The effect of mirabegron on female sexual functio

Not Applicable

Completed

• Conditions: Overactive bladder (OAB), female sexual function; Urological and Genital Diseases

• Registration Number: ISRCTN17199301
• Lead Sponsor: Elpis Hospital

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29940933

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-31
• Study Start: 2017-10-20
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Women over the age of 18 being in a sexually active relationship suffering from OAB for a minimal period of 3 months
2. None of the latter women received previously treatment for OAB
3. Willing of women to comply with the protocol and the capability to complete the voiding diaries and the questionnaires without assistance

Exclusion Criteria

1. Clinically significant stress urinary incontinence
2. Neurogenic bladder and urinary retention or are at risk for these conditions
3. Women with a history of pelvic muscle training programs will be excluded because it is accepted that pelvic floor muscle exercises improve female sexual function
4. Women who state that they are not sexually active will be excluded from further analysis
5. Women who consider that there is no need for long-term treatment for OAB or are afraid of regimen’s adverse effects are included in control group

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Female sexual function is measured using the FSFI score at baseline and 12 months.<br>

Secondary Outcome Measures

Name	Time	Method
1. Voiding frequency is measured using the 3 day micturition diary at baseline and after three months<br>2. Nocturia is measured using the 3 day micturition diary at baseline and after three months<br>3. Urgency episodes measured using the 3 day micturition diary at baseline and after three months<br>4. Incontinent episodes is measured using the 3 day micturition diary at baseline and after three months<br>5. Number of incontinence pads is meaured using the 3 day micturition diary at baseline and after three months<br>6. Voided volume is measured using the 3 day micturition diary at baseline and after three months