Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ChiCTR |
Last refreshed on:
|
18 April 2017 |
Main ID: |
ChiCTR-TRC-13003938 |
Date of registration:
|
2013-05-17 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trial
|
Scientific title:
|
Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trial |
Date of first enrolment:
|
2009-06-01 |
Target sample size:
|
group A:24;group B:24; |
Recruitment status: |
Completed |
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=5629 |
Study type:
|
Interventional study |
Study design:
|
Randomized parallel controlled trial
|
Phase:
|
Post-market
|
|
Countries of recruitment
|
China
| | | | | | | |
Contacts
|
Name:
|
Hongde Chen
|
Address:
|
Department of Urology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.
325000
|
Telephone:
|
+86 13857732266 |
Email:
|
85404206@qq.com |
Affiliation:
|
The First Affiliated Hospital of Wenzhou Medical College |
|
Name:
|
Hongde Chen
|
Address:
|
Department of Urology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.
325000
|
Telephone:
|
+86 13857732266 |
Email:
|
85404206@qq.com |
Affiliation:
|
The First Affiliated Hospital of Wenzhou Medical College |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: All patients underwent the following diagnostic tests: positive modified potassium sensitivity test [17], cystoscopic findings of over 10 glomerulations and non-ulcer lesion in every visual field after hydrodistention (pressure: 80-100 cmH2O, duration: 2 min) under sedation or spinal anesthesia at the discretion of the clinician.
Exclusion criteria: Patients with diabetes mellitus, mental disorder, hypertension, hypohepatia, renal insufficiency or received any treatment for IC/PBS with 3 months were excluded. Patients observed for 1 month to eliminate interference of hydrodistention. Those still having therapeutic response to hydrodistention after 1 month were also excluded.
Age minimum:
35
Age maximum:
55
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
interstitial cystitis
|
Intervention(s)
|
group A:oral sildenafil;group B:oral placebo ;
|
Primary Outcome(s)
|
urodynamic indices;interstitial cystitis symptom indices(ICSI);interstitial cystitis problem indices (ICPI);micturition diar;
|
Source(s) of Monetary Support
|
self-raised
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|