Pudendal NeuralgiaPhase 4INFILTHERANCT00851513
Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
A Phase 4 study testing Lidocaine, Depmedrol and physiological serum in people with Pudendal Neuralgia and Canal Syndrome, run by Nantes University Hospital at 9 sites in France.
Trial summary
Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with: neuropathic pains treatment specific kinesitherapy Alcock's canal and sacrospinal ligament infiltrations under scan with diagnostic block local steroids… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia, Canal Syndrome
- What is being tested?
- Lidocaine, Depmedrol and physiological serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 9 sitesFrance
- Study dates
- Nov 2008to Feb 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting the four indispensable clinical criteria for pudendal neuralgia (Nantes' criteria)
- Man or woman aged more than 18 years old
- Suffering from pudendal neuralgia since more than six months
- Without previous infiltration identical to the one proposed by the protocol
- Without previous surgery of pudendal nerve
- Without any hemorrhagic risk factor
- No contra-indication to Lidocaïne, Depo-medrol or contrast-product injections
- Pain intensity with an average > or = 40/100 (measured by scales during the fifteen days before infiltration)
Who cannot join
- Patient presenting one of the four exclusion clinical criterium for pudendal neuralgia (Nantes' criteria)
- Patient who has filled his "pain note book" during less than 5 days over the 15 days before the infiltration
- Pregnancy
- Depression (Beck scale > 16/39)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CH de la Côte Basque
Bayonne, 64100
Centre MARIENIA
Cambo-les-Bains, 64250
CHU Clermont-Ferrand
Clermont-Ferrand, 63058
Hospices Civils de Lyon
Lyon, 69495
CHU de Nantes
Nantes, 44093
Catherine de Sienne
Nantes, 44200
Hôpital Rothschild
Paris, 75571
Scanner Saint Hilaire
Rouen, 76000
Hôpital Charles Nicolle
Rouen, 76031
About this study
Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:
- neuropathic pains treatment
- specific kinesitherapy
- Alcock's canal and sacrospinal ligament infiltrations under scan
- with diagnostic block
- local steroids injections
- and surgical decompression of pudendal nerve with transrectal approach.
Read more
Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.
The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:
- group A: only local anesthetic (control arm)
- group B: local anesthetics associated with local steroids
- group C: local anesthetics associated with local steroids and important volumes of physiological serum
- Conditions
- Pudendal Neuralgia, Canal Syndrome
- Being tested
- Lidocaine, Depmedrol, physiological serum
- Keywords
- Pudendal neuralgia, pudendal nerve, Alcock's canal syndrome, Canal syndrome, neuropathic pain, infiltration, randomized protocol, pain scales
- Medical subject headings
- Pudendal Neuralgia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
local anesthetics
DepmedrolDrug
local steroids
physiological serumOther
important volumes of physiological serum
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | local anesthetics (lidocaine) associated with local steroids (depo-medrol) Receives: Drug: Lidocaine; Drug: Depmedrol |
| Group C | Experimental | local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum Receives: Drug: Lidocaine; Drug: Depmedrol; Other: physiological serum |
| Group A | Active comparator | only local anesthetic (lidocaine) Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to evaluate, after 3 months, the therapeutical efficacy on pain of steroids pudendal nerve infiltration, in patients suffering from pudendal neuralgia with canal syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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 Pudendal NeuralgiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Jacques LABAT, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851513
- Sponsor's protocol ID
- BRD/08/06-B
- Acronym
- INFILTHERA
- Status last verified
- Sep 2013
- First submitted
- 25 Feb 2009
- Last updated
- 14 Sep 2026
- Results posted
- No
Publications
Labat JJ, Riant T, Lassaux A, Rioult B, Rabischong B, Khalfallah M, Volteau C, Leroi AM, Ploteau S. Adding corticosteroids to the pudendal nerve block for pudendal neuralgia: a randomised, double-blind, controlled trial. BJOG. 2017 Jan;124(2):251-260. doi: 10.1111/1471-0528.14222. Epub 2016 Jul 27.
PubMed 27465823
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
- ClinicalTrials.gov ID
- NCT00851513
- Acronym / sponsor ID
- INFILTHERA / BRD/08/06-B
- Conditions
- Pudendal Neuralgia, Canal Syndrome
- Keywords
- Pudendal neuralgia, pudendal nerve, Alcock's canal syndrome, Canal syndrome, neuropathic pain, infiltration, randomized protocol, pain scales
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Feb 2009 (estimated)
- 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 neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:
- neuropathic pains treatment
- specific kinesitherapy
- Alcock's canal and sacrospinal ligament infiltrations under scan
- with diagnostic block
- local steroids injections
- and surgical decompression of pudendal nerve with transrectal approach.
Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.
The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:
- group A: only local anesthetic (control arm)
- group B: local anesthetics associated with local steroids
- group C: local anesthetics associated with local steroids and important volumes of physiological serum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Drug: Lidocaine, Drug: Depmedrollocal anesthetics (lidocaine) associated with local steroids (depo-medrol) |
| Group C | Experimental | Drug: Lidocaine, Drug: Depmedrol, Other: physiological serumlocal anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum |
| Group A | Active comparator | Drug: Lidocaineonly local anesthetic (lidocaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient presenting the four indispensable clinical criteria for pudendal neuralgia (Nantes' criteria)
- Man or woman aged more than 18 years old
- Suffering from pudendal neuralgia since more than six months
- Without previous infiltration identical to the one proposed by the protocol
- Without previous surgery of pudendal nerve
Key exclusion criteria (4 listed)
- Patient presenting one of the four exclusion clinical criterium for pudendal neuralgia (Nantes' criteria)
- Patient who has filled his "pain note book" during less than 5 days over the 15 days before the infiltration
- Pregnancy
- Depression (Beck scale > 16/39)
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 |
|---|---|---|
| Lidocainelocal anesthetics | Drug | Group A, Group B, Group C |
| Depmedrollocal steroids | Drug | Group B, Group C |
| physiological serumimportant volumes of physiological serum | Other | Group C |
Primary outcome
The main objective is to evaluate, after 3 months, the therapeutical efficacy on pain of steroids pudendal nerve infiltration, in patients suffering from pudendal neuralgia with canal syndrome
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 14 Sep 2026.
- Results publication: PubMed 27465823Labat JJ, Riant T, Lassaux A, Rioult B, Rabischong B, Khalfallah M, Volteau C, Leroi AM, Ploteau S. Adding corticosteroids to the pudendal nerve block for pudendal neuralgia: a randomised, double-blind, controlled trial. BJOG. 2017 Jan;124(2):251-260. doi: 10.1111/1471-0528.14222. Epub 2016 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.
Jean-Jacques LABAT principal investigator
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Depmedrol and physiological serum in people with Pudendal Neuralgia and Canal Syndrome, run by Nantes University Hospital at 9 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 8 inclusion and 4 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The main objective is to evaluate, after 3 months, the therapeutical efficacy on pain of steroids pudendal nerve infiltration, in patients suffering from pudendal neuralgia with canal syndrome. 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 NCT00851513, 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 14 Sep 2026.