Recruiting

Bladder Management

Sponsor:

Blayne Welk

Code:

NCT07642466

Conditions

Spina Bifida or Spinal Dysraphism

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07642466

Start date

Jan 1, 2025

Status verified date

Jun, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • QUAlity of Life Assessment in Spina bifida (bladder and bowel quality of life domain) [ Time Frame: At the time of enrollment ]

Central Contacts and Locations

Central contacts

Locations

St Joseph's Hospital

Recruiting

London, Ontario, Canada

Contacts

More Information

Sponsor

Blayne Welk

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • quality of life
  • spina bifida
  • bladder
  • bowel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blayne Welk on 2026-06-12.