To be completed by clinician at initial clinic appointment. Please complete every question.

Patient’s Surname / Patient’s Forenames
Patient’s Title Mrs/Miss/MS/Dr/Other / Patient’s date of birth / DD--/MMM/ YYYY
Patient’s NHS No. / Patient’s Hospital No.
Patient’s Address
/ Postcode
Patient’s Tel No. / Mobile Telephone No.
Patient’s Email Address
White / Mixed – white & black Caribbean / Asian - Indian / Mixed – white & black African / Asian - Pakistani
Mixed – white & Asian / Asian - Bangladeshi / Mixed – other / Asian - other / Chinese
Black - Caribbean / Black African / Black - other / Other ethnic group / Not stated
If other ethnic group please specify
GP details First name / Surname
GP Title Mr/Dr/Professor/Ms/Other
GP Address
/ Postcode
1: Eligibility Checklist
Confirm the woman has the following characteristics (please tick one): / Yes / No
1.1 Due to undergo vaginal prolapse surgery? / iXi / iXi
1.2 Postmenopausal? (LMP > 12 months previously) / iXi / iXi
1.3 Willing to be randomised and attend 6 month follow up? / iXi / iXi
1.4 Able to understand English or translator available / iXi / iXi
1.5 Has the woman given written consent for participation? / iXi / iXi
1.6 Received HRT in the last 12 months? / IXi / iXi
1.7 Previous breast or uterine malignancy? / iXi / iXi
1.8 Previous hormone-dependant neoplasms? / iXi / iXi
1.9 Genital bleeding of unknown origin? (PMB Investigated) / iXi / iXi
2.0 Previous thrombo-embolic episode related to oestrogen therapy? / iXi / iXi
2.1 Known reaction to vaginal oestrogens? / IXi / iXi
2.2 Two or more culture positive UTI episodes in the last 6 months? / IXi / iXi
2.3 Voiding dysfunction (PVR > 150ml)? / IXi / iXi
2.4 Previous POP surgery involving mesh? / iXi / iXi
2.5 Previous prolapse surgery in the same compartment as current planned surgery / iXi / iX
2.6 Patient is not currently participating in any other CTIMP trial. / iXi / iX
2: Medical Details
Parity (Number of vaginal births) iXi
Maximum stage of prolapse i I ii X iii I iv X
Planned concomitant incontinence surgery Yes iXi No iXi
Eligibility confirmed by delegated clinician Yes iXi No iXi

Signature of Clinician
3: Randomisation to group allocation
LOTUS Trial Number: / / Allocated treatment please tick 
Date of Randomisation: / _DD/MMM/ YYYY / Vagifem iXi
No Treatment iXi

To be completed by clinician at initial clinic appointment. Please insure that each question is completed by placing a tick in the appropriate box.

Please complete all questions / Yes / No / Not Known
Previous operation for prolapse / iXi / iXi / iXi
If Yes what was the previous repair? (please tick both if necessary)
Anterior Number of repairs : iXi Mesh used: Yes iXi No iXi
Posterior: Number of repairs: iXi Mesh used: Yes iXi No iXi
Please complete all questions / Yes / No / Not Known
Hysterectomy? / iXi / iXi / iXi
If yes route: Vaginal iXi Abdominal iXi Laparoscopic iXi Method not known iXi
Vaginal pessary or ring currently in place? / iXi / iXi / iXi
Physiotherapy treatment for prolapse or urinary incontinence within last 12 months? / iXi / iXi / iXi
Surgery for stress urinary incontinence? / iXi / iXi / iXi
If yes tick that apply: Tape iXi Bulking iXi Colposuspension iXi
Any drug treatment for urinary incontinence? / iXi / iXi / iXi
Treatment for overactive bladder? / iXi / iXi / iXi
If yes: Botox iXi Neuromod iXi
If the patient has had children please state types of delivery, if this question does not apply to the patient please tick this box iXi and continue to Section C.
Number of spontaneous vaginal deliveries : iXi Number of forceps deliveries : iXi
Number of Caesareans : iXi Number of ventouse deliveries : iXi

Date of POP-Q : _DD/MMM/ YYYY

From last recorded POP-Q, without pessary.

If not available,repeat before operation (if pessary currently in use, go to C3).

Genital Hiatus / Perineal Body / Total Vaginal Length
cm / cm / cm
Cervix present / Yes / No
Bladder/empty / Yes / No
Bowel/empty / Yes / No
Maximum protrusion seen
Yes / No
Height / Weight
cm / kg
What stage of prolapse does the woman have (0 to 4 in each box)?
Anterior (a) / Posterior (p)
Cervix/uterus (C) / OR Vault/cuff (C)
Form completed by (please print and sign)

ISRCTN Number 46661996 Confidential when completed Information treatmentform V1.1 dated 22.09.2015