Effectiveness of Bryophyllum in Nocturia-Therapy

• Status: Recruiting
• Trial end date: 2021-08-12
• Target enrollment: 0
• Participant gender: Female

Summary

Night-time micturition, called nocturia, is a very common problem that unfavourably influences sleep- and life-qualities. The International Continence Society (ICS) defines nocturia as micturition once or several times during the night. Nocturia is one of the cardinal symptoms of overactive bladder (OAB). Persons with nocturia have the intention to continue sleep after going to the toilet which does not succeed to the same extent, depending on age.

The natural occurrence of the plant, Bryophyllum pinnatum (BP) which is used in this observational study origins from Madagascar as well as in tropical Africa, South America and Asia. In the folk medicine of these countries BP is widely used. BP has a calming, spasmolytic, anti-inflammatory, pain-relieving, diuretic and cytotoxic effects.

According to previous preclinical and clinical studies the inhibiting effect of BP on overactive bladder was proven. The pharmacological effect of this plant on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions, and on detrusor muscle cells in an in-vitro model of the pig's bladder was shown. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). The flavonoid, aglycons and bufadienolides, are components of the pressed juice of the BP leaves that have comparable effects to the standard drug oxybutynin on vesical smooth muscle cells.

Since many year BP is used in obstetrics not only as tocolytics but also as a sedative and sleeping pill.

There are known only few adverse events, such as skin irritation by intravenous application.

The interest in phytotherapeutical drugs for treatment the chronic diseases is very high and Bryophyllum is also frequently used in Switzerland for hyperactive conditions.

In Switzerland, following the vote on complementary medicine on 17.05.2009, alternative treatments will be covered by basic health insurance. Definitive inclusion in the catalogue of benefits will be granted if effectiveness, safety and cost-effectiveness can be demonstrated.

The potential and side-effect profile of BP, as well as the social interest in research into alternative methods is the background to the implementation of this observational study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich

Criteria

Inclusion Criteria:

• Nocturia ≥2 Mal per a night

• Overactive bladder (>8 Mictions/day)

• Age > 18 Years

• local or systemic Therapy with Estrogen, if the therapy dates >4 Weeks before study-start.

• prior incontinence operation (if the operation dates back more than 6 months)

• german speaking Patients and a given informed consent

Exclusion Criteria:

• Intolerance against a substance or a compound

• participation in an other study 4 weeks prior to inclusion

• urinary tract infection

• drug abuse

• bladder affecting drugs like anticholinergics, diuretics, muscle relaxing medicaments and phytotherapeutics

• lactose intolerance

• Pregnant and lactating women

• Incompliance of Patient