E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Urge urinary incontinence |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048335 |
E.1.2 | Term | Urinary incontinence aggravated |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Pilotstudie hvor vi ønsker afprøve om der en klinisk relevant effekt af intravesikal instillation af botulinum tocxin type A hos patienter med urge urininkotitnens og idiopatisk detrusor overaktivitet. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Myndig habil kvinde ≥ 18 år der forstår dansk - Mindst 6 måneders anamnese med UUI som dominerende symptom i.h.t. ICS-definition - Forsøgt mindst 2 forskellige antimuskarinika - Heldøgns vandladningsfrekvens (TV) ≥ 10/døgn ved 4-dages væske-vandladningsskema (VVS) - Inkontinensepisodefrekvens (IEF) ≥ 1/døgn ved 4-dages VVS - Døgndiurese < 40 ml/kg - Residualurin < 100 ml - POP-Q ≤ stadium 2 - Spontan uroflowmetri > 15 ml/sek ved ladt volumen > 150 ml, eller normal invasiv tryk-flow under-søgelse - Cystometrisk overaktiv detrusor inkontinens ved volumen < 300 ml - Naturlig eller kirurgisk menopause, kirurgisk sterilitet eller sikker antikonception (p-piller, spiral, de-potinjektion af gestagen, subdermal implantation, hormonal vaginalring samt transdermal depot-plaster)
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E.4 | Principal exclusion criteria |
- Blæreneoplasier - Symptomer eller tegn på neurologisk eller neuromuskulære lidelser, herunder myastenia gravis - Behandling med aminoglykosider - Graviditet eller amning - Ønsker eller evner ikke oplæring i ren intermitterende selvkateterisation (RIK)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primært: - Median inkontinensepisodefrekvens (IEF) ved 4-dages VVS (antal/døgn) Sekundære: - Median heldøgns vandladningsfrekvens (TV) ved 4-dages VVS (antal/døgn) - Median daglig vandladningsfrekvens (DV) ved 4-dages VVS (antal/dag) - Median natlig vandladningsfrekvens (NV) ved 4-dages VVS (antal/nat) - Symptommålinger (ICIQ-SF, ICIQ-OAB)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |