Clinical trial NCT06892080: Urine Incontinence Occurrence and Sexual Hormones in Women with Chronic Spinal Cord Injury/disease - a Pilot Study
Official title: Urine Incontinence Occurrence and Sexual Hormones in Women with Chronic Spinal Cord Injury/disease - a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Urinary Incontinence
Menstrual Cycle
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2025-03-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female outpatients of the Swiss Paraplegic Centre.

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, saliva samples, 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)

Primary outcomes:
measure: Incontinence event(s)
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Estrogen levels
timeFrame: through study completion, an average of 3 months
measure: Ovulation
timeFrame: through study completion, an average of 3 months
measure: Recruitment rate
timeFrame: at study completion, an average of 2 years
measure: Positive screening rate
timeFrame: at study completion, an average of 2 years
measure: Retention rate
timeFrame: at study completion, an average of 2 years
measure: Assessment completion rate
timeFrame: at study completion, an average of 2 years
measure: Type of urinary incontinence event
timeFrame: through study completion, an average of 3 months
measure: Symptoms of urinary tract infection
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: Maximal detrusor pressure during storage phase
timeFrame: Baseline
measure: Bother by urinary incontinence
timeFrame: Baseline
measure: Menstrual cycle anamnesis
timeFrame: Baseline
measure: Bladder domain from the Australian Pelvic Floor Questionnaire
timeFrame: through study completion, an average of 3 months
measure: Bladder compliance
timeFrame: Baseline
measure: Bladder capacity
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Date of spinal cord injury/disease onset
timeFrame: Baseline
measure: Neurological level of injury
timeFrame: Baseline
measure: ASIA score
timeFrame: Baseline
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center
Study officials:
References: