Evaluation of the effect of pre-operative physiotherapy on quality of life and complications of colporraphy surgery in women suffering from pelvic organ prolapse
The evidence to support physiotherapy treatment of pre and post-operative gynecological surgery patients is limited, and randomized trials in this area have been recommended . This randomized controlled trial investigated the effect of a pre operative physiotherapy-supervised pelvic floor muscle (PFM) training program in women undergoing surgery for prolapse. In this Randomized clinical trial, 70 patients with pelvic organ prolapsed will be enrolled, that be divided into two intervention and control groups. In the intervention group patients before surgery will be 10 sessions of physiotherapy and then will be surgery and in the control group Surgery will be performed for patients. Then the nagging symptoms of prolapsed including, sexual dysfunction, urinary incontinence, dyspareunia measured and compared between the two groups. Also the quality of life of patients in both groups using the SF-36 questionnaire will be evaluated and compared. This study is aimed at the investigation of the effect of physiotherapy prior to surgery on therapy treatment in women diagnosed with mediocre/severe pelvic prolapse who under go surgery. If the effect of physiotherapy on treatment results is positive, it can be suggested along other necessary measures in these patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201188772N1
Registration date:2013-03-08, 1391/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-08, 1391/12/18
Registrant information
Name
Tahereh Mahmoodvand
Name of organization / entity
Hamedan University Medicine of Scinces
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7082
Email address
t.mahmoodvand@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pre-operative physiotherapy on quality of life and complications of colporraphy surgery in women suffering from pelvic organ prolapse
Public title
Effectiveness of physiotherapy in pelvic organ prolapsed treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patients with modderate pelvic organ prolapse candidate for colporraphy surgery; Patients with severe pelvic organ prolapse candidate for colporraphy surgery .
Exclusion criteria: diabetes; obesity; urinary tract infection; genital cyctosel grade 1 and 4; prolapsed uterus; vaginal delivery with forceps and vacuum; history of fetal macrosomia, multiple pregnancy; history of surgery on the muscles and pelvic viscera
Age
From 20 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Mhdiye Blvd
City
Hamedan
Postal code
3519638686
Approval date
2011-12-17, 1390/09/26
Ethics committee reference number
3266/7/70/16/پ/د
Health conditions studied
1
Description of health condition studied
pelvic organs prolapse
ICD-10 code
N81
ICD-10 code description
Female genital prolapsed
Primary outcomes
1
Description
Quality of life
Timepoint
Three months after surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Sexual Dysfunction
Timepoint
Three months after surgery
Method of measurement
Questionnaire
2
Description
Urinary incontinence
Timepoint
Three months after surgery
Method of measurement
Questionnaire
3
Description
Dysparunia
Timepoint
Three months after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
intervention group in 10 sessions of physiotherapy is done with the same technique before surgery. Physiotherapy is performed by a chiropractor with a similar technique and in 10 sessions.
Category
Treatment - Other
2
Description
Control group without any intervention undergo colporraphy surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Mahnaz Yavangi
Street address
Fatemieh Hospital, Pasdaran avenue
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan Univesity of Medical Sciences
Full name of responsible person
Heydar Tavillani
Street address
Mhdiye Blvd, Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan Univesity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Tahereh Mahmoodvand
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh hospital, pasdaran avenue, Hamadan
City
Hamadan
Postal code
3519638686
Phone
+98 81 1252 0183
Fax
+98 81 1827 7012
Email
T.Mahmoodvand@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Yavangi
Position
Obstetric and Gynecology Surgeon
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran avenue
City
Hamadan
Postal code
3519638686
Phone
+98 81 1827 7012
Fax
+98 81 1827 7012
Email
M.yavangi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Tahereh Mahmoodvand
Position
Resident of Surgical Obstetrics and Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, pasdaran avenue
City
Hamadan
Postal code
3519638686
Phone
+98 81 1838 0363
Fax
+98 81 1828 7012
Email
T.mahmoodvand@umsha.ac.ir
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)