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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35911035

Enrollment

556

Registered

2007-01-04

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse Urological and Genital Diseases Noninflammatory disorders of female genital tract

Interventions

Intervention Group: The PFMT intervention to be evaluated was tested in the feasibility study and is based on the best current evidence for pelvic floor muscle strengthening, treatment of urinary st

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

New Zealand, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026