NCT07488442

Brief Summary

The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

June 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 18, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Dyssynergic DefecationCognitive Behavioral TherapyPelvic Floor Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Wexner Constipation Score

    first day of treatment and 5th week of treatment

  • Constipation Severity Scale

    first day of treatment and 5th week of treatment

Secondary Outcomes (2)

  • Bristol Stool Chart

    first day of treatment and 5th week of treatment

  • Beck Depression Scale

    first day of treatment and 5th week of treatment

Study Arms (2)

Pelvic floor rehabilitation

ACTIVE COMPARATOR

Patients in the first group will receive education on lifestyle changes, and a rehabilitation program consisting of 15 sessions of relaxation and Kegel exercises-held three days a week at the pelvic floor unit-will be planned.

Other: Pelvic floor rehabilitation

Pelvic floor rehabilitation+cognitive behavioral therapy

EXPERIMENTAL

In addition to these treatments, patients in the second group will receive a total of five sessions of cognitive-behavioral therapy from a certified psychologist specializing in the field, focusing on their current gastrointestinal issues rather than their personal histories.

Behavioral: Pelvic floor rehabilitation+cognitive behavioral therapy

Interventions

Relaxation and kegel exercises and biofeedback therapy

Pelvic floor rehabilitation

Relaxation and kegel exercises, biofeedback therapy and cognitive behavioral therapy

Pelvic floor rehabilitation+cognitive behavioral therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A history of constipation lasting longer than one year
  • Chronic constipation as defined by the Rome IV criteria
  • Being between the ages of 18 and 55
  • Findings consistent with dyssynergic defecation on anorectal manometry and balloon defecography

You may not qualify if:

  • Active bowel disease
  • Presence of an active anal fissure
  • History of major abdominal surgery
  • Presence of a neurological disorder
  • Presence of a serious psychiatric disorder
  • Use of medications that cause constipation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ayşe Naz Kalem Ozgen, specialist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PM&R Specialist

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 23, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

June 17, 2026

Record last verified: 2026-03

Locations