Pudendal NeuralgiaX-DECONCT06578767
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
An observational study of Pudendal Neuralgia, run by UBOSGA at 1 site in France.
Trial summary
The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2024to Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias
Who may be able to join
- Patients over 18 years old
- Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment
- Patient having given consent after reading the information note
Who cannot join
- Absence of any "Nantes criteria",
- Patient non suitable for surgery/general anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UBOSGA
Bordeaux, Gironde, 33000
Olivier Celhay, MD, +33(0)5 56 11 61 44, celhay.ubsg33@gmail.com
Alexandra Dupire, +33(0)6 07 87 05 56, arc.ubosga@gmail.com
About this study
Official title: Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)
The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.
Read the detailed description
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.
- Conditions
- Pudendal Neuralgia
- Keywords
- pudendal, inferior cluneal, robot, surgery, decompression, neurolysis, laparoscopy
- Medical subject headings
- Pudendal Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score)
Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (> 30 min,> 60min or unlimited) Patients' Global Impression of Change (PGIC) scale (1 "very hightly improved" to 7 "very hightly worsened") are combined to create a composite criteria (significant improvement to complete improvement)
Measured: Pré-operatively, 2 days, 4 months, 1 year after surgery
Secondary outcomes (6)
Report all complications during the follow-up
Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))
Measured: 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on anxiety
Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men)
Measured: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on depression
Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30)
Measured: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on post-traumatic stress syndrome
Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38
Measured: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the impact on quality of life
Quality of life is evaluated with SF-36 (36-item Short Form Health Survey)
Measured: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Long-term efficacy of the surgical technique on pain experience using the composite criteria
Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (>30 min, >60 min or unlimited) and Patients' Global Impression of Change (PGIC) scale (1 to 7) are combined into a composite criterion (significant to complete improvement), assessed annually from 2 to 5 years after surgery.
Measured: 24, 36, 48 and 60 months after surgery (24 months ± 2 months; 36, 48 and 60 months ± 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start31 Jul 2024
- Primary completionJul 2029 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NeuralgiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBOSGA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Celhay, M.D, Principal investigator, UBOSGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578767
- Sponsor's protocol ID
- CERU_2024-034
- Acronym
- X-DECO
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)
- ClinicalTrials.gov ID
- NCT06578767
- Acronym / sponsor ID
- X-DECO / CERU_2024-034
- Conditions
- Pudendal Neuralgia
- Keywords
- pudendal, inferior cluneal, robot, surgery, decompression, neurolysis, laparoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UBOSGAUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 29 Aug 2024 (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 objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.
Detailed description
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment
- Patient having given consent after reading the information note
Key exclusion criteria (2 listed)
- Absence of any "Nantes criteria",
- Patient non suitable for surgery/general anesthesia
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
Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score)
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (> 30 min,> 60min or unlimited) Patients' Global Impression of Change (PGIC) scale (1 "very hightly improved" to 7 "very hightly worsened") are combined to create a composite criteria (significant improvement to complete improvement)
6 secondary outcomes
Report all complications during the follow-up
Time frame: 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on anxiety
Time frame: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on depression
Time frame: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the effect of the surgical technique on post-traumatic stress syndrome
Time frame: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Evaluate the impact on quality of life
Time frame: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Long-term efficacy of the surgical technique on pain experience using the composite criteria
Time frame: 24, 36, 48 and 60 months after surgery (24 months ± 2 months; 36, 48 and 60 months ± 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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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.
Olivier Celhay, M.D principal investigator
UBOSGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pudendal Neuralgia, run by UBOSGA at 1 site 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Celhay, M.D (+33(0)5 56 11 61 44, celhay.ubsg33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score) (time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.