Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary

Status Recruiting

Clinical Trial Summary

Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

Clinical Trial Description

The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the Patient Global Impression of Improvement scale or PGI-I), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3-months and 1-year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without PFPT or biofeedback. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05194462
Study type	Interventional
Source	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact	AHN Clinical Trials
Phone	412-330-6151
Email	clinicaltrials@ahn.org
Status	Recruiting
Phase	N/A
Start date	March 1, 2024
Completion date	January 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05534412` - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence	N/A
Recruiting	`NCT05515198` - Improving Care for Women With Urinary Incontinence (EMPOWER)	N/A
Completed	`NCT04071301` - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence	N/A
Completed	`NCT03623880` - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders	N/A
Recruiting	`NCT05880862` - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls	Early Phase 1
Recruiting	`NCT04159467` - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet	N/A
Completed	`NCT05485922` - Performance of a Single-use Intermittent Micro-hole Zone Catheter	N/A
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	N/A
Not yet recruiting	`NCT03027986` - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy	N/A
Recruiting	`NCT02490917` - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence	N/A
Enrolling by invitation	`NCT02529371` - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients	N/A
Enrolling by invitation	`NCT02530372` - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women	N/A
Completed	`NCT02549729` - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy	N/A
Completed	`NCT02338726` - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study	N/A
Completed	`NCT02600676` - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis	N/A
Completed	`NCT02239796` - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence	N/A
Completed	`NCT02368262` - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy	N/A
Completed	`NCT01942681` - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride	N/A
Recruiting	`NCT01804153` - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)	Phase 1/Phase 2
Completed	`NCT01520948` - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms