Pudendal NeuralgiaREGENNCT06796595
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
An observational study of Pudendal Neuralgia and Neuralgia, run by UBOSGA at 1 site in France.
Trial summary
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia, Neuralgia
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2025to 31 Jan 2027
- 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 the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
Who may be able to join
- Patients over 18 years old
- Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment
- Patient having given consent after reading the information note
Who cannot join
- Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
- Person deprived of liberty or under guardianship
- Person under court protection
- Pregnant or breast-feeding woman
- Minors
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, 33000
Olivier CELHAY, +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
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).
- Conditions
- Pudendal Neuralgia, Neuralgia
- Medical subject headings
- Pudendal Neuralgia, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
Numeric pain scale (0 "no pain" to 10 "maximal pain")
Measured: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery
Secondary outcomes (5)
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 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 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 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 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 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start23 Jan 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBOSGA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796595
- Sponsor's protocol ID
- UBOSGA 2025/01
- Acronym
- REGEN
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
- ClinicalTrials.gov ID
- NCT06796595
- Acronym / sponsor ID
- REGEN / UBOSGA 2025/01
- Conditions
- Pudendal Neuralgia, Neuralgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UBOSGAUniversity, hospital or other
- Study start
- 23 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Jan 2025 (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.
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).
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 the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment
- Patient having given consent after reading the information note
Key exclusion criteria (5 listed)
- Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
- Person deprived of liberty or under guardianship
- Person under court protection
- Pregnant or breast-feeding woman
- Minors
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 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
Time frame: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery
Numeric pain scale (0 "no pain" to 10 "maximal pain")
5 secondary outcomes
Report all complications during the follow-up
Time frame: 2 days, 4 months, 1 year after surgery
Evaluate the effect of the surgical technique on anxiety
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Evaluate the effect of the surgical technique on depression
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Evaluate the effect of the surgical technique on post-traumatic stress syndrome
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Evaluate the impact on quality of life
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 and 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 5 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 28 Jan 2025. 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 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves (time frame: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year 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 28 Jan 2025.