Pain, Chronic PrimaryNCT06507267
Pain and Clinical Reflections in Pelvic Congestion Syndrome
An observational study of Pain, Chronic Primary, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pelvic congestion syndrome (PKS) occurs as a result of dysfunction of the veins in the pelvic area. It is currently called pelvic venous disease. This definition also includes some diseases of the pelvic region such as May-Thurner and Nutcracker syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain, Chronic Primary
- What is being tested?
- Pain and Clinical Reflections in Pelvic Congestion Syndrome
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 30 Sep 2024
- Phase
- Observational
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Exclusion Criteria: * In terms of gynecology, patients with leiomyoma, pelvic inflammatory disease, * endometriosis, postoperative adhesion, * patients who have undergone urological and gynecological surgery, * patients with chronic renal failure, * known allergies to the drugs used during the procedure, * patients with abdominopelvic trauma, malignancy or its history, * patients with a history of radiotherapy chemotherapy, * patients with known neuropsychiatric disorders. * Patients with disease, * pregnant women, * breastfeeding women, * fibromyalgia, * known lumbar disc herniation, * scoliosis, * facet syndrome, * sacroiliac dysfunction, * and patients with genitourinary and gastrointestinal diseases will be excluded from the study.
Who may be able to join
- It is planned to include 54 female patients between the ages of 18-50,
- who have abdominopelvic pain for more than 6 months
- who have >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasonography along with clinical, physical examination and symptoms.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34000
halil ibrahim altun, specialist, +9005072774773, halilibrahim_altun@yahoo.com
About this study
Official title: Pain and Clinical Reflections in Pelvic Congestion Syndrome,
Pelvic congestion syndrome (PKS) occurs as a result of dysfunction of the veins in the pelvic area. It is currently called pelvic venous disease. This definition also includes some diseases of the pelvic region such as May-Thurner and Nutcracker syndrome. Dilatation and reflux are usually observed in the para-uterine or ovarian veins. PCS is one of the important causes of chronic pelvic pain (CPA). Pain in PCS is unrelated to the menstrual cycle. PCS is frequently seen in multiparous women in the reproductive period. Pregnancy worsens the clinical condition of patients with PCS due to mechanical pressure on the pelvic region vessels in pregnant women. Although the underlying cause of PCS is thought to be hormonal factors related to progesterone and estrogen, its etiology has not been fully elucidated and is thought to be multifactorial.GnRH analogues and medroxyprogesterone, which have side effects such as menstrual irregularity, osteoporosis and weight gain, were previously used in the medical treatment of PCS. Combined oral hormonal contraceptives, vasoactive flavonoid fraction drugs, nonsteroidal anti-inflammatory (NSAID) drugs for pain relief, Gabapentin, and Amiltriptyline are still used in the treatment of PCS. In the past, traditional hysterectomy and oophorectomy were performed surgically. Laparoscopic ovarian vein ligation has been performed since the early 2000s, but its popularity has decreased due to potential complications such as retroperitoneal hematoma, ureteral injury, and thrombosis. Endovascular intervention is more preferred today due to its low complications and high success in treatment.
Read the detailed description
The study will be conducted by retrospectively scanning the files of patients diagnosed with pelvic congestion syndrome who underwent endovascular procedures with the plug method between January 2022 and March 2024 in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital. From the patients' files, age, body mass index (BMI), painful areas and painful side, medical treatments, comorbidities, onset of pain and application time for endovascular intervention, symptoms accompanying pain (feeling of heaviness in the perineum, swelling in the labia majora, dysuria, hematuria, dyspareunia) were obtained. , Postcoital pain, Dysmenorrhea, frequent urination) The position in which the pain increases, the branches consulted before endovascular intervention, and the Numerical Rating Scale-11 (NRS-11) score in the first and third months before and after the endovascular procedure for pain evaluation will be recorded on the patient follow-up form.
Numeric Rating Scale-11 (NRS-11) is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life).
NRS-11 will be checked 3 times: before treatment, 1st month and 3rd month after treatment.
- The number of patients and volunteers to be included in the research, their qualifications and the reason for selection (age ranges, gender, etc.).
The study was conducted in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital, from female patients between the ages of 18-50, who had abdominopelvic pain for more than 6 months, with clinical, physical examination and symptoms, and >6 mm in pelvic veins on transvaginal or transabdominal ultrasonography. It is planned to include 54 patients with over-dilatation.
- Conditions
- Pain, Chronic Primary
- Being tested
- Pain and Clinical Reflections in Pelvic Congestion Syndrome
- Keywords
- Pelvic Congestion Syndrome, Pain,chronic pelvic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain and Clinical Reflections in Pelvic Congestion SyndromeOther
Pain and Clinical Reflections in Pelvic Congestion Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Pain and Clinical Reflections in Pelvic Congestion Syndrome | Not described Receives: Other: Pain and Clinical Reflections in Pelvic Congestion Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of pain and application time for endovascular intervention,
numerical rating scala - 11
Measured: 'four months'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Jun 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Chronic PrimaryStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507267
- Sponsor's protocol ID
- altunibrahim
- Status last verified
- Jul 2024
- First submitted
- 24 Apr 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Clinical Reflections in Pelvic Congestion Syndrome,
- ClinicalTrials.gov ID
- NCT06507267
- Acronym / sponsor ID
- altunibrahim
- Conditions
- Pain, Chronic Primary
- Keywords
- Pelvic Congestion Syndrome, Pain,chronic pelvic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Jul 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.
Pelvic congestion syndrome (PKS) occurs as a result of dysfunction of the veins in the pelvic area. It is currently called pelvic venous disease. This definition also includes some diseases of the pelvic region such as May-Thurner and Nutcracker syndrome. Dilatation and reflux are usually observed in the para-uterine or ovarian veins. PCS is one of the important causes of chronic pelvic pain (CPA). Pain in PCS is unrelated to the menstrual cycle. PCS is frequently seen in multiparous women in the reproductive period. Pregnancy worsens the clinical condition of patients with PCS due to mechanical pressure on the pelvic region vessels in pregnant women. Although the underlying cause of PCS is thought to be hormonal factors related to progesterone and estrogen, its etiology has not been fully elucidated and is thought to be multifactorial.GnRH analogues and medroxyprogesterone, which have side effects such as menstrual irregularity, osteoporosis and weight gain, were previously used in the medical treatment of PCS. Combined oral hormonal contraceptives, vasoactive flavonoid fraction drugs, nonsteroidal anti-inflammatory (NSAID) drugs for pain relief, Gabapentin, and Amiltriptyline are still used in the treatment of PCS. In the past, traditional hysterectomy and oophorectomy were performed surgically. Laparoscopic ovarian vein ligation has been performed since the early 2000s, but its popularity has decreased due to potential complications such as retroperitoneal hematoma, ureteral injury, and thrombosis. Endovascular intervention is more preferred today due to its low complications and high success in treatment.
Detailed description
The study will be conducted by retrospectively scanning the files of patients diagnosed with pelvic congestion syndrome who underwent endovascular procedures with the plug method between January 2022 and March 2024 in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital. From the patients' files, age, body mass index (BMI), painful areas and painful side, medical treatments, comorbidities, onset of pain and application time for endovascular intervention, symptoms accompanying pain (feeling of heaviness in the perineum, swelling in the labia majora, dysuria, hematuria, dyspareunia) were obtained. , Postcoital pain, Dysmenorrhea, frequent urination) The position in which the pain increases, the branches consulted before endovascular intervention, and the Numerical Rating Scale-11 (NRS-11) score in the first and third months before and after the endovascular procedure for pain evaluation will be recorded on the patient follow-up form.
Numeric Rating Scale-11 (NRS-11) is an 11-point numerical scale in which patients can evaluate their pain between 0 (no pain) and 10 (the most severe pain they have ever felt in their life).
NRS-11 will be checked 3 times: before treatment, 1st month and 3rd month after treatment.
- The number of patients and volunteers to be included in the research, their qualifications and the reason for selection (age ranges, gender, etc.).
The study was conducted in the Cardiovascular Surgery Department of Kanuni Sultan Süleyman Training and Research Hospital, from female patients between the ages of 18-50, who had abdominopelvic pain for more than 6 months, with clinical, physical examination and symptoms, and >6 mm in pelvic veins on transvaginal or transabdominal ultrasonography. It is planned to include 54 patients with over-dilatation.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain and Clinical Reflections in Pelvic Congestion Syndrome | – | Other: Pain and Clinical Reflections in Pelvic Congestion Syndrome |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Exclusion Criteria: * In terms of gynecology, patients with leiomyoma, pelvic inflammatory disease, * endometriosis, postoperative adhesion, * patients who have undergone urological and gynecological surgery, * patients with chronic renal failure, * known allergies to the drugs used during the procedure, * patients with abdominopelvic trauma, malignancy or its history, * patients with a history of radiotherapy chemotherapy, * patients with known neuropsychiatric disorders. * Patients with disease, * pregnant women, * breastfeeding women, * fibromyalgia, * known lumbar disc herniation, * scoliosis, * facet syndrome, * sacroiliac dysfunction, * and patients with genitourinary and gastrointestinal diseases will be excluded from the study.
Key inclusion criteria (3 listed)
- It is planned to include 54 female patients between the ages of 18-50,
- who have abdominopelvic pain for more than 6 months
- who have >6 mm dilatation in the pelvic veins on transvaginal or transabdominal ultrasonography along with clinical, physical examination and symptoms.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pain and Clinical Reflections in Pelvic Congestion SyndromePain and Clinical Reflections in Pelvic Congestion Syndrome | Other | Pain and Clinical Reflections in Pelvic Congestion Syndrome |
Primary outcome
onset of pain and application time for endovascular intervention,
Time frame: 'four months'
numerical rating scala - 11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Chronic Primary
Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Chronic Primary Orofacial Pain (CPOP), Persistent Idiopathic Facial Pain (PIFP)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use 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. This study is not recruiting at the moment.
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 Pain, Chronic Primary, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 0 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: status not confirmed, as of the sponsor's last update on 18 Jul 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact halil ibrahim altun (+905072774773, halilibrahim_altun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of pain and application time for endovascular intervention, (time frame: 'four months'). 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 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.