Stress Urinary IncontinencePhase 2/3NCT01628991
Behavioral Intervention Program and Vaginal Cones on SUI
A Phase 2/3 study testing behavioural program and Iranian version of vaginal cones in people with Stress Urinary Incontinence, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- behavioural program and Iranian version of vaginal cones
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- symptoms of SUI , at least three episodes of stress incontinence per week
- Age 25-65
- body mass index (BMI) ≤ 30 kg/m2
- physical health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women
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).
Read the detailed description
Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs with stress urinary incontinence were randomly divided in two groups by blocked randomization method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and bladder control strategies. Other group was allocated to use vaginal cones. They were treated for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary dairy. The objective changes were measured by pad test. These two groups were then compared according to the scores of special questionnaires for quality of life, strength of pelvic floor muscles, capability to participate in social activities, severity of urinary incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3 months after finishing interventions. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS.
- Conditions
- Stress Urinary Incontinence
- Being tested
- behavioural program, Iranian version of vaginal cones
- Keywords
- Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioural programBehavioural
Also called bladder training program, exercise therapy
interventional behavioural program
Iranian version of vaginal conesDevice
Also called intravaginal cones with different weights,Physical Therapy
intravaginal device(vaginal cone) for promote the pelvic floor exercises
| Study group | Role | What they receive |
|---|---|---|
| behavioural intervention | Experimental | Recieving interventional behavioural program Receives: Behavioral: behavioural program |
| vaginal cone | Experimental | intravaginal device insertion(vaginal cone) Receives: Device: Iranian version of vaginal cones |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of Stress Urinary Incontinence
Measured: three months
Secondary outcomes (1)
Quality of life
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nahid golmakani, Mashhad University of Medical Sciences
- Investigators
- Nahid golmakani, M.Sc., Study director, Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, IranNayereh khadem, M.D., Study chair, Mashhad university of medical science, Mashhad, IranArezoo Arabipoor, M.Sc., Principal investigator, Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628991
- Sponsor's protocol ID
- clinical trial
- Status last verified
- Jun 2012
- First submitted
- 17 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Vaginal Cones and Behavioral Intervention Program on Urinary Stress Incontinence in Women
- ClinicalTrials.gov ID
- NCT01628991
- Acronym / sponsor ID
- clinical trial
- Conditions
- Stress Urinary Incontinence
- Keywords
- Behavioral Intervention Program, Vaginal Cones, Stress Urinary Incontinence, treatment, Women
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs with stress urinary incontinence were randomly divided in two groups by blocked randomization method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and bladder control strategies. Other group was allocated to use vaginal cones. They were treated for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary dairy. The objective changes were measured by pad test. These two groups were then compared according to the scores of special questionnaires for quality of life, strength of pelvic floor muscles, capability to participate in social activities, severity of urinary incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3 months after finishing interventions. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioural intervention | Experimental | Behavioral: behavioural programRecieving interventional behavioural program |
| vaginal cone | Experimental | Device: Iranian version of vaginal conesintravaginal device insertion(vaginal cone) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptoms of SUI , at least three episodes of stress incontinence per week
- Age 25-65
- body mass index (BMI) ≤ 30 kg/m2
- physical health
Key exclusion criteria (6 listed)
- chronic degenerative diseases affected on muscular and nerve tissues
- vulvovaginitis, atrophic vaginitis,
- pregnancy
- active or recurrent urinary tract infections
- advanced genital prolepses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioural programAlso: bladder training program, exercise therapyinterventional behavioural program | Behavioural | behavioural intervention |
| Iranian version of vaginal conesAlso: intravaginal cones with different weights,Physical Therapyintravaginal device(vaginal cone) for promote the pelvic floor exercises | Device | vaginal cone |
Primary outcome
severity of Stress Urinary Incontinence
Time frame: three months
1 secondary outcome
Quality of life
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahid golmakani, M.Sc. study director
Mashhad university of medical science, faculty of nursing and midwifery, Mashhad, Iran
Nayereh khadem, M.D. study chair
Mashhad university of medical science, Mashhad, Iran
Arezoo Arabipoor, M.Sc. principal investigator
Mashhad university of science, faculty of nursing and midwifery, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing behavioural program and Iranian version of vaginal cones in people with Stress Urinary Incontinence, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of Stress Urinary Incontinence (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.