Exploring the link between menstrual cycles and urinary incontinence in women with spinal cord injuries
Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
This study looks at how changes in hormones during the menstrual cycle might affect bladder control in women with spinal cord injuries to see if it can help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil) |
| Trial ID | NCT06892080 on ClinicalTrials.gov |
What this trial studies
This observational pilot study investigates how fluctuations in sex hormones during the menstrual cycle may affect bladder function in women with chronic spinal cord injury. Participants will document their menstrual cycles and instances of urinary incontinence over three cycles, using diaries, saliva samples, and urine tests to gather data. The goal is to identify potential hormonal influences on urinary incontinence, which has been less studied in premenopausal women compared to postmenopausal women. Understanding these factors could lead to improved treatment options for affected individuals.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with chronic neurogenic bladder dysfunction due to spinal cord injury and a regular menstrual cycle.
Not a fit: Patients who have hormonal imbalances, such as oligomenorrhea or amenorrhea, or those on hormonal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to better management and treatment of urinary incontinence in women with spinal cord injuries.
How similar studies have performed: While studies have explored urinary incontinence in postmenopausal women, this approach focusing on premenopausal women and menstrual cycles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nottwil
- Swiss Paraplegic Center — Nottwil, Switzerland (Recruiting)
Study contacts
- Study coordinator: Jörg Krebs, Dr. med. vet. / PhD
- Email: joerg.krebs@paraplegie.ch
- Phone: +41 41 939 59 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.