women between ages 18-75 who have stage I and II pelvic organ prolapse, will be included. They will be randomized in two groups by simple randomization. One group will do pelvic floor exercises for 12 weeks while the other will do these exercises and biofeedback coincidentally. biofeedback will be done twice a week up to 8 sessions and so will last for 4 weeks.A questionnaire of quality of life will be filled in by the patients at the base time, 4 weeks and 12 weeks after randomization. Vaginal examination and measurement of pelvic muscles contraction pressure by the pressure biofeedback will be done at the same time. Finally the collected data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020620980N1
Registration date:2015-04-17, 1394/01/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-17, 1394/01/28
Registrant information
Name
Neda Taghvadoust
Name of organization / entity
Iran Univercity Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
neda.taghvadoost@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Of Iran University Of Medical Science,Dr Eftekhar Ardebili
Expected recruitment start date
2015-04-20, 1394/01/31
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial of biofeedback for quality of life in women with stages I and II pelvic organ prolapse
Public title
Effects of Biofeedback on pelvic organ prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: women with stages I and II pelvic organ prolapse; women between ages 18-75
Exclusion: a history of pelvic surgery or delivery during recent 6 months; pelvic cancer;inability to pelvic muscles contraction;a history of surgery for prolapse;any kinde of low back pain which interfere the appropriate position for biofeedback;neurologic disorders;stages III and IV pelvic organ prolapse; a plan for pregnancy during next 2 months;any coincident therapies for prolapse;a plan of trip for more than 2 weeks during the intervention;Untreated UTI
Age
From 18 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University Of Medical Sience
Street address
Iran University Of Medical Science, Hemmat Freeway, next to Milad Hospital
City
Tehran
Postal code
Approval date
2014-07-01, 1393/04/10
Ethics committee reference number
93/ D/105/1576
Health conditions studied
1
Description of health condition studied
peivic organ prolapse
ICD-10 code
XIV
ICD-10 code description
Diseases of the genitourinary system
Primary outcomes
1
Description
Quality of life
Timepoint
basetime, 4 weeks and 12 weeks after intervention begins
Method of measurement
questionare
Secondary outcomes
1
Description
stage of prolapse
Timepoint
basetime,4 weeks and 12 weeks after intervention begins
Method of measurement
vaginal examination
2
Description
pelvic muscles contraction force
Timepoint
basetime, 4 weeks and 12 weeks after intervention begins
Method of measurement
pressure biofeedback
Intervention groups
1
Description
Intervention: Biofeedback,Pelvic floor exercises, Life style modification