Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS

NCT05094414 | Unknown Phase 1 DMC

• 1 other identifier: MOST 109 2314 B 303 024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a collective term referring to disorders which is characterized by lower urinary tract symptoms, including bladder pain/discomfort, frequent urination without evidence of bacterial infection. The etiology of IC/BPS is still uncertain, and most current treatment for IC/BPS are only symptoms control. Our previous study revealed Epstein-Barr virus (EBV) infection presented in the IC/BPS bladders and involved the pathogenesis. Hence, using anti-viral medication valacyclovir for the patients with IC/BPS might have clinical efficacy.

Conditions

Pain, Chronic; Urge Incontinence; Overactive Bladder Syndrome; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Global Response Assessment (GRA)

  3: symptoms free, 2: \>50% symptoms improvement, 1: 25-50% symptoms improvement, 0: 0-25% symptoms improvement, -1: symptoms worse

  1 month

Secondary Outcomes (2)

• VAS

  1 month

• OSS

  1 month

Interventions

Valacyclovir DRUG

oral valacyclovir 500 mg twice per day for 4 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with IC/BPS

You may not qualify if:

• patients with neurogenic bladder
• patients with bladder outlet obstruction
• patients with lymphoma
• patients with bacteria cystitis

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• Hualien Tzu Chi General Hospital: collaborator

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

RECRUITING

Related Publications (1)

• Kuo HC, Peng CW, Jiang YH, Jhang JF. Urinary Viral Spectrum in Patients with Interstitial Cystitis/Bladder Pain Syndrome and the Clinical Efficacy of Valacyclovir Treatment. Biomedicines. 2024 Feb 26;12(3):522. doi: 10.3390/biomedicines12030522.

  PMID: 38540138 DERIVED

MeSH Terms

Conditions

Chronic Pain; Urinary Incontinence, Urge

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology department

Model Details: The IC/BPS patients would be investigated for baseline clinical symptoms questionnaire including VAS, QoL, ICPI, ICSI, and OSS. All of our patients would receive open-label oral valacyclovir 500 mg twice per day for 4 weeks. We estimate to enroll 30 IC/BPS patients. The overall improvement of current therapy would be assessed with Global Response Assessment (GRA).The GRA, VAS, and any adverse effect would be investigated in the telephone interview. After the full 4 weeks treatment, the patients would be asked to back to our clinic. All symptoms questionnaire (GRA, VAS, QoL, ICPI, ICSI, and OSS) and adverse effect would be evaluated again. The patients would be asked to provide urine sample again. The primary endpoint of this study is the GRA at 4 weeks. The secondary endpoints include the changes of VAS, VAS, QoL, ICPI, ICSI, and OSS between baseline and end of the study.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: July 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)