Quality of LifeNCT02837796
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
A study testing transobturator tape in people with Quality of Life and Sexual Dysfunction, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital.
Trial summary
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Quality of Life, Sexual Dysfunction
- What is being tested?
- transobturator tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pure urodynamic SUI
- sexual active before and 2 months after the surgery
- married or single
- aged over 20
- have cured after TOT operation
Who cannot join
- preoperative or postoperative detrusor disfunction
- previous history of malignancy
- prior vaginal surgery
- a partner with sexual incapabilities
- a concomitant gynecologic disorder
- patients with pelvic organ prolapse over stage II
- pelvic radiotherapy and a history of psychological diseases
- participants who had no sexual activity with in the past two months
About this study
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.
- Conditions
- Quality of Life, Sexual Dysfunction
- Being tested
- transobturator tape
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transobturator tapeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| inside-outside group | Active comparator | inside-out transobturator tape approach Receives: Procedure: transobturator tape |
| outside-inside group | Active comparator | outside-in transobturator tape approach Receives: Procedure: transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative differences at emotional-behavioral PISQ-12 score
Measured: 1 year
postoperative differences at physical PISQ-12 score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837796
- Sponsor's protocol ID
- Asıcıoglu09
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
Publications
Asoglu MR, Selcuk S, Cam C, Cogendez E, Karateke A. Effects of urinary incontinence subtypes on women's quality of life (including sexual life) and psychosocial state. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:187-90. doi: 10.1016/j.ejogrb.2014.02.008. Epub 2014 Feb 15.
PubMed 24630299
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02837796
- Acronym / sponsor ID
- Asıcıoglu09
- Conditions
- Quality of Life, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jul 2016 (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.
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inside-outside group | Active comparator | Procedure: transobturator tapeinside-out transobturator tape approach |
| outside-inside group | Active comparator | Procedure: transobturator tapeoutside-in transobturator tape approach |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pure urodynamic SUI
- sexual active before and 2 months after the surgery
- married or single
- aged over 20
- have cured after TOT operation
Key exclusion criteria (8 listed)
- preoperative or postoperative detrusor disfunction
- previous history of malignancy
- prior vaginal surgery
- a partner with sexual incapabilities
- a concomitant gynecologic disorder
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 |
|---|---|---|
| transobturator tape | Procedure or surgery | inside-outside group, outside-inside group |
Primary outcome
postoperative differences at emotional-behavioral PISQ-12 score
Time frame: 1 year
postoperative differences at physical PISQ-12 score
Time frame: 1 year
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 20 Jul 2016.
- Results publication: PubMed 24630299Asoglu MR, Selcuk S, Cam C, Cogendez E, Karateke A. Effects of urinary incontinence subtypes on women's quality of life (including sexual life) and psychosocial state. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:187-90. doi: 10.1016/j.ejogrb.2014.02.008. Epub 2014 Feb 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transobturator tape in people with Quality of Life and Sexual Dysfunction, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital.
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 5 inclusion and 8 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
postoperative differences at emotional-behavioral PISQ-12 score (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837796, which also lists 1 linked publication.
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 20 Jul 2016.