An observational study in Spinal Cord Injury, Urinary Incontinence and Menstrual Cycle, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Swiss Paraplegic Research, Nottwil · 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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Swiss Paraplegic Research, Nottwil is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female outpatients of the Swiss Paraplegic Centre.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Incontinence event(s)
Daily patient-reported events of urinary incontinence
Time frame: through study completion, an average of 3 months
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.
Time frame: through study completion, an average of 3 months
Recruitment rate
The number of eligible patients who are enrolled
Time frame: at study completion, an average of 2 years
Positive screening rate
Proportion of eligible patients who are screened
Time frame: at study completion, an average of 2 years
Retention rate
Rate of participants who finish study protocol
Time frame: at study completion, an average of 2 years
Assessment completion rate
Proportion of planned assessments that are completed
Time frame: at study completion, an average of 2 years
Type of urinary incontinence event
Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence
Time frame: 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.
Time frame: through study completion, an average of 3 months
Maximal detrusor pressure during storage phase
Measured during urodynamic examination.
Time frame: Baseline
Bother by urinary incontinence
Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered)
Time frame: Baseline
Menstrual cycle anamnesis
Information about last menstruation, average length of the menstruation, the average length of the cycle
Time frame: 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.
Time frame: through study completion, an average of 3 months
Bladder compliance
Measured during storage phase, ml/cmH2O
Time frame: Baseline
Bladder capacity
Measured during urodynamic examination.
Time frame: Baseline
Age
Time from birth to inclusion into study (years)
Time frame: Baseline
Date of spinal cord injury/disease onset
Time frame: Baseline
Neurological level of injury
Highest intact spinal cord segment
Time frame: 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).
Time frame: Baseline
Plan to share: Yes — Coded data will be shared with a gynechologist.
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Swiss Paraplegic Research, Nottwil