Chronic Pelvic Pain SyndromeSNM_CPPNCT06150599
Sacral Neuromodulation for Chronic Pelvic Pain
A study testing Sacral neuromodulation in people with Chronic Pelvic Pain Syndrome, run by Corewell Health East at 1 site in United States.
Trial summary
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. Read more about this study
- Who is it for?
- Ages 22 to 70 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Sacral neuromodulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 1 Dec 2028
- Phase
- Interventional
- 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 22 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 22-70
- Chronic pelvic pain (= pain below umbilicus) score of 4 or greater on 10-point VAS, present for 6 months or greater (screening patient)
- Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations)
- No changes to current regimen of medications for their pelvic pain for > 4 weeks prior to screening
- For females of reproductive potential: use of highly effective contraception (e.g. licensed hormonal or barrier methods), for at least 1 month prior to screening and agreement to use such a method during study participation
- Participant agrees not to start any new treatment interventions for CPP prior to Visit 4 (Primary Endpoint)
Who cannot join
- History of any active pelvic cancer
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
- Concurrent pain management strategies within the past 3 months that may interfere or mask study intervention (e.g. pelvic floor physical therapy, shockwave therapy, trigger point injections, bladder instillations)
- Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders that are stable.
- Current symptomatic urinary tract infection (UTI) or more than 6 UTIs in past year
- Severe or uncontrolled diabetes (A1C > 7, documented in the last 3 months) or diabetes with peripheral nerve involvement
Show all 16Show fewer
- Interstitial cystitis diagnosis with Hunner's lesions as this is a severe inflammatory bladder condition that can only be treated with eradication of the lesions or a cystectomy. SNM would be be expected to help for IC with Hunner's lesions
- Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial
- Subject with documented history of allergy to titanium, zirconia, polyurethane, epoxy, or silicone
- Implantation of spinal cord stimulator and/or drug delivery pumps, whether turned on or off
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
- Current treatment for active malignancy (skin cancers excluded)
- Patients with spinal pathology that could confound study results. This may include participants with cauda equina syndrome, spinal stenosis, neurogenic claudication, lumbar radiculopathy, patients with primary complaints of leg pain with numbness and or weakness, patients with a primary pain compliant that is vascular in origin, clinical evidence of progressive neurologic pathology, mechanical instability or other spinal pathology that requires surgical intervention, spine or visceral pain secondary to neoplasm, visceral pain in the upper abdomen rather than the pelvis, current diagnosis of fibromyalgia participants with significant cognitive impairment, participants with a condition currently requiring or likely to require use of diathermy or MRI or history of any other condition that in the opinion of the investigator could put the participant at risk or interfere with study results interpretation. (screening patient).
- Participants involved in ongoing litigation and or injury claims or workers compensation claims.
- Participation in a current clinical trial or within the preceding 30 days
- Note- to preserve the scientific integrity of the study some criteria have been omitted from this posting. All eligibility criteria will be listed at the close of the 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
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Jennifer Giordano, BSN, 248-551-3517, Jennifer.Giordano@corewellhealth.org
Julie Swanson, BSN, 248-551-3551, Julie.Swanson2@corewellhealth.org
About this study
Official title: Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.
Read the detailed description
Despite SNM being available for more than 25 years, there are many things about this technology that remain elusive. Enhancing our understanding of SNM in the chronic pelvic pain (CPP) population can rapidly improve the care of current patients suffering from pelvic pain, as well as help develop future technologies, stimulation paradigms, and lead to effective counseling of patients. CPP is one of most common and challenging conditions for clinicians to treat today. CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months. As such, CPP can be caused by numerous underlying conditions from gynecological (e.g. endometriosis), gastrointestinal (e.g. celiac disease, irritable bowel syndrome), urological (e.g. interstitial cystitis), musculoskeletal (e.g. fibromyalgia), prostatitis, and neurological/vascular (e.g. spinal cord injury, ilioinguinal nerve entrapment) origin. From a urological perspective, the pain in CPP syndrome can be associated with symptoms suggesting urinary, sexual or bowel dysfunction, and are commonly associated with Overactive Bladder (OAB) symptoms of urinary frequency, urgency, and incontinence. CPP has a debilitating effect on quality of life, leading to other comorbidities such as depression, anxiety, and sleep disorders. CPP is common in both men and women, but occurs more frequently in women. This study will assess the effectiveness of sacral neuromodulation in women.
This is a prospective single arm and single blinded quasi-placebo controlled study. Patients will be blinded to the device settings. For those that qualify, the sacral neuromodulation device will be placed by an experienced physician. After placement in the operating room the device settings will be adjusted. 2 weeks post-operatively participants return and complete study questionnaires. The devices settings will again be adjusted at this visit. The device may turned on/off, or settings modified throughout the study. To maintain study integrity, patients will not be informed how device settings are changed. At each follow up visit, participants will be asked to complete study questionnaires and will have their device settings adjusted. Participants will follow up over a course of 12 months from the time of device implantation.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Sacral neuromodulation
- Keywords
- Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral neuromodulationDevice
Also called SNM, Interstim X
Interstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure.
| Study group | Role | What they receive |
|---|---|---|
| SNM for the treatment of CPP | Experimental | Patients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7. Receives: Device: Sacral neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
The VAS is a validated tool to determine patient perceived pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 4 (10 weeks post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
Measured: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)
Secondary outcomes (9)
The change in central sensitization score over 13 months
Change in central sensitization will be assessed using the temporal summation test using the TSA2 AIR system. Temporal summation is considered a manifestation of central sensitization and can be assessed using thermal modalities. It is measured as the magnitude of positive slope of the line fitted to the series of 10 stimuli at the target temperature. A larger slope reflects a higher degree of central sensitization. The central sensitization slope at each treatment visit (visits 3 through 8) minus the slope at visit 2 (baseline, 2 weeks post-implementation) will be recorded and analyzed. A positive number reflects more central sensitization, and a negative number reflects less central sensitization.
Measured: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in pelvic floor pain using a 10-point VAS pain score.
A trained provider will palpate all 4 quadrants of the pelvis, while recording pain scores for each quadrant. The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = worst possible pain. The subject will provide a pain score from 0 - 10 for each of the 4 quadrants assessed. The average pain score of the 4 quadrants is then calculated. The average pain score ranges from 0 to 10. The difference in value from visit 2 (baseline, 2 weeks post implant) minus visit 8 (an average of 13 months post implant) is calculated. A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Measured: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in severity of overactive bladder symptoms.
The change in OAB symptoms between baseline (visit 2) and subsequent study visits will be assessed using the 6-question Overactive Bladder Questionnaire Short Form (OABq). OABq is a well-established questionnaire used to assess severity of OAB symptoms. The OAB-Q Short Form (SF) consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. Scores can range from 0 to 100, with higher scores indicating more severe symptoms. The change is calculated from the baseline (visit 2, 2 weeks post-implant) minus the value at visit 8 (an average of 13 months post-implant). A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Measured: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in Female Sexual Function
The Female Sexual Function Index (FSFI) is a 19-question questionnaire evaluating female sexual health in several domains: libido, arousal, lubrication, orgasm, satisfaction, and sexual pain. Each subdomain is scored separately, and the total score calculated. Change in FSFI score will be assessed between baseline (visit 2, 2 weeks-post implant) and visit 8 (an average of 13 months post-implant). A lower FSFI score is equivalent to a higher degree of sexual dysfunction. Scores range from 0 to 36. The change value is calculated from visit 8 (approximately 13 months post-implant) minus visit 2 (baseline, 2 weeks post-implant). A positive number indicates improvement of symptoms. A negative number indicates worsening of symptoms.
Measured: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in mental health and anxiety.
The Pain Catastrophizing Scale (PCS) is used to determine the impact of SNM on mental health related to pain. Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person. The PCS is a validated measure of rumination, magnification, and helplessness related to pain. The PCS has been shown to have adequate to excellent internal consistency. People with higher PCS scores have a tendency to be more likely to report their pain as intense than those with low PCS scores. This objective will be measured at visit 4 (10 weeks post-implant), visit 5 (an average of 11-15 weeks post-implant), visit 7 (12 months post-implant) and visit 8 (an average of 13 months post-implant) and compared to visit 2 scores (baseline, 2 weeks post-implant). Each value will be subtracted from baseline and the difference will be reported. A negative number will indicate more pain catastrophizing, and a positive number will indicate less pain catastrophizing.
Measured: Visit 2 (2 weeks post-implant), Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Patient satisfaction with sacral neuromodulation treatment
Patient satisfaction will be assessed using the Global Response Assessment (GRA) tool on which the patient rates overall patient-perceived symptom improvement on a 7-point scale at visit 4 (10 weeks post-implant) through visit 8 (an average of 13 months post-implant). It is scored as follows: 1 = markedly worse, 2 = moderately worse, 3 = mildly worse, 4 = same (unchanged), 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved. Significant improvement is considered those patient rating their symptoms to be moderately to markedly improved.
Measured: Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Treatment durability measured as change in pain scores from baseline (visit 2) to visit 7 (12 months post-implant) as measured by 10-point visual-analog scale.
Treatment durability will be assessed using the 10-point Visual Analogue Scale (VAS) for pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 7 (12 months post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
Measured: Visit 2 (2 weeks post-implant) and Visit 7 (12 months post-implant)
Number of days of carry-over effect after short and long treatment (an average of 13 months post implant)
This objective will be assessed by counting the number of days after visit 7 (12 months post-implant) until the patient reports pain scores that are consistently worsening (prompting the need for an inperson follow-up visit) than reported at visit 2 (baseline, 2 weeks post-implant). This will indicate how long the treatment effect lasts after treatment has been discontinued.
Measured: Visit 8 (an average of 13 months post-implant)
Safety and tolerability: number of adverse events related to the device implantation.
Safety and tolerability of sacral neuromodulation in chronic pelvic pain patients will be assessed by recording the number of adverse events that are determined to be related to device implantation. Adverse events will be assessed at each scheduled study visit or as reported by patients outside study visits.
Measured: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Jan 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain 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
- Sequential
- Model description
- Single arm and participant-blinded sequential treatment controlled clinical trial. The device will be turned on or off, and settings adjusted at each visit. To minimize bias throughout the study, patients will be blinded to the device settings; however, since there is only one arm, "open label" has been chosen below.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health William Beaumont University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150599
- Sponsor's protocol ID
- 2023-254
- Acronym
- SNM_CPP
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation for the Treatment of Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT06150599
- Acronym / sponsor ID
- SNM_CPP / 2023-254
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Nov 2023 (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.
Sacral neuromodulation (SNM) is a safe, effective, and minimally invasive FDA approved treatment for urinary and fecal incontinence, urinary frequency, urgency, and urinary retention. In this study we are assessing the effectiveness of sacral neuromodulation in women with suffering from chronic pelvic pain (CPP), through a single device implant procedure.
Detailed description
Despite SNM being available for more than 25 years, there are many things about this technology that remain elusive. Enhancing our understanding of SNM in the chronic pelvic pain (CPP) population can rapidly improve the care of current patients suffering from pelvic pain, as well as help develop future technologies, stimulation paradigms, and lead to effective counseling of patients. CPP is one of most common and challenging conditions for clinicians to treat today. CPP is defined as nonmalignant persistent pain perceived in structures or organs of the pelvis for at least 6 months. As such, CPP can be caused by numerous underlying conditions from gynecological (e.g. endometriosis), gastrointestinal (e.g. celiac disease, irritable bowel syndrome), urological (e.g. interstitial cystitis), musculoskeletal (e.g. fibromyalgia), prostatitis, and neurological/vascular (e.g. spinal cord injury, ilioinguinal nerve entrapment) origin. From a urological perspective, the pain in CPP syndrome can be associated with symptoms suggesting urinary, sexual or bowel dysfunction, and are commonly associated with Overactive Bladder (OAB) symptoms of urinary frequency, urgency, and incontinence. CPP has a debilitating effect on quality of life, leading to other comorbidities such as depression, anxiety, and sleep disorders. CPP is common in both men and women, but occurs more frequently in women. This study will assess the effectiveness of sacral neuromodulation in women.
This is a prospective single arm and single blinded quasi-placebo controlled study. Patients will be blinded to the device settings. For those that qualify, the sacral neuromodulation device will be placed by an experienced physician. After placement in the operating room the device settings will be adjusted. 2 weeks post-operatively participants return and complete study questionnaires. The devices settings will again be adjusted at this visit. The device may turned on/off, or settings modified throughout the study. To maintain study integrity, patients will not be informed how device settings are changed. At each follow up visit, participants will be asked to complete study questionnaires and will have their device settings adjusted. Participants will follow up over a course of 12 months from the time of device implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm and participant-blinded sequential treatment controlled clinical trial. The device will be turned on or off, and settings adjusted at each visit. To minimize bias throughout the study, patients will be blinded to the device settings; however, since there is only one arm, "open label" has been chosen below.
| Arm | Type | Receives |
|---|---|---|
| SNM for the treatment of CPP | Experimental | Device: Sacral neuromodulationPatients will be enrolled based on study eligibility criteria. Eligible patients will be scheduled for a Interstim X implant in the operating room. The procedure is completed under anesthesia, either conscious sedation with intubation or breathing assistance. Under fluoroscopic guidance a standard lead will be introduced. Each electrode on the lead will be tested by confirming motor response on at least 3 of 4 leads. Next the implantable pulse generator will be placed in a subcutaneous pocket and secured. Impedance will be tested, 4 standard programs will be set, and then the device will be shut off. The device settings will be adjusted per protocol and the device will be turned on and off during visits 2-7. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 22-70
- Chronic pelvic pain (= pain below umbilicus) score of 4 or greater on 10-point VAS, present for 6 months or greater (screening patient)
- Failed at least 1 or more conservative treatments (e.g. pelvic floor physical therapy, biofeedback, behavioral modification, oral pharmacotherapy, bladder instillations)
Key exclusion criteria (16 listed)
- History of any active pelvic cancer
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
- Concurrent pain management strategies within the past 3 months that may interfere or mask study intervention (e.g. pelvic floor physical therapy, shockwave therapy, trigger point injections, bladder instillations)
- Any psychiatric or personality disorder at the discretion of the study physician. This does not include depression or generalized anxiety disorders that are stable.
- Current symptomatic urinary tract infection (UTI) or more than 6 UTIs in past year
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 |
|---|---|---|
| Sacral neuromodulationAlso: SNM, Interstim XInterstim X, which includes an implantable pulse generator and lead, will be implanted surgically in a single-stage procedure. | Device | SNM for the treatment of CPP |
Primary outcome
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks.
Time frame: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)
The VAS is a validated tool to determine patient perceived pain. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. The value at Visit 4 (10 weeks post-implant) minus the value at Visit 2 (baseline, 2 weeks post-implant) will be used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain
9 secondary outcomes
The change in central sensitization score over 13 months
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in pelvic floor pain using a 10-point VAS pain score.
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
Change in severity of overactive bladder symptoms.
Time frame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in Female Sexual Function
Time frame: Visit 2 (2 weeks post-implant) and Visit 8 (an average of 13 months post-implant)
Change in mental health and anxiety.
Time frame: Visit 2 (2 weeks post-implant), Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Patient satisfaction with sacral neuromodulation treatment
Time frame: Visit 4 (10 weeks post-implant), Visit 5 (an average of 11-15 weeks post-implant), Visit 7 (12 months post-implant), and Visit 8 (an average of 13 months post-implant)
Treatment durability measured as change in pain scores from baseline (visit 2) to visit 7 (12 months post-implant) as measured by 10-point visual-analog scale.
Time frame: Visit 2 (2 weeks post-implant) and Visit 7 (12 months post-implant)
Number of days of carry-over effect after short and long treatment (an average of 13 months post implant)
Time frame: Visit 8 (an average of 13 months post-implant)
Safety and tolerability: number of adverse events related to the device implantation.
Time frame: Visit 2 (2 weeks post-implant) through Visit 8 (an average of 13 months post-implant)
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 13 Jul 2026.
Related trials for Chronic Pelvic Pain Syndrome
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
RecruitingObservational study
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Chronic Pelvic Pain Syndrome (CPPS), Radiation-Induced Disorder
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.
Kenneth Peters, MD principal investigator
Corewell Health William Beaumont University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral neuromodulation in people with Chronic Pelvic Pain Syndrome, run by Corewell Health East 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 16 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 13 Jul 2026. 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 Jennifer Giordano, BSN (248-551-3517, Jennifer.Giordano@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in pain score using a 10-point Visual Analogue Scale (VAS) from 2-10 weeks. (time frame: Visit 2 (2 weeks post-implant) and Visit 4 (10 weeks post-implant)). 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 13 Jul 2026.