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

Study acronym: SexHormInkont
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Mar 1, 2027 → Jul 31, 2029
See other at-risk trials from Swiss Paraplegic Research, Nottwil

Record History

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  1. Notable Primary completion pushed from Mar 1, 2027 to Jul 31, 2029
    • Study completion pushed from Jun 30, 2027 to Nov 30, 2029
    v3
  2. Notable Start date: Mar 1, 2025 to Jul 1, 2025
    • Secondary endpoints: 8 to 7
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06892080
Lead Sponsor Swiss Paraplegic Research, Nottwil
Conditions
(from sponsor)
Spinal Cord Injury, Urinary Incontinence, Menstrual Cycle
Related terms Spinal Cord Injuries, Urinary Incontinence
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov