh, University of Jena, Universität Münster, Universidade do Porto
- Responsible party
- Sponsor
- Investigators
- Katy Vincent, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001244
- Sponsor's protocol ID
- TRiPP WP9
- Acronym
- TRiPP
- Status last verified
- Nov 2022
- First submitted
- 16 May 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41705870
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research in Pelvic Pain. Deep Phenotyping of Women With Endometriosis-associated Pain and Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT04001244
- Acronym / sponsor ID
- TRiPP / TRiPP WP9
- Conditions
- Endometriosis, Bladder Pain Syndrome, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Michigan State University, Bayer, Grünenthal GmbH, Esteve, Queen Mary University of London, Aalborg University, Endometriosis.org, International Painful Bladder Foundation, Pelvic Pain Support Network, King's College London, Heidelberg University, University of Edinburgh, University of Jena, Universität Münster, Universidade do Porto
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pelvic pain is as common as asthma, migraine and back pain and has a very significant impact on quality of life. However, it is still poorly understood and the available treatments are limited and often not successful. This project focuses on two causes of chronic pelvic pain: endometriosis and interstitial cystitis/bladder pain syndrome. Endometriosis (the presence of tissue resembling the lining of the womb outside of the womb) is very common, affecting ~1 in 10 women, and is associated with often disabling pelvic pain symptoms including painful periods, pain throughout the month, and pain associated with sex, passing urine and opening bowels. Interstitial cystitis/bladder pain syndrome is much less common but dramatically reduces quality of life with many women planning their day around trips to the toilet.
This multi-centre study will be carried out at 3 sites in Europe and 1 in the U.S.. Rather than focusing on the pelvis, the investigators will approach these conditions in the context of other chronic pain conditions with which they share many features and thus consider the many different systems that might contribute to generating and maintaining pain. The investigators will combine detailed clinical and questionnaire data with tests of the function of a variety of systems (including nerve function, stress response and psychology) and the results of analyses of different body fluids and tissues (including blood, urine, endometriosis lesions). No study treatment or intervention will be given during TRiPP. The aim is to identify pathways responsible for pain in these women and determine whether they can be divided into subgroups on the basis of different pain pathways that might therefore respond to different treatments. Ultimately the investigators hope to identify new targets for treatment and contribute to the design of more personalised treatment plans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Endometriosis (EAP) | – | –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 (BPS) | – | –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 |
| Endometriosis and Bladder Pain (EABP) | – | –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) |
| Controls | – | –No endometriosis; No pelvic pain (or dysmenorrhea; NRS <3/10) |
| Pelvic Pain (PP) | – | –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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Female, aged 18 - 50 years.
- Participant is willing and able to give informed consent for participation in the study.
- EAP/EABP/CON: previously enrolled in EndOX or BCE cohorts with consent to be contacted again.
- EAP: Surgical diagnosis of endometriosis; at least one pelvic pain >3/10.
- EABP: 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).
Key exclusion criteria (10 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- EAP: pain perceived by the patient as arising from the bladder; urinary symptoms (e.g. urge, frequency).
- CON: previous diagnosis of endometriosis; pelvic pain or dysmenorrhoea (NRS>3/10)
- BPS: previous diagnosis of endometriosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Sensory Testing (QST)
Time frame: 1 year
QST of the dorsal of the foot and midline lower abdomen according to the German Neuropathic Pain Network Protocol.
Presence of abdominal wall muscle tenderness
Time frame: 1 year
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.
Change of pressure pain threshold (PPT)
Time frame: 1 year
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).
Area under the curve (AUC) of single day salivary cortisol profile
Time frame: 1 year
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.
Change in salivary cortisol
Time frame: Saliva collected immediately before and immediately after CPM paradigm (outcome 3).
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).
Heart rate (HR)
Time frame: 1 year
Assessed over a 20 minute period at rest.
Change in heart rate
Time frame: HR assessed immediately before and immediately after the CPM paradigm (outcome 3)
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).
Blood pressure (BP)
Time frame: 1 year
Assessed over a 20 minute period at rest. Measured in mmHG.
Change in Blood pressure
Time frame: BP assessed immediately before and immediately after the CPM paradigm (outcome 3)
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).
Bladder sensitivity to filling
Time frame: 1 year
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.
Volume voided at maximum tolerance
Time frame: 1 year
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.
fMRI scan
Time frame: 1 year
fMRI scan with response to punctate stimuli of midline lower abdomen.
Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan)
Time frame: Baseline
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.
Comorbid psychological distress
Time frame: Baseline
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).
6 secondary outcomes
Metabolomic data
Time frame: Baseline
Proteomic data
Time frame: Baseline
Transcriptomic data
Time frame: Baseline
Comorbidities
Time frame: Baseline
Past trauma
Time frame: Baseline
Recent trauma
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 41705870Coxon 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.
- Project website as part of the overall project IMI-PainCare that TRiPP sits withinLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy Vincent, DPhil principal investigator
University of Oxford
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Bladder Pain Syndrome, run by University of Oxford at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Testing (QST) (time frame: 1 year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.