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Urine incontinence occurrence and sexual hormones in women with chronic spinal cord Injury/Disease - a pilot study

NCT ID NCT06892080

NEW Sponsor: Swiss Paraplegic Research, Nottwil Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Female outpatients of the Swiss Paraplegic Centre.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

spinal cord injury Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Menstrual cycle Spinal cord injury Urinary incontinence

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Swiss Paraplegic Center

    RECRUITING

    Nottwil, 6207, Switzerland

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