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Stress Urinary IncontinencePhase 4NCT01505439

A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

A Phase 4 study testing solifenacin in people with Stress Urinary Incontinence and Urgency Urinary Incontinence, run by Jeong Gu Lee at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
solifenacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
311 participants
Where
6 sitesSouth Korea
Study dates
Jun 2011to Jun 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are selected from those who meets one of criteria
  • Patients with a positive cough provocation test
  • Based on 3-day voiding diary, patients with:
  • Urinary frequency (eight or more micturitions per day or 24 hours)
  • Urinary urgency (two or more episodes per day or 24 hours)
  • Urge incontinence (three or more episodes for 3 days)

Who cannot join

  • Breast-feeding women or females of childbearing potential with the intention to become pregnant during the study
  • Post-void residual urine volume (PRV) of 150 cc or more
  • Patients who experienced acute ureteral obstruction requiring an indwelling catheter
  • Patients who experienced clinically significant pelvic organ prolapse or lower urinary tract surgery within 6 months prior to the initiation of the present study
  • Patients who underwent a urinary incontinence operation within 1 year
  • Any condition that, in the opinion of the investigator, is a contraindication for anticholinergic treatment, including severe narrow-angled glaucoma, urinary retention, gastric retention, severe myasthenia, severe hepatic insufficiency or severe ulcerative colitis
Show all 19Show fewer
  • Significant hepatic or renal disease, defined as having greater than twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine
  • Patients who have any of neurological disorders such as stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease
  • Patients who use an indwelling catheter or practice intermittent self-catheterization
  • Recurrent UTIs defined as having been treated for symptomatic UTIs 3 times or more in the last year
  • Symptomatic acute urinary tract infection (UTI) during the run-in period
  • Patients who received any of the following prohibited concomitant drugs within 14 days prior to randomization: Treatment performed within the 14 days preceding randomization, or expected to initiate treatment during the study with:
  • Any anticholinergics other than the trial drug
  • Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
  • Patients taking an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  • Patients with chronic constipation or history of severe constipation
  • Treatment with any of potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
  • Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study initiation and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives, surgical procedures (tubal ligation or vasectomy), or continence
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Site KR00003

    Daegu

  • SIte KR00004

    Incheon

  • Site KR00001

    Jeonam

  • Site KR00002

    Jungnam

  • Site KR00005

    Pusan

  • Site KR00006

    Seoul

Other trials in South Korea

About this study

Official title: A Prospective, Open Label, Single Arm, Multicenter Study to Estimate the Efficacy and Safety of Solifenacin in Female With Clinically Significant Stress Urinary Incontinence and Urgency Urinary Incontinence

This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.

Being tested
solifenacin
Keywords
solifenacin, bladder symptom
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • solifenacinDrug

    Also called Vesicare

    oral

Study groups in NCT01505439
Study groupRoleWhat they receive
Solifenacin groupExperimentalOnce daily
Receives: Drug: solifenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12

    Measured: Baseline and week 12

Secondary outcomes (10)

  1. Percent change in the mean number of urge urinary incontinence episodes per 24 hours

    Measured: Baseline, week 4 and week 12

  2. Change in the mean number of urge urinary incontinence episodes per 24 hours

    urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 3 in the voiding diary

    Measured: Baseline, week 4 and week 12

  3. Change in the mean frequency of urination per 24 hours

    Measured: Baseline, week 4 and week 12

  4. Percent change in the mean frequency of urination

    Measured: Baseline, week 4 and week 12

  5. Changes in the mean and sum rating on the Bladder Sensation Scale per 24 hours

    Measured: Baseline, week 4 and week 12

  6. Change in the mean number of severe urgency episodes per 24 hours

    severe urgency episodes: defined as those with a Bladder Sensation Scale rating of ≥ 4 in the voiding diary

    Measured: Baseline, week 4 and week 12

  7. Changes in overactive bladder symptom score (OABSS) questionnaire

    Change in total and each of OABSS items

    Measured: Baseline, week 4 and week 12

  8. Changes in short urogenital distress inventory (UDI-6)

    Change in total and each UDI-6 items

    Measured: Baseline, week 4 and week 12

  9. Changes in short incontinence impact questionnaire (IIQ-7)

    Change in total and each of IIQ-7 items

    Measured: Baseline, week 4 and week 12

  10. Safety assessed by the incidence and severity of side effects

    Measured: For 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01505439
Sponsor's protocol ID
VENUS-MUI
Status last verified
Jun 2016
First submitted
4 Jan 2012
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing solifenacin in people with Stress Urinary Incontinence and Urgency Urinary Incontinence, run by Jeong Gu Lee at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the number of urge urinary incontinence episodes per 24 hours between baseline and week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01505439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.

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