[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584648":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":60,"studyPopulation":70,"armGroups":71,"interventions":60,"overallOfficials":60,"centralContacts":76,"locations":85,"responsibleParty":103,"collaborators":60,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":60,"enrollmentInfo":114,"targetDuration":60,"studyType":117,"phases":60,"briefSummary":118,"conditions":119,"keywords":60,"overallStatus":88,"whyStopped":60,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Swiss Paraplegic Research, Nottwil","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Incontinence event(s)","Daily patient-reported events of urinary incontinence","through study completion, an average of 3 months",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"Ovulation","To confirm the occurrence of ovulation, urine samples are tested with luteinizing hormone (LH) stripes at following days of the menstrual cycle: 11, 12, 13, 14 and 15, where 1 is the first day of menstruation.",{"measure":18,"description":19,"timeFrame":20},"Recruitment rate","The number of eligible patients who are enrolled","at study completion, an average of 2 years",{"measure":22,"description":23,"timeFrame":20},"Positive screening rate","Proportion of eligible patients who are screened",{"measure":25,"description":26,"timeFrame":20},"Retention rate","Rate of participants who finish study protocol",{"measure":28,"description":29,"timeFrame":20},"Assessment completion rate","Proportion of planned assessments that are completed",{"measure":31,"description":32,"timeFrame":12},"Type of urinary incontinence event","Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence",{"measure":34,"description":35,"timeFrame":12},"Symptoms of urinary tract infection","Measured through a custom-made questionnaire at following days of the menstrual cycle: 3, 15 and 28, where 1 is the first day of menstruation.",[37,41,44,47,50,53,55,58,61,64],{"measure":38,"description":39,"timeFrame":40},"Maximal detrusor pressure during storage phase","Measured during urodynamic examination.","Baseline",{"measure":42,"description":43,"timeFrame":40},"Bother by urinary incontinence","Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered)",{"measure":45,"description":46,"timeFrame":40},"Menstrual cycle anamnesis","Information about last menstruation, average length of the menstruation, the average length of the cycle",{"measure":48,"description":49,"timeFrame":12},"Bladder domain from the Australian Pelvic Floor Questionnaire","Impact of bladder on quality of life and overall well-being, APFQ range 0 to 48, where higher scores mean more severe symptoms: on following days of the menstrual cycle: 3, 15 and 28, where 1 is the first day of menstruation.",{"measure":51,"description":52,"timeFrame":40},"Bladder compliance","Measured during storage phase, ml\u002FcmH2O",{"measure":54,"description":39,"timeFrame":40},"Bladder capacity",{"measure":56,"description":57,"timeFrame":40},"Age","Time from birth to inclusion into study (years)",{"measure":59,"description":60,"timeFrame":40},"Date of spinal cord injury\u002Fdisease onset",null,{"measure":62,"description":63,"timeFrame":40},"Neurological level of injury","Highest intact spinal cord segment",{"measure":65,"description":66,"timeFrame":40},"ASIA score","The American Spinal Injury Association (ASIA) Impairment Scale (AIS) is a standardized system for assessing the severity of spinal cord injuries (SCI). It classifies the level and completeness of an injury based on motor and sensory function.\n\nASIA Impairment Scale (AIS) Classification:\n\nA (Complete): No sensory or motor function preserved below the injury level, including the sacral segments (S4-S5).\n\nB (Sensory Incomplete): Sensory function preserved below the injury level, including S4-S5, but no motor function.\n\nC (Motor Incomplete): Some motor function preserved below the injury level, with more than half of key muscles below the level having a muscle grade \\\u003C3 (not strong enough to move against gravity).\n\nD (Motor Incomplete): Motor function preserved below the injury level, with more than half of key muscles below the level having a muscle grade ≥3 (can move against gravity).",{"allocation":60,"interventionModel":60,"interventionModelDescription":60,"primaryPurpose":60,"observationalModel":68,"timePerspective":69,"maskingInfo":60},"COHORT","PROSPECTIVE","Female outpatients of the Swiss Paraplegic Centre.",[72,74],{"label":73,"type":60,"description":60,"interventionNames":60},"Premenopausal women with spinal cord injury and urinary incontinence",{"label":75,"type":60,"description":60,"interventionNames":60},"Premenopausal women with spinal cord injury without urinary incontinence",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":60,"email":81},"Jörg Krebs, Dr. med. vet. \u002F PhD","CONTACT","+41 41 939 59 46","joerg.krebs@paraplegie.ch",{"name":83,"role":79,"phone":60,"phoneExt":60,"email":84},"Jürgen Pannek, Prof. Dr. med.","juergen.pannek@paraplegie.ch",[86],{"facility":87,"status":88,"city":89,"state":60,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Swiss Paraplegic Center","RECRUITING","Nottwil","6207","Switzerland","CH",{"type":94,"coordinates":95},"Point",[96,97],8.13774,47.13469,{"lat":97,"lon":96},[100],{"name":101,"role":79,"phone":102,"phoneExt":60,"email":84},"Jürgen Pannek, Prof","+41 41 939 59 22",{"type":104,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100584648","urine-incontinence-occurrence-and-sexual-hormones-in-women-with-chronic-spinal-cord-injurydisease---a-pilot-study-100584648",false,"NCT06892080","Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury\u002FDisease - a Pilot Study","SexHormInkont","Inclusion Criteria:\n\n* women\n* age ≥ 18 years\n* chronic neurogenic bladder dysfunction due to acquired spinal cord injury\n* regular menstrual cycle (26-30 days\u002Fcycle)\n* written consent given\n* UI group only: UI at least once per month\n\nExclusion Criteria:\n\n* Detrusor overactivity in storage phase above 15cmH20\n* Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods)\n* Hormonal intake\u002Fcontraception\n* Intake of androgens\n* Intake of drugs which interfere with female sex hormones significantly\n* Individuals who underwent sex reassignment surgery\n* Pregnant or breastfeeding women\n* Women who are trying to conceive\n* Gynaecological carcinoma\n* Endometriosis\n* Ovariectomy\n* Current pelvic floor physiotherapy\n* Reconstructive surgery of bladder\n* Local irritation of the bladder, such as bladder tumour, bladder stones, acute urinary tract infection at study start\n* Inability to follow study procedures (cognitive or language barriers)","FEMALE","18 Years",{"count":115,"type":116},24,"ESTIMATED","OBSERVATIONAL","There is a knowledge gap about the influence of the menstrual cycle on bladder function in women with spinal cord injury. So far, studies regarding urinary incontinence have primarily focused on women after menopause. It has become clear that a lack of the sex hormone estrogen, which occurs after menopause, can lead to urinary incontinence. During the course of the menstrual cycle, women also experience fluctuations in their sex hormones, particularly estrogen. The estrogen level is highest before ovulation and decreases afterwards. The investigators aim to explore whether this drop in hormone levels could lead to more frequent urinary incontinence during this phase. In order to offer the patients optimal treatment for urinary incontinence, it is important to understand the potential causes behind it. Participants will document their menstrual cycles and episodes of urinary incontinences over three menstrual cycles using a diary, and urine tests. This research project is a pilot study and is being conducted by Swiss Paraplegic Research at the Swiss Paraplegic Centre. The investigators are recruiting 12 participants who experience incontinence at least once a month and 12 participants who experience incontinence less frequently or not at all.",[120,121,122],"Spinal Cord Injury","Urinary Incontinence","Menstrual Cycle","2026-09-09",{"date":125,"type":126},"2026-09-10","ACTUAL",{"date":128,"type":126},"2025-07-01",{"date":130,"type":116},"2029-11-30",{"name":5,"class":6},1]