Bryophyllum Versus Placebo for Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      E: The pharmacological effect of Bryophyllum pinnatum could be shown on uterine smooth muscle
      cells, on spontaneous and oxytocin-stimulated contractions. Smooth muscle relaxation is not
      only required for preventing premature labour but also for symptom's relief of overactive
      bladder (OAB). According to previous preclinical and clinical studies, an inhibiting effect
      of Bryophyllum on OAB is assumed.

      20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in form
      of the commercially available Bryophyllum tablets into capsules (verum: 3x2capsules/day) or
      lactose capsules (placebo: 3x2 capsules/day), 10 women in each group. Duration of the drug
      administration is 8 weeks.

      Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a
      voiding dairy), secondary endpoints are the improvement of quality of life (measured by using
      the King's Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the
      german language, for women with incontinence), increase of the micturition volumes and
      reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the
      registration of adverse events during the study phase. Ethics committee approval has been
      given 10th March 2010. - Trial with medicinal product
    

Detailed description: 
      In the therapeutic concept of the treatment of OAB, antimuscarinic drugs play a central role.
      Antimuscarinics are known to inhibit the contraction of detrusor muscle (smooth muscle cells)
      and block the muscarinic receptor (M2/M3) important for efferent nerve conduction. This
      conventional therapy for OAB can have important adverse effects, notably on the
      gastrointestinal tract with constipation, on the excretory glands in the sense of
      xerostomia/xerophthalmia, on the nerve cells of the brain inhibiting cognitive function and
      in the heart muscle cells accelerating the heart rate. Especially elderly people are affected
      by these undesirable effects. Because of changes in the receptor profile, the effect of
      antimuscarinics and improvement of symptoms might be lowered in elderly people and another
      substance with less side effects would be of great interest. No such adverse effects are
      reported for B. pinnatum. Until now, there are no data for its use in OAB. Efficacy and
      tolerability of B. pinnatum in the treatment of OAB are the major outcome measures of this
      clinical trial.

        -  20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in
           form of the commercially available Bryophyllum tablets into capsules (verum:
           3x2capsules/day) or lactose capsules (placebo: 3x2 capsules/day), 10 women in each
           group. Recruitment time is planned from July 2010 to June 2011.

        -  Duration of the drug administration is 8 weeks.

        -  Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a
           voiding dairy)

        -  secondary endpoints are the improvement of quality of life (measured by using the King's
           Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the german
           language, for women with incontinence), increase of the micturition volumes and
           reduction of urge episodes (measured by the patients and recorded in a voiding dairy)
           and the registration of adverse events during the study phase. Ethics committee decision
           has been given.
    

Intervention name(s): Bryophyllum pinnatum, Placebo in form of Lactose
Intervention type(s): Drug
Intervention description(s): Comparison Bryophyllum (2100mg/d) against Placebo (2100mg/d) regarding effectivity and safety.
Bryophyllum and Placebo are both administered for 8 weeks. Bryophyllum and Placebo are both given in form of capsules, 350mg per capsule, 2-2-2/d.
Other intervention name(s): Bryophyllum pinnatum/Kalanchoe; Lactose/milk sugar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment