NCT01628991

Brief Summary

This study is a single blind randomized clinical trial to compare the efficacy of a behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

June 17, 2012

Last Update Submit

June 26, 2012

Conditions

Stress Urinary Incontinence

Keywords

Behavioral Intervention ProgramVaginal ConesStress Urinary IncontinencetreatmentWomen

Outcome Measures

Primary Outcomes (1)

  • severity of Stress Urinary Incontinence

    three months

Secondary Outcomes (1)

  • Quality of life

    three months

Study Arms (2)

behavioural intervention

EXPERIMENTAL

Recieving interventional behavioural program

Behavioral: behavioural program

vaginal cone

EXPERIMENTAL

intravaginal device insertion(vaginal cone)

Device: Iranian version of vaginal cones

Interventions

behavioural programBEHAVIORAL

interventional behavioural program

Also known as: bladder training program, exercise therapy
behavioural intervention
Iranian version of vaginal conesDEVICE

intravaginal device(vaginal cone) for promote the pelvic floor exercises

Also known as: intravaginal cones with different weights,Physical Therapy
vaginal cone

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptoms of SUI , at least three episodes of stress incontinence per week
  • Age 25-65
  • body mass index (BMI) ≤ 30 kg/m2
  • physical health

You may not qualify if:

  • chronic degenerative diseases affected on muscular and nerve tissues
  • vulvovaginitis, atrophic vaginitis,
  • pregnancy
  • active or recurrent urinary tract infections
  • advanced genital prolepses
  • patients with cardiac pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad university of medical science

Mashhad, Iran

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Exercise TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Nahid golmakani, M.Sc.

    Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran

    STUDY DIRECTOR

  • Nayereh khadem, M.D.

    Mashhad university of medical science, Mashhad, Iran

    STUDY CHAIR

  • Arezoo Arabipoor, M.Sc.

    Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member,MSc of Midwifery

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 27, 2012

Study Start

April 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations

IR(1)