Spinal Cord InjurySexHormInkontNCT06892080
Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
An observational study of Spinal Cord Injury and Urinary Incontinence, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Cord Injury, Urinary Incontinence, Menstrual Cycle
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2025to 30 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female outpatients of the Swiss Paraplegic Centre.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jürgen Pannek, Prof. Dr. med. contact
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Center
Nottwil, 6207
Jürgen Pannek, Prof, +41 41 939 59 22, juergen.pannek@paraplegie.ch
About this study
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
- Medical subject headings
- Spinal Cord Injuries, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women with spinal cord injury and urinary incontinence | Not described | |
| Premenopausal women with spinal cord injury without urinary incontinence | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence event(s)
Daily patient-reported events of urinary incontinence
Measured: through study completion, an average of 3 months
Secondary outcomes (7)
Ovulation
To confirm the occurrence of ovulation, urine samples are tested with luteinizing hormone (LH) stripes at following days of the menstrual cycle: 11, 12, 13, 14 and 15, where 1 is the first day of menstruation.
Measured: through study completion, an average of 3 months
Recruitment rate
The number of eligible patients who are enrolled
Measured: at study completion, an average of 2 years
Positive screening rate
Proportion of eligible patients who are screened
Measured: at study completion, an average of 2 years
Retention rate
Rate of participants who finish study protocol
Measured: at study completion, an average of 2 years
Assessment completion rate
Proportion of planned assessments that are completed
Measured: at study completion, an average of 2 years
Type of urinary incontinence event
Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence
Measured: through study completion, an average of 3 months
Symptoms of urinary tract infection
Measured through a custom-made questionnaire at following days of the menstrual cycle: 3, 15 and 28, where 1 is the first day of menstruation.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jul 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892080
- Sponsor's protocol ID
- 2023-15
- Acronym
- SexHormInkont
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data will be shared with a gynechologist.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
- ClinicalTrials.gov ID
- NCT06892080
- Acronym / sponsor ID
- SexHormInkont / 2023-15
- Conditions
- Spinal Cord Injury, Urinary Incontinence, Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women with spinal cord injury and urinary incontinence | – | – |
| Premenopausal women with spinal cord injury without urinary incontinence | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female outpatients of the Swiss Paraplegic Centre.
Key inclusion criteria (6 listed)
- women
- age ≥ 18 years
- chronic neurogenic bladder dysfunction due to acquired spinal cord injury
- regular menstrual cycle (26-30 days/cycle)
- written consent given
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incontinence event(s)
Time frame: through study completion, an average of 3 months
Daily patient-reported events of urinary incontinence
7 secondary outcomes
Ovulation
Time frame: through study completion, an average of 3 months
Recruitment rate
Time frame: at study completion, an average of 2 years
Positive screening rate
Time frame: at study completion, an average of 2 years
Retention rate
Time frame: at study completion, an average of 2 years
Assessment completion rate
Time frame: at study completion, an average of 2 years
Type of urinary incontinence event
Time frame: through study completion, an average of 3 months
Symptoms of urinary tract infection
Time frame: through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Coded data will be shared with a gynechologist.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jürgen Pannek, Prof. Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Urinary Incontinence, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörg Krebs, Dr. med. vet. / PhD (+41 41 939 59 46, joerg.krebs@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence event(s) (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.