A multi-centre randomised controlled trial of a pelvic floor muscle training intervention for women with pelvic organ prolapse

Completed

• Conditions: Urological and Genital Diseases; Pelvic organ prolapse; Noninflammatory disorders of female genital tract

• Registration Number: ISRCTN35911035
• Lead Sponsor: Glasgow Caledonian University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 556

Inclusion Criteria

Potential participants will be new attendees at outpatient gynaecology clinics presenting with symptoms of prolapse. At their clinic appointment, type and stage of prolapse will be confirmed by their gynaecologist using the Pevic Organ Prolapse Quantification (POP-Q) grading system. Women with any type of prolapse will be included:
1. Anterior vaginal wall prolapse (urethrocele, cystocele, paravaginal defect)
2. Uterine/cervical prolapse
3. Vaginal vault (after hysterectomy) prolapse
4. Posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency)

Exclusion Criteria

1. Stage four prolapse
2. Previous treatment for prolapse (surgery or formal instruction in pelvic floor muscle training [PFMT])
3. Unable to comply with PFMT treatment
4. Local atrophy
5. Pregnant
6. Unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Prolapse symptom score (questions developed in feasibility study and undergoing validation)<br>2. The primary economic outcome measures of cost effectiveness are:<br>2.1. Use of health services,<br>2.2. Average number of days of prolapse symptoms, and<br>2.3. Further prolapse treatment needed/received

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include:<br>1. Prolapse-related quality of life (single item scored zero to ten)<br>2. Prolapse severity (POP-Q)<br>3. Need for further prolapse treatment including a pessary or surgery<br><br>Other outcomes include:<br>1. Lifestyle changes<br>2. Urinary symptoms (International Consultation on Incontinence Questionnaire [ICIQ] short-form)<br>3. Bowel symptoms (ICIQ bowel symptoms module)<br>4. Sexual symptoms (Prolapse Incontinence Sexual Questionnaire [PISQ])<br>5. General health status (Short Form health survey [SF-12])