Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06719635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management Modalities of Chronic Pelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue pain score', 'timeFrame': 'At the end of the first month after the procedure.', 'description': 'The percentage of patients who achieved \\> 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month.'}], 'secondaryOutcomes': [{'measure': 'Daily analgesic requirements', 'timeFrame': 'At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.', 'description': 'Daily analgesic requirements at the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.'}, {'measure': 'Associated adverse events', 'timeFrame': 'At the end of the first month after the procedure.', 'description': 'Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '8233527', 'type': 'BACKGROUND', 'citation': 'de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.'}, {'pmid': '32654406', 'type': 'BACKGROUND', 'citation': "Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1."}, {'pmid': '32214294', 'type': 'BACKGROUND', 'citation': 'Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.'}, {'pmid': '12615830', 'type': 'BACKGROUND', 'citation': 'Soysal ME, Soysal S, Gurses E, Ozer S. Laparoscopic presacral neurolysis for endometriosis-related pelvic pain. Hum Reprod. 2003 Mar;18(3):588-92. doi: 10.1093/humrep/deg127.'}]}, 'descriptionModule': {'briefSummary': 'Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.', 'detailedDescription': 'Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient acceptance.\n* Body mass index \\< 35 kg/m2.\n* Adult patients with chronic pelvic and perineal pain due to pelvic cancer.\n* Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.\n\nExclusion Criteria:\n\n* Uncooperative patient.\n* Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.'}, 'identificationModule': {'nctId': 'NCT06719635', 'briefTitle': 'Management Modalities of Chronic Pelvic Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: A Double-Blind, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Pelvic Pain Management'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic Presacral Neurectomy', 'description': 'The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.', 'interventionNames': ['Procedure: Laparoscopic Presacral Neurectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoroscopically guided Superior Hypogastric Neurolysis', 'description': 'The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4.', 'interventionNames': ['Procedure: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis']}], 'interventions': [{'name': 'Laparoscopic Presacral Neurectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopy will be performed under general anesthesia. Then, nerve plexuses will be identified and freed from their underlying tissue, which contains the left common iliac and middle sacral veins. This will be followed by cauterization and cutting of the nerve plexuses.', 'armGroupLabels': ['Laparoscopic Presacral Neurectomy']}, {'name': 'Fluoroscopically guided Superior Hypogastric Plexus Neurolysis', 'type': 'PROCEDURE', 'description': 'The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis using 3 mL of 75% ethanol and Radiofrequency of the Sacral nerve Roots 2-4.', 'armGroupLabels': ['Fluoroscopically guided Superior Hypogastric Neurolysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Al-Sharkia', 'country': 'Egypt', 'facility': 'Zagazig university hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Abdalla Mohamed Gouda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia, Intensive Care & Pain Management, Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}