Menstrual Cycle, Spinal Cord Injury, Urinary Incontinence
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women * age ≥ 18 years * chronic neurogenic bladder dysfunction due to acquired spinal cord injury * regular menstrual cycle (26-30 days/cycle) * written consent given * UI group only: UI at least once per month
Exclusion criteria
* Detrusor overactivity in storage phase above 15cmH20 * Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods) * Hormonal intake/contraception * Intake of androgens * Intake of drugs which interfere with female sex hormones significantly * Individuals who underwent sex reassignment surgery * Pregnant or breastfeeding women * Women who are trying to conceive * Gynaecological carcinoma * Endometriosis * Ovariectomy * Current pelvic floor physiotherapy * Reconstructive surgery of bladder * Local irritation of the bladder, such as bladder tumour, bladder stones, acute urinary tract infection at study start * Inability to follow study procedures (cognitive or language barriers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence event(s) | through study completion, an average of 3 months | Daily patient-reported events of urinary incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation | through study completion, an average of 3 months | 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 | at study completion, an average of 2 years | The number of eligible patients who are enrolled |
| Positive screening rate | at study completion, an average of 2 years | Proportion of eligible patients who are screened |
| Retention rate | at study completion, an average of 2 years | Rate of participants who finish study protocol |
| Assessment completion rate | at study completion, an average of 2 years | Proportion of planned assessments that are completed |
| Type of urinary incontinence event | through study completion, an average of 3 months | Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence |
| Symptoms of urinary tract infection | through study completion, an average of 3 months | 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. |
Countries
Switzerland
Contacts
CONTACTJörg Krebs, Dr. med. vet. / PhD
CONTACTJürgen Pannek, Prof. Dr. med.
Outcome results
None listed