Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-03
Brief Title:
Training for Urinary Leakage Improvement After Pregnancy
Sponsor:
NICHD Pelvic Floor Disorders Network
Organization:
NICHD Pelvic Floor Disorders Network
Study Overview
Official Title:
Training for Urinary Leakage Improvement After Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TULIP
Brief Summary:
This is a multi-center randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolongedsustained pelvic floor disorders with symptomatic bothersome urinary incontinence UI amenable to nonsurgical treatment
TULIP is a 3-Arm trial with two active interventions Arms 1 and 2 and a Patient Education control arm Arm 3 Arm 1 consists of pelvic floor muscle training PFMT Arm 2 uses a home biofeedback device leva
The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors and follow-up will continue until 12 months postpartum
TULIP is a 3-Arm trial with two active interventions Arms 1 and 2 and a Patient Education control arm Arm 3 Arm 1 consists of pelvic floor muscle training PFMT Arm 2 uses a home biofeedback device leva
The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors and follow-up will continue until 12 months postpartum
Detailed Description:
TULIP is a 3-Arm trial with two active interventions Arms 1 and 2 and a Patient Education control arm Arm 3 Arm 1 consists of pelvic floor muscle training PFMT sessions with a skilled interventionist Arm 2 uses a home biofeedback device leva
All groups will have access to basic education on stress urinary incontinence overactive bladder pelvic floor muscle function and continence mechanisms
Arm 1 will consist of interventionist-guided training at baseline approximately 6 weeks postpartum followed by a Home Exercise Prescription HEP a second interventionist-guided training session approximately 4 weeks later and then continued HEP until 12 months postpartum Home exercises will be encouraged using a PFDN research smartphone app resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed
Arm 2 will consist of home pelvic floor exercises guided by the leva device and its accompanying appsoftware for gradually increasing strength and duration of pelvic floor contractions until 12 months postpartum As in Arm 1 the PFDN research smartphone app resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed
Arm 3 participants will only be provided basic education materials No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises
The primary outcome is change in UI as measured by the ICIQ-SF comparing scores from baseline to 6 months postpartum The questionnaire will be sent to participants monthly from baseline through 12 months postpartum
Secondary outcomes include assessments of 1 a broader spectrum of lower urinary tract symptoms particularly incontinence bladder pain and post-micturition symptoms LURN-SI-10 2 The Patient Global Impression of Improvement PGI-I 3 anal incontinence will be assessment using the St Marks questionnaire 4 Sexual functiondysfunction using the Female Sexual Function Index FSFI 5 a Health Utility Measure EuroQOL 5D EQ-5D 6 changes in physical examination findings POP-Q PFM integrity strength and pain and 7 adherence to Interventionist PFMT Arm 1 or Home Biofeedback Arm 2
All groups will have access to basic education on stress urinary incontinence overactive bladder pelvic floor muscle function and continence mechanisms
Arm 1 will consist of interventionist-guided training at baseline approximately 6 weeks postpartum followed by a Home Exercise Prescription HEP a second interventionist-guided training session approximately 4 weeks later and then continued HEP until 12 months postpartum Home exercises will be encouraged using a PFDN research smartphone app resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed
Arm 2 will consist of home pelvic floor exercises guided by the leva device and its accompanying appsoftware for gradually increasing strength and duration of pelvic floor contractions until 12 months postpartum As in Arm 1 the PFDN research smartphone app resources to help participants with home exercises and prompts for participants to confirm the number of exercise sets completed
Arm 3 participants will only be provided basic education materials No specific prescription or verbal direction will be given regarding the suggested number and frequency of home pelvic floor muscle exercises
The primary outcome is change in UI as measured by the ICIQ-SF comparing scores from baseline to 6 months postpartum The questionnaire will be sent to participants monthly from baseline through 12 months postpartum
Secondary outcomes include assessments of 1 a broader spectrum of lower urinary tract symptoms particularly incontinence bladder pain and post-micturition symptoms LURN-SI-10 2 The Patient Global Impression of Improvement PGI-I 3 anal incontinence will be assessment using the St Marks questionnaire 4 Sexual functiondysfunction using the Female Sexual Function Index FSFI 5 a Health Utility Measure EuroQOL 5D EQ-5D 6 changes in physical examination findings POP-Q PFM integrity strength and pain and 7 adherence to Interventionist PFMT Arm 1 or Home Biofeedback Arm 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24HD069031 | NIH | None | httpsreporternihgovquickSearchU24HD069031 |
| UG1HD069013 | NIH | None | None |
| UG1HD054214 | NIH | None | None |
| UG1HD041267 | NIH | None | None |
| UG1HD054241 | NIH | None | None |
| UG1HD110057 | NIH | None | None |
| UG1HD069010 | NIH | None | None |