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To evaluate the efficacy and safety of intravesical instillation of dimethyl sulfoxide solution in the treatment of interstitial cystitis (Hunner type), a multi-center, randomized, double-blind, parallel controlled confirmatory clinical trial

To evaluate the efficacy and safety of intravesical instillation of dimethyl sulfoxide solution in the treatment of interstitial cystitis (Hunner type), a multi-center, randomized, double-blind, parallel controlled confirmatory clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070519
Enrollment
Unknown
Registered
2023-04-14
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Interstitial cystitis (Hunner type)

Interventions

Dimethyl sulfoxide solution group:The bladder was instilled with dimethyl sulfoxide solution.
Saline solution group:The bladder was instilled with saline.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age of 18-75 years old, both sexes; 2) Interstitial cystitis; 3) Hunner's ulcer was detected by cystoscopy; 4) O'Leary-Sant interstitial cystitis symptom index (ICSI) =9 at screening; 5) those who are willing and able to tolerate intravesical instillation; 6) Contraception 7) Be able to maintain good communication with the investigators, fully understand the purpose, process and risks of the trial, agree to comply with the requirements of the clinical trial and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) previous allergic history to local anesthetics of dimethyl sulfoxide or amides; 2) complicated with some uncured diseases within 4 weeks before screening, which may affect the efficacy evaluation or increase the risk of the trial; 3) Urine routine or urine culture at screening suggested bacterial cystitis; 4) previous or current bladder augmentation or cystectomy; b) Hydrodistention and bladder detrusor injection of botulinum toxin within 3 months before screening; 5) intravesical instillation of dimethyl sulfoxide within 6 months before screening; 6) receiving intravesical instillation of drugs other than dimethyl sulfoxide within 2 months before screening.

Design outcomes

Primary

MeasureTime frame
Interstitial Cystitis Symptom Index Score (ICSI);Interstitial Cystitis Problem Index Score (ICPI);

Secondary

MeasureTime frame
Numerical pain score (NRS);

Countries

China

Contacts

Public ContactDeyi Luo

West China Hospital, Sichuan University

luodeyi1985@163.com+86 18980606809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026