An interventional study of Telehealth intervention in Incontinence and Prolapse, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.
The purpose of this project is to understand surgical preparedness in Latinas undergoing urogynecologic surgery and to develop TIPPS-Latina a refined version of our telehealth intervention for Latinas undergoing urogynecologic surgery using HCD and D\&I methods. The goal of the first aim is to develop a participatory design approach and understand surgical preparedness in Latinas undergoing urogynecologic surgery. This cross-sectional study will run in parallel to the other aims. The participatory action framework will guide Aims 1-3. The goals of Aim 2 and Aim 3 are develop and test TIPPS-Latina using the Discover, Design/Build, and Test (DDBT) framework, which is a HCD method to generate evidence-based interventions and their implementations9. During the Discover phase investigators will identify preferences for refinement of TIPPS-Latina and its contextual deployment using mixed methods. During the Design/Build phase investigators will use an iterative process to generate, modify, and adapt our intervention. During the Test phase investigators will conduct pilot testing of TIPPS-Latina using a mixed methods approach that determines feasibility and implementation outcomes. Throughout our study, surgical preparedness will be measured using the Surgical Preparedness Assessment (SPA), a validated survey for measuring preparedness in women undergoing urogynecologic surgery that was developed by our group
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's planned enrollment of 357 is above the median of 70 across 65 interventional studies indexed under Prolapse.
Browse Prolapse studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who
Urogynecologists who -Routinely perform urogynecologist surgeries to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses
Nurses who
Exclusion Criteria:
Patients who
Urogynecologists who
-Do not routinely perform urogynecologic surgery
Nurses who
Participants scheduled to undergo urogynecologic surgery will receive routine preoperative counseling.
Patient scheduled to undergo urogynecologic surgery will receive routine preoperative counseling in addition to the modified telehealth intervention.
Behavioral: Telehealth intervention
This telehealth intervention will be made using human centered design methods
Feasibility of the Intervention
A feasible study will be defined a 1) \>4 on 1-5 Likert-type scales of acceptability, appropriateness, and feasibility; 2) \>70% for adherence; and 3)\> 90% for dose delivery, and percent completed intervention. Acceptability will be measured by the Acceptability of the Intervention Measure Appropriateness will be measured by the Intervention Appropriateness Measure Feasibility will be measured by the Feasibility of Intervention Measure
Time frame: Day of Surgery, before surgery, in the preoperative holding
Acceptability of the Intervention
As measured by the Acceptability of the Intervention Measure
Time frame: Day of Surgery, before surgery, in the preoperative holding
Appropriateness of the Intervention
As measured by the Intervention Appropriateness Measure
Time frame: Day of Surgery, before surgery, in the preoperative holding
Surgical Preparedness
As measured by the Surgical Preparedness Assessment survey
Time frame: Day of Surgery, before surgery, in the preoperative holding
Health Literacy
As measured by the Brief Health Literacy Screen
Time frame: Preoperative Visit, before surgery
Self-Efficacy
As measured by the General Self-Efficacy Scale
Time frame: Preoperative Visit, before surgery
Trust in Provider
As measured by the Trust in Provider Scale
Time frame: Preoperative Visit, before surgery
Decisional Conflict
As measured by the Decisional Conflict Scale
Time frame: Day of Surgery, before surgery, in the preoperative holding
Postoperative Anxiety/Depression
As measured by the Hospital Anxiety/Depression Scale
Time frame: Preoperative Visit, before surgery
Satisfaction with Healthcare Services
As measured by the CAHPS Clinician \& Group Visit Adult Survey
Time frame: Postoperative Visit 6-8 weeks after surgery
Demographics
Baseline Case Report Form
Time frame: Preoperative Visit 6-8 weeks after surgery
Surgical Data
Surgical Case Report Form
Time frame: Day of Surgery, before surgery, in the preoperative holding
Adverse Events
Adverse Events Case Report Form
Time frame: Postoperative Visit 6-8 weeks after surgery
Symptom Bother - PFDI 20
As measured by the Pelvic Floor Distress Inventory-20
Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery
Symptom Bother - PGI-S
As measured by the Global Impressions of Severity
Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgery
General Health
EQ-5D-5L
Time frame: Preoperative Visit, before surgery and Postoperative Visit 6-8 after surgery
Self-Esteem
Rosenberg Self-Esteem Scale
Time frame: Preoperative Visit, before surgery
Plan to share: No
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