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Completed

NCT Number: NCT01533597

The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

About this study

Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.

The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.

Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 20 ≤ and < 70 years
  • History of OAB symptoms for ≥ 3 months
  • International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
  • An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

Exclusion criteria

  • Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
  • Any condition that would contraindicate their usage of anticholinergics or alpha blockers
  • History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
  • History of stress urinary incontinence or urinary retention
  • History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
  • Pregnant or nursing women
  • Current urinary tract infection
  • Neurological bladder dysfunction
  • Treatment with drugs that may interfere with CYP3A4 metabolic function
  • Significant hepatic or renal disease
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Treatment and study plan

solifenacin

Drug

Solifenacin (5mg, qd, oral)

Other names: Vesicare

Solifenacin plus Tamsulosin

Drug

Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Other names: Vesicare, Harnal

Primary outcomes

  1. Change in Mean Number of Micturition Episodes Per 24 Hours

    Time frame: at week 24 relative to baseline

Secondary outcomes

  1. Numeric Change of Urgency Episodes Per 24 Hours

    Time frame: at week 24 relative to baseline

  2. Change in Total Score of OABSS

    Time frame: at week 24 relative to baseline

    Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)

  3. Change in Score of IPSS

    Time frame: at week 24 relative to baseline

    Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.

  4. Change of PVR

    Time frame: at week 24 relative to baseline

    Change from baseline in Post-Void Residual (PVR) volume

  5. Change of Qmax

    Time frame: at week 24 relative to baseline

    maximal urinary flow rate (Qmax) assessed by uroflowmetry

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2012
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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