Real-life Clinical Experience With Ialuadapter Study

NCT06540248 | Completed

• 1 other identifier: Ialudapter Study
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Conditions

Interstitial Cystitis, Chronic; Overactive Bladder Syndrome; Recurrent Urinary Tract Infection

Keywords

IALUDAPTER; intravesical therapy; GAG therapy; Intravesical treatment; IC/BPS; recurrent urine tract infection; catheterization

Outcome Measures

Primary Outcomes (1)

• Number of participants who reported success (in using syringe adapter) Yes/No

  pt self reported general assessment of successful instillation using the syringe adapter

  6 months

Secondary Outcomes (4)

• PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)

  6 months

• Total number of UTI's during syringe adapter use amongst all patients

  6 months

• Number of participants who use syringe adapter 3 years after initial assessment (yes/no)

  1 yr

• PRO ; patient reported reasons to continue syringe adapter (5 options)

  6 months

Study Arms (1)

61 patients evaluated

with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7)

Device: Ialuadapter

Interventions

Ialuadapter DEVICE

minimally invasive syringe device for bladder catherization

61 patients evaluated

Eligibility Criteria

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

Study Population

* Patients with IC/BPS, recurrent UTIs and/or OAB * Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).

You may qualify if:

• Patients with IC/BPS, recurrent UTIs and/or OAB
• Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).

You may not qualify if:

• Patients with a high post-void residue of \>100ml or with an indwelling catheter were excluded from the analyses.
• Patients who cannot sign informed consent.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 HB, Netherlands

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: August 6, 2024
• Study Start: November 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

NL (1)