Skip to content

RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.

RCT study of bladder instillation therapy in patients with refractory interstitial cystitis. - RCT study of bladder instillation therapy for refractory interstitial cystitis.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026714
Enrollment
20
Registered
2017-03-27
Start date
2016-02-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial cystitis

Interventions

Treated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows w

Sponsors

Department of Urology, Mitsui Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 20 years old with interstitial cystitis who were diagnosed by hydrodistension at present institution. 2. Patients who are willing to participate in the study after written informed consent. 3. Patients with both OSSI and OSPI scores more than 6points and visual analogue scale for pain more than 3 points. 4. Patients who are able to be treated at outpatient.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot fulfill the above inclusion criteria. 2. Patients with gross hematuria. 3. Patients with lidocaine allergy. 4. Patients who are regarded not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Global response assessment at 3rd month of maintenance therapeutic phase.

Secondary

MeasureTime frame
1. daily urinary frequency, nocturnal urinary frequency, average voided volume per urination. 2. Maximum urine flow rate, average urine flow rate, residual urine volume. 3. O'Leary & Sant's symptom score, problem score, visual analogue scale for pain, overactive bladder symptom score, international prostate symptom score 4. adverse event at 6,12 the weeks after enrollment and 3rd,6th ,9th months at maintenance therapy.

Countries

Japan

Contacts

Public ContactAkira Nomiya

Mitsui Memorial Hospital Department of Urology

anomiya-jua@umin.ac.jp03-3862-9111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026