Multi-institution study on efficacy and safety of Propiverine Hydrochloride for female patients with urge and stress urinary incontinence

Not Applicable

• Conditions: mixed urinary incontinence

• Registration Number: JPRN-UMIN000011491
• Lead Sponsor: Foundation for Biomedical Research and Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-01
• Study Completion: 2015-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with organ disease such as bladder stones, bladder tumors and urethral stricture in the lower urinary tract 2)Patients with bacterial infections (i.e. bacterial cystitis) or nonbacterial infections (i.e. interstitial cystitis) 3)Patients with advanced lower urinary tract obstruction or urinary retention 4)Patients without urinary sensation 5)Patients with overflow incontinence 6)Patients with history or complications of pelvic organ prolapse 7)Patients with pyloric, duodenal or intestinal obstruction 8)Patients with gastric or intestinal atony 9)Patients with angle-closure glaucoma 10)Patients with myasthenia gravis 11)Patients with severe heart disease 12)Patients with severe constipation 13)Patients with dementia, who are not able to complete the questionnaires 14)Patients with history of allergic reaction to Propiverine Hydrochloride or other similar medicine 15)Patients with history of surgery that affect urination such as TOT or TVT 16) Women who are pregnant, lactating, potentially pregnant or willing to get pregnant 17)Patients with previous surgery of the abdomen and pelvis or radiation within 6 months 18)Patients who started pelvic floor muscle exercise within 3 months 19)Patients who took Propiverine Hydrochloride or other similar medicine within 2 weeks before entry 20)Judged as being unsuitable for the trial by physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of incontinence in 1 week

Secondary Outcome Measures

Name	Time	Method
the frequency of micturitions in 1 week the occurrence of episodes of urgency without incontinence in 1 week the number of protective pad used in 1 week the reduction ratio of the occurrance of incontinence QOL score (ICIQ-SF, I-QOL, IPSS-QOL) symptom score(IPSS, OABSS) response rate, blood pressure pulse rate, residual urine volume safety assessment