Efficacy Study of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy for Bladder Pain Syndrome

NCT01895153 | Completed

• 1 other identifier: 2012-03-029
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of pentosan polysulfate sodium, hydrodistension and combination therapy in patients with bladder pain syndrome.

Conditions

Bladder Pain Syndrome; Pentosan Polysulfate; Hydrodistension

Keywords

bladder pain syndrome; pentosan polysulfate; hydrodistension

Outcome Measures

Primary Outcomes (1)

• the change of IC-Q symptom index(ICSI)score from baseline to 6 months after each treatment

  6months

Secondary Outcomes (7)

• The change of voiding dairy parameters(mean number of micturition,Urgency etc) after each treatment.

  1,2,4 and 6months after each treatment .

• The change of O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q)score after each treatment

  1,2,4 and 6months after each treatment .

• The change of Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF)

  1,2,4 and 6months after each treatment .

• The change of Global Response Assessment(GRA) score

  1,2,4 and 6months after each treatment .

• The change of EQ-5D Health Questionnaire score

  1,2,4 and 6months after each treatment .

Study Arms (3)

pentosan polysulfate cohort

pentosan polysulfate monotherapy

hydrodistension(HD) cohort

hydrodistension(HD) monotherapy

combination cohort

combination therapy of pentosan polysulfate and hydrodistension.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bladder pain syndrome patients have not been treated with hydrodistention.

You may qualify if:

• men and women who were over 18 years old and had symptoms over 6 months.
• or more with an pain visual analogue score
• or more O'Leary-Sant Intersttial Cystitis questionnaire (IC-Q) symptom and problem score and with a pain score and nocturia score of 2 or more.

You may not qualify if:

• history of hydrodistention,augumentation cystoplasty due to IC/BPS
• pentosan polysulfate sodium (Elmiron) history over 1 month within 6 months.
• Women of child-bearing potential who were pregnant or nursing
• mean voided volume lesser than 40ml or over than 400ml.
• hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
• urinary tract infection during run-in periods.
• genitourinary tuberculosis or bladder,urethral and prostate cancer
• recurrent urinary tract infection
• history of hystrectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate opreation or treatment etc within 6months.
• neurologic disease history of cerebral infaction,multiple sclerosis or parkinsonism etc.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyu-Sung Lee, MD,Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: July 10, 2013
• Study Start: April 1, 2012
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

KR (1)