Pelvic organ prolapse
Conditions
Interventions
Trade Name: Vagifem 10 micrograms vaginal tablets
Product Name: Vagifem 10 micrograms vaginal tablets
Pharmaceutical Form: Vaginal tablet
INN or Propose
Sponsors
University of Birmingham
Birmingham Women's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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. ; 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. ; Main Objective: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: Secondary outcomes would be collected at 6 weeks, 6 and 12 months. | — |
Countries
United Kingdom
Contacts
Public ContactDr Tina Verghese
University of Birmingham
Outcome results
None listed