Stress Urinary IncontinencesensiTVTNCT03603535
Prospective Study of the sensiTVT
An observational study of Stress Urinary Incontinence, run by Medical University of Graz at 1 site in Austria.
Trial summary
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- sensiTVT
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- 8 Oct 2018to 30 Sep 2023
- Phase
- Observational
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women with stress urinary incontinence (SUI)
Who may be able to join
- Planned surgery for verified predominant stress urinary incontinence
- women between 18 and 80 years of age
- good German language skills
- informed consent
Who cannot join
- Pregnant or lactating women
- Active surgical treatment for invasive malignant diseases within 3 months
- Contraindications for surgery or anesthesia
- Severe neurologic disease
- Concomitant prolapse surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.
Read the detailed description
Stress urinary incontinence (SUI) is defined as the involuntary leakage during physical activity and situations that result in an increase of abdominal pressure like sneezing, coughing or laughing and affects up to 25% of women. Currently there are a number of tapes on the market with GYNECARE TVT EXACT® (Tension free Vaginal Tape) and TVT- Obturator being one of the tapes with the highest subjective and objective cure rates and relatively low adverse events in women with normal sphincter pressure. Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed. Data from other tapes are available, however data especially from newer tapes is lacking.
- Conditions
- Stress Urinary Incontinence
- Being tested
- sensiTVT
- Keywords
- Stress urinary incontinence, objective outcome
- 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.
sensiTVTDevice
The study is designed as a prospective single arm study. All women with an indication for suburethral tape placement for therapy of SUI and meeting the inclusion criteria will be offered study participation to record the objective outcome after one year.
What is being measured
The primary outcome is the main question the study is designed to answer.
objective success of stress urinary incontinence
determined by a standardized cough stress test at 300 ml bladder, a negative cough stress test is a success.
Measured: one year
Secondary outcomes (11)
Subjective success as determined using the Patient Global Impression of Improvement questionnaire.
defined as very much improved/much improved (1,2) on the Patient Global Impression of Improvement scale, while any other response (improved, same, worse, or much worse- 3-7) will be considered as failures.
The Patient Global Impression of Improvement is a seven item scale validated for incontinence.
Measured: 3 months+ one year
Peri- and postoperative complications
any surgical complications recorded
Measured: 3 months+ one year
Subjective incontinence cure rate using the Incontinence Outcome Questionnaire
The Incontinence Outcome Questionnaire was validated for postoperative assessment of quality of life after surgical treatment for stress urinary incontinence and has 27 items with lower scores indicating worse treatment outcome. The total score is calculated.
Measured: 3 months+ one year
quality of life using the Kings Health Questionnaire
The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Measured: 3 months+ one year
Subjective bother using the Patient Global Impression of Severity
Patient Global Impression of Severity The Patient Global Impression of Severity is a 7-item urinary symptom severity scale that is used to rate the severity of a specific condition -a single-state scale. The higher the number the worse the outcome of subjective bother of stress urinary incontinence.
Measured: 3 months+ one year
Patient satisfaction measured using a visual analogue scale
Patient satisfaction is defined as a score 8 to 10 on a 10-point visual analogue scale
Measured: 3 months+ one year
Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.
Measured: 3 months+ one year
Erosion rate
Erosion rate from the tape in the vagina or bladder
Measured: 3 months+ one year
Reoperation rate
Reoperation rate
Measured: 3 months+ one year
De novo urgency
De novo OAB- overactive bladder as determined by clinical history taking
Measured: 3 months+ one year
De novo pain in the operated region
De novo pain in the operated region as determined by clinical history taking
Measured: 3 months+ one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start8 Oct 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: The recruitment proceeded much slower than expected. The planned number of patients could not be reached within the planned time.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
- Investigators
- Daniela Gold (prev. Ulrich), MD PhD, Principal investigator, Universitätsklinik für Frauenheilkunde und Geburtshilfe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603535
- Sponsor's protocol ID
- 29-481 ex 16/17
- Acronym
- sensiTVT
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2018
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the sensiTVT (Midurethral Sling) for the Surgical Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03603535
- Acronym / sponsor ID
- sensiTVT / 29-481 ex 16/17
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence, objective outcome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The recruitment proceeded much slower than expected. The planned number of patients could not be reached within the planned time.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Jul 2018 (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.
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.
Detailed description
Stress urinary incontinence (SUI) is defined as the involuntary leakage during physical activity and situations that result in an increase of abdominal pressure like sneezing, coughing or laughing and affects up to 25% of women. Currently there are a number of tapes on the market with GYNECARE TVT EXACT® (Tension free Vaginal Tape) and TVT- Obturator being one of the tapes with the highest subjective and objective cure rates and relatively low adverse events in women with normal sphincter pressure. Due to the recent FDA announcements several tapes have been withdrawn from the market and several new ones have been designed. Data from other tapes are available, however data especially from newer tapes is lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women with stress urinary incontinence (SUI)
Key inclusion criteria (4 listed)
- Planned surgery for verified predominant stress urinary incontinence
- women between 18 and 80 years of age
- good German language skills
- informed consent
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Active surgical treatment for invasive malignant diseases within 3 months
- Contraindications for surgery or anesthesia
- Severe neurologic disease
- Concomitant prolapse 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 |
|---|---|---|
| sensiTVTThe study is designed as a prospective single arm study. All women with an indication for suburethral tape placement for therapy of SUI and meeting the inclusion criteria will be offered study participation to record the objective outcome after one year. | Device | – |
Primary outcome
objective success of stress urinary incontinence
Time frame: one year
determined by a standardized cough stress test at 300 ml bladder, a negative cough stress test is a success.
11 secondary outcomes
Subjective success as determined using the Patient Global Impression of Improvement questionnaire.
Time frame: 3 months+ one year
Peri- and postoperative complications
Time frame: 3 months+ one year
Subjective incontinence cure rate using the Incontinence Outcome Questionnaire
Time frame: 3 months+ one year
quality of life using the Kings Health Questionnaire
Time frame: 3 months+ one year
Subjective bother using the Patient Global Impression of Severity
Time frame: 3 months+ one year
Patient satisfaction measured using a visual analogue scale
Time frame: 3 months+ one year
Sexual health using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire
Time frame: 3 months+ one year
Erosion rate
Time frame: 3 months+ one year
Reoperation rate
Time frame: 3 months+ one year
De novo urgency
Time frame: 3 months+ one year
De novo pain in the operated region
Time frame: 3 months+ one year
Results and safety
The study was stopped early (reason given: The recruitment proceeded much slower than expected. The planned number of patients could not be reached within the planned time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- 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.
Daniela Gold (prev. Ulrich), MD PhD principal investigator
Universitätsklinik für Frauenheilkunde und Geburtshilfe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Medical University of Graz at 1 site in Austria.
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 5 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: stopped early, as of the sponsor's last update on 28 Feb 2025. 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 Austria. 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?
The study was stopped early (reason given: The recruitment proceeded much slower than expected. The planned number of patients could not be reached within the planned time.). Results are not available in the source record.
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?
objective success of stress urinary incontinence (time frame: one year). 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 28 Feb 2025.