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

NCT ID: NCT06892080

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-06-30

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.

Conditions

Spinal Cord Injury; Urinary Incontinence; Menstrual Cycle

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Premenopausal women with spinal cord injury and urinary incontinence

No interventions assigned to this group

Premenopausal women with spinal cord injury without urinary incontinence

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Swiss Paraplegic Center

Nottwil, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Jörg Krebs, Dr. med. vet. / PhD

Role: CONTACT

joerg.krebs@paraplegie.ch

+41 41 939 59 46

Jürgen Pannek, Prof. Dr. med.

Role: CONTACT

juergen.pannek@paraplegie.ch

Facility Contacts

Jürgen Pannek, Prof

Role: primary

juergen.pannek@paraplegie.ch

+41 41 939 59 22

Other Identifiers

2023-15

Identifier Type: -

Identifier Source: org_study_id