A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interstitial Cystitis
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Enrollment
- 47
- Locations
- 5
- Primary Endpoint
- Number consenting to join study out of eligible patients approached
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
Detailed Description
This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.
Investigators
Eligibility Criteria
Inclusion Criteria
- •female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
- •male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome
Exclusion Criteria
- •neurologic disorder affecting bladder
- •bladder cancer, prostate cancer, or urethral cancer
Outcomes
Primary Outcomes
Number consenting to join study out of eligible patients approached
Time Frame: 6 months
This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
Number of times therapists adhered to prescribed therapeutic protocol
Time Frame: 12 weeks
For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant
Secondary Outcomes
- Global response assessment (GRA) Global response assessment(12 weeks)
- Tolerability of treatment measured by number of treatment sessions participants completed(12 weeks)
- Number of adverse events reported by the participants(12 weeks)