N/A N=65 Other

Engaging Families to Improve the Care of Patients With Hypospadias

Hypospadias

Bottom Line

View on ClinicalTrials.gov: NCT05056311 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Percent of Eligible Parents Screened (Feasibility) — 90.5 percentage of parents recruited

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Decision Aid Website (Other)
Age: Pediatric · 0+ yrs
Sex: Male
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Eligible Parents Screened (Feasibility)	90.5	—
PRIMARY Percent of Eligible Parents Enrolled (Feasibility)	48.5	—
PRIMARY Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)	0; 4; 38; 7; 5; 1	—
PRIMARY Percentage of Parents Retained in the Study (Feasibility)	42.2	—
SECONDARY Mean Decisional Conflict Scale (DCS) Score at T1 and T2	35.97; 21.93	0.001 sig
SECONDARY Mean Decisional Conflict Scale (DCS) Score at T2 and T3	21.93; 8.78	0.001 sig
SECONDARY Mean Decision-Specific Knowledge Scores	54.32; 75.62	0.001 sig
SECONDARY Mean Decisional Regret Scale Score	25.0	—
SECONDARY Hypospadias Treatment Preference by Category at T1 and T2	31; 2; 31; 27; 2; 25	0.0001 sig
SECONDARY Hypospadias Treatment Preference by Category at T2 and T3	27; 25; 2; 18; 1; 10	0.6374
SECONDARY Awareness of Decision by Category at T1 and T2	37; 6; 21; 34; 0; 20	—
SECONDARY Awareness of Decision by Category at T2 and T3	34; 20; 0; 20; 1; 8	—
SECONDARY Mean Shared Decision Making Questionnaire Score	82.5	—
SECONDARY Mean Preparation for Decision Making Score	82.6	—

Summary

Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach. A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.

Eligibility Criteria

Inclusion Criteria

parents 18 years of age and older of sons with hypospadias, or a tentative hypospadias diagnosis, and/or referral to a urologist for hypospadias
patient newborn up to age 5 years
parent able to consent and do interview in English
parent access to a reliable internet and smart phone, tablet, or computer to view the website
child/patient scheduled to see a urologist, but must not have yet seen the urologist at the time of enrollment
parent aware that there is an issue with child's pee hole
parent planning to attend urology appointment

Exclusion Criteria

As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05056311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.