No registrations found.
ID
Source
Brief title
Health condition
Pelvic organ prolapse
Urogenitale prolaps (Nederlands)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pelvic Floor Distress Inventory (PFDI-20) score after 3, 12 and 24 months.
Secondary outcome
1. Global perception of improvement and VAS score of improvement of the symptoms after 3, 12 and 24 months;
2. Pelvic Floor Impact Questionnaire (PFIQ-7) score, Pelvic organ prolapse / urinary incontinence sexual questionnaire (PISQ-12) score, MOS SF-12 score, EQ-5D score, after 3, 12 and 24 months;
3. POP stage (POP-Q) after 3, 12 and 24 months;
4. Costs of treatment;
5. Number of women succesfully treated with a pessary;
6. Number of women referred to a gynaecologist.
Background summary
Pelvic organ prolapse (POP) is a common disorder in postmenopausal women, causing a variety of symptoms and influencing quality of life. A large portion of women with POP in the Netherlands are treated by their general practitioner (GP), but evidence on which to base the choice between watchful waiting, pelvic muscle training (PMT) and pessary treatment is lacking.
This study aims to investigate the effects and costs of PMT compared with watchful waiting in women with mild POP, and PMT compared with pessary treatment in women with moderate POP.
In this randomized controlled clinical trial, all women in 35 selected GP offices who are older than 54 years will receive a questionnaire concerning POP symptoms. In women with POP symptoms who want to participate in the study, presence and stage of prolapse will be determined using the pelvic organ prolapse quantification (POP-Q). Symptomatic women with POP will be included in the study after informed consent.
Women with mild POP will either receive PMT or watchful waiting, women with moderate POP will either receive PMT or pessary treatment.
Primary outcome measure is the score on the Pelvic Floor Distress Inventory (PFDI), a questionnaire that measures POP symptoms and bother. Secondary outcome measures are Global perception of improvement and VAS score of improvement of the symptoms, quality of life, POP stage and cost of treatment.
Follow up visits will be at 3, 12 and 24 months.
Study objective
Pelvic organ prolapse (POP) is a common disorder in postmenopausal women, causing a variety of symptoms and influencing quality of life. A large portion of women with POP in the Netherlands are treated by their general practitioner (GP), but evidence on which to base the choice between watchful waiting, pelvic muscle training (PMT) and pessary treatment is lacking.
This study aims to investigate the effects and costs of PMT compared with watchful waiting in women with mild POP, and PMT compared with pessary treatment in women with moderate POP.
We expect that treatment of POP by pelvic muscle training or pessary use will result in a decrease in the amount and severity of POP symptoms and will improve quality of life at reasonable costs.
Study design
Follow up visits will be at 6, 12 and 24 months.
Women being treated with a pessary will have recheck visits every 3 months.
Intervention
Women with POP-Q stages I and II not beyond the hymen will either receive PMT or watchful waiting.
Women with POP-Q stages II beyond the hymen and III will either receive PMT or pessary treatment.
M. Wiegersma
Groningen
The Netherlands
+31 (0)50 3632966
m.wiegersma@umcg.nl
M. Wiegersma
Groningen
The Netherlands
+31 (0)50 3632966
m.wiegersma@umcg.nl
Inclusion criteria
1. Women older than 54 years;
2. Symptomatic stage I, II or III POP (pelvic organ prolapse quantification (POP-Q) );
3. Informed consent.
Exclusion criteria
1. Cognitive impairment (eg dementia);
2. Poor physical condition (according to their GP);
3. Urogynecological malignancy;
4. Treatment of POP within the last 12 months;
5. Not being able to visit the general practitioner's of physiotherapist's office due to impaired mobility.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1930 |
| NTR-old | NTR2047 |
| Other | ZonMw : 80-81000-98-089 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |