Protocol summary

Summary
Sexual well being is an important aspect of woman's health, and dysfunction can lead to a decrease in quality of life and affect martial relationship. Although female sexual dysfunction is a common problem among general population, especially in urogynecological patient. This study was performed to compare sexual function in the surgical versus physiotherapy effects on pelvic floor dysfunction. Ninety patients with sexual function disorder were divided in two groups randomly ( 1- surgical repair pelvic relaxation and 2- physiotherapy). Inclusion criteria were: age between 25-55 years old; history of previous normal vaginal delivery; sexual dysfunction complain; pelvic floor dysfunction and exclusion criteria were: systemic and psychotic disease; single; past history of pelvic floor surgery; drug abuse and grade 3,4 pelvic organ prolapse. The female sexual function index (FSFI) was used to evaluate the sexual function in cases before and after intervention. Then scores were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031112790N1
Registration date: 2013-05-03, 1392/02/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-03, 1392/02/13
Registrant information
Name
Tahereh Eftekhar
Name of organization / entity
Valie-Asr Repductive Health Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
eftekhart@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2009-07-30, 1388/05/08
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physiotherapy and surgery on sexual function in pelvic disorder patients
Public title
The effect of physiotherapy in women with pelvic prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 25-55 years old; history of previous normal vaginal delivery; sexual dysfunction complain; pelvic floor dysfunction. Exclusion criteria: systemic and psychotic disease; single; past history of pelvic floor surgery; drug abuse and grade 3,4 pelvic organ prolapse .
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Vice Chancellor for Research ,Tehran University of Medical Sciences
Street address
Central Bulding ,Ghods Street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2006-09-23, 1385/07/01
Ethics committee reference number
85-04-394767

Health conditions studied

1

Description of health condition studied
Sexual function in pelvic disorder
ICD-10 code
N81
ICD-10 code description
Female genital prolapse

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
Before intervention and 3 months after intervention
Method of measurement
FSFI Questionaire

Secondary outcomes

1

Description
Sexual desire
Timepoint
Before and 3 months after intervention
Method of measurement
FSFI Questionaire

2

Description
Sexual arousal
Timepoint
Before and 3 months after intervention
Method of measurement
FSFI Questionaire

3

Description
Orgasm
Timepoint
Before and 3 months after intervention
Method of measurement
FSFI Questionaire

4

Description
Dysparunia
Timepoint
Before and 3 months after intervention
Method of measurement
FSFI Questionaire

Intervention groups

1

Description
Surgical group: Rectocele repair perinoraphy Levator pelication
Category
Treatment - Surgery

2

Description
Physiotherapy group: 2 session in week for 8 weeks by physiotherapist
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Urogynecologial Clinic of Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research ,Tehran University of medical sciences
Full name of responsible person
Ms. Alamdar
Street address
Central bulding of Tehran University, Ghods Street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research ,Tehran University 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
Vali-e-Asr reproductive health research center
Full name of responsible person
Fedyeh Haghollahi
Position
Msc
Other areas of specialty/work
Street address
Vali-e-Asr reproductive health research center, Val-asr Hospital, Imam khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
fedyeh_hagh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-asr Reoroductive Health Research Center
Full name of responsible person
Tahereh Eftekhar
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
eftekhar35@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Haghollahi Fedyeh
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
fedyeh_hagh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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