NCT06892080 Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
| NCT ID | NCT06892080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swiss Paraplegic Research, Nottwil |
| Condition | Spinal Cord Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-07-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06892080 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06892080 currently recruiting?
Yes, NCT06892080 is actively recruiting participants. Contact the research team at joerg.krebs@paraplegie.ch for enrollment information.
Where is the NCT06892080 trial being conducted?
This trial is being conducted at Nottwil, Switzerland.
Who is sponsoring the NCT06892080 clinical trial?
NCT06892080 is sponsored by Swiss Paraplegic Research, Nottwil. The trial plans to enroll 24 participants.