---
title: Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
nct_id: NCT01512004
overall_status: COMPLETED
phase: PHASE3
sponsor: "Lee's Pharmaceutical Limited"
study_type: INTERVENTIONAL
primary_condition: Overactive Bladder
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01512004.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01512004"
ct_last_update_post_date: 2012-01-25
last_seen_at: "2026-05-12T07:28:54.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

**Official Title:** Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence

**NCT ID:** [NCT01512004](https://clinicaltrials.gov/study/NCT01512004)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 324
- **Lead Sponsor:** Lee's Pharmaceutical Limited
- **Collaborators:** APOGEPHA Arzneimittel GmbH
- **Conditions:** Overactive Bladder
- **Start Date:** 2010-01
- **Completion Date:** 2011-08
- **CT.gov Last Update:** 2012-01-25

## Brief Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

## Detailed Description

This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB\>3 months subject has urinary frequency (average micturition frequency within 24h\>8 times), urgency and/or urge incontinence by micturition diary card during screening period
* Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
* The subject is willing and able to complete the micturition diary card correctly
* Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form

Exclusion Criteria:

* Confirmed by the investigator that subject has severe stress incontinence.
* Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
* Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
* Subject who has a symptomatic acute urinary tract infection.
* Subject who has a recurrent urinary tract infection.
* Subject who has interstitial cystitis.
* Subject who has an agnogenic hematuria.
* Subject who has a bladder outlet obstruction of clinical significance.
* Subject who needs retention catheterization or intermittent catheterization.
* Patient with malignant tumor.
* Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
* Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
* Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
```

## Arms

- **Propiverine Hydrochloride Extended-Release Capsule** (ACTIVE_COMPARATOR) — 30 mg/capsule; oral; once per day
- **Tolterodine Extended-release Tablet** (PLACEBO_COMPARATOR) — 4mg/tablet; oral; once per day

## Interventions

- **Propiverine Hydrochloride** (DRUG) — drug of oral capsule
- **Tolterodine Extended-release Tablet** (DRUG) — 4mg/tablet; oral; once per day

## Primary Outcomes

- **Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record** _(time frame: prior to medication and 8 weeks after medication)_ — The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication

## Secondary Outcomes

- **The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record** _(time frame: prior to medication, 2 weeks and 8 weeks after medication)_

## Locations (1)

- Beijing Chaoyang Hospital, Beijing, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing chaoyang hospital|beijing||china` — added _(2026-05-12)_

---

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