Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premenopausal women with spinal cord injury and urinary incontinence | |||
| Premenopausal women with spinal cord injury without urinary incontinence |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence event(s) | Daily patient-reported events of urinary incontinence | through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 3 months |
| Recruitment rate |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal detrusor pressure during storage phase | Measured during urodynamic examination. | Baseline |
| Bother by urinary incontinence | Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered) |
Inclusion Criteria:
Exclusion Criteria:
Only individuals with menstrual cycle
Not provided
Female outpatients of the Swiss Paraplegic Centre.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg Krebs, Dr. med. vet. / PhD | Contact | +41 41 939 59 46 | joerg.krebs@paraplegie.ch | |
| Jürgen Pannek, Prof. Dr. med. | Contact | juergen.pannek@paraplegie.ch |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Center | Recruiting | Nottwil | 6207 | Switzerland |
Coded data will be shared with a gynechologist.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Not provided
Not provided
Not provided
Saliva
The number of eligible patients who are enrolled |
| at study completion, an average of 2 years |
| Positive screening rate | Proportion of eligible patients who are screened | at study completion, an average of 2 years |
| Retention rate | Rate of participants who finish study protocol | at study completion, an average of 2 years |
| Assessment completion rate | Proportion of planned assessments that are completed | at study completion, an average of 2 years |
| Type of urinary incontinence event | Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence | through study completion, an average of 3 months |
| 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. | through study completion, an average of 3 months |
| Baseline |
| Menstrual cycle anamnesis | Information about last menstruation, average length of the menstruation, the average length of the cycle | Baseline |
| 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. | through study completion, an average of 3 months |
| Bladder compliance | Measured during storage phase, ml/cmH2O | Baseline |
| Bladder capacity | Measured during urodynamic examination. | Baseline |
| Age | Time from birth to inclusion into study (years) | Baseline |
| Date of spinal cord injury/disease onset | Baseline |
| Neurological level of injury | Highest intact spinal cord segment | Baseline |
| 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. ASIA Impairment Scale (AIS) Classification: A (Complete): No sensory or motor function preserved below the injury level, including the sacral segments (S4-S5). B (Sensory Incomplete): Sensory function preserved below the injury level, including S4-S5, but no motor function. C (Motor Incomplete): Some motor function preserved below the injury level, with more than half of key muscles below the level having a muscle grade <3 (not strong enough to move against gravity). D (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). | Baseline |
| D014947 | Wounds and Injuries |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |