Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study (SexHormInkont)

Swiss Paraplegic Research, Nottwil

Status: Enrolling

Conditions: Menstrual Cycle; Spinal Cord Injury; Urinary Incontinence

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06892080

2023-15

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

24 participants in 2 patient groups

Premenopausal women with spinal cord injury and urinary incontinence

Premenopausal women with spinal cord injury without urinary incontinence