Prospective Assessment of Health-Related Quality of Life and Caregiver Burden in Children and Parents of Children with Lower Urinary Tract Dysfunction with Validation of the Riley Bladder Quality of Life Questionnaire (RiBQQ)

Study on Quality of Life in Children with Bladder Problems and Their Caregivers

N
Nikhil Batra

Primary Investigator

Enrolling By Invitation
8 years - 17 years
All
Phase N/A
80 participants needed
3 Locations

Brief description of study

This is a prospective study to assess both validated and non-validated questionnaires and quality of life tools in children with LUTD. Additionally, we will obtain data from parents/guardians of children with LUTD and parents/guardians of children without LUTD to assess health care burden of LUTD.

THIS STUDY IS ENROLLING BY INVITATION ONLY - The study is open to patients being assessed by a urology provider after often waiting months with chronic urinary problems which primarily affect quality of life (the subject of this study) and not physical health. Subjects will be identified during clinic visits from the medical record, clinic schedules, or provider recommendation. A researcher/physician/NP will provide study information during the clinic visit and a brief description of the study or a researcher will call subjects by phone to introduce study and obtain email for sending additional information.In clinic: A research team member will approach eligible families as early as possible about a study for their consideration. This may occur shortly after check-in (while in the waiting room) or when brought into a room.

Detailed description of study

Surveys will be sent to subjects via email and can be completed at any location the subject feels comfortable at. 

Patient (child) and parent/guardian must both complete the questionnaires for each interval (baseline, 1-week retest*, 3-month, 1-year).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lower Urinary Tract Dysfunction, LUTD, Riley
  • Age: 8 years - 17 years
  • Gender: All

Inclusion Criteria

Cases inclusion criteria
•    Children with bladder dysfunction (as diagnosed by pediatric urologist)
•    Children ages 8-17
•    Parent/guardian present ≥ 18 (for children 8-17 years old)
•    English proficiency and appropriate literacy level to answer online questions

Parent/Guardian Inclusion Criteria:
•    ≥ 18 years of age
•    English Proficiency
•    Able to provide email
•    Has child (8-17) with bladder dysfunction
2.2    Exclusion Criteria

Exclusion criteria:
•    Children <8 years old and ≥18
•    No parent/guardian present (or parent/guardian is <18)
•    Not proficient in English and/or not at an appropriate literacy level to answer online questions
•    Severe developmental delay, cognitive impairment, impaired mobility (wheelchair users), neuropathic bladder (spina bifida, cerebral palsy, tethered cord, etc.)
•    Currently passing a kidney stone or has an internal ureteral stent (JJ)
•    Currently completing treatment for a urinary tract infection
•    Urethral catheterization or cystoscopy in last 1 month
•    History of pelvic trauma, malignancy or radiation, sexually transmitted infections, hypospadias, bladder exstrophy, epispadias, meatal stenosis, posterior urethral valves, urethral atresia, urethral stricture, anorectal malformation
•    History of spinal surgery, bladder surgery (including reimplantation), MACE surgery, Hirschsprung's disease (appendectomy ok)

Parent/Guardian Exclusion Criteria:
•    <18 years of age
•    Not proficient in English
•    Unable to provide email
•    No child, or child is <8 years old and ≥18

This study investigates the quality of life in children with lower urinary tract dysfunction (LUTD) and their caregivers. The purpose is to understand how LUTD affects daily life and to validate the Riley Bladder Quality of Life Questionnaire (RiBQQ). Lower urinary tract dysfunction refers to problems with storing or emptying urine that can affect a child's life. The study involves children with LUTD and their parents, as well as parents of children without LUTD, to compare experiences.

Participants will complete surveys sent via email at different times: when they start the study, after one week, after three months, and after one year. These surveys can be filled out wherever the participants feel comfortable. Both the child and their parent or guardian need to complete the questionnaires at each time point.

  • Who can participate: Children aged 8 to 17 with bladder dysfunction, diagnosed by a pediatric urologist, and their parents or guardians who are 18 or older, must be proficient in English and able to answer online questions.
  • Study details: Surveys will be completed at home or any comfortable location by both the child and parent/guardian at several intervals. There is no medicine or placebo involved in this study.
Updated on 10 Jun 2026. Study ID: UROL-IIR-RIBQQ-VALIDATION-2, 31654
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only