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Search / Trial NCT06892080

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

Launched by SWISS PARAPLEGIC RESEARCH, NOTTWIL · Mar 18, 2025

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how the menstrual cycle affects bladder function in women with spinal cord injuries, particularly focusing on urinary incontinence, which is the unintentional loss of urine. Researchers want to understand if changes in hormone levels, especially estrogen, during the menstrual cycle might lead to more frequent episodes of urinary incontinence. This study is important because most previous research has only looked at women after menopause, so the findings could help improve treatments for women of all ages experiencing this issue.

The trial is currently recruiting women aged 18 and older with a chronic bladder condition due to spinal cord injury, who have regular menstrual cycles and experience urinary incontinence at least once a month. Participants will keep a diary to track their menstrual cycles and any episodes of incontinence over three cycles, and they will provide saliva samples and urine tests. This is a pilot study, meaning it's an initial small-scale investigation to gather information. If you think you might be eligible or are interested in participating, it could be a valuable opportunity to contribute to our understanding of this important issue.

Gender

FEMALE

Eligibility criteria

  • 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)

About Swiss Paraplegic Research, Nottwil

Swiss Paraplegic Research (SPER) in Nottwil is a leading institution dedicated to advancing the understanding and treatment of spinal cord injuries and related conditions. As a prominent clinical trial sponsor, SPER focuses on innovative research that aims to improve the quality of life for individuals affected by paralysis. The organization collaborates with a network of academic and clinical partners to conduct rigorous studies, translating scientific discoveries into practical therapies and rehabilitation strategies. With a commitment to excellence and patient-centered care, SPER plays a vital role in shaping the future of spinal cord injury research and rehabilitation.

Locations

Nottwil, , Switzerland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported