Local Oestrogen Treatment in Postmenopausal Women Undergoing Pelvic Organ Prolapse Surgery (LOTUS)
B.4.1 Name of organisation providing support NIHR RfPB grant
B.5.2 Functional name of contact point Dr Tina Verghese
B.5.3.1 Street Address Birmingham Women's Hospital
B.5.3.3 Post code B15 2Tg
B.5.6 E-mail t.s.verghese@bham.ac.uk
B.1.1 Name of Sponsor Birmingham Women's Hospital
B.5.1 Name of organisation Birmingham Women's NHS Foundation Trust
B.5.2 Functional name of contact point Kelly Hard
B.5.3.1 Street Address Metchley Park Road
B.5.3.2 Town/ city Edgbaston, Birmingham
B.5.6 E-mail kelly.hard@bwnft.nhs.uk
D.2.1.1.1 Trade name Vagifem 10 micrograms vaginal tablets
D.2.1.1.2 Name of the Marketing Authorisation holder Novo-Nordisk
D.3.1 Product name Vagifem 10 micrograms vaginal tablets
D.3.4 Pharmaceutical form Vaginal tablet
D.3.8 INN - Proposed INN Estradiol hemihydrate
D.3.9.2 Current sponsor code ZK 5018
D.3.9.3 Other descriptive name b-Estradiol hemihydrate
D.8.3 Pharmaceutical form of the placebo Vaginal tablet
D.8.4 Route of administration of the placebo Vaginal use
Prolapse of womb or vagina
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
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.
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
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
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.
The evaluation of this endpoint will occur after 12 month follow-up.
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.
Secondary outcomes would be collected at 6 weeks, 6 and 12 months.
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.