Pelvic Floor DisordersNCT03623880
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
A study testing Unified Protocol and Supportive Therapy in people with Pelvic Floor Disorders and Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders, Anxiety, Urinary Urgency
- What is being tested?
- Unified Protocol and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18 years or older
- Presence of one or more of the following urinary symptoms in past 12 months and currently seeking treatment: frequency, nocturia, urgency, leakage, hesitancy, straining, or dribbling
- Willing and able to provide informed consent
- Anxious presentation and/or history of anxiety
- English speaking
- Willing to defer usual treatment for urinary problems
Who cannot join
- Blood in the urine, positive urine culture, signs of infection
- Pregnant, or 6 months or less postpartum
- Psychosis, dementia, or other cognitive impairment that would preclude participation
- Recent (within 6 months) pelvic or endoscopic surgery, urethral stricture, pelvic malignancy, current chemotherapy or other cancer therapy, pelvic device or implant complication
- Recent (within 12 months) Botox injection to the bladder or pelvic structures
- Currently in psychotherapy
- Current alcohol or substance use disorder
- Difficulty communicating in English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's emotional health and help to reduce urinary symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are often seen in the urogynecology clinic, which makes this setting ideal for offering additional interventions that may improve their quality of life. Unfortunately, many women with pelvic floor disorders may not receive effective behavioral treatment, such as cognitive behavior therapy, because urogynecologists and other medical professionals may not be aware of providers in their community who offer this treatment. The investigators will enhance treatment options by 1) providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2) offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving clinical outcomes for these patients.
Specific Aims:
- To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms.
- To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy.
- To use mediation analyses to test a possible causal chain of events - Does treatment lead to lower anxiety, which in turn leads to fewer urinary symptoms?
- Conditions
- Pelvic Floor Disorders, Anxiety, Urinary Urgency, Urinary Incontinence, Nocturia, Urinary Frequency/Urgency
- Being tested
- Unified Protocol, Supportive Therapy
- Medical subject headings
- Pelvic Floor Disorders, Anxiety Disorders, Urinary Incontinence, Nocturia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
The unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities.
Supportive TherapyBehavioural
Supportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol | Experimental | This is a type of CBT for emotional distress. Receives: Behavioral: Unified Protocol |
| Supportive Therapy | Active comparator | This is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score
Self-report measure of anxiety symptoms. Min T Score = 40.3; Max T Score = 81.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of anxiety symptoms).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Urinary Distress Inventory (UDI-6)
Self-report measure of urinary symptoms and bother. Scores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the Pelvic Organ Prolapse Distress Inventory (POPDI-6) and Colorectal-Anal Distress Inventory (CRAD-8) to form the Pelvic Floor Distress Inventory (PFDI-20) summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater urinary symptoms and bother).
Measured: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Secondary outcomes (10)
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6)
Self-report measure of pelvic symptoms and bother. Sores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the UDI-6 and CRAD-8 to form the PFDI-20 summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater pelvic symptoms and bother).
Measured: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Colorectal-Anal distress Inventory 8 (CRAD-8)
Self-report measure of colorectal-anal symptoms and bother. Sores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the POPDI-6 and UDI-6 to form the PFDI-20 summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater colorectal-anal symptoms and bother).
Measured: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Depression 4a T Score
Self-report measure of depression symptoms. Min T Score = 41.0; Max T Score = 79.4. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of depressive symptoms).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Physical Function 4a T Score
Self-report measure of physical function. Min T Score = 22.9; Max T Score = 56.9. Raw scores are summed, then converted to T Scores from a lookup table. Lower T scores represent a worse outcome (i.e., worse physical functioning).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Fatigue 4a T Score
Self-report measure of fatigue. Min T Score = 33.7; Max T Score = 75.8. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater fatigue).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Sleep Disturbance 4a T Score
Self-report measure of sleep quality and disturbance. Min T Score = 32.0; Max T Score = 73.3. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater sleep disturbance).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Ability to Participate in Social Roles and Activities 4a T Score
Self-report measure of social role function. Min T Score = 27.5; Max T Score = 64.2. Raw scores are summed, then converted to T Scores from a lookup table. Lower T scores represent a worse outcome (i.e., greater difficulty participating in social roles/activities).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Pain Interference 4a T Score
Self-report measure of pain interference with daily activities. Min T Score = 41.6; Max T Score = 75.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater pain interference).
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
PROMIS Pain Intensity
Self-report measure of average pain intensity. One item 0-10 numeric rating scale. Min score = 0, Max score = 10. Higher score represents worse outcome (i.e., greater pain intensity)
Measured: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient Global Impression of Improvement (PGI-I)
Single item self-report measure of patient perception of improvement in their urinary symptoms compared to before treatment. Rating scale from 1 (very much better) to 7 (very much worse). Lower score represents better outcome (i.e., more improvement).
Measured: This item assess how the patient is "right now" compared to beginning treatment; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start3 Sep 2018
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W Griffith, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623880
- Sponsor's protocol ID
- STU00207124
- Status last verified
- Mar 2023
- First submitted
- 3 Aug 2018
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taple BJ, Griffith JW, Weaver C, Kenton KS. Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2020 Jan 3;17:100514. doi: 10.1016/j.conctc.2019.100514. eCollection 2020 Mar.
PubMed 31956723
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT03623880
- Acronym / sponsor ID
- STU00207124
- Conditions
- Pelvic Floor Disorders, Anxiety, Urinary Urgency, Urinary Incontinence, Nocturia, Urinary Frequency/Urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's emotional health and help to reduce urinary symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are often seen in the urogynecology clinic, which makes this setting ideal for offering additional interventions that may improve their quality of life. Unfortunately, many women with pelvic floor disorders may not receive effective behavioral treatment, such as cognitive behavior therapy, because urogynecologists and other medical professionals may not be aware of providers in their community who offer this treatment. The investigators will enhance treatment options by 1) providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2) offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving clinical outcomes for these patients.
Specific Aims:
- To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms.
- To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy.
- To use mediation analyses to test a possible causal chain of events - Does treatment lead to lower anxiety, which in turn leads to fewer urinary symptoms?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol | Experimental | Behavioral: Unified ProtocolThis is a type of CBT for emotional distress. |
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapyThis is a commonly-used form of all-purpose psychotherapy, often used as a comparator in CBT clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age 18 years or older
- Presence of one or more of the following urinary symptoms in past 12 months and currently seeking treatment: frequency, nocturia, urgency, leakage, hesitancy, straining, or dribbling
- Willing and able to provide informed consent
- Anxious presentation and/or history of anxiety
Key exclusion criteria (8 listed)
- Blood in the urine, positive urine culture, signs of infection
- Pregnant, or 6 months or less postpartum
- Psychosis, dementia, or other cognitive impairment that would preclude participation
- Recent (within 6 months) pelvic or endoscopic surgery, urethral stricture, pelvic malignancy, current chemotherapy or other cancer therapy, pelvic device or implant complication
- Recent (within 12 months) Botox injection to the bladder or pelvic structures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified ProtocolThe unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities. | Behavioural | Unified Protocol |
| Supportive TherapySupportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening. | Behavioural | Supportive Therapy |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Self-report measure of anxiety symptoms. Min T Score = 40.3; Max T Score = 81.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of anxiety symptoms).
Urinary Distress Inventory (UDI-6)
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Self-report measure of urinary symptoms and bother. Scores are scale scores: mean value of items answered multiplied by 25; min scale score = 0; max scale score = 100. This scale score can be combined with the scale scores of the Pelvic Organ Prolapse Distress Inventory (POPDI-6) and Colorectal-Anal Distress Inventory (CRAD-8) to form the Pelvic Floor Distress Inventory (PFDI-20) summary score: add three scale scores together (range 0 to 300). Higher score indicates worse outcome (i.e., greater urinary symptoms and bother).
10 secondary outcomes
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6)
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Colorectal-Anal distress Inventory 8 (CRAD-8)
Time frame: 3 months; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Depression 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Physical Function 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Fatigue 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Sleep Disturbance 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Ability to Participate in Social Roles and Activities 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Pain Interference 4a T Score
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
PROMIS Pain Intensity
Time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Patient Global Impression of Improvement (PGI-I)
Time frame: This item assess how the patient is "right now" compared to beginning treatment; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 31956723Taple BJ, Griffith JW, Weaver C, Kenton KS. Enhancing behavioral treatment for women with pelvic floor disorders: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials Commun. 2020 Jan 3;17:100514. doi: 10.1016/j.conctc.2019.100514. eCollection 2020 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol and Supportive Therapy in people with Pelvic Floor Disorders and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - Profile V2.0: Adult v1.0 - Anxiety 4a T Score (time frame: 1 week; Administered at baseline, mid-treatment (6 weeks), post-treatment (12 weeks), and 3- and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.