To find out whether pelvic physiotherapy added to an information folder describing pelvic exercises, as is the standard post-operative policy, gives an improved pelvic related quality of life compared to patients receiving the folder only.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pelvic floor related quality of life.
Secondary outcome
General quality of life.
Bladder function.
Provided hours of physiotherapy additional to the standard intervention
Health care consumption because of pelvic floor symptoms in the first year
after radical hysterectomy.
Background summary
Patients suffering from cervical cancer FIGO stage IB-IIA are treated in most
cases with a radical hysterectomy. Shortly after the surgery micturition and
defecation problems occur in most women, whereas in 10-80% of patients these
problems remain a problem longer period after treatment. The problems vary from
urinary and fecal incontinence to urinary retention and constipation. Pelvic
floor related quality of life has never been investigated with validated
questionnaires in this group of patients.
In literature pelvic physiotherapy is mentioned as an effective treatment or
stress-incontinence. After radical prostatectomy a significant improvement in
micturition frequency and severity of complaints is seen in patients treated
with physiotherapy.
Study objective
To find out whether pelvic physiotherapy added to an information folder
describing pelvic exercises, as is the standard post-operative policy, gives an
improved pelvic related quality of life compared to patients receiving the
folder only.
Study design
randomised controlled trial in which the standard post-operative management,
i.e. handing out an information folder with pelvic floor exercises, is compared
to the standard management plus pelvic physiotherapy.
Intervention
We will do this with a validated questionnaires. The general quality of life is
measured with the questionnaire RAND-36. Furthermore bladder function is
evaluated until 12 months after the surgical treatment, with a voiding diary,
uroflowmetry and residue measurements with a bladder scan. The amount of hours
patients need of pelvic physiotherapy or other medical treatment for pelvic
floor problems are monitored.
Study burden and risks
To fill in the questionnaires, 4 times in total: burden: approximately 30
minutes every time, risks: none.
Two times extra visit to the out-patient clinic at 3 months and 12 months after
the operation: burden: journey: depending on the distance between house and
hospital; the visit takes approximately an hour. risks: none
Uroflowmetry: burden: the patient is asked to void once every visit on a chair
above a tredmill, which records the strenght of the bladder: burden: low.
risks: none.
Bladderscan for urinary residue measurement: the bladderscan is held via the
abdomen aganist the bladder to measure possible residue. burden: low. risks:
none.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
cervical cancer FIGO stage IB-IIA
undergone radical hysterectomy
physically and mentally able to perform pelvic training
Exclusion criteria
Bowel and/or bladder surgery or radiotherapy in medical history
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 |
|---|---|
| CCMO | NL17694.018.07 |