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

September 9, 2026 updated by: Swiss Paraplegic Research, Nottwil
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female outpatients of the Swiss Paraplegic Centre.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Premenopausal women with spinal cord injury and urinary incontinence
Premenopausal women with spinal cord injury without urinary incontinence

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incontinence event(s)
Time Frame: through study completion, an average of 3 months
Daily patient-reported events of urinary incontinence
through study completion, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ovulation
Time Frame: through study completion, an average of 3 months
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.
through study completion, an average of 3 months
Recruitment rate
Time Frame: at study completion, an average of 2 years
The number of eligible patients who are enrolled
at study completion, an average of 2 years
Positive screening rate
Time Frame: at study completion, an average of 2 years
Proportion of eligible patients who are screened
at study completion, an average of 2 years
Retention rate
Time Frame: at study completion, an average of 2 years
Rate of participants who finish study protocol
at study completion, an average of 2 years
Assessment completion rate
Time Frame: at study completion, an average of 2 years
Proportion of planned assessments that are completed
at study completion, an average of 2 years
Type of urinary incontinence event
Time Frame: through study completion, an average of 3 months
Daily patient-reported incontinence event: stress, urge or mixed urinary incontinence
through study completion, an average of 3 months
Symptoms of urinary tract infection
Time Frame: through study completion, an average of 3 months
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.
through study completion, an average of 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal detrusor pressure during storage phase
Time Frame: Baseline
Measured during urodynamic examination.
Baseline
Bother by urinary incontinence
Time Frame: Baseline
Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered)
Baseline
Menstrual cycle anamnesis
Time Frame: Baseline
Information about last menstruation, average length of the menstruation, the average length of the cycle
Baseline
Bladder domain from the Australian Pelvic Floor Questionnaire
Time Frame: through study completion, an average of 3 months
Impact of bladder on quality of life and overall well-being, APFQ range 0 to 48, where higher scores mean more severe symptoms: on following days of the menstrual cycle: 3, 15 and 28, where 1 is the first day of menstruation.
through study completion, an average of 3 months
Bladder compliance
Time Frame: Baseline
Measured during storage phase, ml/cmH2O
Baseline
Bladder capacity
Time Frame: Baseline
Measured during urodynamic examination.
Baseline
Age
Time Frame: Baseline
Time from birth to inclusion into study (years)
Baseline
Date of spinal cord injury/disease onset
Time Frame: Baseline
Baseline
Neurological level of injury
Time Frame: Baseline
Highest intact spinal cord segment
Baseline
ASIA score
Time Frame: Baseline

The American Spinal Injury Association (ASIA) Impairment Scale (AIS) is a standardized system for assessing the severity of spinal cord injuries (SCI). It classifies the level and completeness of an injury based on motor and sensory function.

ASIA Impairment Scale (AIS) Classification:

A (Complete): No sensory or motor function preserved below the injury level, including the sacral segments (S4-S5).

B (Sensory Incomplete): Sensory function preserved below the injury level, including S4-S5, but no motor function.

C (Motor Incomplete): Some motor function preserved below the injury level, with more than half of key muscles below the level having a muscle grade <3 (not strong enough to move against gravity).

D (Motor Incomplete): Motor function preserved below the injury level, with more than half of key muscles below the level having a muscle grade ≥3 (can move against gravity).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Coded data will be shared with a gynechologist.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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