Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-29 @ 5:42 PM
Study NCT ID:
NCT06724250
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of symptoms of constipation for one year follow up', 'timeFrame': 'One year', 'description': '* Follow-up was conducted for about 1 year as regard the improvement in bowel habits.\n* Patients was asked to fill up a symptom questionnaire (Wexner constipation score with a maximum score of 30 and a minimum of 0) following the therapeutic procedure The wexner constipation score : include 8-item questionnaire about bowel movements frequency, anal pain during evacuation, abdominal pain, incomplete evacuation, time taken for evacuation per attempt, number of attempts for a successful bowel movement in the previous 24 hours, type of assistance for defecation, and duration of constipation. All items are scored from 0 to 4 except for the "type of assistance for defecation," which is scored from 0 to 2.The clinical improvement was chosen when there was decrease in the score.'}], 'secondaryOutcomes': [{'measure': 'Improvement of pain for one year follow up', 'timeFrame': 'One year', 'description': 'Pain improvement on the visual analogue scale is from 0 to 10, where 0 means no pain and 10 means the worst pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructed Defaecation Syndrome']}, 'descriptionModule': {'briefSummary': 'assessment the Improvement symptoms of obstructed defecation after biofeedback training versus botulinum toxin injection', 'detailedDescription': 'This is a randomized controlled trial including 78 patients diagnosed with obstructed defecation syndrome confirmed by detailed history talking, full clinical examination, anorectal manometry and defecography.\n\nIncluded patients divided into two equal groups: first group ( biofeedback therapy group) patients recieved biofeedback therapy for six sessions over one month, the second group:( botulinum toxin group) received botulinum toxin injection 100 IU in buborectalis muscle.\n\nThe primary outcome is improvement of symptoms after one year'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of both genders\n* age of 18 years or older\n* fulfillment of the Rome 3 constipation criteria for the past 3 months, symptom onset as a maximum six months prior to diagnosis, patients suffer from prolonged, incomplete and challenging evacuation\n\nExclusion Criteria:\n\n* Anismus cases with secondary reason for constipation\n* patients who undergone anorectal surgery Patients with colonic inertia\n* conditions that make biofeedback training impossible\n* cases with primary illness causing constipation as hypothyroidism'}, 'identificationModule': {'nctId': 'NCT06724250', 'briefTitle': 'Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Biofeedback Versus Botox Injection in Treatment of Dyssynergic Defecation (Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': 'MS.23.090.2539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Biofeedback therapy group', 'description': 'Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month', 'interventionNames': ['Device: Biofeedback therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox injection group', 'description': 'Participants in this group received 100 international unit of botulinum toxin type A that was injected injections into the puborectalis muscle to alleviate dyssynergic defecation by reducing muscle overactivity and improving coordination.', 'interventionNames': ['Drug: Botulinum Toxin A (Botox )']}], 'interventions': [{'name': 'Biofeedback therapy', 'type': 'DEVICE', 'description': 'Biofeedback therapy involves the use of specialized equipment to provide real-time feedback on pelvic floor muscle activity. Participants are trained to improve muscle coordination and relaxation through guided exercises, targeting the resolution of dyssynergic defecation.', 'armGroupLabels': ['Biofeedback therapy group']}, {'name': 'Botulinum Toxin A (Botox )', 'type': 'DRUG', 'description': 'Botulinum toxin is injected into the pelvic floor muscles to reduce muscle overactivity and improve coordination, aiming to relieve symptoms of dyssynergic defecation.', 'armGroupLabels': ['Botox injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura faculty of medicine', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}