Adult Bladder and Quality of Life Evaluation in Spina Bifida

NCT07642466 | Recruiting

• 1 other identifier: 15140
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Spina bifida (SB) is a birth defect that affects the spine, often causing paralysis in the legs and problems with bladder and bowel control. Managing these bladder issues is important, but different methods, like using a catheter or surgery, can impact a person's quality of life. This study looks at how different bladder management methods affect the quality of life for young people with SB. Researchers will ask people with SB to complete a survey about how they manage their bladder and how it impacts their daily lives. The main goal is to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with SB.

Conditions

Spina Bifida or Spinal Dysraphism

Keywords

quality of life; spina bifida; bladder; bowel

Outcome Measures

Primary Outcomes (1)

• QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain)

  The QUALAS is a validated quality of life measure for teens and adults with spina bifida. It is scored from 0-100, with a higher score meaning better QOL

  At the time of enrollment

Secondary Outcomes (1)

• Neurogenic Bladder Symptom Score-Short Form

  At time of enrollment

Study Arms (4)

Voiding/incontinence

SB patients who manage their bladder with voiding/incontinence

CIC

SB patients who manage their bladder with clean intermittent catheters

Diversion

SB patients who manage their urination with a surgical bladder diversion

Indwelling catheter

SB patients who manage their bladder with an indwelling catheter

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To be included in the study, participants have to be adolescents (13-17 years of age) or adults (≥18 years of age) with SB and no acute health changes. SB included all types, including SB occulta, meningocele, lipomeningocele, and myelomeningocele. The investigators are interested in including the SB transitional age group as well, recognizing this age group represents unique and diverse psychosocial, cognitive and functional abilities.

You may qualify if:

• Diagnosis of SB
• Age ≥13 years of age
• Able to effectively communicate in English or Spanish
• Willing to provide informed consent for participation and answer a set of questionnaires

You may not qualify if:

• Reconstructive surgery or urinary diversion in the last 3 months
• Hospital admission in the last 1 month
• Inconsistent or newly changed (within the last month) method of bladder management

Sponsors & Collaborators

• Blayne Welk: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

St Joseph's Hospital

London, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Blayne Welk, MD MSc

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary McKibbon, BNSc

CONTACT

519-646-6367; mary.mckibbon@sjhc.london.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CA (1)