Chronic Pelvic PainNCT06413277
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
An observational study of Chronic Pelvic Pain and Pudendal Neuralgia, run by Ainsworth Institute of Pain Management at 1 site in United States.
Trial summary
The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pelvic Pain, Pudendal Neuralgia
- What is being tested?
- Saluda Evoke Smart SCS System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 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: Patients aged 18 or older with chronic, intractable pelvic pain
Who may be able to join
- Subject is 18 years of age or older at the time of enrollment.
- Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
- Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
- Subject has pain resulting from a known injury (surgery or trauma).
- Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause.
- Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
- Subject is willing and capable of giving informed consent.
- Subject is willing and able to comply with study-related requirements, procedures, and visits.
Who cannot join
- Subject is pregnant or nursing.
- Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
- Subject's mechanism of pain is unknown.
- Suspected cause and onset of pain are more than 30 days apart.
- Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
- Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
Show all 14Show fewer
- Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
- Subject has a history of sexual abuse and/or sexual trauma.
- Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
- Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
- Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
- Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
- Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator.
- Subject is concomitantly participating in another clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ainsworth Institute of Pain Management
New York, New York, 10022
Zoey Smith, 212-203-2813, zsmith@ainpain.com
Corey W Hunter, MD, FIPP
About this study
Official title: Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain: HOPE Trial
The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord).
Read the detailed description
Primary Objective Evaluate the efficacy of ECAP CL-SCS in treating chronic pelvic pain.
Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency.
Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters.
Study design This protocol describes an observational, prospective, single-arm, single center study. Eligible subjects will undergo an implant procedure as per standard of care for SCS. The system will be used within its licensed use. Data will be collected prospectively from 1 US study center. Time points of data collection are at baseline, trial, device implant and at 3-, 6-, -12 months post-implant.
Study population Subjects with chronic, intractable pelvic pain will be screened for participation in this study.
Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo a trial procedure.
Following the trial phase subjects may receive a permanent implant and be followed up at 3-, 6-, and 12-months following the permanent implant.
Enrollment will continue until 15 subjects receive a permanent implant. We estimate that up to 20 subjects will be enrolled in this study.
Statistical analyses will be conducted using an appropriate software package (e.g., SAS, SPSS, R, Statistics). Standard summary statistics will be used to summarize endpoints and key study variables. Categorical variables, including the incidence of adverse events, will be summarized via counts and percentages. Continuous variables will be summarized via mean, median, standard deviation, and range. 95% confidence intervals will also be included with summary statistics for primary and secondary endpoints as well as other variables where appropriate. Any p-values for secondary or other endpoints will be nominal and not adjusted for multiplicity.
- Conditions
- Chronic Pelvic Pain, Pudendal Neuralgia
- Being tested
- Saluda Evoke Smart SCS System
- Keywords
- Chronic Pelvic Pain, Pudendal Neuralgia, Levator Ani Syndrome
- Medical subject headings
- Pudendal Neuralgia, Levator syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saluda Evoke Smart SCS SystemDevice
Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline
Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores.
Measured: 12 months
Secondary outcomes (10)
Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline.
Evaluate changes in impact of pain on activities of daily living from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Disability Index (PDI).
Measured: 12 months
Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline
Evaluate changes in Pain quality from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using the Short Form-McGill Pain Questionnaire-2 (SF-MPQ2).
Measured: 12 months
Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline.
Evaluate changes in health-related quality of life from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using EQ-5D-5L (The EuroQol 5 Dimension 5 Level self-report survey).
Measured: 12 months
Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline.
Evaluate changes in sleep quality and disturbances from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Measured: 12 months
Changes in Anxiety and Depression: Proportion of patients achieving at least 50% and 80% reduction in anxiety and depression compared to baseline.
Evaluate changes in Anxiety and Depression from baseline to 3-, 6-, and 12-month post ECAP CL-SCS Implant using Hospital Anxiety and Depression Scale (HADS).
Measured: 12 months
Changes in Pain Catastrophizing: Proportion of patients achieving at least 50% and 80% reduction in pain catastrophizing compared to baseline.
Evaluate changes in Pain Catastrophizing from baseline to at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Pain Catastrophizing Scale (PCS).
Measured: 12 months
Global Improvement: Proportion of patients achieving at least 50% and 80% increase in global improvement compared to baseline.
Evaluate changes in Global improvement with treatment at 3-, 6-, and 12-month post ECAP CL-SCS Implant using Patient global impression of change (PGIC) questionnaire.
Measured: 12 months
Changes in Urinary Urgency Frequency: Proportion of patients achieving at least 50% and 80% reduction of urinary urgency frequency compared to baseline.
Evaluate changes in Urinary Urgency Frequency Patient Symptoms from baseline to 3-, 6-, and 12- month post ECAP CL-SCS Implant using Pelvic Pain and Urinary Urgency Frequency (PUF) Patient Symptom Scale.
Measured: 12 months
Safety of ECAP CL-SCS: Number of participants who experience study-related adverse events (AEs) and serious AEs (SAEs), the seriousness and severity of the AEs/SAEs and how the AEs/SAEs relate to procedure, device, and/or stimulation.
Evaluate safety of ECAP CL-SCS in treating chronic pelvic pain by analyzing the incidence of study-related adverse event (AE) and serious AE (SAE).
Measured: 12 months
Optimal device settings: Device settings at which participants achieved at least 50% and 80% increase in global improvement compared to baseline.
Device settings and data (e.g., ECAP target, amplitude, pulse width, frequency, programmed electrodes, recharge characteristics and patient usage) will be collected and summarized at the end of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start5 Feb 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic PainStudies 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
- Ainsworth Institute of Pain Management
- Sponsor type
- University, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Corey W Hunter, MD, FIPP, Principal investigator, Ainsworth Institute of Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413277
- Sponsor's protocol ID
- 1351927
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hunter CW, Falowski S. Neuromodulation in Treating Pelvic Pain. Curr Pain Headache Rep. 2021 Feb 3;25(2):9. doi: 10.1007/s11916-020-00927-y.
PubMed 33534006Hunter CW, Stovall B, Chen G, Carlson J, Levy R. Anatomy, Pathophysiology and Interventional Therapies for Chronic Pelvic Pain: A Review. Pain Physician. 2018 Mar;21(2):147-167.
PubMed 29565946Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
PubMed 22607834Fayaz A, Croft P, Langford RM, Donaldson LJ, Jones GT. Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open. 2016 Jun 20;6(6):e010364. doi: 10.1136/bmjopen-2015-010364.
PubMed 27324708Schappert SM, Burt CW. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02. Vital Health Stat 13. 2006 Feb;(159):1-66.
PubMed 16471269Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
PubMed 30586067Stein SL. Chronic pelvic pain. Gastroenterol Clin North Am. 2013 Dec;42(4):785-800. doi: 10.1016/j.gtc.2013.08.005. Epub 2013 Oct 23.
PubMed 24280400Smith CP. Male chronic pelvic pain: An update. Indian J Urol. 2016 Jan-Mar;32(1):34-9. doi: 10.4103/0970-1591.173105.
PubMed 26941492Valovska, A. T. Pelvic Pain Management. (Oxford University Press, 2016).
Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
PubMed 8598948Engeler DS, Baranowski AP, Dinis-Oliveira P, Elneil S, Hughes J, Messelink EJ, van Ophoven A, Williams AC; European Association of Urology. The 2013 EAU guidelines on chronic pelvic pain: is management of chronic pelvic pain a habit, a philosophy, or a science? 10 years of development. Eur Urol. 2013 Sep;64(3):431-9. doi: 10.1016/j.eururo.2013.04.035. Epub 2013 Apr 28.
PubMed 23684447Miller-Matero LR, Saulino C, Clark S, Bugenski M, Eshelman A, Eisenstein D. When treating the pain is not enough: a multidisciplinary approach for chronic pelvic pain. Arch Womens Ment Health. 2016 Apr;19(2):349-54. doi: 10.1007/s00737-015-0537-9. Epub 2015 May 5.
PubMed 25941014Lorencatto C, Petta CA, Navarro MJ, Bahamondes L, Matos A. Depression in women with endometriosis with and without chronic pelvic pain. Acta Obstet Gynecol Scand. 2006;85(1):88-92. doi: 10.1080/00016340500456118.
PubMed 16521687Williams DA. The importance of psychological assessment in chronic pain. Curr Opin Urol. 2013 Nov;23(6):554-9. doi: 10.1097/MOU.0b013e3283652af1.
PubMed 24080806Romao AP, Gorayeb R, Romao GS, Poli-Neto OB, dos Reis FJ, Rosa-e-Silva JC, Nogueira AA. High levels of anxiety and depression have a negative effect on quality of life of women with chronic pelvic pain. Int J Clin Pract. 2009 May;63(5):707-11. doi: 10.1111/j.1742-1241.2009.02034.x.
PubMed 19392920
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain: HOPE Trial
- ClinicalTrials.gov ID
- NCT06413277
- Acronym / sponsor ID
- 1351927
- Conditions
- Chronic Pelvic Pain, Pudendal Neuralgia
- Keywords
- Chronic Pelvic Pain, Pudendal Neuralgia, Levator Ani Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ainsworth Institute of Pain ManagementUniversity, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 May 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 aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord).
Detailed description
Primary Objective Evaluate the efficacy of ECAP CL-SCS in treating chronic pelvic pain.
Secondary Objectives Evaluate changes in impact of pain on activities of daily living, pain quality, quality of life, sleep, anxiety and depression, pain catastrophizing, patient satisfaction, and symptoms related to urinary urgency frequency.
Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical programming parameters.
Study design This protocol describes an observational, prospective, single-arm, single center study. Eligible subjects will undergo an implant procedure as per standard of care for SCS. The system will be used within its licensed use. Data will be collected prospectively from 1 US study center. Time points of data collection are at baseline, trial, device implant and at 3-, 6-, -12 months post-implant.
Study population Subjects with chronic, intractable pelvic pain will be screened for participation in this study.
Subjects who provide informed consent and meet the study eligibility criteria will be enrolled and will undergo a trial procedure.
Following the trial phase subjects may receive a permanent implant and be followed up at 3-, 6-, and 12-months following the permanent implant.
Enrollment will continue until 15 subjects receive a permanent implant. We estimate that up to 20 subjects will be enrolled in this study.
Statistical analyses will be conducted using an appropriate software package (e.g., SAS, SPSS, R, Statistics). Standard summary statistics will be used to summarize endpoints and key study variables. Categorical variables, including the incidence of adverse events, will be summarized via counts and percentages. Continuous variables will be summarized via mean, median, standard deviation, and range. 95% confidence intervals will also be included with summary statistics for primary and secondary endpoints as well as other variables where appropriate. Any p-values for secondary or other endpoints will be nominal and not adjusted for multiplicity.
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
- Patients aged 18 or older with chronic, intractable pelvic pain
Key inclusion criteria (8 listed)
- Subject is 18 years of age or older at the time of enrollment.
- Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
- Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
- Subject has pain resulting from a known injury (surgery or trauma).
- Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause.
Key exclusion criteria (14 listed)
- Subject is pregnant or nursing.
- Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
- Subject's mechanism of pain is unknown.
- Suspected cause and onset of pain are more than 30 days apart.
- Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
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 |
|---|---|---|
| Saluda Evoke Smart SCS SystemSurgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation | Device | – |
Primary outcome
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline
Time frame: 12 months
Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores.
10 secondary outcomes
Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline.
Time frame: 12 months
Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline
Time frame: 12 months
Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline.
Time frame: 12 months
Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline.
Time frame: 12 months
Changes in Anxiety and Depression: Proportion of patients achieving at least 50% and 80% reduction in anxiety and depression compared to baseline.
Time frame: 12 months
Changes in Pain Catastrophizing: Proportion of patients achieving at least 50% and 80% reduction in pain catastrophizing compared to baseline.
Time frame: 12 months
Global Improvement: Proportion of patients achieving at least 50% and 80% increase in global improvement compared to baseline.
Time frame: 12 months
Changes in Urinary Urgency Frequency: Proportion of patients achieving at least 50% and 80% reduction of urinary urgency frequency compared to baseline.
Time frame: 12 months
Safety of ECAP CL-SCS: Number of participants who experience study-related adverse events (AEs) and serious AEs (SAEs), the seriousness and severity of the AEs/SAEs and how the AEs/SAEs relate to procedure, device, and/or stimulation.
Time frame: 12 months
Optimal device settings: Device settings at which participants achieved at least 50% and 80% increase in global improvement compared to baseline.
Time frame: 12 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 14 May 2024.
- Background: PubMed 33534006Hunter CW, Falowski S. Neuromodulation in Treating Pelvic Pain. Curr Pain Headache Rep. 2021 Feb 3;25(2):9. doi: 10.1007/s11916-020-00927-y.
- Background: PubMed 29565946Hunter CW, Stovall B, Chen G, Carlson J, Levy R. Anatomy, Pathophysiology and Interventional Therapies for Chronic Pelvic Pain: A Review. Pain Physician. 2018 Mar;21(2):147-167.
- Background: PubMed 22607834Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.
- Background: PubMed 27324708Fayaz A, Croft P, Langford RM, Donaldson LJ, Jones GT. Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open. 2016 Jun 20;6(6):e010364. doi: 10.1136/bmjopen-2015-010364.
- Background: PubMed 16471269Schappert SM, Burt CW. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02. Vital Health Stat 13. 2006 Feb;(159):1-66.
- Background: PubMed 30586067Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
- Background: PubMed 24280400Stein SL. Chronic pelvic pain. Gastroenterol Clin North Am. 2013 Dec;42(4):785-800. doi: 10.1016/j.gtc.2013.08.005. Epub 2013 Oct 23.
- Background: PubMed 26941492Smith CP. Male chronic pelvic pain: An update. Indian J Urol. 2016 Jan-Mar;32(1):34-9. doi: 10.4103/0970-1591.173105.
- BackgroundValovska, A. T. Pelvic Pain Management. (Oxford University Press, 2016).
- Background: PubMed 8598948Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
- Background: PubMed 23684447Engeler DS, Baranowski AP, Dinis-Oliveira P, Elneil S, Hughes J, Messelink EJ, van Ophoven A, Williams AC; European Association of Urology. The 2013 EAU guidelines on chronic pelvic pain: is management of chronic pelvic pain a habit, a philosophy, or a science? 10 years of development. Eur Urol. 2013 Sep;64(3):431-9. doi: 10.1016/j.eururo.2013.04.035. Epub 2013 Apr 28.
- Background: PubMed 25941014Miller-Matero LR, Saulino C, Clark S, Bugenski M, Eshelman A, Eisenstein D. When treating the pain is not enough: a multidisciplinary approach for chronic pelvic pain. Arch Womens Ment Health. 2016 Apr;19(2):349-54. doi: 10.1007/s00737-015-0537-9. Epub 2015 May 5.
- 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.
Corey W Hunter, MD, FIPP principal investigator
Ainsworth Institute of Pain Management
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 Chronic Pelvic Pain and Pudendal Neuralgia, run by Ainsworth Institute of Pain Management at 1 site in United States.
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 14 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 14 May 2024. 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 United States. 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 Zoey Smith ((212) 203 2813, zsmith@ainpain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline (time frame: 12 months). 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 NCT06413277, which also lists 42 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 14 May 2024.