Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07404397 · ClinicalTrials.gov registry record · Phase 2
Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction
A Phase 2 study of High Tone Pelvic Floor Dysfunction, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07404397: Recruiting Phase 2 study of High Tone Pelvic Floor Dysfunction, sponsored by University of Michigan.
NCT07404397 is a Phase 2 study of High Tone Pelvic Floor Dysfunction that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07404397, a Phase 2 study of High Tone Pelvic Floor Dysfunction, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the researchers will compare a muscle relaxant medicine (cyclobenzaprine IR) to using a vibrating pelvic floor massage wand. Everyone in the study will also do pelvic floor physical therapy. The researchers want to see how these treatments affect pain, sexual health, physical ability, and overall quality of life.
Primary Outcome
PROMIS pain interference 4a score is from 4 questions with score ranging from 4-20. Higher scores indicate greater pain interference
Conditions Studied
Interventions
- DRUG Cyclobenzaprine
- DEVICE Pelvic floor massage wand
- PROCEDURE Pelvic floor physical therapy
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-02-18 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT07404397 shows while recruiting
NCT07404397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with High Tone Pelvic Floor Dysfunction appearing as the primary indexed condition, and to 3 interventions - of which Cyclobenzaprine is the first listed.
NCT07404397 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT07404397 about?
NCT07404397 is a clinical study titled "Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction". The researchers are comparing two treatments for high tone pelvic floor dysfunction (HTPFD) in conjunction with pelvic floor physical therapy (PFPT). The goal of this study is to find out which of two extra treatments works better for people with HTPFD when they also do regular PFPT. First, the rese...
What is the current status of trial NCT07404397?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-02-18. Estimated completion is 2026-12.
What conditions does trial NCT07404397 study?
This clinical trial studies the following conditions: High Tone Pelvic Floor Dysfunction.
What interventions are being tested in trial NCT07404397?
The interventions under investigation include: Cyclobenzaprine (DRUG), Pelvic floor massage wand (DEVICE), Pelvic floor physical therapy (PROCEDURE).
Who is sponsoring clinical trial NCT07404397?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07404397 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07404397's enrollment target sits among peer trials
60 1027th of 2000 higher than 869 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI