Chronic Pelvic Pain SyndromePROM for CPPNCT06083597
Development of a Patient-reported Outcome Measure for Women With Chronic Pelvic Pain
An observational study of Chronic Pelvic Pain Syndrome and Pelvic Congestive Syndrome, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to develop a patient questionnaire that can be utilized to assess the benefit of treatments of chronic pelvic pain in research studies. The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Pain Syndrome, Pelvic Congestive Syndrome
- What is being tested?
- Qualitative interview
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2026
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with chronic pelvic pain (CPP) meeting the American College of Obstetricians and Gynecologists criteria.
Who may be able to join
- Non-menopausal women ≥18 years old.
- Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
- CPP meeting the American College of Obstetricians and Gynecologists criteria.
- Patient pain is primarily of pelvic and/or pelvic floor origin. Patient may experience other pain symptoms, including bowel, bladder, musculoskeletal, skin allodynia and hyperalgesia, or lower extremity venous or vulvar pain.
- Imaging demonstrating multiple tortuous pelvic varicose veins > 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.
- Imaging must be documented from trans vaginal ultrasound, trans abdominal ultrasound, magnetic resonance imaging, computed tomography, catheter venogram, or trans fundal pelvic venogram. If laparoscopic images are available to confirm veins this size, this would be acceptable as well.
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- Venous contribution to CPP, as determined by clinical impression from a CPP specialist. Clinical impression will be based on the presence of the following symptoms and physical findings:
- Symptoms: i. CPP increased with standing, walking, or lifting ii. CPP increased at the end of the day iii. CPP improved by laying down iv. Sexually provoked prolonged post-coital ache b. Physical findings: i. Adnexal tenderness on gentle bimanual exam ii. Tenderness at the ovarian point trans-abdominally iii. Tenderness of the uterus
- Participant can read, communicate clearly, and understand English or Spanish.
- Participant is willing and able to participate in an interview and complete questionnaires.
- Participant is willing and able to provide informed consent.
- Non-menopausal women ≥18 years old.
- Women who are not menstruating because of ovarian suppression therapy for CPP are eligible.
- CPP meeting the American College of Obstetricians and Gynecologists criteria.
- Patient pain is primarily of pelvic and/or pelvic floor origin. Patient may experience other pain symptoms, including bowel, bladder, musculoskeletal, skin allodynia and hyperalgesia, or lower extremity venous or vulvar pain.
- Imaging demonstrating multiple tortuous pelvic varicose veins > 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.
- Imaging must be documented from trans vaginal ultrasound, trans abdominal ultrasound, magnetic resonance imaging, computed tomography, catheter venogram, or trans fundal pelvic venogram. If laparoscopic images are available to confirm veins this size, this would be acceptable as well.
- Venous contribution to CPP, as determined by clinical impression from a CPP specialist. Clinical impression will be based on the presence of the following symptoms and physical findings:
- Symptoms: i. CPP increased with standing, walking, or lifting ii. CPP increased at the end of the day iii. CPP improved by laying down iv. Sexually provoked prolonged post-coital ache b. Physical findings: i. Adnexal tenderness on gentle bimanual exam ii. Tenderness at the ovarian point trans-abdominally iii. Tenderness of the uterus
- Participant can read, communicate clearly, and understand English or Spanish.
- Participant is willing and able to participate in an interview and complete questionnaires.
- Participant is willing and able to provide informed consent.
Who cannot join
- Pain symptoms should primarily be of pelvic and/or pelvic floor origin (inclusion criteria #3 above). Pain should not be exclusively low back, hips, symphysis, allodynia or hyperalgesia of the skin, or from varicose veins of the vulvar and/or lower extremities.
- Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
- Obvious endometriosis based on physical exam or laparoscopy findings.
- Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
- Participant has any clinically relevant medical condition (e.g., severe co morbid condition, severe mental illness, severe visual or auditory impairment, or cognitive impairment) that, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures
- Second phase of study evaluation women with non-venous origin chronic pelvic pain
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- Pain symptoms should primarily be of pelvic and/or pelvic floor origin (inclusion criteria #3 above). Pain should not be exclusively low back, hips, symphysis, allodynia or hyperalgesia of the skin, or from varicose veins of the vulvar and/or lower extremities.
- Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
- Obvious endometriosis based on physical exam or laparoscopy findings.
- Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
- Participant has any clinically relevant medical condition (e.g., severe co morbid condition, severe mental illness, severe visual or auditory impairment, or cognitive impairment) that, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Patient-reported Outcome (PRO) Measure for Women With Chronic Pelvic Pain (CPP)
The purpose of this study is to develop a patient questionnaire that can be utilized to assess the benefit of treatments of chronic pelvic pain in research studies.
The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic pelvic pain from an affected woman's perspective.
Read the detailed description
The purpose of this study is to develop a patient-reported outcome (PRO) instrument that can be utilized as an efficacy endpoint to assess medical and surgical treatments of chronic pelvic pain (CPP) in comparative outcomes research.
This instrument will be developed consistent with Food and Drug Administration (FDA) guidance to be appropriate as an efficacy measurement in a clinical trial. The development of such a PRO measure is iterative, and this research protocol includes the qualitative research to develop a draft measure and document content validity. Content validity is first assessed through concept elicitation interviews, followed by cognitive interviews.
Patients who are eligible and consent to participate will:
- complete a series of standardized health questionnaires
- participate in an interview with a scientist who is an expert at developing this kind of PRO instrument who will ask patients about the impacts of their COO on their overall health and well being.
The information collected from a series of these interviews will lead to the development of a draft questionnaire which will then be reviewed with additional women with similar causes of CPP as well as with women with other causes of CPP to determine its usability and accuracy at assessing the impacts of CPP on their health and well being.
A final version of the PROM instrument will then be shared with women with CPP before and after any treatment to determine its ability to identify changes in their health and wellbeing.
- Being tested
- Qualitative interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
Qualitative interviews will be performed on women with chronic pelvic pain of venous origin.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pelvic pain of venous origin | Women who are thought to have chronic pelvic pain of venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being. Receives: Other: Qualitative interview | |
| Chronic pelvic pain of non-venous origin | Women who are thought to have chronic pelvic pain of a non-venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being. They will be asked of the concepts identified by the women with venous origin CPP apply to them and if the impacts of the pain are similar or differ. Receives: Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 qualitative concept elicitation interview
Phase 1 qualitative interview about VO-CPP (Chronic pelvic pain originating from venous contribution) signs, symptoms, and impacts, from which a novel VO-CPP questionnaire (PeVD HRQoL) will be drafted, and ultimately assessed for content validity in the Phase 2 interviews. This Phase 1 interview will be conducted with subjects with VO-CPP.
Measured: 1 month
Secondary outcomes (3)
Phase 2 Qualitative cognitive interview
Phase 2 qualitative interview will include questions about item clarity, how the participants interpret the items, ease of completing the PeVD HRQoL questions, questionnaire comprehensiveness, and the appropriateness of the questionnaire format and response scales. This Phase 2 interview will be conducted with subjects with VO-CPP.
Measured: 1 month
Phase 2 qualitative open-ended concept elicitation questions
Phase 2 qualitative open-ended concept elicitation questions. This Phase 2 interview will be conducted with subjects with chronic pelvic pain originating from non-venous causes (NVO-CCP).
Measured: 1 month
Phase 2 qualitative cognitive interview
Phase 2 qualitative interview about the content validity of the novel questionnaire, PeVD HRQoL, with subjects with chronic pelvic pain originating from non-venous causes (NVO-CCP).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Interventional Radiology Foundation, Evidera
- Responsible party
- Sponsor
- Investigators
- Neil M Khilnani, MD, Principal investigator, Weill Medical College of Cornell UniversityRobin Pokrzywinski, PhD, Study director, Evidera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083597
- Sponsor's protocol ID
- 23-02025699
- Acronym
- PROM for CPP
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, informed consent forms, de-identified data, analytic process and the clinical study report will be available for other researchers. The final patient reported outcome instrument will be made available for use by any investigator for clinical research by the study funder SIR Foundation
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient-reported Outcome (PRO) Measure for Women With Chronic Pelvic Pain (CPP)
- ClinicalTrials.gov ID
- NCT06083597
- Acronym / sponsor ID
- PROM for CPP / 23-02025699
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Society of Interventional Radiology Foundation, Evidera
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 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.
The purpose of this study is to develop a patient questionnaire that can be utilized to assess the benefit of treatments of chronic pelvic pain in research studies.
The information collected from a series of patient interviews will lead to the development of a questionnaire that accounts for the full impact of chronic pelvic pain from an affected woman's perspective.
Detailed description
The purpose of this study is to develop a patient-reported outcome (PRO) instrument that can be utilized as an efficacy endpoint to assess medical and surgical treatments of chronic pelvic pain (CPP) in comparative outcomes research.
This instrument will be developed consistent with Food and Drug Administration (FDA) guidance to be appropriate as an efficacy measurement in a clinical trial. The development of such a PRO measure is iterative, and this research protocol includes the qualitative research to develop a draft measure and document content validity. Content validity is first assessed through concept elicitation interviews, followed by cognitive interviews.
Patients who are eligible and consent to participate will:
- complete a series of standardized health questionnaires
- participate in an interview with a scientist who is an expert at developing this kind of PRO instrument who will ask patients about the impacts of their COO on their overall health and well being.
The information collected from a series of these interviews will lead to the development of a draft questionnaire which will then be reviewed with additional women with similar causes of CPP as well as with women with other causes of CPP to determine its usability and accuracy at assessing the impacts of CPP on their health and well being.
A final version of the PROM instrument will then be shared with women with CPP before and after any treatment to determine its ability to identify changes in their health and wellbeing.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pelvic pain of venous origin | – | Other: Qualitative interviewWomen who are thought to have chronic pelvic pain of venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being. |
| Chronic pelvic pain of non-venous origin | – | Other: Qualitative interviewWomen who are thought to have chronic pelvic pain of a non-venous origin will be interviewed to determine the impacts of their pain on physical, social and emotional aspects of their health and well being. They will be asked of the concepts identified by the women with venous origin CPP apply to them and if the impacts of the pain are similar or differ. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with chronic pelvic pain (CPP) meeting the American College of Obstetricians and Gynecologists criteria.
Key inclusion criteria (22 listed)
- Non-menopausal women ≥18 years old.
- CPP meeting the American College of Obstetricians and Gynecologists criteria.
- Patient pain is primarily of pelvic and/or pelvic floor origin. Patient may experience other pain symptoms, including bowel, bladder, musculoskeletal, skin allodynia and hyperalgesia, or lower extremity venous or vulvar pain.
- Imaging demonstrating multiple tortuous pelvic varicose veins > 5 mm in diameter in the ovarian, utero vaginal, and/or uterine arcuate venous plexus.
- Venous contribution to CPP, as determined by clinical impression from a CPP specialist. Clinical impression will be based on the presence of the following symptoms and physical findings:
Key exclusion criteria (11 listed)
- Pain symptoms should primarily be of pelvic and/or pelvic floor origin (inclusion criteria #3 above). Pain should not be exclusively low back, hips, symphysis, allodynia or hyperalgesia of the skin, or from varicose veins of the vulvar and/or lower extremities.
- Pain thought primarily to be due to endometriosis, pelvic floor myalgia, a musculoskeletal etiology, irritable bowel disease, or painful bladder syndrome/interstitial cystitis.
- Obvious endometriosis based on physical exam or laparoscopy findings.
- Patients previously treated with a technically successful surgery or vascular procedure for a venous disorder of the pelvis or renal vein.
- Participant has any clinically relevant medical condition (e.g., severe co morbid condition, severe mental illness, severe visual or auditory impairment, or cognitive impairment) that, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures
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 |
|---|---|---|
| Qualitative interviewQualitative interviews will be performed on women with chronic pelvic pain of venous origin. | Other | Chronic pelvic pain of non-venous origin, Chronic pelvic pain of venous origin |
Primary outcome
Phase 1 qualitative concept elicitation interview
Time frame: 1 month
Phase 1 qualitative interview about VO-CPP (Chronic pelvic pain originating from venous contribution) signs, symptoms, and impacts, from which a novel VO-CPP questionnaire (PeVD HRQoL) will be drafted, and ultimately assessed for content validity in the Phase 2 interviews. This Phase 1 interview will be conducted with subjects with VO-CPP.
3 secondary outcomes
Phase 2 Qualitative cognitive interview
Time frame: 1 month
Phase 2 qualitative open-ended concept elicitation questions
Time frame: 1 month
Phase 2 qualitative cognitive interview
Time frame: 1 month
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 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The study protocol, informed consent forms, de-identified data, analytic process and the clinical study report will be available for other researchers. The final patient reported outcome instrument will be made available for use by any investigator for clinical research by the study funder SIR Foundation
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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.
Neil M Khilnani, MD principal investigator
Weill Medical College of Cornell University
Robin Pokrzywinski, PhD study director
Evidera
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 Syndrome and Pelvic Congestive Syndrome, run by Weill Medical College of Cornell University 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 22 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. 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?
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?
Phase 1 qualitative concept elicitation interview (time frame: 1 month). 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 18 Dec 2025.