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NCT Number: NCT06892080

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

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Menstrual Cycle Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Incontinence event(s)

    Time frame: through study completion, an average of 3 months

    Daily patient-reported events of urinary incontinence

Secondary outcomes

  1. 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.

  2. Recruitment rate

    Time frame: at study completion, an average of 2 years

    The number of eligible patients who are enrolled

  3. Positive screening rate

    Time frame: at study completion, an average of 2 years

    Proportion of eligible patients who are screened

  4. Retention rate

    Time frame: at study completion, an average of 2 years

    Rate of participants who finish study protocol

  5. Assessment completion rate

    Time frame: at study completion, an average of 2 years

    Proportion of planned assessments that are completed

  6. 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

  7. 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.

Other outcomes

  1. Maximal detrusor pressure during storage phase

    Time frame: Baseline

    Measured during urodynamic examination.

  2. Bother by urinary incontinence

    Time frame: Baseline

    Evaluted using a numeric rating scale from 0 (no bother) to 10 (fully bothered)

  3. Menstrual cycle anamnesis

    Time frame: Baseline

    Information about last menstruation, average length of the menstruation, the average length of the cycle

  4. 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.

  5. Bladder compliance

    Time frame: Baseline

    Measured during storage phase, ml/cmH2O

  6. Bladder capacity

    Time frame: Baseline

    Measured during urodynamic examination.

  7. Age

    Time frame: Baseline

    Time from birth to inclusion into study (years)

  8. Date of spinal cord injury/disease onset

    Time frame: Baseline

  9. Neurological level of injury

    Time frame: Baseline

    Highest intact spinal cord segment

  10. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jörg Krebs, Dr. med. vet. / PhD

CONTACT

[email protected]

+41 41 939 59 46

Jürgen Pannek, Prof. Dr. med.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Acronym: SexHormInkont

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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