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Pelvic organ prolapse in general practice: effects of pelvic floor physiotherapy and of pessary treatment

Pelvic organ prolapse in general practice: effects of pelvic floor physiotherapy and of pessary treatment - Genital prolapse study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33065
Enrollment
274
Registered
2009-12-15
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

cystocele and rectocele pelvic relaxation

Interventions

Women, who have a pelvic organ prolapse according to the urogynaecological examination, will be included in one of two intervention studies, depending on the degree of prolapse: 1. A study in women

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Symptomatic prolapse, able to fill in a Dutch questionnaire, mobile enough to visit a pelvic floor physiotherapist, informed consent

Exclusion criteria

Exclusion criteria: Severe cognitive decline, serious or teminal disease (according to the general practitioner), urogynaecological malignancies, being currently treated for urogynaecological disorders, conservative prolapse therapies in the preceding year, severe (stage 4) prolapse.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the score on the Pelvic Floor Distress Inventory (which measures prolapse-related symptoms) and the satisfaction with the results of the treatment (the global perception of improvement).

Secondary

MeasureTime frame
Secondary outcome parameters are the quality of life (condition specific and general) and the degree of prolapse and the function of bladder and bowel. Also, the number of women in which a succesful fitting of a pessary is possible will be recorded and the number of referrals to secondary care. The acceptance of the treatments and the side effects will be assessed, just as the costs of the treatments under study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)