Chronic Pelvic PainDOPECNCT03541954
Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population
A study testing Sensory testing of lower urinary tract., Sensory testing of lower rectal tract and Sensory testing of vulva muscles in people with Chronic Pelvic Pain and Chronic Perineal Pain, run by Nantes University Hospital at 2 sites in France.
Trial summary
The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain, Chronic Perineal Pain
- What is being tested?
- Sensory testing of lower urinary tract., Sensory testing of lower rectal tract and Sensory testing of vulva muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jul 2018to 14 Feb 2022
- Phase
- Interventional
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 25 years,
- Pelvic or perineal pain since > 3 months,
- No injury in pelvic imagery or clinical examination that may explain all the pain complaint,
- Patient who can understand the protocol,
- Patient who agreed and signed the informed consent for participation.
Who cannot join
- Poor understanding of French language,
- Pregnancy or lactation,
- Severe depression (Beck Depression Inventory-Short form > 16),
- Initial pain estimation at 10 on numeric analog scale,
- Inadequately cooperating,
- Isolated dysmenorrhea,
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- Deep endometriosis with rectal or bladder lesion,
- Genital or bladder infection,
- Urogenital tumor history,
- Anorectal surgery history a type of digestive resection,
- Anal stenosis,
- Advanced vaginal prolapse (stage 2 on POP-Q scale),
- Post-traumatic stress disorder history,
- Deprived of liberty (trusteeship, guardianship).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes university Hospital
Nantes, 44093
Groupe Confluent
Nantes, 44277
About this study
Official title: Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study
The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.
Read the detailed description
Some patient with chronic pelvic or perineal pain, present complex manifestations, comprising pain and dysfunction which does not involved a single organ. The gap between clinical symptoms and pathological signs is a constant feature of these pain syndromes. A possible explanation for these pain syndromes is central sensitization. This sensitization is defined by decrease nociceptive thresholds, a more intense and more prolonged response to nociceptive stimulus, and spatial extension of the painful area. It has been defined by international expert consensus in 2016 a clinical evaluation tool with 10 criteria for sensitization diagnosis: Convergences PP criteria. The aim of this study is to objectivize lower threshold, spatial and temporal diffusion of pain in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) compared to women without sensitization (Convergences PP criteria < 5). A sensory testing of lower urinary tract, lower rectal tract, vulva and pelvic muscles will be achieved.
- Conditions
- Chronic Pelvic Pain, Chronic Perineal Pain
- Being tested
- Sensory testing of lower urinary tract., Sensory testing of lower rectal tract, Sensory testing of vulva muscles, Sensory testing of pelvic muscles
- Keywords
- sensitization, pain thresholds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory testing of lower urinary tract.Other
Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.
Sensory testing of lower rectal tractOther
Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).
Sensory testing of vulva musclesOther
Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.
Sensory testing of pelvic musclesOther
Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.
| Study group | Role | What they receive |
|---|---|---|
| Patient with pelvic or perineal pain with sensitization | Other | Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) Receives: Other: Sensory testing of lower urinary tract.; Other: Sensory testing of lower rectal tract; Other: Sensory testing of vulva muscles; Other: Sensory testing of pelvic muscles |
| Patient with pelvic or perineal pain without sensitization | Other | Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5) Receives: Other: Sensory testing of lower urinary tract.; Other: Sensory testing of lower rectal tract; Other: Sensory testing of vulva muscles; Other: Sensory testing of pelvic muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pelvic pain threshold
Comparison of pelvic pain threshold obtained by 4 neurophysiological testing, between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Secondary outcomes (6)
Identification of temporal distribution of pain
Identification of temporal distribution of pain in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) compared to women without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Identification of lower pain perception thresholds
Identification of lower pain perception thresholds in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) compared to women without sensitization (Convergences PP criteria < 5) for each of the 4 neurophysiological testing.
Measured: 1 month after inclusion in the study
Comparison of state anxiety
Comparison of state anxiety between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Comparison of depression
Comparison of depression between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Comparison of catastrophizing
Comparison of catastrophizing between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Comparison of quality of life
Comparison of quality of life between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
Measured: 1 month after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start17 Jul 2018
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Why it stopped: End of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 types of patients will be included: * 30 patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5) * 30 patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541954
- Sponsor's protocol ID
- RC17_0427
- Acronym
- DOPEC
- Status last verified
- Mar 2022
- First submitted
- 17 May 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cardaillac C, Trottier C, Brochard C, Aubert P, Bordron P, Perrouin-Verbe MA, Thubert T, Chaffron S, Levesque A, Ploteau S, Marchix J, Neunlist M. Gut, vaginal, and urinary microbiota as potential biomarkers of sensitization in women with chronic pelvic pain. Am J Obstet Gynecol. 2025 Aug;233(2):103.e1-103.e18. doi: 10.1016/j.ajog.2025.01.013. Epub 2025 Jan 16.
PubMed 39826623Cardaillac C, Levesque A, Riant T, Mortier A, Neunlist M, Perrouin-Verbe MA, Volteau C, Thubert T, Brochard C, Ploteau S. Evaluation of a scoring system for the detection of central sensitization among women with chronic pelvic pain. Am J Obstet Gynecol. 2023 Nov;229(5):530.e1-530.e17. doi: 10.1016/j.ajog.2023.07.044. Epub 2023 Jul 27.
PubMed 37516398
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study
- ClinicalTrials.gov ID
- NCT03541954
- Acronym / sponsor ID
- DOPEC / RC17_0427
- Conditions
- Chronic Pelvic Pain, Chronic Perineal Pain
- Keywords
- sensitization, pain thresholds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of inclusions
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 31 May 2018 (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.
The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.
Detailed description
Some patient with chronic pelvic or perineal pain, present complex manifestations, comprising pain and dysfunction which does not involved a single organ. The gap between clinical symptoms and pathological signs is a constant feature of these pain syndromes. A possible explanation for these pain syndromes is central sensitization. This sensitization is defined by decrease nociceptive thresholds, a more intense and more prolonged response to nociceptive stimulus, and spatial extension of the painful area. It has been defined by international expert consensus in 2016 a clinical evaluation tool with 10 criteria for sensitization diagnosis: Convergences PP criteria. The aim of this study is to objectivize lower threshold, spatial and temporal diffusion of pain in women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) compared to women without sensitization (Convergences PP criteria < 5). A sensory testing of lower urinary tract, lower rectal tract, vulva and pelvic muscles will be achieved.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 types of patients will be included: * 30 patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) * 30 patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5)
| Arm | Type | Receives |
|---|---|---|
| Patient with pelvic or perineal pain with sensitization | Other | Other: Sensory testing of lower urinary tract., Other: Sensory testing of lower rectal tract, Other: Sensory testing of vulva muscles, Other: Sensory testing of pelvic musclesPatients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) |
| Patient with pelvic or perineal pain without sensitization | Other | Other: Sensory testing of lower urinary tract., Other: Sensory testing of lower rectal tract, Other: Sensory testing of vulva muscles, Other: Sensory testing of pelvic musclesPatients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria < 5) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women > 25 years,
- Pelvic or perineal pain since > 3 months,
- No injury in pelvic imagery or clinical examination that may explain all the pain complaint,
- Patient who can understand the protocol,
- Patient who agreed and signed the informed consent for participation.
Key exclusion criteria (14 listed)
- Poor understanding of French language,
- Pregnancy or lactation,
- Severe depression (Beck Depression Inventory-Short form > 16),
- Initial pain estimation at 10 on numeric analog scale,
- Inadequately cooperating,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory testing of lower urinary tract.Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds. | Other | Patient with pelvic or perineal pain with sensitization, Patient with pelvic or perineal pain without sensitization |
| Sensory testing of lower rectal tractLower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension). | Other | Patient with pelvic or perineal pain with sensitization, Patient with pelvic or perineal pain without sensitization |
| Sensory testing of vulva musclesVulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer. | Other | Patient with pelvic or perineal pain with sensitization, Patient with pelvic or perineal pain without sensitization |
| Sensory testing of pelvic musclesMyofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer. | Other | Patient with pelvic or perineal pain with sensitization, Patient with pelvic or perineal pain without sensitization |
Primary outcome
Comparison of pelvic pain threshold
Time frame: 1 month after inclusion in the study
Comparison of pelvic pain threshold obtained by 4 neurophysiological testing, between women with chronic pelvic or perineal pain with sensitization (Convergences PP criteria > 5) and without sensitization (Convergences PP criteria < 5).
6 secondary outcomes
Identification of temporal distribution of pain
Time frame: 1 month after inclusion in the study
Identification of lower pain perception thresholds
Time frame: 1 month after inclusion in the study
Comparison of state anxiety
Time frame: 1 month after inclusion in the study
Comparison of depression
Time frame: 1 month after inclusion in the study
Comparison of catastrophizing
Time frame: 1 month after inclusion in the study
Comparison of quality of life
Time frame: 1 month after inclusion in the study
Results and safety
The study was stopped early (reason given: End of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 39826623Cardaillac C, Trottier C, Brochard C, Aubert P, Bordron P, Perrouin-Verbe MA, Thubert T, Chaffron S, Levesque A, Ploteau S, Marchix J, Neunlist M. Gut, vaginal, and urinary microbiota as potential biomarkers of sensitization in women with chronic pelvic pain. Am J Obstet Gynecol. 2025 Aug;233(2):103.e1-103.e18. doi: 10.1016/j.ajog.2025.01.013. Epub 2025 Jan 16.
- Derived from this study: PubMed 37516398Cardaillac C, Levesque A, Riant T, Mortier A, Neunlist M, Perrouin-Verbe MA, Volteau C, Thubert T, Brochard C, Ploteau S. Evaluation of a scoring system for the detection of central sensitization among women with chronic pelvic pain. Am J Obstet Gynecol. 2023 Nov;229(5):530.e1-530.e17. doi: 10.1016/j.ajog.2023.07.044. Epub 2023 Jul 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory testing of lower urinary tract., Sensory testing of lower rectal tract and Sensory testing of vulva muscles in people with Chronic Pelvic Pain and Chronic Perineal Pain, run by Nantes University Hospital at 2 sites in France.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Apr 2022. 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 France. 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 was stopped early (reason given: End of inclusions). Results are not available in the source record.
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?
Comparison of pelvic pain threshold (time frame: 1 month after inclusion in the study). 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 NCT03541954, which also lists 2 linked publications.
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 5 Apr 2022.