Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury, Urinary Incontinence, Menstrual Cycle. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Incontinence event(s) [Time frame: through study completion, an average of 3 months]
Secondary outcome measures (7)
- Ovulation [Time frame: through study completion, an average of 3 months]
- Recruitment rate [Time frame: at study completion, an average of 2 years]
- Positive screening rate [Time frame: at study completion, an average of 2 years]
- Retention rate [Time frame: at study completion, an average of 2 years]
- Assessment completion rate [Time frame: at study completion, an average of 2 years]
- Type of urinary incontinence event [Time frame: through study completion, an average of 3 months]
- Symptoms of urinary tract infection [Time frame: through study completion, an average of 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Swiss Paraplegic Center — Nottwil
Identifiers
NCT: NCT06892080 · 2023-15