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TerminatedNCT03541954DOPECUpdated Apr 5, 2022

Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population

An interventional study of Sensory testing of lower urinary tract. and Sensory testing of lower rectal tract in Chronic Pelvic Pain and Chronic Perineal Pain, sponsored by Nantes University Hospital. Terminated at 2 sites in France. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Basic science

Why this study was terminated
End of inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
25 Years and older
Sex
Female
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Study 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 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.

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Conditions studied

  • Chronic Pelvic Pain
  • Chronic Perineal Pain

Keywords

  • sensitization
  • pain thresholds
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In context

Lead sponsor

Nantes University Hospital is the lead sponsor of 837 studies on the registry; 196 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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).
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Other
    Patient with pelvic or perineal pain with sensitization

    Patients with chronic pelvic or perineal pain with sensitization (Convergences PP criteria \> 5)

    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

  • Other
    Patient with pelvic or perineal pain without sensitization

    Patients with chronic pelvic or perineal pain without sensitization (Convergences PP criteria \< 5)

    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

Interventions

  • OtherSensory testing of lower urinary tract.

    Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.

  • OtherSensory testing of lower rectal tract

    Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).

  • OtherSensory testing of vulva muscles

    Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.

  • OtherSensory testing of pelvic muscles

    Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 month after inclusion in the study

Secondary outcomes

  1. 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).

    Time frame: 1 month after inclusion in the study

  2. 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.

    Time frame: 1 month after inclusion in the study

  3. 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).

    Time frame: 1 month after inclusion in the study

  4. 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).

    Time frame: 1 month after inclusion in the study

  5. 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).

    Time frame: 1 month after inclusion in the study

  6. 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).

    Time frame: 1 month after inclusion in the study

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Study locations

2 sites
  • Nantes university Hospital
    Nantes, 44093, France
  • Groupe Confluent
    Nantes, 44277, France
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References and documents

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 39826623 ↗
  • Cardaillac 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03541954
Responsible party
Sponsor
First posted
May 31, 2018
Start date
Jul 17, 2018
Primary completion
Feb 14, 2022
Completion
Feb 14, 2022
Last update
Apr 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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