E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Prolapse of womb or vagina |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 |
Study Aim The aim of the feasibility study is to find out if an appropriately powered randomised controlled trial can be realistically undertaken. The feasibility study will also allow the research team to identify any barriers to recruitment and compliance, and fine tune study procedures such as data collection and prescription of the study treatments. The aim of the definitive study would be to test the hypothesis that vaginal oestrogen treatment of postmenopausal women undergoing pelvic floor repair surgery leads to improved patient reported outcomes in relation to urinary, bowel, sexual function and prolapse related quality of life (QoL).
Feasibility study specific objectives: 1.To obtain estimates for important aspects of the protocol to allow development of a definitive trial 2.To derive real- time data on the design aspects of the study I.Proportion of eligible women of those screened II.Proportion of eligible women randomised III.Attrition rates IV.Compliance with tr |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives of the definitive trial: 1.Improvement sexual function related quality of life (QoL) at 12 months with the use of PISQ 12. 2.Reduction of intraoperative complications like tearing or button holing of the vagina and blood loss. 3.Reduction in the incidence of surgical wound infection and urinary tract infection postoperatively. 4.Validate Patient Global Impression of Improvement (PGI-I) in relation to the POP surgery, PFDI SF20 and PFIQ-7.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: 1.Postmenopausal women 2.Consented to undergo surgical intervention for pelvic organ prolapse 3.Have not received HRT in the last 12 months 4.Willing to be randomised 5.Give written informed consent
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E.4 | Principal exclusion criteria |
Exclusion criteria: 1. Previous breast or uterine malignancy or other hormone- dependent neoplasms 2. Genital bleeding of unknown origin 3. Previous thrombo-embolic episodes in relation to oestrogen therapy 4. Women who cannot understand speak or write in English 5. Women known to be allergic to any of the components of vaginal oestrogens 6. Two or more episodes of culture positive UTI in the last 6 months 7. Previous POP surgery 8. Voiding dysfunction(PVR>150ml) 9. Current or previous POP surgery involving mesh
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E.5 End points |
E.5.1 | Primary end point(s) |
As a feasibility study, the objectives is to obtain estimates for important aspects of the protocol to allow development of a definitive trial. A primary outcome measure is not defined.
The primary clinical outcome of a definitive trial would be improvement in prolapse related QoL at 12 months as assessed by PFDI SF20.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The evaluation of this endpoint will occur after 12 month follow-up. |
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E.5.2 | Secondary end point(s) |
As a feasibility study, the objectives is to obtain estimates for important aspects of the protocol to allow development of a definitive trial. Secondary outcome measures are not defined.
The secondary clinical outcomes of a definitive trial would be: 1. Sexual function related quality of life (QoL) at 12 months with the use of PISQ 12 2. Intraoperative complications like tearing or button holing of the vagina and blood loss. 3. Incidence of surgical wound infection and urinary tract infection postoperatively.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary outcomes would be collected at 6 weeks, 6 and 12 months. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
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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The definition of the end of the interventional phase of the trial will be when the last participant has completed her final course of pessaries, and for the observation phase, when she has completed 12 month follow-up. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |