Stress Urinary IncontinenceNCT04465578
Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
A study testing Sling tension adjustment by classic technique and Sling tension adjustment by height of 4 cm in people with Stress Urinary Incontinence and Urinary Retention Postoperative, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Retention Postoperative, Urinary Retention After Procedure
- What is being tested?
- Sling tension adjustment by classic technique and Sling tension adjustment by height of 4 cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Feb 2020to 30 Nov 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and no improvement with conservative management
Who cannot join
- Prior anti incontinence surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Aline Silva, MD, +555133598286, aline.urologia@gmail.com
About this study
The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.
Read the detailed description
A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue > 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).
- Conditions
- Stress Urinary Incontinence, Urinary Retention Postoperative, Urinary Retention After Procedure
- Being tested
- Sling tension adjustment by classic technique, Sling tension adjustment by height of 4 cm
- Keywords
- Stress urinary incontinence, Pubovaginal sling, Urinary retention
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sling tension adjustment by classic techniqueProcedure or surgery
We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
Sling tension adjustment by height of 4 cmProcedure or surgery
We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
| Study group | Role | What they receive |
|---|---|---|
| Sling tension adjustment by classic technique | Active comparator | We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot) Receives: Procedure: Sling tension adjustment by classic technique |
| Sling tension adjustment by height of 4 cm | Active comparator | We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm Receives: Procedure: Sling tension adjustment by height of 4 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
Urinary retention will be considered the need for bladder catheterization or post-voiding residue> 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.
Measured: 1 month
Secondary outcomes (1)
To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.
Cure will be considered the answer "NO" to the 3rd question of Urogenital Distress Inventory and a negative cough test.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start10 Feb 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiago Rosito, Doctor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465578
- Sponsor's protocol ID
- 2020-0001
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
- ClinicalTrials.gov ID
- NCT04465578
- Acronym / sponsor ID
- 2020-0001
- Conditions
- Stress Urinary Incontinence, Urinary Retention Postoperative, Urinary Retention After Procedure
- Keywords
- Stress urinary incontinence, Pubovaginal sling, Urinary retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 10 Jul 2020 (actual)
- 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 aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.
Detailed description
A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue > 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sling tension adjustment by classic technique | Active comparator | Procedure: Sling tension adjustment by classic techniqueWe will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot) |
| Sling tension adjustment by height of 4 cm | Active comparator | Procedure: Sling tension adjustment by height of 4 cmWe will adjust the tension of the sling by using the height between the fascia and the knot of 4cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old and no improvement with conservative management
Key exclusion criteria (1 listed)
- Prior anti incontinence surgery
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 |
|---|---|---|
| Sling tension adjustment by classic techniqueWe will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot) | Procedure or surgery | Sling tension adjustment by classic technique |
| Sling tension adjustment by height of 4 cmWe will adjust the tension of the sling by using the height between the fascia and the knot of 4cm | Procedure or surgery | Sling tension adjustment by height of 4 cm |
Primary outcome
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
Time frame: 1 month
Urinary retention will be considered the need for bladder catheterization or post-voiding residue> 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.
1 secondary outcome
To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Tiago Rosito, Doctor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling tension adjustment by classic technique and Sling tension adjustment by height of 4 cm in people with Stress Urinary Incontinence and Urinary Retention Postoperative, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2020. 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline Silva, MD (+5551991911801, aline.urologia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling (time frame: 1 month). 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 10 Jul 2020.