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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSwiss Paraplegic Research, Nottwil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women

age ≥ 18 years

chronic neurogenic bladder dysfunction due to acquired spinal cord injury

regular menstrual cycle (26-30 days/cycle)

Disqualifiers

Detrusor overactivity in storage phase above 15cmH20

Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods)

Hormonal intake/contraception

Intake of androgens

Trial population

Female outpatients of the Swiss Paraplegic Centre.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

24 Participants
are grouped into 2 trial groups
Group A: Premenopausal women with spinal cord injury and urinary incontinence
Group B: Premenopausal women with spinal cord injury without urinary incontinence

Trial outcomes

Primary outcomes

1

Incontinence event(s)

Daily patient-reported events of urinary incontinence

Time frame
through study completion, an average of 3 months

Secondary outcomes

1

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.

Time frame
through study completion, an average of 3 months
2

Recruitment rate

The number of eligible patients who are enrolled

Time frame
at study completion, an average of 2 years
3

Positive screening rate

Proportion of eligible patients who are screened

Time frame
at study completion, an average of 2 years
4

Retention rate

Rate of participants who finish study protocol

Time frame
at study completion, an average of 2 years

Other outcomes

1

Maximal detrusor pressure during storage phase

Measured during urodynamic examination.

Time frame
Baseline
2

Bother by urinary incontinence

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

Time frame
Baseline
3

Menstrual cycle anamnesis

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

Time frame
Baseline
4

Bladder domain from the Australian Pelvic Floor Questionnaire

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.

Time frame
through study completion, an average of 3 months

Sponsors and contacts

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