About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
women
age ≥ 18 years
chronic neurogenic bladder dysfunction due to acquired spinal cord injury
regular menstrual cycle (26-30 days/cycle)
Disqualifiers
Detrusor overactivity in storage phase above 15cmH20
Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods)
Hormonal intake/contraception
Intake of androgens
Trial population
Female outpatients of the Swiss Paraplegic Centre.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incontinence event(s)
Daily patient-reported events of urinary incontinence
Secondary outcomes
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.
Recruitment rate
The number of eligible patients who are enrolled
Positive screening rate
Proportion of eligible patients who are screened
Retention rate
Rate of participants who finish study protocol
Other outcomes
Maximal detrusor pressure during storage phase
Measured during urodynamic examination.
Bother by urinary incontinence
Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered)
Menstrual cycle anamnesis
Information about last menstruation, average length of the menstruation, the average length of the cycle
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.
Sponsors and contacts
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