Stress Urinary Incontinence Clinical Trial
— TIPPSOfficial title:
Telephone Intervention to Increase Patient Preparedness and Satisfaction Trial (TIPPS): A Randomized Control Trial Evaluating the Effect of Preoperative Telephone Calls on Patient Preparedness and Satisfaction in Urogynecologic Surgery
NCT number | NCT03890471 |
Other study ID # | 2018120057 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2019 |
Est. completion date | May 11, 2020 |
Verified date | October 2020 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical preparedness improves patient satisfaction and perioperative outcomes. In
urogynecology, interventions to increase preoperative patient preparedness have not been
adequately studied. Our objective is to evaluate the ability of preoperative
provider-initiated telephone calls to increase patient preparedness for surgery. The
investigators will conduct a randomized control trial comparing surgical preparedness between
provider-initiated telephone call three days before surgery plus usual preoperative
counseling versus usual preoperative counseling alone among women planning to undergo pelvic
reconstructive surgery as measured by the Preoperative Patient Questionnaire (PPQ) and the
Modified Preparedness for Colorectal Cancer Surgery Questionnaire (Modified PCSQ). Surgical
satisfaction, perioperative outcomes, and medical costs will be also be compared between the
two groups. Our hypothesis is that preoperative telephone calls will result in improved
surgical preparedness. This novel approach in preoperative counseling has the potential to
positively impact perioperative patient care.
The investigators will also conduct an ancillary qualitative study of sexually active women
undergoing pelvic reconstructive surgery who are enrolled in the randomized control trial.
This work will aim to describe the patient experience, concerns, and the quality of the first
sexual encounter following surgery. This ancillary study will lay the foundation for future
investigations into how to better counsel patients and discuss sexual activity after surgical
repair.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 11, 2020 |
Est. primary completion date | May 11, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 18 years of age - Speak and read English: Only English-speaking women will be allowed to participate because the questionnaires used in the study are validated only in English and Swedish; they are not validated in other languages. - Planned surgery for pelvic organ prolapse and/or stress urinary incontinence Exclusion Criteria: - Less than 18 years of age - Do not read or speak English - Unable to participate in a telephone call (dementia, hard of hearing, deaf) - Scheduled for surgery in 3 days or less |
Country | Name | City | State |
---|---|---|---|
United States | Pelvic Floor Integrated Practice Unit at the University of Texas Health Austin | Austin | Texas |
United States | Seton Midtown Medical Tower | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical preparedness | Patient Preparedness Questionnaire, Modified Preparedness for Colorectal Cancer Surgery Questionnaire | Baseline | |
Secondary | Surgical satisfaction | Decision Regret Scale and Satisfaction with Decision Scale, Scale of 1-5, Scoring consists of reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items (range, 1-5). | Will be measured at postoperative visit 4-8 weeks after surgery. | |
Secondary | Patient-reported outcomes | Pelvic Floor Distress Inventory - 20 | Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery. | |
Secondary | Cost-effectiveness | The European Quality of Life-5 Dimensions | Will be measured at baseline and at the postoperative visit 4-8 weeks after surgery. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04829357 -
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
|
||
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT04512053 -
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
|
Phase 2 | |
Active, not recruiting |
NCT06224335 -
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
|
||
Recruiting |
NCT05304312 -
The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women
|
N/A | |
Not yet recruiting |
NCT05527665 -
Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
|
||
Not yet recruiting |
NCT04558762 -
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
|
||
Withdrawn |
NCT02524366 -
A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
|
N/A | |
Completed |
NCT01924728 -
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
|
N/A | |
Completed |
NCT01676662 -
Solace European Confirmatory Trial
|
N/A | |
Unknown status |
NCT01455779 -
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
|
N/A | |
Terminated |
NCT01029106 -
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
|
N/A | |
Withdrawn |
NCT00573703 -
Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
|
Phase 4 | |
Completed |
NCT01123096 -
Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
|
N/A | |
Completed |
NCT01770691 -
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
|
N/A | |
Completed |
NCT00234754 -
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
|
N/A | |
Completed |
NCT00441454 -
Retropubic vs. Transobturator Tension-free Vaginal Tape
|
N/A | |
Completed |
NCT03985345 -
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
|
N/A | |
Active, not recruiting |
NCT03671694 -
Laser Vaginal Treatment for SUI
|
N/A | |
Completed |
NCT04097288 -
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects
|
Phase 1 |