ocal oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery

Not Applicable

Completed

• Conditions: Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth; Pregnancy and Childbirth

• Registration Number: ISRCTN46661996
• Lead Sponsor: Birmingham & Black Country (University Hospital Birmingham NHS Foundation Trust)

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32912971/ results (added 15/09/2020) 2020 Results article in https://doi.org/10.1007/s00192-020-04480-5 (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-28
• Study Completion: 2017-07-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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; Target Gender: Female; Upper Age Limit 90 years ; Lower Age Limit 30 years

Exclusion Criteria

1. Previous breast or uterine malignancy or other hormone dependent neoplasms
2. Genital bleeding of unknown origin
3. Previous thromboembolic 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified