Pudendal Impingement SyndromeNCT03880786
Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
A study testing pudendal PNE test lead in people with Pudendal Impingement Syndrome, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Pudendal nerve release surgery in case of pudendal impingement syndrome is well described in literature.Pudendal nerve modulation in case of chronic perineal pain is also a promising technique and some small studies exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Impingement Syndrome
- What is being tested?
- pudendal PNE test lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2019to 9 Nov 2021
- 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
- Candidates for release surgery
- Patients meeting the five Nantes criteria
- Chronic pain for more than 3 months
Who cannot join
- Pregnancy
- Progressive neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
Pudendal nerve release surgery in case of pudendal impingement syndrome is well described in literature.Pudendal nerve modulation in case of chronic perineal pain is also a promising technique and some small studies exist. However, in the latter group, patient inclusion criteria are very heterogenous and so conclusions about efficacy are difficult to draw. In the surgery group, outcome results also vary between the different approaches but in general, there is room for improvement. After pudendal nerve release in chronic perineal pain syndrome, it can take up to 6 months before improvement for the patient is recorded. This is partially due to the complex chronic pain syndrome mechanism.
Nothing is known about the possible effect of early neuromodulation at the level of the pudendal nerve after his release.
Read more
Recently, two cadaveric studies were published which described a minimal invasive trans gluteal approach for pudendal nerve decompression and a pudendal electrode placement.
In the present trial, the investigators would like to combine the endoscopic trans gluteal pudendal release with pudendal neuromodulation to improve the outcome for patients suffering from pudendal impingement syndrome.
The aim is to improve the results of pain score and quality of life of patients undergoing surgery for pudendal release in case of chronic perineal pain syndrome.
- Conditions
- Pudendal Impingement Syndrome
- Being tested
- pudendal PNE test lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudendal PNE test leadDevice
All patients eligible for release surgery will be implanted a PNE test lead (Medtronic) which will be placed (transforaminal or transgluteally) next to the pudendal nerve, at the level of the ischial spine, after surgical release and connected to an external stimulation device. The PNE lead will be fixed at the ischial-spinal ligament with an absorbable suture to prevent dislocation. If a bilateral dissection is needed, bilateral test leads will be placed. Stimulation will be switched on at the second postoperative day, according to the sensory threshold described by the patient. After three weeks the PNE test lead will be removed at the outpatient clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| PNE test lead | Experimental | Not described Receives: Device: pudendal PNE test lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Visual Analog Pain scores (VAS)
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Measured: Change from baseline at first postoperative day
Maximum VAS pain scores
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Measured: Change from baseline at three weeks of stimulation
Wexner constipation score
Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation)
Measured: Change from baseline at three weeks of stimulation
Fecal incontinence severity index
Score computed according to a questionnaire.Scores range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
Measured: Change from baseline at three weeks of stimulation
Quality of life assessed by 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 three weeks of stimulation
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR )
The PISQ-IR is a validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF) in women with female pelvic floor disorders.
Measured: Change from baseline at three weeks of stimulation
Brief Male Sexual Function Inventory (BSFI)
The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory)
Measured: Change from baseline at three weeks of stimulation
Female sexual function index (FSFI)
The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory).
Measured: Change from baseline at three weeks of stimulation
Patient Health Questionnaire Mood Scale (PHQ-9)
The purpose of QSP-9 is to gather information on the presence and intensity of depressive symptoms.Scores range from 0 (no depression) to 27 (severe depression).
Measured: Change from baseline at three weeks of stimulation
Score on the DN4 questionnaire
The DN4 (which stands for "Douleur Neuropathique 4") is one of the questionnaires that can be useful in diagnosing neuropathic pain. It ranges from 0 to 10. Values equal to superior to 4 give a diagnostic of neuropathic pain.
Measured: Change from baseline at three weeks of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start8 Jan 2019
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
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 Pudendal Impingement SyndromeStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katleen JOTTARD, Brugmann University Hospital
- Investigators
- Katleen Jottard, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880786
- Sponsor's protocol ID
- CHUB-ENTRAMI
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robert 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 15716208Possover M. Laparoscopic management of endopelvic etiologies of pudendal pain in 134 consecutive patients. J Urol. 2009 Apr;181(4):1732-6. doi: 10.1016/j.juro.2008.11.096. Epub 2009 Feb 23.
PubMed 19233408Beco 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 15516268Heinze K, Hoermann R, Fritsch H, Dermietzel R, van Ophoven A. Comparative pilot study of implantation techniques for pudendal neuromodulation: technical and clinical outcome in first 20 patients with chronic pelvic pain. World J Urol. 2015 Feb;33(2):289-94. doi: 10.1007/s00345-014-1304-7. Epub 2014 Apr 29.
PubMed 24777254Peters KM, Killinger KA, Jaeger C, Chen C. Pilot Study Exploring Chronic Pudendal Neuromodulation as a Treatment Option for Pain Associated with Pudendal Neuralgia. Low Urin Tract Symptoms. 2015 Sep;7(3):138-42. doi: 10.1111/luts.12066. Epub 2014 Jul 8.
PubMed 26663728Ploteau S, Robert R, Bruyninx L, Rigaud J, Jottard K. A new endoscopic minimal invasive approach for pudendal nerve and inferior cluneal nerve neurolysis: An anatomical study. Neurourol Urodyn. 2018 Mar;37(3):971-977. doi: 10.1002/nau.23435. Epub 2017 Oct 26.
PubMed 29072775Jottard K, Bonnet P, Bruyninx L, Ploteau S, De Wachter S. The ENTRAMI technique: Endoscopic transgluteal minimal invasive technique for implantation of a pudendal electrode under full visual control: A cadaver study. Neurourol Urodyn. 2019 Jan;38(1):130-134. doi: 10.1002/nau.23850. Epub 2018 Oct 12.
PubMed 30311696Jottard K, Bruyninx L, Bonnet P, Mathieu N, De Wachter S. Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results. Int Urogynecol J. 2021 Oct;32(10):2765-2770. doi: 10.1007/s00192-020-04565-1. Epub 2020 Oct 13.
PubMed 33048179
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
- ClinicalTrials.gov ID
- NCT03880786
- Acronym / sponsor ID
- CHUB-ENTRAMI
- Conditions
- Pudendal Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 19 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 release surgery in case of pudendal impingement syndrome is well described in literature.Pudendal nerve modulation in case of chronic perineal pain is also a promising technique and some small studies exist. However, in the latter group, patient inclusion criteria are very heterogenous and so conclusions about efficacy are difficult to draw. In the surgery group, outcome results also vary between the different approaches but in general, there is room for improvement. After pudendal nerve release in chronic perineal pain syndrome, it can take up to 6 months before improvement for the patient is recorded. This is partially due to the complex chronic pain syndrome mechanism.
Nothing is known about the possible effect of early neuromodulation at the level of the pudendal nerve after his release.
Recently, two cadaveric studies were published which described a minimal invasive trans gluteal approach for pudendal nerve decompression and a pudendal electrode placement.
In the present trial, the investigators would like to combine the endoscopic trans gluteal pudendal release with pudendal neuromodulation to improve the outcome for patients suffering from pudendal impingement syndrome.
The aim is to improve the results of pain score and quality of life of patients undergoing surgery for pudendal release in case of chronic perineal pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNE test lead | Experimental | Device: pudendal PNE test lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates for release surgery
- Patients meeting the five Nantes criteria
- Chronic pain for more than 3 months
Key exclusion criteria (2 listed)
- Pregnancy
- Progressive neurological disease
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 |
|---|---|---|
| pudendal PNE test leadAll patients eligible for release surgery will be implanted a PNE test lead (Medtronic) which will be placed (transforaminal or transgluteally) next to the pudendal nerve, at the level of the ischial spine, after surgical release and connected to an external stimulation device. The PNE lead will be fixed at the ischial-spinal ligament with an absorbable suture to prevent dislocation. If a bilateral dissection is needed, bilateral test leads will be placed. Stimulation will be switched on at the second postoperative day, according to the sensory threshold described by the patient. After three weeks the PNE test lead will be removed at the outpatient clinical visit. | Device | PNE test lead |
Primary outcome
Maximum Visual Analog Pain scores (VAS)
Time frame: Change from baseline at first postoperative day
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Maximum VAS pain scores
Time frame: Change from baseline at three weeks of stimulation
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Wexner constipation score
Time frame: Change from baseline at three weeks of stimulation
Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation)
Fecal incontinence severity index
Time frame: Change from baseline at three weeks of stimulation
Score computed according to a questionnaire.Scores range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
Quality of life assessed by the SF-36 questionnaire
Time frame: Change from baseline at three weeks of stimulation
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).
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR )
Time frame: Change from baseline at three weeks of stimulation
The PISQ-IR is a validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF) in women with female pelvic floor disorders.
Brief Male Sexual Function Inventory (BSFI)
Time frame: Change from baseline at three weeks of stimulation
The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory)
Female sexual function index (FSFI)
Time frame: Change from baseline at three weeks of stimulation
The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory).
Patient Health Questionnaire Mood Scale (PHQ-9)
Time frame: Change from baseline at three weeks of stimulation
The purpose of QSP-9 is to gather information on the presence and intensity of depressive symptoms.Scores range from 0 (no depression) to 27 (severe depression).
Score on the DN4 questionnaire
Time frame: Change from baseline at three weeks of stimulation
The DN4 (which stands for "Douleur Neuropathique 4") is one of the questionnaires that can be useful in diagnosing neuropathic pain. It ranges from 0 to 10. Values equal to superior to 4 give a diagnostic of neuropathic pain.
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 4 Mar 2022.
- 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.
- Background: PubMed 19233408Possover M. Laparoscopic management of endopelvic etiologies of pudendal pain in 134 consecutive patients. J Urol. 2009 Apr;181(4):1732-6. doi: 10.1016/j.juro.2008.11.096. Epub 2009 Feb 23.
- 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 24777254Heinze K, Hoermann R, Fritsch H, Dermietzel R, van Ophoven A. Comparative pilot study of implantation techniques for pudendal neuromodulation: technical and clinical outcome in first 20 patients with chronic pelvic pain. World J Urol. 2015 Feb;33(2):289-94. doi: 10.1007/s00345-014-1304-7. Epub 2014 Apr 29.
- Background: PubMed 26663728Peters KM, Killinger KA, Jaeger C, Chen C. Pilot Study Exploring Chronic Pudendal Neuromodulation as a Treatment Option for Pain Associated with Pudendal Neuralgia. Low Urin Tract Symptoms. 2015 Sep;7(3):138-42. doi: 10.1111/luts.12066. Epub 2014 Jul 8.
- Background: PubMed 29072775Ploteau S, Robert R, Bruyninx L, Rigaud J, Jottard K. A new endoscopic minimal invasive approach for pudendal nerve and inferior cluneal nerve neurolysis: An anatomical study. Neurourol Urodyn. 2018 Mar;37(3):971-977. doi: 10.1002/nau.23435. Epub 2017 Oct 26.
- Background: PubMed 30311696Jottard K, Bonnet P, Bruyninx L, Ploteau S, De Wachter S. The ENTRAMI technique: Endoscopic transgluteal minimal invasive technique for implantation of a pudendal electrode under full visual control: A cadaver study. Neurourol Urodyn. 2019 Jan;38(1):130-134. doi: 10.1002/nau.23850. Epub 2018 Oct 12.
- Derived from this study: PubMed 33048179Jottard K, Bruyninx L, Bonnet P, Mathieu N, De Wachter S. Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results. Int Urogynecol J. 2021 Oct;32(10):2765-2770. doi: 10.1007/s00192-020-04565-1. Epub 2020 Oct 13.
- 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, MD 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 pudendal PNE test lead in people with Pudendal Impingement Syndrome, run by Brugmann University Hospital 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 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: finished, as of the sponsor's last update on 4 Mar 2022. 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?
Maximum Visual Analog Pain scores (VAS) (time frame: Change from baseline at first postoperative day). The study lists 10 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 NCT03880786, 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 4 Mar 2022.