PudendopathieNCT03883178
New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study
A study testing Minimal-invasive endoscopic transgluteal approach in people with Pudendopathie and Clunealgie, run by Katleen JOTTARD at 1 site in Belgium.
Trial summary
Pudendal nerve and cluneal nerve entrapment can cause a neuropathic pain syndrome in one, many or all of the sensitive areas innervated by this nerve. In literature, several techniques for the liberation of the pudendal nerve have been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendopathie, Clunealgie
- What is being tested?
- Minimal-invasive endoscopic transgluteal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 16 May 2017to 29 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from pudendalgie and/ or clunealgie, according to the 5 Nantes criteria and who are candidates for transgluteal surgical treatment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Pudendal nerve and cluneal nerve entrapment can cause a neuropathic pain syndrome in one, many or all of the sensitive areas innervated by this nerve. In literature, several techniques for the liberation of the pudendal nerve have been described. Here, transvaginal, transperineal and abdominal laparoscopic approaches have been proposed, but none of the latter were able to visualize the entire course of the nerve or allowed to explore the main, currently identified sites of entrapment. Although there have been reports and series of case reports on different surgical approaches, until now, the transgluteal approach is the only one which is validated by a prospective randomized study comparing the medical treatment to these surgical approach.
The investigators already performed a study to describe for the first time a new endoscopic minimal invasive technique using a transgluteal approach which permits to visualize all the nerve structures of the gluteal region. They performed an anatomic description of the region reachable with this minimally invasive approach, and described the anatomic landmarks for the visualization of the pudendal and cluneal nerve and their neurolysis.
Read more
In this study, the investigators would like to put in clinical practice this minimal invasive approach for pudendal and cluneal neurolysis. They will perform this endoscopic approach, on patients suffering from pudendalgie or/and clunealgie, who are programmed for a surgical intervention by transgluteal approach.
The investigators would like to test the feasibility of the transgluteal trocar positioning and if necessary, optimize this first important step. Secondly, they will put in practice the step-by-step surgical approach that they have worked out during their cadaver study. Finally, they will perform the entire neurolysis and nerve transposition under endoscopic control.
- Conditions
- Pudendopathie, Clunealgie
- Being tested
- Minimal-invasive endoscopic transgluteal approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal-invasive endoscopic transgluteal approachProcedure or surgery
Every patient, suffering from a pudendopathie or clunealgie, conform the Nantes criteria, and who are candidates for a surgical treatment through the transgluteal open approach, will be asked their permission to perform the procedure through a minimal-invasive endoscopic transgluteal approach.
| Study group | Role | What they receive |
|---|---|---|
| Neurolysis | Experimental | Not described Receives: Procedure: Minimal-invasive endoscopic transgluteal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
score on the SF-36 questionnaire
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. It covers several health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.The recommended scoring system for the SF-36 is a weighted Likert system for each item. The items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative to health) to 100 (positive for health).
Measured: Change from baseline at 3 months after surgery
Pain intensity according to EVA scale
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Measured: Change from baseline at 3 months after surgery
Pain intensity according to EVA scale
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Measured: Change from baseline at 6 months after surgery
Surgery duration
Surgery duration
Measured: 24 hours
Adverse events during surgery
Exhaustive list of the adverse events occuring during surgery
Measured: 24 hours
Adverse events after surgery
Exhaustive list of the adverse events occuring after surgery.
Measured: 48 hours
Conversion rate
Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery.
Measured: 24 hours
Number of trocars used during surgery
Number of 5 mm trocars used in transgluteal position during the surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start16 May 2017
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PudendopathieStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katleen JOTTARD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katleen JOTTARD, Brugmann University Hospital
- Investigators
- Katleen Jottard, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883178
- Sponsor's protocol ID
- CHUB-neurolysis
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J. Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10. doi: 10.1002/nau.20505.
PubMed 17828787Ploteau S, Salaud C, Hamel A, Robert R. Entrapment of the posterior femoral cutaneous nerve and its inferior cluneal branches: anatomical basis of surgery for inferior cluneal neuralgia. Surg Radiol Anat. 2017 Aug;39(8):859-863. doi: 10.1007/s00276-017-1825-z. Epub 2017 Feb 24.
PubMed 28236130Beco J, Climov D, Bex M. Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15. doi: 10.1186/1471-2482-4-15.
PubMed 15516268Erdogru T, Avci E, Akand M. Laparoscopic pudendal nerve decompression and transposition combined with omental flap protection of the nerve (Istanbul technique): technical description and feasibility analysis. Surg Endosc. 2014 Mar;28(3):925-32. doi: 10.1007/s00464-013-3248-1. Epub 2013 Oct 23.
PubMed 24149853Konschake M, Brenner E, Moriggl B, Hormann R, Bauer S, Foditsch E, Janetschek G, Kunzel KH, Sievert KD, Zimmermann R. New laparoscopic approach to the pudendal nerve for neuromodulation based on an anatomic study. Neurourol Urodyn. 2017 Apr;36(4):1069-1075. doi: 10.1002/nau.23090. Epub 2016 Aug 4.
PubMed 27490402Robert R, Labat JJ, Bensignor M, Glemain P, Deschamps C, Raoul S, Hamel O. Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. Eur Urol. 2005 Mar;47(3):403-8. doi: 10.1016/j.eururo.2004.09.003.
PubMed 15716208Jottard K, Bruyninx L, Bonnet P, De Wachter S. Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up. Neurourol Urodyn. 2020 Sep;39(7):2003-2007. doi: 10.1002/nau.24462. Epub 2020 Jul 17.
PubMed 32678485Jottard K, Bruyninx L, Bonnet P, De Wachter S. A minimally invasive, endoscopic transgluteal procedure for pudendal nerve and inferior cluneal nerve neurolysis in case of entrapment: 3- and 6-month results. The ENTRAMI technique for neurolysis. Int J Colorectal Dis. 2020 Feb;35(2):361-364. doi: 10.1007/s00384-019-03480-2. Epub 2019 Dec 11.
PubMed 31828369
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study
- ClinicalTrials.gov ID
- NCT03883178
- Acronym / sponsor ID
- CHUB-neurolysis
- Conditions
- Pudendopathie, Clunealgie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Katleen JOTTARDUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 20 Mar 2019 (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 nerve and cluneal nerve entrapment can cause a neuropathic pain syndrome in one, many or all of the sensitive areas innervated by this nerve. In literature, several techniques for the liberation of the pudendal nerve have been described. Here, transvaginal, transperineal and abdominal laparoscopic approaches have been proposed, but none of the latter were able to visualize the entire course of the nerve or allowed to explore the main, currently identified sites of entrapment. Although there have been reports and series of case reports on different surgical approaches, until now, the transgluteal approach is the only one which is validated by a prospective randomized study comparing the medical treatment to these surgical approach.
The investigators already performed a study to describe for the first time a new endoscopic minimal invasive technique using a transgluteal approach which permits to visualize all the nerve structures of the gluteal region. They performed an anatomic description of the region reachable with this minimally invasive approach, and described the anatomic landmarks for the visualization of the pudendal and cluneal nerve and their neurolysis.
In this study, the investigators would like to put in clinical practice this minimal invasive approach for pudendal and cluneal neurolysis. They will perform this endoscopic approach, on patients suffering from pudendalgie or/and clunealgie, who are programmed for a surgical intervention by transgluteal approach.
The investigators would like to test the feasibility of the transgluteal trocar positioning and if necessary, optimize this first important step. Secondly, they will put in practice the step-by-step surgical approach that they have worked out during their cadaver study. Finally, they will perform the entire neurolysis and nerve transposition under endoscopic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurolysis | Experimental | Procedure: Minimal-invasive endoscopic transgluteal approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from pudendalgie and/ or clunealgie, according to the 5 Nantes criteria and who are candidates for transgluteal surgical treatment.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Minimal-invasive endoscopic transgluteal approachEvery patient, suffering from a pudendopathie or clunealgie, conform the Nantes criteria, and who are candidates for a surgical treatment through the transgluteal open approach, will be asked their permission to perform the procedure through a minimal-invasive endoscopic transgluteal approach. | Procedure or surgery | Neurolysis |
Primary outcome
score on the SF-36 questionnaire
Time frame: Change from baseline at 3 months after surgery
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. It covers several health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.The recommended scoring system for the SF-36 is a weighted Likert system for each item. The items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative to health) to 100 (positive for health).
Pain intensity according to EVA scale
Time frame: Change from baseline at 3 months after surgery
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Pain intensity according to EVA scale
Time frame: Change from baseline at 6 months after surgery
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Surgery duration
Time frame: 24 hours
Surgery duration
Adverse events during surgery
Time frame: 24 hours
Exhaustive list of the adverse events occuring during surgery
Adverse events after surgery
Time frame: 48 hours
Exhaustive list of the adverse events occuring after surgery.
Conversion rate
Time frame: 24 hours
Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery.
Number of trocars used during surgery
Time frame: 24 hours
Number of 5 mm trocars used in transgluteal position during the surgery.
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 20 Mar 2019.
- Background: PubMed 17828787Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J. Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10. doi: 10.1002/nau.20505.
- Background: PubMed 28236130Ploteau S, Salaud C, Hamel A, Robert R. Entrapment of the posterior femoral cutaneous nerve and its inferior cluneal branches: anatomical basis of surgery for inferior cluneal neuralgia. Surg Radiol Anat. 2017 Aug;39(8):859-863. doi: 10.1007/s00276-017-1825-z. Epub 2017 Feb 24.
- Background: PubMed 15516268Beco J, Climov D, Bex M. Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15. doi: 10.1186/1471-2482-4-15.
- Background: PubMed 24149853Erdogru T, Avci E, Akand M. Laparoscopic pudendal nerve decompression and transposition combined with omental flap protection of the nerve (Istanbul technique): technical description and feasibility analysis. Surg Endosc. 2014 Mar;28(3):925-32. doi: 10.1007/s00464-013-3248-1. Epub 2013 Oct 23.
- Background: PubMed 27490402Konschake M, Brenner E, Moriggl B, Hormann R, Bauer S, Foditsch E, Janetschek G, Kunzel KH, Sievert KD, Zimmermann R. New laparoscopic approach to the pudendal nerve for neuromodulation based on an anatomic study. Neurourol Urodyn. 2017 Apr;36(4):1069-1075. doi: 10.1002/nau.23090. Epub 2016 Aug 4.
- Background: PubMed 15716208Robert R, Labat JJ, Bensignor M, Glemain P, Deschamps C, Raoul S, Hamel O. Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. Eur Urol. 2005 Mar;47(3):403-8. doi: 10.1016/j.eururo.2004.09.003.
- Derived from this study: PubMed 32678485Jottard K, Bruyninx L, Bonnet P, De Wachter S. Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up. Neurourol Urodyn. 2020 Sep;39(7):2003-2007. doi: 10.1002/nau.24462. Epub 2020 Jul 17.
- Derived from this study: PubMed 31828369Jottard K, Bruyninx L, Bonnet P, De Wachter S. A minimally invasive, endoscopic transgluteal procedure for pudendal nerve and inferior cluneal nerve neurolysis in case of entrapment: 3- and 6-month results. The ENTRAMI technique for neurolysis. Int J Colorectal Dis. 2020 Feb;35(2):361-364. doi: 10.1007/s00384-019-03480-2. Epub 2019 Dec 11.
- Individual participant dataSharing planned: No
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.
Katleen Jottard principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal-invasive endoscopic transgluteal approach in people with Pudendopathie and Clunealgie, run by Katleen JOTTARD at 1 site in Belgium.
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 1 inclusion and 1 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 20 Mar 2019. 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 Belgium. 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 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?
score on the SF-36 questionnaire (time frame: Change from baseline at 3 months after surgery). The study lists 8 primary outcomes in all. 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 NCT03883178, which also lists 8 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 20 Mar 2019.